[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prostate-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prostate-cancer":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,797,0,25,[9,48,86,109,136,164,185,220,240,264,286,312,345,366,403,422,445,471,494,516,543,568,587,622,647],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100645567","il-15-superagonist-with-or-without-vaccine-in-biochemically-recurrent-prostate-cancer-after-previous-stereotactic-body-radiation-therapy-100645567",false,"NCT07686380","IL-15 Superagonist With or Without Vaccine in Biochemically Recurrent Prostate Cancer After Previous Stereotactic Body Radiation Therapy","Phase II Trial of IL-15 Superagonist With or Without Vaccine in Biochemically Recurrent Prostate Cancer After Previous Stereotactic Body Radiation Therapy","* INCLUSION CRITERIA:\n* Histopathological confirmation of prostate adenocarcinoma by the Laboratory of Pathology at the National Institutes of Health (NIH) Clinical Center prior to the study treatment initiation. If no pathologic specimen is available, participants may enroll with a pathologist s report showing a histologic diagnosis of prostate adenocarcinoma and a clinical course consistent with the disease from any outside site.\n* Biochemically recurrent prostate cancer, defined as PSA over 0.8 ng\u002Fml following radical prostatectomy or \\>= 2 ng\u002Fml above the nadir following definitive radiotherapy or definitive radiotherapy (including brachytherapy) for localized prostate cancer.\n* Participants must be at least 1 year removed from definitive local therapy before the study treatment initiation.\n* Recovery to baseline from acute toxicity related to prior therapy, including surgery and radiation.\n* Hepatic function eligibility parameters: Bilirubin (total and direct) \\\u003C= upper limit of normal (ULN) (OR in participants with Gilbert s syndrome, a total bilirubin \\\u003C= 3.0), aspartate transaminase (AST) and alanine transaminase (ALT) \\\u003C= 1.5 times upper limit of normal.\n* Adequate renal function defined by a calculated creatinine clearance \\> 50 mL\u002Fmin according to the Cockcroft-Gault formula or by measure of creatinine clearance from 24-hour urine collection.\n* ECOG performance score 0-1.\n* No other active malignancies within the 36 months prior to the study treatment initiation (with the exception of nonmelanoma skin cancers or carcinoma in situ of the bladder).\n* 18 years of age or older.\n* Individuals must agree to use effective contraception (barrier, vasectomy and\u002For abstinence) for the duration of study therapy and for four months after the last treatment administration. Individuals with partners with birthing potential will be recommended that their partner use a highly effective contraception (includes use of oral, injected or implanted hormonal methods of contraception, placement of certain intrauterine devices (IUD) or intrauterine systems (IUS), hysterectomy, oophorectomy, salpingectomy.\n* Individuals must agree to not donate sperm during the restricted period (for the duration of study therapy and for four months after the last dose of study treatment).\n* Negative CT scan\u002F Magnetic resonance imaging (MRI) for evidence of soft tissue metastasis (visceral or lymph node).\n* Negative Tc99 for evidence of bone disease.\n* Participants must have had prior SBRT to PSMA+ findings beyond the prostate and have had a documented 25% or more PSA rise from post-SBRT nadir\n* Baseline testosterone \\>= 100 ng\u002Fdl.\n* Hematological parameters:\n\n  * Granulocyte count \\>= 1000\u002Fmm\\^3\n  * Platelet count \\>= 100000\u002Fmm\\^3\n  * Hemoglobin (Hgb) \\>= 10 g\u002FdL\n* Participants must be able to understand and willing to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Immunocompromised status due to:\n\n  * Human immunodeficiency virus (HIV) seropositivity\n  * HBV or HCV seropositivity\n  * Other immunodeficiency diseases\n* Active autoimmune diseases such as Addison's disease, Hashimoto's thyroiditis, systemic lupus erythematosus, Sjogren syndrome, scleroderma, myasthenia gravis, Goodpasture syndrome or active Grave's disease. Participants with a history of autoimmunity that has not required systemic immunosuppressive therapy or does not threaten vital organ function including central nervous system (CNS), heart, lungs, kidneys, skin, and gastrointestinal (GI) tract will be allowed. Participants with diabetes type I, vitiligo, or alopecia are allowed.\n* Receipt of any organ transplantation, including allogeneic stem-cell transplantation, but with the exception of transplants that do not require immunosuppression (e.g., corneal transplant, hair transplant).\n* Chronic administration (defined as daily or every other day for continued use \\> 14 days) of systemic corticosteroids within 28 days before the study treatment initiation. Note: Use of corticosteroids with minimal systemic absorption (e.g., inhaled steroids, nasal sprays, and topical agents) is allowed.\n* Other medications used for urinary symptoms including 5-alpha reductase inhibitors (finasteride and dutasteride) and alternative medications known to alter PSA (e.g., phytoestrogens and saw palmetto) within 28 days prior to the study treatment initiation.\n* Major surgery within 28 days prior to study treatment initiation.\n* Systemic therapy, including any investigational therapy within 28 days prior to the study treatment initiation.\n* Radiation therapy within 14 days prior to the study treatment initiation.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drugs.\n* Clinically significant cardiovascular\u002Fcerebrovascular disease as follows: cerebral vascular accident\u002Fstroke (\\\u003C 6 months prior to the first planned dose of study drugs), myocardial infarction (\\\u003C 6 months prior to the first planned dose of study drugs), or any of the following at time of enrollment: unstable angina, congestive heart failure (New York Heart Association Classification Class \\>= II), serious cardiac arrhythmia, or uncontrolled hypertension (SBP\\>170\u002F DBP\\>105).\n* Serious intercurrent medical illness evaluated by medical history and physical exam that would interfere with participant's ability to carry out the treatment program.","MALE","18 Years","120 Years",{"count":21,"type":22},65,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","Background:\n\nBiochemically recurrent prostate cancer (BCR) occurs when prostate-specific antigen (PSA) levels in the blood rise after surgery or radiation. BCR affects 30,000 to 50,000 men each year. Researchers want to know if a drug (N-803) alone or combined with a vaccine (ETBX-071) can reduce PSA in BCR prostate cancer after radiation.\n\nObjective:\n\nTo test a study drug alone and combined with a vaccine in people with BCR prostate cancer who have been treated with targeted radiation to areas of recurrent prostate cancer in the past.\n\nEligibility:\n\nPeople aged 18 years and older with BCR prostate cancer who have previously undergone treatment with stereotactic body radiation therapy (SBRT).\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood tests. They will have tests of their heart and kidney function. They will have 3 different imaging scans of their tumors.\n\nN-803 is injected under the skin of the abdomen. ETBX-071 is injected under the skin of thigh.\n\nParticipants will be divided into 2 groups: 1 group will get N-803 alone; 1 group will get both N-803 and ETBX-071.\n\nThe drug or drugs will be given on the first day of 21-day treatment cycles. Participants will have 8 treatment cycles.\n\nParticipants will have a follow-up visit 3 weeks after their last dose of the study drugs. Blood tests and all 3 imaging scans will be repeated.\n\nFollow-up visits will continue every 4 to 8 weeks for 5 years. These visits will include a positron emission tomography (PET) scan every 6 months.",[28,29],"Recurrent Prostate Cancer","Prostate Cancer",[28,31,32,33,34],"IL-15 Superagonist","N-803","ETBX-071","PSA Vaccine","NOT_YET_RECRUITING","2026-08-20",{"date":38,"type":39},"2026-08-21","ACTUAL",{"date":41,"type":22},"2026-08-26",{"date":43,"type":22},"2029-01-30",{"name":45,"class":46},"National Cancer Institute (NCI)","NIH",1,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":55,"minAge":18,"maxAge":19,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":60,"conditions":61,"keywords":73,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":81,"startDateStruct":82,"completionDateStruct":83,"leadSponsor":85,"locationsCount":47},"100643883","docetaxel-and-sx-682-in-recurrentmetastatic-head-and-neck-squamous-cell-carcinoma-salivary-gland-carcinoma-and-advanced-prostate-cancer-100643883","NCT07667400","Docetaxel and SX-682 in Recurrent\u002FMetastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer","Phase I\u002FII Trial of Docetaxel and SX-682 in Recurrent\u002FMetastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer","* INCLUSION CRITERIA:\n\nAll Participants\n\n* Age \\>= 18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) \\\u003C= 2\n* Participants must have adequate organ and marrow function as defined below:\n\n  * ANC \\>= 1,500\u002FmcL\n  * Hemoglobin (Hgb) \\>= 9 g\u002FdL\n  * Platelets (PLTs) \\>= 100,000\u002FmcL\n  * Creatinine clearance \\>= 50 mL\u002Fmin (by Cockroft-Gault formula)\n  * Total bilirubin \\\u003C= 1.5 x iULN (\\\u003C= 3 x ULN in participants with known\u002Fsuspected Gilbert s disease)\n  * ALT\u002FAST \\\u003C= 2.5 x iULN\n  * Activated partial thromboplastin time (aPTT) \\\u003C= 1.5 x iULN\n* Contraception as follows:\n* Women of child-bearing potential (WOCBP) must agree to use an effective method of contraception (barrier, hormonal, intrauterine device \\[IUD\\], surgical sterilization, abstinence) prior to study entry, for the duration of study treatment, and for up to 2 months after discontinuation of the study drugs. A participant may request a male partner to use an effective form of contraception to fulfill this requirement.\n* Men able to father a child must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and up to 4 months after discontinuation of the study drugs. A participant may request a female partner to use an effective form of contraception to fulfill this requirement. Men able to father a child must not freeze or donate sperm within the same period.\n* Nursing participants must be willing to discontinue nursing from study treatment initiation through one week after the last dose of study drugs.\n* Participants must be able to swallow oral medications.\n* Human immunodeficiency virus (HIV)-infected participants must have undetectable viral load (VL) and be on effective anti-retroviral therapy within 4 weeks prior to the study treatment initiation and have no history of opportunistic infections or Castleman s disease within 12 months prior to the study treatment initiation.\n* Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV VL.\n* Participants with evidence of chronic hepatitis C virus (HCV) infection must have undetectable HCV VL.\n* Participants must be able to understand and willing to sign a written informed consent document.\n\nParticipants with HNC\n\n* Histologically confirmed HNSCC (including oral cavity, oropharynx, larynx, hypopharynx, paranasal sinuses, nasopharynx) or SGC (including ACC and non-ACC) and recurrent\u002Fmetastatic (R\u002FM) or advanced incurable disease.\n* Prior treatment as follows:\n\n  * Participants with R\u002FM HNSCC must have prior systemic treatment (platinum-based chemotherapy and\u002For anti-PD(L)1 treatment).\n  * Participants with R\u002FM SGC may have any number of prior systemic treatment lines; prior systemic treatment not required for participation.\n  * Participants must not have received systemic anticancer treatment within 3 weeks prior to first treatment administration. Note: Treatment-related toxicities must have resolved to Grade \\\u003C2 or be minimal and not constitute a safety risk. Participants with SGC previously treated with hormonal therapies (e.g., drugs targeting the androgen receptor) may continue these drugs concomitantly with study therapy. Participants with bone metastases or hypercalcemia on intravenous bisphosphonate medications, denosumab, or similar agents, are eligible to participate and may continue this treatment.\n* Presence of \\>= 1 measurable lesion by RECIST v 1.1 criteria.\n\nParticipants with mCRPC\n\n* Documented histopathological confirmation of prostate cancer. If no pathologic report or specimen is available, participants may enroll with a history of clinical course consistent with the disease.\n* Participants must have mCRPC, defined as at least one lesion on TC-99 bone scan or at least one lesion that is measurable per RECIST 1.1.\n* Participants must need ADT as part of their cancer therapy (unless previous orchiectomy)\n* Castrate testosterone level (\\\u003C50 ng\u002Fdl or 1.7 nmol\u002FL)\n* Prior treatment as follows:\n\n  * DTX for mCRPC is allowed but participants must not have had progression while on docetaxel or within 3 months after completing DTX for mCRPC\n  * Participants must have been previously treated with modern anti-androgens such as abiraterone, enzalutamide, apalutamide, or darolutamide.\n* Progression defined as two consecutive rising PSA values at least 1 week apart or radiographic evidence of progression seen on computed tomography (CT) scan or TC- 99 bone scan.\n* Toxicities related to prior therapy, including surgery and\u002For radiation, must have resolved to \\\u003C Grade 1 per CTCAE v.6.0.\n\nEXCLUSION CRITERIA:\n\nAll participants\n\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to DTX, SX-682, or other agents used in study (e.g., polysorbate 80).\n* Known active brain metastases. Note: Participants with previously treated brain metastases are eligible if imaging at least four weeks prior to first trial treatment shows no evidence of progression and neurologic symptoms have resolved, have no new or enlarging brain metastases, and are not using glucocorticoids for at least a week prior to first trial treatment\n* Participants must not have received other investigational agents within 3 weeks prior to the first dose of the study drug(s).\n* Participants must not have received major surgery within 14 days prior to the first drug administration (minimally invasive procedures such as diagnostic biopsies are permitted). If participant underwent major surgery, they must have recovered adequately (according to the Principal Investigator) from the toxicity and\u002For complications from the intervention prior to starting study treatment.\n* Treatment (systemic) with any medications or substances that are moderate or strong inducers or moderate or strong inhibitors of cytochrome P450 (CYP3A4) listed at https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-interactions-labeling\u002Fdrug-development-and-druginteractions- table-substrates-inhibitors-and-inducers#table2-2,table3-3,table5-2 within 2 weeks or 5 half-lives (whichever is shorter) prior to the start of the study treatment.\n* Prior or concurrent malignancy whose natural history or treatment has potential to interfere with the safety or efficacy assessment of the study treatment.\n* Participants with serious uncontrolled intercurrent illness evaluated by medical history, electrocardiogram (EKG), and physical exam that would unacceptably increase risk for the participant or impair the ability to evaluate the endpoints of the study or that would limit compliance with study requirements.\n\nParticipants with HNC\n\n* Participants must not have received large-field radiotherapy within 2 weeks prior to first treatment administration. All residual treatment-related toxicities must have resolved to Grade \\\u003C2 (except for radiation-induced xerostomia\u002Fdysgeusia) or be minimal and not constitute a safety risk.\n* Positive pregnancy serum or urine beta-human chorionic gonadotropin (beta-hCG) test\n\nParticipants with mCRPC\n\n* Use of other medications for urinary symptoms including 5-alpha reductase inhibitors (finasteride and dutasteride) and alternative medications known to alter PSA (e.g., phytoestrogens and saw palmetto) within 1 week prior to the study treatment initiation.\n* Cancer related neuropathy at screening\n* Baseline QTcF \\>= 470 ms","ALL",{"count":57,"type":22},120,[59,25],"PHASE1","Background:\n\nHead and neck cancers (HNCs) account for about 5% of all cancers worldwide. They grow in the mouth, throat, nasal cavity, or salivary glands. Prostate cancer is the most common cancer in men in the United States. Survival rates for these cancers are lower than 50% if they spread to other parts of the body or return after treatment. Better treatments are needed.\n\nObjective:\n\nTo test a new drug (SX-682), combined with an approved drug (docetaxel, or DTX), in people with HNCs or prostate cancer.\n\nEligibility\n\nPeople aged 18 years and older with an HNC or prostate cancer that has returned after treatment or has spread.\n\nDesign:\n\nParticipants will be screened. They will have blood tests, imaging scans, and a test of their heart function. A tissue sample (biopsy) of the tumor may be taken.\n\nParticipants will take the study drugs in 3-week cycles. SX-682 is a tablet taken by mouth twice a day from Days 1 to 11 of each cycle. Participants will get a supply of the drug to take home. DTX is given on Day 8 of each cycle through a tube attached to a needle inserted into a vein in the arm. Participants will come to the clinic on Days 1 and 8 of every cycle. They will take both drugs for up to 6 cycles.\n\nParticipants will have follow-up visits 1 week and 1 month after they finish taking the drugs. Follow-ups will continue every 3 months for 2 years. Then they will have phone or email check-ins twice a year until 5 years have passed.",[62,63,64,65,66,67,68,69,70,71,29,72],"Head and Neck Cancer","Head and Neck Squamous Cell Carcinoma","Paranasal Sinus Neoplasms","Nasopharyngeal Carcinoma","Oropharyngeal Squamous Cell Carcinoma","Hypopharyngeal Cancer","Carcinoma of Larynx","Oral Squamous Cell Carcinoma","Salivary Gland Cancer","Adenoid Cystic Carcinoma","Metastatic Castration Resistant Prostate Cancer",[74,75,76,77,78,79,80],"Solid Tumors","Infusion","Chemotherapy","Carcinoma","Head and Neck","Prostate","molecule inhibitor",{"date":38,"type":39},{"date":41,"type":22},{"date":84,"type":22},"2037-10-01",{"name":45,"class":46},{"id":87,"slug":88,"hasResults":12,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":93,"targetDuration":4,"studyType":23,"phases":95,"briefSummary":96,"conditions":97,"keywords":102,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":104,"startDateStruct":105,"completionDateStruct":106,"leadSponsor":108,"locationsCount":47},"100641793","multitargeted-recombinant-ad5-psamuc-1brachyury-based-immunotherapy-triadeno-vaccine-with-il-15-superagonist-n-803-in-participants-with-clinically-localized-prostate-cancer-undergoing-active-surveillance-100641793","NCT07574541","Multitargeted Recombinant Ad5 PSA\u002FMUC-1\u002FBrachyury-Based Immunotherapy (TriAdeno) Vaccine With IL-15 Superagonist N-803 in Participants With Clinically Localized Prostate Cancer Undergoing Active Surveillance","Phase II Trial of a Multitargeted Recombinant Ad5 PSA\u002FMUC-1\u002FBrachyury-based Immunotherapy (TriAdeno) Vaccine With IL-15 Superagonist N-803 in Participants With Clinically Localized Prostate Cancer Undergoing Active Surveillance","* INCLUSION CRITERIA:\n* Histologically confirmed diagnosis of organ confined, low- or intermediate-risk PCa (Gleason grade group 1 or 2) identified in at least one prostate biopsy core. Biopsies performed at outside institutions should have Gleason score confirmed at the NCI by a genitourinary (GU) pathologist.\n* Participants must be on active surveillance.\n* Pre-study treatment tissue availability (at least one formalin-fixed paraffin embedded \\[FFPE\\] biopsy core or one H and E-stained slide and at least 5 unstained slides) obtained between 3 and 24 months prior to treatment initiation is mandatory for study initiation.\n* Serum PSA level of \\\u003C20 ng\u002FmL (or \\\u003C10ng\u002FmL for participants being treated with 5- alpha-reductase inhibitors)\n* Clinical stage \\\u003C=T2a by digital rectal exam (DRE)\n* Age \\>=18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C=1.\n* Adequate organ and marrow function as defined below:\n\n  * Absolute neutrophil count (ANC) \\>=1.0 x 109\u002FL\n  * Hemoglobin (Hgb) \\>=9 g\u002FdL\n  * Platelets \\>=75,000\u002FmcL\n  * Prothrombin International Normalized Ratio (INR) \\\u003C1.5 x upper limit of normal (ULN)\n  * Partial thromboplastin time (PTT) \\\u003C1.5 x ULN\n  * Total bilirubin \\\u003C1.5 x ULN\n  * Aspartate aminotransferase (AST) \\\u003C=2.5 x ULN\n  * Alanine aminotransferase (ALT) \\\u003C=2.5 x ULN\n  * Creatinine \\\u003C=1.5 x ULN\n\nOR\n\n--Calculated Creatinine clearance \\>=40 mL\u002Fmin\u002F1.73 m2 for individuals with creatinine levels above institutional normal (using either Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] equation)\n\n* Treatment with steroid therapy must have a washout of at least 6 weeks prior to initiation of study treatment. Physiologic (replacement) doses of steroids as well as nasal, topical, or inhaled steroids are allowed.\n* Vaccination with a live (attenuated) vaccine (e.g., FluMist(R)) or a killed (inactivated)\u002Fsubunit vaccine (e.g., PNEUMOVAX(R), Fluzone(R)) must occur not sooner than 28 days or 14 days, respectively, prior to initiation of study treatment.\n* Participants must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and up to one (1) month after the last vaccine injection. We also will recommend participants with female partners of childbearing potential to ask them to be on highly effective birth control (hormonal, intrauterine device \\[IUD\\], surgical sterilization). Participants must not freeze or donate sperm within the same period.\n* Participants must be able to understand and willing to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Prior treatment for PCa by surgery, radiation, local ablative (i.e., cryosurgery or highintensity focused ultrasound), or androgen-deprivation therapy.\n* Evidence of PCa with metastatic disease.\n* Prior treatment with adenovirus-based vector immunotherapy, adenovirus-based vaccines, or investigational vaccines.\n* Prior solid organ or bone marrow transplant.\n* Immunodeficiency or splenectomy.\n* Presence of a known active acute or chronic infection, including human immunodeficiency virus (HIV), confirmed by PCR, and hepatitis B virus (HBV) and hepatitis C virus (HCV), as determined by hepatitis B surface antigen (HBsAg) and HCV serology.\n* History of autoimmune disease (active or past), except for autoimmune-related thyroid disease, type I diabetes, and vitiligo if the condition(s) is well controlled.\n* History of heart disease, such as congestive heart failure (class II, III, or IV defined by the New York Heart Association functional classification), history of unstable or poorly\n\ncontrolled angina, or history (\\\u003C1 year prior to initiation of study therapy) of ventricular arrhythmia.\n\n* Acute or chronic skin disorders that will interfere with injection into the skin of the extremities or subsequent assessment of potential skin reactions.\n* Second malignancy within 3 years prior to initiation of study therapy. Note: Individuals with curatively treated non-melanoma skin cancers or non-muscle invasive bladder cancer will not be excluded.\n* History of herbal products that may decrease PSA levels (e.g., saw palmetto).\n* Participants who have undergone surgery within 4 weeks prior to initiation of study therapy.\n* Participants receiving any other investigational agents within 30 days prior to initiation of study therapy.\n* History of allergic reaction attributed to compounds of similar chemical or biological composition to the study drugs.\n* Uncontrolled intercurrent illness that would limit compliance with study requirements suggested by medical history, physical examination, or standard clinical assessments such as imaging, EKG, and laboratory studies.",{"count":94,"type":22},52,[25],"Background:\n\nProstate cancer is the second most common cause of cancer-related death among men in the United States. Early-stage, low-grade prostate cancer is managed with active monitoring. However, 35% of men with this cancer will need treatment within 5 years because of tumor growth. Researchers want to know if a new vaccine that targets 3 anti-cancer proteins (TriAdeno) plus a drug (N-803) approved for bladder cancer can help stop prostate tumors from growing.\n\nObjective:\n\nTo test TriAdeno and N-803 in people with early-stage prostate cancer.\n\nEligibility:\n\nPeople aged 18 years and older with early-stage low- or medium-risk prostate cancer.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood tests. They will have a test of their heart function. They will have an imaging scan. They may have a rectal exam.\n\nTriAdeno is injected under the skin of the upper thigh; N-803 is injected under the skin of the abdomen. Participants will be treated in up to four 21-day cycles. They will get both injections on the first day of each cycle.\n\nParticipants may opt to complete a memory aid: They may record all of their symptoms for 7 days after each injection. They may also complete a questionnaire about their prostate symptoms.\n\nBlood tests, imaging scans, and other tests will be repeated during the study.\n\nA tissue sample (biopsy) of the tumor will be collected during or after cycle 2; a second biopsy may be taken about 1 year later.\n\nParticipants will have follow-up phone calls for 5 years....",[98,29,99,77,100,101],"Adenocarcinoma","Neoplasms","Neoplasms, Glandular and Epithelial","Neoplasms by Histologic Type",[103],"Immune Infiltration",{"date":38,"type":39},{"date":41,"type":22},{"date":107,"type":22},"2028-06-15",{"name":45,"class":46},{"id":110,"slug":111,"hasResults":12,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":23,"phases":118,"briefSummary":119,"conditions":120,"keywords":123,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":127,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":135},"100593339","phase-2-a-phase-2-study-to-evaluate-the-effects-of-asp5541-in-participants-with-prostate-cancer-100593339","NCT07005154","A Phase 2 Study to Evaluate the Effects of ASP5541 in Participants With Prostate Cancer","A Phase 2, Open-label, Multi-cohort Study to Assess the Efficacy and Safety of ASP5541 in Participants With Advanced Prostate Cancer","Inclusion Criteria:\n\n* Participant is diagnosed with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features.\n* Participant has ECOG performance status of 0 or 1, or ECOG performance status of 2 if due to bone pain.\n* Participant must have an estimated life expectancy of ≥ 12 months with mHSPC or ≥ 6 months with mCRPC.\n* Participant is able to understand and comply with all study requirements and procedures.\n* Participant has been diagnosed with mCRPC or mHSPC documented by metastatic lesions on a bone scan, computed tomography (CT), magnetic resonance imaging (MRI) or prostate-specific membrane antigen positron emission tomography (PSMA-PET).\n* Participant is receiving ongoing ADT with a gonadotropin-releasing hormone (GnRH) analogue or has a history of bilateral orchiectomy (i.e., surgical or medical castration). Participant with mHSPC must have started castration therapy (medical or surgical) at least 14 days prior to Cycle 1 Day 1 (C1D1).\n\nNote: Participant who has not had a bilateral orchiectomy must have a plan to maintain effective GnRH analogue therapy for the duration of the study.\n\n* If the participant has mCRPC, participant has evidence of disease progression defined as 1 or more of the following criteria at study entry:\n\n  * Evidence of radiographic progression of disease prior to first dose and following the most recent prostate cancer treatment, defined as progressive disease on CT\u002FMRI per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 or on a bone scan per PCWG3.\n  * PSA progression defined as an increase in PSA of at least 25% and ≥ 1 ng\u002FmL above the nadir, confirmed by a second value 1 week later, and with at least 1 of the measurements within 90 days prior to screening. PSA nadir is defined as the lowest PSA during or after the most recent treatment.\n* If the participant has mCRPC, participant has a serum testosterone level \\\u003C 1.73 nmol\u002FL (\\\u003C 50 ng\u002FdL) at the Screening visit.\n* Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 7 months after final ASP5541 administration.\n* Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 7 months after final ASP5541 administration.\n* Male participant must not donate sperm during the treatment period and for 7 months after final ASP5541 administration.\n* Participant agrees not to participate in another interventional study while receiving ASP5541 in the present study.\n* Participant should have normal serum potassium (within the local laboratory normal range) at screening without supplementation.\n\nExclusion Criteria:\n\n* Participant has any concurrent disease, infection or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data.\n* Participant has known active central nervous system (CNS) metastases. Note: Participant with CNS metastases who has been treated with surgery and\u002For radiation therapy, who is off pharmacologic doses of glucocorticoids and who is neurologically stable is eligible.\n* Participant has a known additional malignancy beyond prostate cancer that requires active treatment with the exception of any of the following:\n\n  * Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ carcinoma of any type\n  * Adequately treated Stage I cancer from which the participant is currently in remission and has been in remission for ≥ 2 years\n  * Any other cancer from which the participant has been disease-free for ≥5 years\n* Participant has clinically significant cardiac disease, defined as any of the following:\n\n  * Clinically significant cardiac arrhythmias including bradyarrhythmia which are poorly controlled. Rate-controlled atrial fibrillation is permitted.\n  * Congenital long QT syndrome.\n  * QT interval corrected by Fridericia's formula (QTcF) ≥450 msec at Screening. If the QT interval corrected for heart rate intervals (QTc) is prolonged in a participant with a pacemaker or bundle branch block, the participant may be enrolled in the study if confirmed by the medical monitor.\n  * History of clinically significant cardiac disease or congestive heart failure greater than New York Heart Association (NYHA) Class II or left ventricular ejection fraction measurement of \\\u003C 50% at baseline.\n  * Cohorts 1 and 3: Participant must not have unstable angina (symptoms at rest) or new-onset angina within the last 3 months or myocardial infarction within the past 6 months.\n  * Cohort 2: Participants must not have symptomatic heart failure, unstable or new-onset angina or myocardial infarction within the past 12 months.\n  * Cohorts 1 and 3: Uncontrolled hypertension, defined as systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg that has been confirmed by 2 successive measurements despite optimal medical management.\n  * Cohort 2: Uncontrolled hypertension, defined as systolic BP \\> 140 mmHg or diastolic BP \\> 90 mmHg that has been confirmed by 2 successive measurements despite optimal medical management. Participants may be receiving a maximum of 2 antihypertensives that were initiated at least 3 months prior to Cycle 1 Day 1.\n  * Cohort 1 and 3: Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within the 3 months before start of study medication (except for adequately treated catheter related venous thrombosis occurring \\> 1 month before Cycle 1 Day 1).\n  * Cohort 2: Arterial thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks) within the last 12 months.\n* Participant has any unresolved National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) (version 5.0) Grade \\> 2 toxicity at the Screening visit. Note: Participant receiving ongoing hormone replacement therapy for endocrine immune-related AEs without clinical symptoms will not be excluded.\n* Participant has had major surgery (e.g., requiring general anesthesia) within 30 days before screening, or has not fully recovered from surgery, or has major surgery planned during the time the participant is expected to participate in the study.\n* Participant has\u002Fhad febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 28 days prior to day 1.\n* Participant received a blood transfusion within 1 month of the first dose of study intervention.\n* Participant has a history of impaired pituitary or adrenal gland function (e.g., Addison's disease, Cushing's syndrome).\n* Participant has hemoglobin A1c (HbA1c) \\> 10% (if diabetes mellitus was previously diagnosed) or HbA1c \\> 8% (if diabetes mellitus was previously undiagnosed). (Excluded participant may be rescreened after referral and evidence of improved control of their condition.)\n* Participant has jaundice or known current active liver disease from any cause, including hepatitis A (hepatitis A virus IgM positive, but testing for hepatitis A in screening is not required), hepatitis B (hepatitis B virus surface antigen positive, confirmed by hepatitis B virus DNA), or hepatitis C (hepatitis C virus antibody positive, confirmed by hepatitis C virus RNA).\n* Participant has moderate or severe hepatic impairment (Child-Pugh Class B or C).\n* Participant has a known history of human immunodeficiency virus (HIV) infection (HIV antibody positive).\n* Participant has a body mass index \\> 40 kg\u002Fm2.\n* Participant has a history of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition criteria within 2 years before screening.\n* Participant received treatment with glucocorticoids greater than the equivalent of 10 mg per day of prednisone within 4 weeks prior to C1D1. The use of topical, intraocular, inhalational, intranasal or intra-articular glucocorticoids is permitted.\n* Participant received treatment with herbal medications with known anti-cancer properties or known effects on prostate physiology within 4 weeks prior to Cycle 1 Day 1 (e.g., saw palmetto, St. John's wort, turmeric\u002Fcurcumin). Participants must agree not to use herbal products during study participation.\n* Participant is receiving current treatment with systemic ketoconazole, abiraterone acetate (AA) or any other cytochrome P450 17A1 (CYP17) inhibitor. Participant who has received systemic ketoconazole, AA or any other CYP17 inhibitor must have discontinued these agents ≥ 4 weeks prior to the first dose of study intervention.\n* Participant received prior systemic treatment with a strong inducer or inhibitor of cytochrome p450 3A4 (CYP3A4) within 4 weeks of first dose of study intervention. Concomitant use of strong inducers or inhibitors of CYP3A4 are not permitted on study.\n* Participant requires use of biotin (i.e., vitamin B7) or supplements containing biotin higher than the daily adequate intake of 30 μg. Note: Participant who switches from a high dose to a dose of 30 μg\u002Fday or less prior to first dose of study drug is eligible for study entry.\n* Participant is required to use any prohibited medication on the List of Excluded Concomitant Medications.\n* For mCRPC participants only: Participant has been treated with any of the following for prostate cancer, during the indicated time frame prior to enrollment:\n\n  * Hormonal therapy (e.g., androgen receptor blockers \\[AR\\] antagonists, second-generation androgen receptor pathway inhibitors \\[including enzalutamide, apalutamide, darolutamide, rezvilutamide and AA\\], 5-alpha reductase inhibitors, estrogens, cyproterone acetate) within 4 weeks of C1D1. Note: Participant has been treated with bicalutamide within 6 weeks prior to enrollment is not permitted. Participant has been treated with all other GnRH analogues or antagonists is permitted.\n  * Chemotherapy within 2 weeks or 5 half-lives of C1D1 (whichever is longer)\n  * Biologic therapy within 4 weeks of C1D1\n  * Immunotherapy within 4 weeks of C1D1\n  * Radiation therapy (includes radioligands) within 4 weeks of C1D1\n* For mHSPC participants only: Participant has received any prior pharmacotherapy, radiation therapy or surgery for metastatic prostate cancer (the following exceptions are permitted):\n\n  * Up to 4 months of ADT with GnRH agonists or antagonists or orchiectomy (within 3 months prior to C1D1) with or without concurrent antiandrogens.\n  * Participant may have 1 course of palliative radiation or surgical therapy to treat symptoms resulting from metastatic disease if it was administered at least 4 weeks prior to C1D1.\n  * Up to 6 cycles of docetaxel therapy, with the last dose of docetaxel ≤ 2 months prior to C1D1. A participant who has received docetaxel should have maintained a response to docetaxel of stable disease or better, by imaging and PSA, prior to C1D1.\n  * Up to 6 months of ADT with GnRH agonists or antagonists or orchiectomy with or without concurrent antiandrogens prior to C1D1 if subject was treated with docetaxel, with no radiographic evidence of disease progression or rising PSA levels prior to C1D1.\n* Participant has received any investigational therapy within 4 weeks or 5 half-lives (whichever is longer) prior to C1D1.\n* Participant has received ASP5541 previously.\n* Participant has absolute neutrophil count \\\u003C 1500\u002FμL, platelet count \\\u003C 100000\u002FμL or hemoglobin \\\u003C 9 g\u002FdL (6.2 mmol\u002FL) or international normalized ratio (INR) ≥ 1.5 (unless participant is taking oral anticoagulants in which case INR ≤ 2.0 is permitted) at Screening. Note: Participant may not have received any growth factors within 7 days or blood transfusions within 28 days prior to the hematology values obtained at Screening.\n* Participant has serum total bilirubin \\> 1.5 x upper limit of normal (ULN) (or \\> 3 x ULN for participants with documented Gilbert's disease), or serum alanine aminotransferase or aspartate aminotransferase \\> 2.5 x ULN at Screening.\n* Participant does not have adequate renal function defined as a calculated creatinine clearance \\\u003C 30 mL\u002Fmin as determined by a validated algorithm for calculating creatinine clearance.\n* Participant has serum albumin \\\u003C 3.0 g\u002FdL (30 g\u002FL) at Screening.\n* Participant has a known or suspected hypersensitivity to ASP5541, prednisone, or any components of the formulations used.\n* Participant has a gastrointestinal disorder affecting absorption.",{"count":117,"type":22},218,[25],"Hormone therapy, or androgen deprivation therapy (ADT) is a standard way to treat prostate cancer. It works by reducing the amount of the main male sex hormone, testosterone in the body. Androgen receptor pathway inhibitors (ARPIs) are another type of hormone therapy. They either slow down how much testosterone is made or block testosterone from reaching the prostate cancer cells. Abiraterone acetate (AA) is an ARPI that is used to treat advanced prostate cancer. This type of treatment is usually given as a tablet with a steroid called prednisone\u002Fprednisolone to manage any medical problems from the hormone therapy.\n\nASP5541 is a different form of abiraterone acetate. It is given as an injection into the muscle. In this study, ASP5541 will be given to men with advanced prostate cancer, both with and without prednisone\u002Fprednisolone. This study will check the safety of ASP5541 and compare how well ASP5541 works in men with advanced prostate cancer compared to abiraterone acetate.\n\nThe main aims of the study are:\n\n* To check how well ASP5541 with prednisone\u002Fprednisolone works compared to AA with prednisone\u002Fprednisolone in men with advanced prostate cancer who haven't previously been treated with an ARPI.\n* To check the safety of ASP5541 given by itself in men with advanced prostate cancer that haven't previously been treated with an ARPI.\n* To check how well ASP5541 given by itself works compared to AA with prednisone\u002Fprednisolone in men with advanced prostate cancer that haven't previously been treated with an ARPI.\n* To check the safety of ASP5541 with prednisone\u002Fprednisolone in Japanese men with advanced prostate cancer.\n\nAdult men with a certain type of advanced prostate cancer can take part. Their cancer has spread to other parts of the body (metastatic). The different types are:\n\n* Metastatic hormone-sensitive prostate cancer (mHSPC). Prostate cancer that needs testosterone to grow.\n* Metastatic castration-resistant prostate cancer (mCRPC). Prostate cancer that continues to grow even when testosterone levels are low.\n\nIn this study there will be 3 treatment groups:\n\n* In Group 1, men with mCRPC who haven't previously been treated with an androgen receptor pathway inhibitor will either be given ASP5541 and prednisone\u002Fprednisolone or be given abiraterone acetate and prednisone\u002Fprednisolone.\n* In Group 2, men with mHSPC who haven't previously been treated with an androgen receptor pathway inhibitor will either be given ASP5541 by itself or be given abiraterone acetate with prednisone\u002Fprednisolone.\n* In Group 3, Japanese men with mCRPC or mHSPC who may or may not have previously been treated with an androgen receptor pathway inhibitor will be given ASP5541 with prednisone\u002Fprednisolone.\n\nASP5541 will be given as an injection into a muscle every 12 weeks. Men with mCRPC will take prednisone\u002Fprednisolone twice daily and men with mHSPC will take prednisone\u002Fprednisolone once daily. Abiraterone acetate will be given as tablets to be taken once daily. All groups will also receive the standard of care treatment, such as androgen deprivation therapy.\n\nThe men in the study will visit their clinic regularly during and after treatment for health checks, including checking for any medical problems. Some men (Group 2) will check their blood pressure weekly at home. On some visits they will also have scans to check for any changes in their cancer. The number of visits and type of safety checks done at each visit will depend on the health of each person and when they completed their treatment.",[29,121,122],"Metastatic Castration-Resistant Prostate Cancer","Metastatic Hormone Sensitive Prostate Cancer",[124,125],"ASP5541","PRL-02","RECRUITING",{"date":38,"type":39},{"date":129,"type":39},"2025-08-19",{"date":131,"type":22},"2032-05-31",{"name":133,"class":134},"Astellas Pharma Global Development, Inc.","INDUSTRY",53,{"id":137,"slug":138,"hasResults":12,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":23,"phases":146,"briefSummary":148,"conditions":149,"keywords":150,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":156,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":163},"100589314","phase-3-a-study-of-metastases-free-survival-with-saruparib-vs-placebo-added-to-a-standard-rtadt-in-men-with-high-risk-prostate-cancer-with-a-brca-mutation-100589314","NCT06952803","A Study of Metastases Free Survival With Saruparib vs Placebo Added to a Standard RT\u002FADT in Men With High-risk Prostate Cancer With a BRCA Mutation","A Randomised, Double-blind, Placebo-controlled, Phase III Study of Adjuvant Saruparib (AZD5305) in Patients With BRCAm Localised High-Risk Prostate Cancer Receiving Radiotherapy With Androgen Deprivation Therapy (EvoPAR-Prostate02).","EvoPAR-PR02","Inclusion Criteria:\n\n* Male participants with a histologically documented diagnosis of prostate adenocarcinoma.\n* Newly diagnosed high-risk and very high-risk (localised\u002Flocally advanced) prostate cancer or a high-risk biochemical recurrence (BCR) following radical prostatectomy.\n* Provision of a formalin fixed and paraffin embedded (FFPE) tumour tissue sample.\n* Confirmed BRCA1 or BRCA2 mutation status by central tumour tissue is required for enrolment.\n* Participants required to have a computed tomography (CT) or magnetic resonance imaging (MRI) and a bone scan following the completion of their planned RT. This screening scan must confirm no evidence of disease or evidence of disease confined to the pelvis (M0).\n* Participants required to have a prostate-specific membrane antigen-positron emission tomography (PSMA-PET) following the completion of their planned RT. This screening scan must confirm no evidence of disease or evidence of disease confined to the pelvis (M0).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no deterioration over the 2 weeks prior to randomization.\n* Minimum life expectancy of 12 months.\n* Adequate organ and bone marrow function as described in study protocol.\n* All participants will have received either primary or salvage RT. Participants must be eligible for randomisation within 10 months of initial diagnosis (de novo or BCR). Radiotherapy administered to the prostate (± pelvis) either in the primary or salvage setting must be delivered with curative intent. Use of metastases-directed therapy, as part of the RT radiation plan, is permitted as localised RT treatment for a metastatic lesion(s) outside the pelvis.\n* All participants will have received a planned regimen of ADT with a gonadotropin releasing hormone (GnRH) analogue.\n* Participants must not father children or donate sperm from signing informed consent form (ICF), during the study intervention and for 6 months after the last dose of study intervention.\n* Participants must use a condom (with spermicide - where permitted) from signing ICF, during study intervention, and for 6 months after the last dose of study drug, with all sexual partners.\n\nExclusion Criteria:\n\n* Participants with a history of myelodysplastic syndrome (MDS)\u002F acute myeloid leukemia (AML) or with features suggestive of MDS\u002FAML.\n* Participants with any known predisposition to bleeding \\[e.g., active peptic ulceration, recent (within 6 months) hemorrhagic stroke, proliferative diabetic retinopathy\\].\n* Any history of persisting (\\> 2 weeks) severe cytopenia due to any cause.\n* Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of saruparib and\u002For abiraterone.\n* History of another primary malignancy, with exceptions.\n* Persistent toxicities \\[Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2\\] caused by previous anticancer therapy.\n* Cardiac criteria, including history of arrhythmia and cardiovascular disease.\n* Evidence of active and uncontrolled hepatitis B and\u002For hepatitis C.\n* Evidence of active and uncontrolled human immunodeficiency virus (HIV) infection.\n* Active tuberculosis infection.\n* Any prior chemotherapy (i.e., docetaxel) or immunotherapy; any prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor.\n* Prior treatment within 14 days with blood product support or growth factor support.\n* Concomitant use of strong inducers and inhibitors of CYP3A4 (applies to saruparib and abiraterone) or herbal supplements within 21 days or at least 5 half-lives (whichever is longer), of randomization.\n* Concomitant use of drugs that are known to prolong QT and have a known risk of Torsades de Pointes (TdP).\n* Participants with a known hypersensitivity to saruparib or any excipients of these products.",{"count":145,"type":22},700,[147],"PHASE3","The purpose of the study is to demonstrate superiority of Saruparib (AZD5305) relative to placebo added to a standard radiation therapy (RT) + androgen deprivation therapy (ADT) regimen by assessment of metastases-free survival in participants with high-risk and very high-risk localised\u002Flocally advanced prostate cancer with a breast cancer gene mutation (BRCAm).",[29],[151,152,153,154,155],"Localised\u002Flocally advanced prostate cancer","High-risk biochemical recurrence (BCR)","Poly (ADP-ribose) polymerase","Radiation therapy or radiotherapy","Breast cancer gene (BRCA) mutation",{"date":38,"type":39},{"date":158,"type":39},"2025-08-06",{"date":160,"type":22},"2036-04-30",{"name":162,"class":134},"AstraZeneca",346,{"id":165,"slug":166,"hasResults":12,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":23,"phases":173,"briefSummary":174,"conditions":175,"keywords":4,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":177,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":184},"100587234","a-clinical-study-of-ifinatamab-deruxtecan-i-dxd-in-people-with-metastatic-prostate-cancer-mk-2400-001-100587234","NCT06925737","A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)","A Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (IDeate-Prostate01)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology\n* Has prostate cancer progression while on androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months prior to Screening\n* Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and\u002For soft tissue disease by computed tomography (CT)\u002Fmagnetic resonance imaging (MRI)\n* Has received prior treatment with 1 or 2 androgen receptor pathway inhibitors (ARPIs) and progressed during or after at least 8 weeks of treatment\n* Has provided tumor tissue from a core or excisional biopsy from soft tissue not previously irradiated and obtained after disease progression on the most recent prior therapy\n* Has recovered from adverse events (AEs) due to previous anticancer therapies\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Is unable to swallow tablets\u002Fcapsules\n* Has any of the following indicators of interstitial lung disease (ILD)\u002Fpneumonitis:\n\n  1. Has any history of ILD\u002Fpneumonitis that required steroid use, except for a history of radiation pneumonitis that did not require steroids\n  2. Has current ILD\u002Fpneumonitis\n  3. Has a clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out\n* Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses\n* Has uncontrolled or significant cardiovascular disease\n* Has received prior treatment with a taxane-based chemotherapy agent for metastatic castration-resistant prostate cancer (mCRPC)\n* Has had prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities\n* Has a \"superscan\" bone scan",{"count":172,"type":22},1440,[147],"Researchers are looking for new ways to treat metastatic castration-resistant prostate cancer (mCRPC). Researchers have designed a study medicine called ifinatamab deruxtecan (also called I-DXd or MK-2400) to treat mCRPC. The goal of this study is to learn if people who receive I-DXd live longer overall and live longer without the cancer growing or spreading than people who receive chemotherapy.",[29,176],"Prostatic Neoplasms",{"date":38,"type":39},{"date":179,"type":39},"2025-05-13",{"date":181,"type":22},"2031-01-06",{"name":183,"class":134},"Merck Sharp & Dohme LLC",294,{"id":186,"slug":187,"hasResults":12,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":23,"phases":194,"briefSummary":195,"conditions":196,"keywords":197,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":212,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":219},"100379512","phase-1-study-of-amg-509-in-participants-with-metastatic-castration-resistant-prostate-cancer-100379512","NCT04221542","Study of AMG 509 in Participants With Metastatic Castration-Resistant Prostate Cancer","A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 509 in Subjects With Metastatic Castration-Resistant Prostate Cancer","Inclusion Criteria:\n\n* Parts 1, 2, 5 and 7: Participants with histologically or cytologically confirmed metastatic castration-resistant prostate cancer (mCRPC) who are refractory to a novel antiandrogen therapy (abiraterone acetate and\u002For enzalutamide, apalutamide, or darolutamide) and have failed at least 1 (but not more than 2) taxane regimens including for metastatic hormone-sensitive prostate cancer (mHSPC) (or who are deemed medically unsuitable to be treated with a taxane regimen or have actively refused treatment with a taxane regimen). Note: A taxane regimen is defined as a minimum exposure of 2 cycles of a taxane. Any NHT that has been administered and has been stopped for reasons other than progression will not be counted as an additional line of treatment.\n\n  1. Dose exploration phase: Novel antiandrogen therapy must have been given for treatment of metastatic disease.\n  2. Dose-expansion phase: participants must not have had more than 2 NHTs and 2 taxane regimens in any setting, and an additional up to 2 other systemic anti-cancer treatments are allowed (eg, anti-PD1, PARP inhibitors, radioligand therapies, sipuleucel-T, experimental agents) Note: Combinations are considered one systemic anti-cancer treatment.\n* Part 3: Participants with histologically or cytologically confirmed mCRPC who have received no or 1-2 prior NHTs (abiraterone acetate, enzalutamide, apalutamide, or darolutamide) given in any disease setting and who are deemed medically unsuitable to be treated with a taxane regimen or have actively refused treatment with a taxane regimen (unless taxane treatment was administered in HSPC setting). 0 1 prior PARP inhibitors or sipuleucel-T treatments are acceptable. Participants who received prior investigational therapy for the treatment of metastatic disease are not eligible.\n* Parts 4A, 4B and 7:\n\n  1. Participants with histologically or cytologically confirmed mCRPC who have received no or 1-2 prior NHTs (given in any disease setting depending on the part), and no or 1 taxane regimen (for HSPC).\n  2. Dose-expansion phase: at least 1 prior NHT must have been given; 0-1 prior PARP inhibitors are acceptable.\n  3. 4A: Participants planning to receive abiraterone acetate for the first time (participants who received prior abiraterone acetate are not eligible). Participants may have had exposure to up to 2 NHTs with a similar mechanism of action (apalutamide, enzalutamide or darolutamide) in the non-mCRPC and mCRPC setting.\n* Dose-expansion phase: up to approximately 10 participants with prior exposure to abiraterone acetate may be enrolled into Part 4A expansion cohort.\n\n  d. 4B: Participants planning to receive enzalutamide for the first time (participants who received prior enzalutamide\u002Fapalutamide or daralutamide are not eligible).\n* Part 6:\n\n  1. Prior disease progression on 1, and only 1, NHT (either enzalutamide, apalutamide, or darolutamide) is required. NOTE: Prior progression on or intolerance to abiraterone is not allowed.\n  2. No prior treatment with any chemotherapy regimen in the mCRPC setting; ≤ 6 cycles of docetaxel treatment in the mHSPC setting is allowed.\n  3. mCRPC with ≥ 1 RECIST v1.1 measurable lesion that is present on baseline computed tomography (CT) or magnetic resonance imaging (MRI).\n* All parts:\n* Participants must have undergone bilateral orchiectomy or be on continuous androgen-deprivation therapy with a gonadotropin releasing hormone (GnRH) agonist or antagonist.\n* Total serum testosterone ≤ 50 ng\u002FdL or 1.7 nmol\u002FL.\n* Evidence of progressive disease, defined as 1 or more Prostate Cancer Working Group 3 (PCWG3) criteria:\n\n  1. PSA level ≥ 1 ng\u002FmL that has increased on at least 2 successive occasions at least 1 week apart.\n  2. Nodal or visceral progression as defined by RECIST v1.1 with PCGW3 modifications.\n  3. Appearance of 2 or more new lesions in bone scan.\n* Eastern Cooperative Oncology Group performance status of 0-1.\n* Life expectancy ≥ 3 months.\n* Adequate organ function, defined as follows:\n\n  1. Hematological function:\n\n     1. absolute neutrophil count ≥ 1 x 10\\^9\u002FL (without growth factor support within 7 days from screening assessment).\n     2. platelet count ≥ 75 x 10\\^9\u002FL (without platelet transfusion within 7 days from screening assessment).\n     3. hemoglobin ≥ 9 g\u002FdL (90 g\u002FL) (without blood transfusion within 7 days from screening assessment).\n  2. Renal function:\n\n     1\\. estimated glomerular filtration rate based on Modification of Diet in Renal Disease calculation ≥ 30 ml\u002Fmin\u002F1.73 m\\^2.\n  3. Hepatic function:\n\n     1. aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 3 x upper limit of normal (ULN) (or \\\u003C 5 x ULN for participants with liver involvement).\n     2. total bilirubin (TBL) \\\u003C 1.5 x ULN (or \\\u003C 2 x ULN for participants with liver metastases).\n  4. Cardiac function:\n\n     1. left ventricular ejection fraction \\> 50% (2-D transthoracic echocardiogram \\[ECHO\\] is the preferred method of evaluation; multi-gated acquisition scan is acceptable if ECHO is not available).\n     2. Baseline electrocardiogram (ECG) QTcF ≤ 470 msec (average of triplicate values).\n  5. Pulmonary function:\n\n     1. baseline oxygen saturation \\> 92% on room air at rest and no oxygen supplementation.\n\nPart 3-Retreatment group:\n\n* Deriving benefit from initial treatment with AMG 509 as evidenced by one of the following:\n\n  1. confirmed PSA50 response.\n  2. radiographic stable disease\u002Fpartial response\u002Fcomplete response during 6 cycles of initial treatment with AMG 509 and without progression during the first 6 cycles.\n* No discontinuation for toxicity during the initial treatment with 6 cycles of AMG 509.\n* Progressive disease as defined in I106 within 12 months of final dose in their initial treatment with 6 cycles (EOT\\_1).\n* Willingness to have a fresh tumor biopsy prior to initiating the additional course of treatment, depending on safety and feasibility as assessed by investigator.\n\nKey Exclusion Criteria:\n\n* Pathological finding consistent with pure small cell, neuroendocrine carcinoma of the prostate or any other histology different from adenocarcinoma.\n* Radiation therapy within 4 weeks of first dose (or local or focal radiotherapy within 2 weeks of first dose).\n* Untreated central nervous system (CNS) metastases or leptomeningeal disease. Participants with a history of treated CNS metastases are eligible if there is radiographic evidence of improvement upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study.\n* Prior major surgery within 4 weeks of first dose.\n* Participants with symptoms and\u002For clinical signs and\u002For radiographic signs that indicate an acute and\u002For uncontrolled active systemic infection within 7 days prior to the first dose of investigational product administration. Simple urinary tract infections and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with sponsor. Screening for chronic infectious conditions is not required.\n* Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy.\n* History of arterial or venous thrombosis (eg, stroke, transient ischemic attack, pulmonary embolism, or deep vein thrombosis); for arterial thrombosis within 12 months of AMG 509 initiation; for venous thrombosis, 6 months and stable on anti-coagulation. Participants with a recent history of venous thrombosis must be maintained on the same anti-coagulation therapy for a minimum of 28 days prior to first dose of study treatment.\n* Myocardial infarction and\u002For symptomatic congestive heart failure (New York Heart Association \\> class II) within 12 months of first dose of AMG 509 with the exception of ischemia or non-ST segment elevation myocardial infarction controlled with stent placement and confirmed by a cardiologist more than 6 months prior to first dose of AMG 509.\n* Any anti-cancer therapy or immunotherapy within 4 weeks of start of first dose, not including luteinizing hormone-releasing hormone (LHRH)\u002FGnRH analogue (agonist\u002Fantagonist).\n* Prior prostate specific membrane antigen (PSMA) radionuclide therapy within 2 months prior to AMG 509 unless participant received \\\u003C 2 cycles (Note: a participant cannot have received PSMA radionuclide therapy \\\u003C 35 days prior to enrollment if 1 cycle was given). Parts 3 and 4: prior PSMA radionuclide therapy is prohibited. Participants on a stable bisphosphonate or denosumab regimen for ≥ 30 days prior to enrollment are eligible (exception: part 3 retreatment).\n* Part 3-Retreatment only: Any anti-cancer therapy or immunotherapy, not including luteinizing hormone-releasing hormone\u002Fgonadotropin releasing hormone (LHRH\u002FGnRH) analogue (agonist\u002Fantagonist), and\u002For bisphosphonate or denosumab regimen after last dose of AMG 509 initial course of treatment.",{"count":193,"type":22},479,[59],"The overall aim of the trial is to evaluate the safety, tolerability, and pharmacokinetics (PK) of AMG 509 (monotherapy and in combination with abiraterone acetate and enzalutamide) and to evaluate preliminary efficacy. As of Protocol Amendment 10 (09 July 2025), only Parts 4A expansion, 6, and 7 are open to accrual.",[29],[198,199,200,201,202,203,204,205,206,207,208,209,210,211],"AMG 509","mCRPC","Metastatic Castration-resistant Prostate Cancer","Prostate cancer","PSMA","STEAP1","STEAP1 targeted therapy","Solid tumor","Immunotherapy","Immuno-oncology","Immunooncology","Bispecific T-Cell engager®","BiTE®","XmAb®",{"date":38,"type":39},{"date":214,"type":39},"2020-03-04",{"date":216,"type":22},"2032-03-21",{"name":218,"class":134},"Amgen",57,{"id":221,"slug":222,"hasResults":12,"nctId":223,"briefTitle":224,"officialTitle":224,"acronym":4,"eligibilityCriteria":225,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":226,"enrollmentInfo":227,"targetDuration":4,"studyType":23,"phases":229,"briefSummary":230,"conditions":231,"keywords":4,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":47},"100649527","phase-1-a-multicenter-open-label-phase-i-clinical-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-efficacy-of-shr-6914-injection-in-participants-with-prostate-cancer-100649527","NCT07735377","A Multicenter, Open-label Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-6914 Injection in Participants With Prostate Cancer","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed prostate adenocarcinoma without neuroendocrine or small cell features\n2. Presence of metastatic lesions confirmed by evaluable imaging examinations (per PCWG4, evaluable imaging examinations refer to examinations with definite lesion assessment criteria, including CT, MRI or bone scan).\n3. Has an ECOG PS 0-1.\n4. Has a life expectancy of ≥ 3 months.\n5. Has adequate organ function\n\nExclusion Criteria:\n\n1. With untreated local therapy (radiotherapy or surgery) or active central nervous system (CNS) tumor metastases. Participants with a history of leptomeningeal metastasis or current leptomeningeal metastasis.\n2. Patients with other malignant tumors within 5 years prior to the first study drug administration, excluding adequately treated basal cell carcinoma or squamous cell carcinoma.\n3. Those with uncontrolled tumor-related pain as judged by the investigator, who require analgesic medication.\n4. Having severe cardiovascular and cerebrovascular diseases\n5. Suffering from active severe digestive system diseases\n6. History of prior interstitial pneumonia\n7. Has active infection requiring systemic treatment.\n8. Adverse reactions from prior anti-tumor therapy have not recovered to CTCAE grade ≤1","80 Years",{"count":228,"type":22},118,[59],"This is a phase 1 study to assess the safety and tolerability of SHR-6914 as monotherapy therapy in adult subjects with prostate cancer.",[29],"2026-08-19",{"date":36,"type":39},{"date":235,"type":22},"2026-08",{"date":237,"type":22},"2028-08",{"name":239,"class":134},"Suzhou Suncadia Biopharmaceuticals Co., Ltd.",{"id":241,"slug":242,"hasResults":12,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":246,"eligibilityCriteria":247,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":248,"targetDuration":4,"studyType":23,"phases":250,"briefSummary":251,"conditions":252,"keywords":254,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":256,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":47},"100642245","phase-2-mri-based-focal-intraprostatic-simultaneous-integrated-boost-sib-intensification-with-de-escalated-adaptive-risk-sbrt-for-patients-with-low-to-intermediate-risk-prostate-cancer-100642245","NCT07644598","MRI-based Focal Intraprostatic Simultaneous Integrated Boost (SIB) Intensification With De-escalated Adaptive-risk SBRT for Patients With Low to Intermediate Risk Prostate Cancer","A Phase II Study of MRI-based Focal Intraprostatic SIB (Simultaneous Integrated Boost) Intensification With De-escalated Adaptive-risk SBRT for Patients With Low to Intermediate Risk Prostate Cancer","MIDAS","Inclusion Criteria:\n\n1. Patients age 18 or older.\n2. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n3. Patients with histologically confirmed adenocarcinoma of the prostate who have not received prior pelvic radiation therapy or prostatectomy.\n4. Patients with low to intermediate risk group defined by the NCCN (National Comprehensive Cancer Network) guidelines as follows:\n\n   * Low risk prostate cancer:\n\n     * cT1-cT2a (AJCC; 8TH edition, 2017)\n     * Grade Group 1 (GG1)\n     * PSA \\\u003C10 ng\u002FmL\n   * Intermediate risk prostate cancer:\n\n     * cT2b-cT2c (AJCC; 8TH edition, 2017)\n     * Grade Group 2 (GG2) or Grade Group 3 (GG3)\n     * PSA 10-20 ng\u002FmL\n5. Patients with unfavorable intermediate risk prostate cancer defined by the NCCN guidelines are recommended to undergo a PSMA (Prostate-Specific Membrane Antigen) PET, then the PSMA PET must show localized disease.\n6. Patients must have preferably undergone a standard of care pretreatment MRI fusion biopsy\\* to identify visible intraprostatic lesions and confirm the absence of regional or distant metastatic disease, with criteria as follows:\n\n   * Ability to undergo an MRI fusion biopsy;\n   * Prostate size \\\u003C100 cc on any diagnostic MRI;\n   * Presence of a visible prostatic lesion:\n\n     * PIRADS (Prostate Imaging-Reporting and Data System) 4+ lesion, and\u002For\n     * PIRADS 3 lesion with evidence of grade group 2-3\n   * Less than or equal to 4 lesions in total allowed;\n   * Lesion may contact the capsular edge, \"possible\" extracapsular extension (ECE) permitted; \\*MRI fusion biopsy is preferred but if the positive core is in the same region as the target on the MRI based on a systemic biopsy, the patient can be included.\n7. Genitourinary function with a baseline score ≤20 as defined by any pre-treatment IPSS questionnaire.\n8. Patients are mandated to get a fiducial placement. Optional proper rectal spacer placement is recommended as determined by the treating radiation oncologist based upon whether there is overt rectal wall invasion from the hydrogel spacer or if there is minimal to no separation of the prostate-rectal interface measured at the prostate mid-gland.\n9. Patients with a life expectancy of greater than 5 years as assessment by the investigator. Life expectancy can be estimated using any 1 of the following tools:\n\n   * The Social Security Administration tables: https:\u002F\u002Fwww.ssa.gov\u002FOACT\u002FSTATS\u002Ftable4c6.html\n   * The WHO's Life Tables by country: https:\u002F\u002Fapps.who.int\u002Fgho\u002Fdata\u002Fview.main.60000?lang=en\n   * The Memorial Sloan Kettering Male Life Expectancy tool: https:\u002F\u002Fwww.mskcc.org\u002Fnomograms\u002Fprostate\n   * If using a life expectancy table, life expectancy should be adjusted using the clinician's assessment of overall health as follows: best quartile of health - add 50%; worst quartile of health - subtract 50%; and middle two quartiles of health - no adjustment. See the NCCN Prostate Cancer Guidelines for more information.\n10. Patients who agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agree to refrain from donating sperm, as defined below:\n\n    * With a female partner of childbearing potential who is not pregnant, men who are not surgically sterile must remain abstinent or use a condom plus an additional contraceptive method, which together result in a failure rate of \\\u003C 1% per year, during the treatment period and for 1 year after treatment per local and institutional guidelines. Men must refrain from donating sperm during this same period.\n    * With a pregnant female partner, men must remain abstinent or use a condom during the treatment period per local and institutional guidelines to avoid potential exposure to the embryo.\n    * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not adequate methods of contraception.\n11. Patients who are able to give informed consent.\n\nExclusion Criteria:\n\n1. Patients with evidence of disease Grade Group 4 (GG4) or higher.\n2. Patients with PSA \\>20 ng\u002FmL.\n3. Patients with evidence of clinical stage T3a+ or gross extracapsular extension on the diagnostic MRI.\n4. Patients who received prior or concurrent androgen deprivation therapy for prostate cancer.\n5. Patients with more than 4 disease foci identifiable on MRI.\n6. Patients with evidence of metastatic disease on imaging (e.g., bone scan, PSMA PET scan, or MRI\u002FCT scan).\n7. Patients with ineligibility to undergo an MRI due to:\n\n   * The presence of a cardiac pacemaker, defibrillator, or other implanted metallic or electronic device which is considered MRI unsafe;\n   * Severe claustrophobia;\n   * Inability to lie flat for the duration of the study;\n   * Metallic implant or device in the pelvis that might distort the local magnetic field and compromise quality of MRI;\n   * Any other reason as determined by the investigator or treating physician.\n8. Patients with an I-PSS score \\>20 as defined by any pre-treatment IPSS questionnaire.\n9. Patients with a prior history of transurethral resection of the prostate, TURP, Urolift, or other similar trans-urethral LUTS management procedure within the last 6 months.\n10. Patients with a prior history of severe urethral stricture.\n11. Patients with a prior history of pelvic irradiation.\n12. Patients unable to meet dosimetric constraints\n13. Patients with a prior history of non-cutaneous solid malignancy within the last 5 years.\n14. Patients with a history of active and uncontrolled inflammatory bowel disease.\n15. Patients who are unable to comply with follow-up visits and treatment plans.",{"count":249,"type":22},58,[25],"The goal of this clinical trial is to determine the safety of stereotactic body radiation therapy (SBRT) microboost technique in patients with low to intermediate risk prostate cancer. The main question it aims to answer is: Is microboost SBRT with whole gland de-escalation both safe and effective in managing patients with low to intermediate-risk prostate cancer while maintaining acceptable toxicity levels? All patients will receive microboost SBRT at a dose of 45 Gy delivered in 5 fractions in up to 4 MRI-defined lesions. Patients (Arm 1) with highest grade disease in the microboost target lesion in the absence of GG2-3 beyond the microboost target (only GG1 disease can be present outside of the microboost region) will receive whole gland de-escalation at a dose of 30 Gy delivered in 5 fractions. Patients (Arm 2) with highest grade disease outside of the target lesion will receive whole gland de-escalation at a dose of 35 Gy delivered in 5 fractions. Participants will be treated every other day over a two week period and then follow up after radiation treament for up to 5 years. Participants will be asked to complete questionnaires and provide blood and urine samples for research purposes.",[29,253],"Localized Prostate Carcinoma",[255],"Localized prostate cancer",{"date":36,"type":39},{"date":258,"type":22},"2026-09",{"date":260,"type":22},"2035-01",{"name":262,"class":263},"Georgetown University","OTHER",{"id":265,"slug":266,"hasResults":12,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":270,"eligibilityCriteria":271,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":272,"targetDuration":4,"studyType":23,"phases":274,"briefSummary":276,"conditions":277,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":278,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":285},"100639087","weekly-online-ct-or-mr-adaptive-definitive-sbrt-for-very-high-risk-localized-or-regionally-metastatic-prostate-cancer-100639087","NCT07591051","Weekly Online CT or MR Adaptive Definitive SBRT for Regionally Metastatic Prostate Cancer","Weekly Online CT or MR Adaptive Definitive SBRT for Regionally Metastatic Prostate Cancer (WARP)","WARP","Inclusion criteria include:\n\n* Regionally metastatic prostate cancer (cN1, any T, Gleason 6-10, any PSA) according to NCCN guidelines consisting of ≤ 5 regional lymph node metastases\n* Good to moderate performance status (WHO 0-2)\n* Written informed consent.\n* A PSMA PET and multiparametric MRI is mandatory according to staging guidelines.\n* Age ≥ 18 years\n\nExclusion criteria include:\n\n* \\>5 regional lymph nodes\n* Patients with cT4 disease (tumor is fixed or invades adjacent structures other than seminal vesicles such as external sphincter, rectum, bladder, levator muscles, and\u002For pelvic wall)\n* Previous radiotherapy to the pelvis or prostate\n* Previous radical prostatectomy\n* Large body size that would not fit into the MRI-simulator bore\n* Presence of distant metastases (i.e. cM1)\n\n  * Non-regional lymph nodes (M1a):\n  * Bone metastases (M1b)\n  * Other sites (M1c)\n* Contraindications to CT or MR-adaptive SBRT (e.g., pacemakers, severe claustrophobia).\n* Severe comorbidities that may interfere with treatment or follow-up (e.g. inflammatory bowel disease).\n* Significant concomitant diseases (e.g. hepatic dysfunction, cardiovascular disease, etc.).\n* Inability to follow procedures or insufficient knowledge of project language, inability to give consent.\n* Participation in a clinical trial which might influence the results of this project.\n* Enrolment of the investigator, his\u002Fher family members, employees and other dependent persons.\n* Severe genitourinary or gastrointestinal symptoms (e.g. recent urinary retention or diarrhea ≥ grade 3 or obstipation to CTCAE v.6.0).\n* Severe urinary symptoms (e.g. IPSS \\>12 and\u002For prostate volume \\> 80 mL)",{"count":273,"type":22},54,[275],"NA","This interventional prospective multicenter international study will include 54 patients with regionally metastatic (i.e. cN1 cM0) prostate cancer according to the NCCN criteria.\n\nPatients will be treated with weekly CT or MR-informed online adaptive SBRT of the prostate and elective pelvic lymph nodes with 5 x 5 Gy. A simultaneous integrated boost (SIB) of involved lymph nodes will be performed. In the case of up to 2 dominant intraprostatic lesion (DIL) a SIB of the DIL can be performed (optional). Importantly, coverage of these DIL volumes must be compromised as needed to respect OAR constraints.\n\nThis study is classified as risk category A according to ClinO, Art. 61, as stereotactic radiotherapy (SBRT) for regionally metastatic prostate cancer has been extensively evaluated in prospective interventional trials and is considered an established therapeutic modality.\n\nWeekly CT- or MR-guided online adaptive SBRT to the prostate and elective pelvic lymph nodes with 5 × 5 Gy is, however, not yet routinely implemented for this specific patient population.\n\nA diagnostic high field MRI during radiotherapy, e.g. week 3 is optional.\n\nFollow-up is also according to standard of care (except for patient reported outcome measure using QLQ-C30 and QLQ-PR25 and a diagnostic MRI at 9 months after SBRT (optional), and 12 months in the case of an image non-complete response at 9 months (optional).",[29],{"date":38,"type":39},{"date":280,"type":22},"2027-01",{"date":282,"type":22},"2033-01",{"name":284,"class":263},"University of Zurich",2,{"id":287,"slug":288,"hasResults":12,"nctId":289,"briefTitle":290,"officialTitle":290,"acronym":291,"eligibilityCriteria":292,"healthyVolunteers":12,"sex":17,"minAge":293,"maxAge":226,"enrollmentInfo":294,"targetDuration":4,"studyType":296,"phases":4,"briefSummary":297,"conditions":298,"keywords":301,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":305,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":47},"100627897","a-prospective-clinical-trial-evaluating-prostest-a-blood-based-molecular-assay-for-risk-stratification-and-biopsy-decision-support-in-men-with-suspected-prostate-cancer-100627897","NCT07454603","A Single-arm, Multicenter Prospective Study to Evaluate the Diagnostic Performance of PROSTest in Men With PSA ≥ 3ng\u002Fml Using Biopsy as the Sole Ground Truth","PROSTest_STRAT","Inclusion Criteria:\n\n* elevated PSA and\u002For abnormal digital rectal examination\n\nExclusion Criteria:\n\n* Previous Prostate cancer diagnosis","45 Years",{"count":295,"type":22},1500,"OBSERVATIONAL","This prospective observational study will enroll men referred for prostate biopsy due to elevated PSA and\u002For abnormal digital rectal examination, with or without pre-biopsy MRI. Peripheral blood will be collected prior to biopsy for PROSTest analysis. Biopsy histopathology will serve as the reference standard. PROSTest results will be analyzed blinded to pathology.",[29,299,300],"Urology","Prostate Cancer (Diagnosis)",[302,303,304],"BIOPSY","MRI","PROSTATE CANCER",{"date":38,"type":39},{"date":307,"type":39},"2026-04-15",{"date":309,"type":22},"2027-06-01",{"name":311,"class":134},"Wren Laboratories LLC",{"id":313,"slug":314,"hasResults":12,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":4,"eligibilityCriteria":318,"healthyVolunteers":12,"sex":55,"minAge":319,"maxAge":4,"enrollmentInfo":320,"targetDuration":4,"studyType":23,"phases":322,"briefSummary":323,"conditions":324,"keywords":331,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":338,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":47},"100610399","dosing-physical-activity-among-older-cancer-survivors-who-experience-chronic-pain-a-micro-randomized-trial-100610399","NCT07227077","Dosing Physical Activity Among Older Cancer Survivors Who Experience Chronic Pain: a Micro-randomized Trial","An Adaptive Design for Dosing Physical Activity Among Older Cancer Survivors Who Experience Chronic Pain: a Micro-randomized Trial","Inclusion Criteria:\n\n1. Age greater than or equal to 65 years.\n2. Patients with a history of bladder, breast, cervical, colorectal, endometrial, lung, and prostate cancer diagnosis and treatment.\n3. Fluent in spoken and written English.\n4. Patient has access to smartphone\n5. Ability to understand a written informed consent document, and the willingness to sign it.\n\nExclusion Criteria:\n\n1. Patient has metastatic disease.\n2. Patient has cancer recurrence.","65 Years",{"count":321,"type":22},50,[275],"The purpose of this study is to assess the best time to deliver a message to increase physical activity and how often participants will experience a pain episode in the 24 hours following their receipt of a message to increase physical activity.",[325,326,327,328,329,330,29],"Breast Cancer","Cervical Cancer","Bladder Cancer","Colorectal Cancer","Endometrial Cancer","Lung Cancer",[332,333,334,335,336,337],"Physical Activity","Exercise","Survivorship","Supportive Care","Pain","Symptom Management",{"date":36,"type":39},{"date":340,"type":39},"2026-02-07",{"date":342,"type":22},"2027-05-01",{"name":344,"class":263},"Medical College of Wisconsin",{"id":346,"slug":347,"hasResults":12,"nctId":348,"briefTitle":349,"officialTitle":349,"acronym":350,"eligibilityCriteria":351,"healthyVolunteers":12,"sex":17,"minAge":352,"maxAge":353,"enrollmentInfo":354,"targetDuration":4,"studyType":23,"phases":356,"briefSummary":357,"conditions":358,"keywords":4,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":359,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":47},"100588728","comparison-of-prostate-cancer-related-quality-of-life-in-sexually-active-men-with-favourable-intermediate-risk-localised-prostate-cancer-treated-with-total-prostatectomy-or-focal-hifu-100588728","NCT06945172","Comparison of Prostate Cancer-related Quality of Life in Sexually Active Men With Favourable Intermediate-risk Localised Prostate Cancer Treated With Total Prostatectomy or Focal HIFU","QUALIFY","Inclusion Criteria:\n\n* Patient, male, aged between ≥ 40 and ≤ 75 years\n* Patient with a life expectancy \\> 10 years at the time of inclusion.\n* Patient with a therapeutic strategy (prostatectomy or focal HIFU) defined during a PCR.\n* Patient with a diagnosis of localised prostate cancer at favourable intermediate risk\n* Patient able to tolerate general anaesthesia or type IV sedation\n* Patient with normal urinary continence status\n* Patient with satisfactory erectile function allowing penetration:\n* Patient with targeted biopsies and systematic biopsies\n* Patient affiliated to or benefiting from a social security scheme\n* French-speaking patients who do not object to the use of their data.\n\nExclusion Criteria:\n\n* Patients with a contraindication to MRI\n* Stage T3a or b on MRI\n* Patient on long-term anticoagulants and unable to stop them.\n* Patient already included in another study\n* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision","40 Years","75 Years",{"count":355,"type":22},102,[275],"The goal of this trial is to assess the impact of focal HIFU therapy on quality of life in patients with favourable intermediate-risk localised prostate cancer. The main question it aims to answer is:\n\nWhat is the prostate cancer-related quality of life in patients with favourable intermediate-risk localised cancer treated by total prostatectomy or focal HIFU ?\n\nResearchers will compare patients with favourable intermediate-risk localised cancer treated by total prostatectomy to patients with favourable intermediate-risk localised cancer treated by focal HIFU to see their quality of life.\n\nParticipants will answer EPIC-CP questionnaire 6 months, 12 months and 24 months after treatment",[29],{"date":36,"type":39},{"date":361,"type":39},"2025-09-01",{"date":363,"type":22},"2028-12-31",{"name":365,"class":263},"GCS Ramsay Santé pour l'Enseignement et la Recherche",{"id":367,"slug":368,"hasResults":12,"nctId":369,"briefTitle":370,"officialTitle":371,"acronym":4,"eligibilityCriteria":372,"healthyVolunteers":12,"sex":55,"minAge":18,"maxAge":4,"enrollmentInfo":373,"targetDuration":4,"studyType":23,"phases":375,"briefSummary":376,"conditions":377,"keywords":385,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":395,"startDateStruct":396,"completionDateStruct":398,"leadSponsor":400,"locationsCount":402},"100529338","a-study-of-her3-dxd-in-subjects-with-locally-advanced-or-metastatic-solid-tumors-100529338","NCT06172478","A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors","HERTHENA-PanTumor01 (U31402-277): A Phase 2, Multicenter, Multicohort, Open-Label, Proof of Concept Study of Patritumab Deruxtecan (HER3-DXd; U3-1402) in Subjects With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria\n\nParticipants must meet all of the following criteria to be eligible for enrollment into the study:\n\n1. Sign and date the informed consent form prior to the start of any study-specific qualification procedures. A separate tissue screening consent will be obtained from all subjects to meet the baseline tumor tissue requirement.\n2. Participants aged ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is \\>18 years old).\n3. Has locally advanced unresectable or metastatic disease (not curable by surgery or radiation) as follows:\n\n   Cutaneous (acral and non-acral) melanoma\n   1. Histologically or cytologically confirmed cutaneous (acral or non-acral) melanoma\n   2. Disease progression while on or after having received treatment with ≥1 prior line of anti-programmed cell death protein (PD-1) or anti-programmed death-ligand 1 (PD-L1) based therapy (previous use of other immune checkpoint inhibitors \\[ICIs\\] \\[ie, anti-CTLA4, anti- LAG-3\\] is acceptable). Prior anti-PD-(L)1 therapy in the adjuvant setting is allowed if there is recurrence within 12 weeks of the last dose. If the participant had BRAFm melanoma, they must have had disease progression on BRAF\u002FMEK inhibitor therapy as well.\n\n      Squamous cell carcinomas of the head and neck\n   3. Squamous cell carcinoma of the head and neck (with a primary location of oral cavity,oropharynx, larynx, hypopharynx) that is human papillomavirus (HPV) positive or negative (as determined by local standard). Excludes tumor location in the nasopharynx, nasal cavity, paranasal sinuses, and unknown primary locations.\n   4. Disease progression after having received treatment with ≥1 and \\\u003C3 prior lines of systemic therapy in the unresectable recurrent or metastatic setting.\n\n      Must have had disease progression on anti-PD-(L)1 (either as monotherapy or in combination with chemotherapy or other therapies). Must also have had disease progression on a platinum-based chemotherapy (PBC) regimen either in the recurrent or metastatic setting or in the locally advanced setting with curative intent.\n\n      Gastric or GEJ adenocarcinoma\n   5. Tumor tissue must be confirmed as negative for HER2 expression (immunohistochemistry \\[IHC\\] 0\u002F1+ or IHC 2+\u002Fin situ hybridization negative) as classified by American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO-CAP) guidelines and determined prior to enrollment by assessment in a local laboratory that is Clinical Laboratory Improvement Amendments certified (US sites) or accredited based on specific country regulations.\n   6. Disease progression after having received treatment with ≥2 prior lines of therapy that include PBC with or without anti-PD-1 therapy.\n\n      Ovarian Carcinoma\n   7. Pathologically documented high-grade serous epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.\n   8. Documented disease progression ≥4 weeks after the last dose of PBC and \\\u003C6 months of last dose of PBC in the advanced or metastatic setting. Prior use of folate reductase alpha targeting antibody-drug conjugate (ADC) (ie, mirvetuximab soravtansine) is allowed.\n\n      Cervical Cancer\n   9. Pathologically or cytologically documented recurrent or persistent squamous, adenosquamous, or adenocarcinoma of the uterine cervix.\n   10. Disease progression after having received ≥1 line of systemic therapy in the recurrent or metastatic setting. This may include prior anti-PD-(L)1 treatment and\u002For tissue factor directed ADC (tisotumab vedotin \\[TV\\]) per regional standard of care.\n\n       Endometrial Cancer\n   11. Pathologically or cytologically documented endometrial cancer (carcinoma of any histological sub-type or endometrial carcinosarcoma), irrespective of microsatellite instability (MSI) or mismatch repair (MMR) status.\n   12. Documented disease progression after having received ≥1 prior line of therapy (maximum of 3) PBC containing systemic treatment and an anti-PD(L)-1 therapy-containing regimen (combined or sequential) in the advanced\u002Fmetastatic setting.\n\n       Bladder Cancer\n   13. Pathologically or cytologically documented locally advanced\u002Funresectable or metastatic urothelial carcinoma of the bladder, renal pelvis, ureter, or urethra. Histological variants are allowed if urothelial histology is predominant. Small cell\u002Fneuroendocrine tumors are not allowed even if mixed histology.\n   14. Relapsed or progressed after treatment with ≥1 prior line of therapy (maximum of 3) that contains anti-PD-(L)1 therapy in the perioperative or metastatic setting. At least 1 line of therapy must also contain one of the following treatment modalities: chemotherapy or enfortumab vedotin. Prior fibroblast growth factor receptor (FGFR)-inhibitor treatment for those who are eligible are allowed.\n\n       * Required treatments can be given in combination or sequentially\n       * Prior cisplatin-based therapy or PD-(L)1 inhibitor therapy given for the treatment of muscle invasive urothelial carcinoma is counted as 1 line of therapy\n       * The same regimen administered twice in different disease settings will be counted as 1 line of prior therapy\n       * Participants in the second-line setting who have previously received enfortumab vedotin and pembrolizumab in combination can be enrolled.\n\n       Esophageal Carcinoma\n   15. Pathologically or cytologically documented esophageal squamous cell carcinoma.\n   16. Must have documented disease progression after having received 2 prior lines of therapy including previous PBC with or without an anti-PD-1 therapy-containing regimen (combined or sequential) in the advanced\u002Fmetastatic setting.\n\n       Pancreatic Carcinoma\n   17. Pathologically or cytologically documented unresectable or metastatic pancreatic adenocarcinoma.\n   18. Relapsed or disease progression after having received 1 prior line of systemic therapy in the locally advanced\u002Fmetastatic setting.\n\n       Prostate Cancer\n   19. Pathologically or cytologically documented unresectable locally advanced or metastatic castration-resistant prostate cancer (CRPC).\n   20. Adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology.\n   21. Surgically or medically castrated, with testosterone levels of \\\u003C50 ng\u002FdL.\n   22. Documented objective progression as determined by radiographic progression for subjects with measurable disease after androgen deprivation.\n   23. Relapsed or disease progression after having received treatment with ≥1 of the following novel hormonal agents: abiraterone, enzalutamide, apalutamide, or darolutamide.\n   24. Relapsed or disease progression after having received ≥1 cytotoxic chemotherapy regimen that included a taxane.\n\n       Gastric Cancer 2L\n   25. Must have had gastric or GEJ adenocarcinoma confirmed as negative for HER2 expression (IHC 0\u002F1+ or IHC 2+\u002Fin situ hybridization negative) as classified by American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO-CAP) guidelines and determined prior to enrollment by assessment in a local laboratory that is Clinical Laboratory Improvement Amendments certified (US sites) or accredited based on specific country regulations.\n   26. Disease progression after having received treatment with only 1 prior line of systemic anti-cancer therapy that includes 5-FU-based chemotherapy with or without an anti-PD-1 therapy. For subjects whose tumors are claudin (CLDN) 18.2 positive, treatment with 5-FU based chemotherapy with CLDN18.2 directed therapy in the first-line setting is allowed.\n\n   Non-small Cell Lung Cancer aa. Histologically or cytologically documented metastatic or locally advanced nonsquamous NSCLC not amenable to curative surgery or radiation bb. Documentation of absence of actionable driver mutation (ie, ALK rearrangement, BRAF V600E mutation, EGFR-activating mutations \\[exon 19 deletion or L858R mutation\\], EGFR exon 20 insertion mutation, HER2 mutation, KRAS G12C mutation, MET exon 14 skipping mutation, NTRK 1\u002F2\u002F3 gene fusion, RET rearrangement, or ROS1 rearrangement). New testing for these genomic alterations is not required for Screening.\n\n   cc. Relapsed or disease progression after receiving only anti-PD-(L)1 and PBC (ie, platinum doublet) administered in combination or sequentially for metastatic disease.\n\n   Breast Cancer dd. Pathologically documented breast cancer that is assessed as HER2 negative (IHC2+\u002FISH-, IHC1+, or IHC0 per ASCO\u002FCAP guidelines), and HR positive (either ER and\u002For PgR positive \\[ER or PgR ≥1%\\] per ASCO\u002FCAP guidelines). The HER2 and HR results must be from a tumor sample obtained in the metastatic setting.\n\n   ee. Participant must have received one line of chemotherapy for mBC, but not more than one line and must have a clinically or radiologically documented evidence of tumor progression on or after CDK 4\u002F6 inhibitor combined with endocrine therapy; previous treatments with phosphoinositide 3-kinase (PI3K) inhibitors, mammalian target of rapamycin (mTOR) inhibitors, protein kinase B (PKB) inhibitors also known as AKT-inhibitors and poly ADP ribose polymerase (PARP)-inhibitors are allowed.\n4. Has ≥1 measurable lesion on CT or MRI as per RECIST v1.1 by investigator assessment. Prostate cancer participants with bone only disease may be eligible.\n5. Provides a pretreatment tumor tissue sample that meets 1 of the following collection requirements:\n\n   1. Tumor biopsy from ≥1 lesion not previously irradiated and performed since progression with the most recent systemic cancer therapy regimen and prior to signature of the tissue ICF (ARCHIVAL PRETREATMENT sample).\n\n      OR\n   2. Newly obtained pretreatment tumor biopsy from ≥1 lesion not previously irradiated and amenable to sampling, after signature of tissue ICF (FRESH PRETREATMENT sample)\n6. Has Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at screening.\n\nExclusion Criteria\n\nParticipants who meet any of the following criteria will be disqualified from entering the study:\n\n1. Has HER2-positive gastric cancer as classified by ASCO-CAP guidelines and determined prior to enrollment by assessment in a local laboratory that is Clinical Laboratory Improvement Amendments certified (US sites) or accredited based on specific country regulations.\n2. Has nasopharyngeal cancer.\n3. Has mucosal or uveal melanoma.\n4. Has a history of (non-infectious) interstitial lung disease (ILD), that required corticosteroids, has current ILD\u002Fpneumonitis, or suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n5. Has clinically severe respiratory compromise (based on the investigator's assessment) resulting from intercurrent pulmonary illnesses\n6. Is receiving chronic systemic corticosteroids dosed at \\>10 mg prednisone daily or equivalent anti-inflammatory activity or any form of immunosuppressive therapy prior to Cycle 1 Day 1.\n\n   Participants who require use of bronchodilators, inhaled or topical steroids, or local steroid injections may be included in the study.\n7. Had prior treatment with an anti-HER3 antibody and\u002For antibody-drug conjugate (ADC) that consists of an exatecan derivative that is a topoisomerase I inhibitor (eg, trastuzumab deruxtecan).\n8. Has history of other active malignancy within 3 years prior to Cycle 1 Day 1, except the following:\n\n   1. Adequately treated nonmelanoma skin cancer\n   2. Adequately treated intraepithelial carcinoma of the cervix\n   3. Any other curatively treated in situ disease\n9. Has any evidence of severe or uncontrolled diseases (eg, active bleeding diatheses, active serious infection) psychiatric illness\u002Fsocial situations, geographical factors, substance abuse, or other factors that, in the investigator's opinion, make it high risk for the subject to participate in the study or that would jeopardize compliance with the protocol\n10. Has previously received topoisomerase-1 inhibitors (e.g., irinotecan) treatment in the advanced or metastatic disease setting.",{"count":374,"type":22},740,[25],"This is a proof-of-concept study designed to investigate HER3-DXd monotherapy in locally advanced unresectable or metastatic solid tumors. The study is enrolling cohorts of participants with melanoma \\[cutaneous\u002Facral\\], squamous cell carcinomas of the head and neck (SCCHN), HER2-negative gastric cancer ovarian carcinoma, cervical cancer, endometrial cancer, bladder cancer, esophageal carcinoma, pancreatic carcinoma, prostate cancer, second-line gastric cancer, lung cancer, and breast cancer.",[378,379,62,380,381,326,329,327,382,383,29,384,330,325],"Advanced Solid Tumor","Melanoma","Gastric Cancer","Ovarian Carcinoma","Esophageal Cancer","Pancreatic Carcinoma","Non-small Cell Lung Cancer (NSCLC)",[378,379,62,380,386,387,388,389,390,391,201,392,393,394,330,325],"Ovarian carcinoma","Cervical cancer","Endometrial cancer","Bladder cancer","Esophageal carcinoma","Pancreatic carcinoma","Patritumab Deruxtecan","HER3-DXd","U3-1402",{"date":38,"type":39},{"date":397,"type":39},"2024-02-26",{"date":399,"type":22},"2028-10-10",{"name":401,"class":134},"Daiichi Sankyo",86,{"id":404,"slug":405,"hasResults":12,"nctId":406,"briefTitle":407,"officialTitle":408,"acronym":4,"eligibilityCriteria":409,"healthyVolunteers":12,"sex":17,"minAge":352,"maxAge":4,"enrollmentInfo":410,"targetDuration":4,"studyType":23,"phases":411,"briefSummary":412,"conditions":413,"keywords":4,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":416,"completionDateStruct":418,"leadSponsor":420,"locationsCount":47},"100610749","ai-algorithm-informed-biopsy-for-prostate-cancer-detection-with-indeterminate-and-low-risk-prostate-mri-lesions-100610749","NCT07231627","AI Algorithm-Informed Biopsy for Prostate Cancer Detection With Indeterminate and Low-Risk Prostate MRI Lesions","A Prospective Randomized Phase I\u002FII Study of Artificial Intelligence Algorithm-Informed Biopsy for Detection of Prostate Cancer in Patients With Indeterminate and Low-risk Prostate MRI Lesions","Inclusion Criteria:\n\n1. 40 years of age or older.\n2. A recent pMRI performed within last 12 weeks\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.\n4. Any patient with PIRADS 3 lesions per pMRI, AND elevated PSA (\"=\\> 3.0 ng\u002Fml\" for patients between 40 and 75 years old, and \"=\\> 4.0 ng\u002Fml\" for the patients older than 75 years).\n5. Patients with PIRADS 1-2 lesions per pMRI, AND elevated PSA (\"=\\> 3.0 ng\u002Fml\" for patients between 40 and 75 years old, and \"=\\> 4.0 ng\u002Fml\" for the patients older than 75 years), AND at least one of the following:\n\n   1. High PSA density (0.15 ng\u002Fml\u002Fg or higher),\n   2. suspicious DRE,\n   3. a positive\u002Fhigh-risk blood or urine biomarker test,\n   4. high-risk ancestry (Black\u002FAfrican American),\n   5. those with germline mutations that increase the risk for prostate cancer,\n   6. significant personal medical history,\n   7. significant family history,\n   8. persistent and significant increase in PSA levels (persistently elevated PSA for at least 12 months with an increase of at least 100% or more within 24 months, last level confirmed twice).\n\nExclusion Criteria:\n\n1. Patients younger than 18 years old.\n2. Any patient with PIRADS 4-5 lesion per pMRI.\n3. Any patient with known csPCa (GS ≥7 (3+4)) per biopsy.\n4. Any patient with PCa and managed with active surveillance, surgery or radiation.\n\n   a. (Patients who never scanned with pMRI before, had GS 6 (3+3) PCa only per systematic biopsy, and currently need confirmatory prostate biopsy will be allowed to enroll in the trial).\n5. Medically unfit for anesthesia.\n6. Any history of allergic reactions attributed to contrast agents, or other compounds of similar chemical compositions.\n7. Any medical history preventing pMRI or prostate biopsy.\n8. Any medical condition distorting quality of pMRI such as artificial hip prosthesis, and excessive rectal gas.\n9. Any other condition that, in the opinion of the investigator, might interfere with the safe conduct of the study.\n\nInclusion of Women and Minorities: All participants will be men without previous diagnosis for PCa. Men of all ethnic groups and races are eligible for the study. Thus, women will not be included in this study.",{"count":321,"type":22},[275],"Use of AI algorithm for PCa detection is feasible, and AI-informed biopsies (AI-targeted and perilesional biopsy) improves csPCa detection in patients with indeterminate MRI lesions and in patients with low-risk MRI lesions and high-risk clinical features.",[29],"2026-08-18",{"date":232,"type":39},{"date":417,"type":39},"2026-06-19",{"date":419,"type":22},"2029-01",{"name":421,"class":263},"University of Arkansas",{"id":423,"slug":424,"hasResults":12,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":428,"eligibilityCriteria":429,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":226,"enrollmentInfo":430,"targetDuration":432,"studyType":296,"phases":4,"briefSummary":433,"conditions":434,"keywords":4,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":437,"startDateStruct":438,"completionDateStruct":440,"leadSponsor":442,"locationsCount":444},"100582532","adjuvant-chemotherapy-for-high-malignant-prostate-cancer-100582532","NCT06864533","Adjuvant Chemotherapy for High Malignant Prostate Cancer","Evaluation of Chemotherapy With Adjuvant Docetaxel After Radiotherapy for Localized High Malignant Prostate Cancer: A Prospective Muti-center Non-Randomized Controlled Trial","PKUFH-GS5","Inclusion Criteria:\n\n1. Histologically confirmed prostate cancer diagnosed by biopsy or surgery with a Gleason score of 9-10 (GG grade 5) or containing Gleason 5 components.\n2. No evidence of distant metastasis confirmed by imaging.\n3. Expected to receive standard radical treatment or postoperative radiotherapy.\n4. Estimated survival time greater than 12 months.\n5. Aged ≥ 18 years.\n6. Karnofsky Performance Status (KPS) ≥ 80.\n7. Adequate blood count: white blood cell ≥ 3.5 × 10\\^9\u002FL, neutrophils ≥ 1.5 × 10\\^9\u002FL, platelets ≥ 100.0 × 10\\^\n\nExclusion Criteria:\n\n1. History of malignant tumors (except those cured for more than 5 years).\n2. Previous abdominal radiation therapy.\n3. Weight loss \\> 10% within the past 6 months.\n4. Pre-existing or concomitant bleeding disorders.\n5. Active infections.\n6. Significant cardiovascular disease (e.g., controlled hypertension, unstable angina, NYHA class ≥ II congestive heart failure, unstable symptomatic arrhythmias, or ≥ II peripheral vascular disease) or any condition deemed intolerable to chemotherapy by the oncology department.",{"count":431,"type":22},315,"5 Years","This study aims to evaluate the efficacy of adjuvant docetaxel chemotherapy following radical radiotherapy in patients with localized high-grade prostate cancer. Eligible participants include those diagnosed with prostate cancer confirmed by biopsy or surgical pathology, with a Gleason score of 9-10 or containing a Gleason 5 component, and no evidence of distant metastasis. Patients will be divided into two groups: the standard treatment group receiving only radical treatment (radiotherapy or surgery), and the standard treatment plus chemotherapy group, receiving four to six cycles of docetaxel chemotherapy after standard treatment. The primary endpoint is Failure-Free Survival (FFS), with secondary endpoints including Biochemical Relapse-Free Survival (BRFS), Metastasis-Free Survival (MFS), Overall Survival (OS), and assessment of adverse events The study aims to better understand the impact of adjuvant chemotherapy on the prognosis of patients with high-risk prostate cancer and determine whether it improves survival outcomes.",[29,435,76,436],"Radiation Therapy","Gleason Score",{"date":36,"type":39},{"date":439,"type":39},"2019-09-01",{"date":441,"type":22},"2031-09-01",{"name":443,"class":263},"Peking University First Hospital",3,{"id":446,"slug":447,"hasResults":12,"nctId":448,"briefTitle":449,"officialTitle":450,"acronym":451,"eligibilityCriteria":452,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":453,"targetDuration":4,"studyType":23,"phases":454,"briefSummary":455,"conditions":456,"keywords":458,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":463,"startDateStruct":464,"completionDateStruct":466,"leadSponsor":468,"locationsCount":470},"100576464","phase-1-a-phase-1b2a-study-of-pocenbrodib-as-monotherapy-and-in-combination-with-darolutamide-in-participants-with-mcrpc-100576464","NCT06785636","A Phase 1b\u002F2a Study of Pocenbrodib as Monotherapy and in Combination With Darolutamide in Participants With mCRPC","PATHWAY: A Phase 1b\u002F2a, Multicenter, Open- Label Study of Pocenbrodib as Monotherapy and in Combination With Darolutamide in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)","P300","1b \u002F 2a Inclusion Criteria:\n\n1. ≥18 years of age\n2. Histologic documentation of prostate adenocarcinoma\n3. Metastatic disease, documented by imaging. Imaging performed within 56 days prior to Screening is acceptable\n\n1b \u002F 2a Exclusion Criteria:\n\n1. Current or prior evidence of any small cell or neuroendocrine histology on the most recent prostate biopsy.\n2. Any liver metastases confirmed by biopsy or evidence of lesions \\>1 cm consistent with liver metastases on imaging.\n3. Intervention with any chemotherapy, investigational agent, or other anticancer drug, including enzalutamide, apalutamide, or darolutamide, 14 days prior to Cycle 1 Day 1 or 5 half-lives (whichever is shorter).\n4. Any other serious underlying medical, psychiatric, psychological, familial, or geographical condition, which in the judgment of the Investigator may interfere with study participation and compliance or place the participant at high risk from treatment-related complications.\n\n2a only -key inclusion criteria:\n\n1. Must have received at least 2 cycles of PLUVICTO®\n2. 1 line of prior any ARPI therapy\n3. No prior chemotherapy for mCRPC",{"count":57,"type":22},[59,25],"This is a dose-finding study to assess the safety and preliminary antitumor activity of Pocenbrodib alone or with darolutamide in patients with metastatic castration-resistant prostate cancer (mCRPC)",[457,29],"mCRPC (Metastatic Castration-resistant Prostate Cancer)",[459,460,461,462],"mCRPC, metastatic castrate resistant prostate cancer, prostate cancer,","darolutamide","Pocenbrodib","p300-CBP Transcription Factors",{"date":36,"type":39},{"date":465,"type":39},"2025-02-07",{"date":467,"type":22},"2029-04-30",{"name":469,"class":134},"Pathos AI, Inc.",19,{"id":472,"slug":473,"hasResults":12,"nctId":474,"briefTitle":475,"officialTitle":476,"acronym":4,"eligibilityCriteria":477,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":478,"targetDuration":4,"studyType":23,"phases":480,"briefSummary":481,"conditions":482,"keywords":485,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":487,"startDateStruct":488,"completionDateStruct":490,"leadSponsor":492,"locationsCount":444},"100527642","phase-2-mdrt-in-prostate-cancer-treated-with-long-term-androgen-deprivation-therapy-in-the-stampede-trial-metanova-100527642","NCT06150417","MDRT in Prostate Cancer Treated With Long-term Androgen Deprivation Therapy in the STAMPEDE Trial (METANOVA)","Metastasis-directed Radiotherapy (MDRT) for Men With De-novo Oligometastatic Prostate Cancer Treated With Long-term Androgen Deprivation Therapy in the STAMPEDE Trial (METANOVA)","Inclusion Criteria:\n\n* Participant must be ≥ 18 years of age.\n* Participant must have an ECOG performance status ≤ 1.\n* Histologic confirmation of prostate adenocarcinoma of the prostate gland, with evidence of metastasis on imaging by conventional imaging (MRI, CT, or 99mTc bone scan) or PSMA PET\u002FCT. Biopsy of sites of metastasis is strongly encouraged, but not required.\n\n  * There must be at least 10-15 unstained slides from 2 cores of the highest tumor cellularity available.\n* Newly diagnosed disease with no prior treatment(surgery, radiation or systemic treatment, ie hormone therapy or chemotherapy) to the primary disease.\n\n  * Participants may have started LHRH agonist or antagonist therapy, and\u002For androgen receptor signaling inhibitor (ARSI) as long as it was not started more than 30 days before the participant is enrolled on this study.\n* In participants who undergo only conventional imaging, oligometastatic disease is defined as 1-5 discrete metastatic sites in the bone and\u002For extra-pelvic lymph node (LN) stations.\n\n  * Extra-pelvic LN stations are superior to the regional\u002Fpelvic LN stations. Pelvic LN stations commence at the bifurcation of the aorta and bifurcation of the proximal inferior vena cava to the common iliac veins.\n\n    * Radiographic criteria for a LN to be considered a metastatic focus is defined as short-axis diameter in the axial plane of ≥ 1.0 cm, with irregular border and\u002For heterogeneous morphology\n* In participants who undergo PSMA PET\u002FCT (in the presence or absence of conventional imaging), oligometastatic disease is defined as 1-10 PSMA avid bone lesions and\u002For extra-pelvic LN stations. The MI-RADS reporting system will be followed to guide PSMA PET interpretation\n\n  * In participants extra-pelvic nodal (M1a) disease only by PSMA PET\u002FCT and M0 by conventional imaging (i.e. extra-pelvic LN did not meet size criteria by CT), participant must meet 2 of 3 following criteria in order to be eligible:\n\n    * 1\\. PSA ≥ 40\n    * 2\\. Evidence of cN1 disease (pelvic LN)\n    * 3\\. Decipher score ≥ 0.89\n* Adequate organ and marrow function to receive treatment per treating physician\n* Medically fit for treatment and agreeable to follow-up.\n* Ability to understand and the willingness to sign a written informed consent.\n\nExclusion Criteria:\n\nParticipants with the presence of any of the following:\n\n* Castration resistant prostate cancer (CRPC).\n* Evidence of visceral or intracranial metastases.\n* Participant receiving any other investigational agents for cancer.\n* Participant is participating in a concurrent treatment protocol for cancer.\n* Unable to lie flat during or tolerate PET\u002FMRI, PET\u002FCT or SBRT.\n* Prior definitive treatment to the primary prostate cancer or pelvis.\n* Participant with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled diabetes (HgA1c \\> 10), active pituitary or adrenal dysfunction, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* History of another active malignancy within the previous 2 years, except for non-melanoma skin cancer, non-muscle invasive bladder cancer, or a malignancy that is considered cured with minimal risk of recurrence\n* Active Crohn's disease or ulcerative colitis despite medical management.\n* Refusal to sign informed consent.\n* Any condition that in the opinion of the investigator would preclude participation in this study",{"count":479,"type":22},200,[25],"The purpose of this study is to find out if giving radiation therapy (RT) to areas of metastatic prostate cancer at the time a participant is diagnosed will help control disease better than the usual treatment. This treatment is called metastasis-directed radiotherapy (MDRT).\n\nThe usual treatment for prostate cancer that has spread to other parts of the body is to give lifelong treatment with hormone therapy (also known as androgen deprivation therapy or ADT). Participants may also be given prostate RT even if the disease is metastatic. Participants will receive hormone therapy (the standard treatment for prostate cancer) for 12 months. The hormone therapy agents may be taken by mouth or given as an injection. Participants will also have prostate RT. Up to 50 participants will have surgery to remove the prostate instead of having prostate RT. A portion of the participants will be randomized to receive MDRT to areas where the cancer has spread. For participants who have surgery to remove their prostate, they will be asked to allow tissue samples collected during the surgery to be sent to an outside lab for research tests and extra blood samples drawn for research tests before starting the study, and at the time the cancer becomes worse if applicable. Participation in the study will last approximately 12 months, and will be followed by their doctor for up to five years per standard of care.\n\nThe main goal is to compare the efficacy of the standard of care (standard systemic therapy + definitive prostate-directed local therapy) versus the standard of care with metastasis-directed radiotherapy (MDRT) for consolidation of metastatic disease.",[29,483,484],"Malignant Neoplasm of Prostate","Secondary Malignant Neoplasm of Prostate",[486],"Metastasis-directed Radiotherapy",{"date":232,"type":39},{"date":489,"type":39},"2024-07-01",{"date":491,"type":22},"2028-12-01",{"name":493,"class":263},"Case Comprehensive Cancer Center",{"id":495,"slug":496,"hasResults":12,"nctId":497,"briefTitle":498,"officialTitle":499,"acronym":4,"eligibilityCriteria":500,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":501,"targetDuration":4,"studyType":23,"phases":502,"briefSummary":503,"conditions":504,"keywords":506,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":510,"startDateStruct":511,"completionDateStruct":513,"leadSponsor":515,"locationsCount":47},"100523529","phase-2-enzalutamide-and-pds01adc-in-pet-positive-recurrent-prostate-cancer-pprpc-without-testosterone-lowering-therapy-100523529","NCT06096870","Enzalutamide and PDS01ADC in PET Positive Recurrent Prostate Cancer (pprPC) Without Testosterone Lowering Therapy","Phase II Trial of Enzalutamide and PDS01ADC in PET Positive Recurrent Prostate Cancer (pprPC) Without Testosterone Lowering Therapy","* INCLUSION CRITERIA:\n* Participant must provide documentation of histologic or cytological confirmation of prostate cancer or tumor sample for diagnosis confirmation. Note: in the absence of pathology or documentation, participant must have a rising PSA, PSMA+ disease, and his history consistent with prostate cancer as documented by the investigator.\n* History of primary treatment for prostate cancer (either surgery or radiation).\n* Prostate-specific antigen (PSA) doubling time within less than 12 months.\n* Testosterone \\>100 ng\u002FdL.\n* Age \\>=18 years.\n* Evidence of prostate cancer on PSMA PET\u002FCT scan.\n* Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C2.\n* Men must agree to use an effective method of contraception (barrier or surgical sterilization) after study entry and for 3 months after completion of enzalutamide or PDS01ADC therapy whatever comes later.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * Absolute neutrophil count (ANC) \\>=1,500\u002Fmicroliter, without granulocyte colony-stimulating factor (G-CSF) support\n  * Platelets \\>=100,000\u002Fmicroliter\n  * Aspartate aminotransferase (AST) \u002FAlanine aminotransferase (ALT) \\\u003C=2.5 x institutional upper limit of normal (ULN)\n  * Hemoglobin (Hgb) \\>= 10 g\u002FdL (packed red blood cell (pRBC) transfusions are not allowed to achieve acceptable Hgb)\n  * Total bilirubin \\\u003C= 1.5 x ULN, OR \\\u003C= 3.0 ULN in participants with Gilbert s syndrome\n  * Serum albumin \\>= 2.8 g\u002FdL\n  * Creatinine \\\u003C 1.5 X institution ULN\n\nOR\n\n--Measured or calculated creatinine clearance (CrCl) (estimated glomerular filtration rate (eGFR) may also be used in place of CrCl) \\> 45 mL\u002Fmin\u002F1.73 m\\^2 for participant with creatinine levels \\> 1.5 x institutional ULN\n\n* Hepatitis B virus (HBV)-infected participants can be enrolled if HBV DNA is undetectable at screening. Hepatitis C virus (HCV)-infected participants can be enrolled if the HCV RNA level is undetectable at screening. Human immunodeficiency virus (HIV)-positive participants can be enrolled if HIV DNA is undetectable.\n* Participants must be able to swallow tablets\u002Fcapsules.\n* Participants must be able to understand and willing to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Evidence of soft tissue disease on CT scan (or magnetic resonance imaging (MRI) if assessment cannot be done by CT scan) per RECIST 1.1 criteria (lymph nodes up to 2.0 cm in the shortest dimension are allowed).\n* Evidence of bone lesions on Tc99 bone scan.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study drugs or imaging agents used in the study.\n* Any medical condition that requires chronic systemic steroid therapy, or any other form of immunosuppressive medication (inhaled and topical steroids are permitted).\n* History of seizures within the last 10 years.\n* Therapy with strong inhibitors or inducers of CYP2C8 or CYP3A4 within 5 half-lives prior to the study treatment initiation. Standard clinical resources (e.g., Lexidrug) should be consulted to determine the classification of CYP inhibitors and inducers.\n* Participants with prior malignancy active within 3 years prior to study treatment initiation except for locally curable cancers that have been apparently cured such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the breast.\n* Uncontrolled intercurrent illness that would limit compliance with study requirements.",{"count":21,"type":22},[25],"Background:\n\nProstate cancer may return after treatment in 30,000 to 50,000 people each year. There is no clear best way to treat these people. Better treatments are needed.\n\nObjective:\n\nTo test a study drug (enzalutamide), both alone and combined with a second drug (PDS01ADC), in people with prostate cancer that returned after treatment.\n\nEligibility:\n\nPeople aged 18 years and older with prostate cancer that returned after treatment.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam, with blood tests. All their urine will be collected for 24 hours. They will have imaging scans of their chest, abdomen, pelvis, and bones. Their ability to perform everyday activities will be assessed. They may opt to give a stool sample.\n\nParticipants will be treated in 4-week cycles.\n\nEnzalutamide is a pill taken by mouth once a day, every day. All participants will be given a supply of this drug to take at home.\n\nPDS01ADC is injected under the skin once a month, on the first day of each cycle. Half of the participants will receive both drugs.\n\nAll participants will visit the clinic once a month. Each visit should last no more than 8 hours. Blood and urine tests will be repeated.\n\nAll participants will receive the study treatment for 3 cycles. Some participants may need 3 more cycles of treatment with enzalutamide only. This re-treatment can be done only once.\n\nParticipants will have a follow-up visit 1 month after they finish treatment. After that, they will have visits every 6 weeks for up to 5 years. Imaging scans and blood tests will be repeated.\n\n...",[29,28,505],"PET Positive",[507,28,505,508,509],"Combination Therapy","Enzalutamide","PDS01ADC",{"date":232,"type":39},{"date":512,"type":39},"2024-04-22",{"date":514,"type":22},"2029-12-31",{"name":45,"class":46},{"id":517,"slug":518,"hasResults":12,"nctId":519,"briefTitle":520,"officialTitle":521,"acronym":4,"eligibilityCriteria":522,"healthyVolunteers":12,"sex":17,"minAge":523,"maxAge":4,"enrollmentInfo":524,"targetDuration":4,"studyType":23,"phases":526,"briefSummary":527,"conditions":528,"keywords":529,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":536,"startDateStruct":537,"completionDateStruct":539,"leadSponsor":541,"locationsCount":47},"100611183","phase-2-abipred--adt-vs-adt-in-psma-positive-conventionally-node-negative-prostate-cancer-100611183","NCT07237269","Abi\u002FPred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer","Abiraterone\u002FPrednisone + Standard ADT vs Standard ADT for Prostate Cancer Patients With PSMA-Positive Conventional Imaging Negative Pelvic Lymphadenopathy","Inclusion Criteria:\n\n1. Histopathologically proven diagnosis of local prostate cancer. Biopsies will be confirmed by UNMC pathology review if collected outside our institution.\n2. Targetable PSMA-avid pelvic lymph node measuring \\\u003C1cm in short axis diameter.\n3. No prior definitive treatment or intervention received.\n4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 within 14 days prior to registration.\n5. Age ≥ 30 years.\n6. Patient must be able to provide study-specific informed consent prior to study entry.\n7. Patient must be able to swallow medications.\n\nExclusion Criteria:\n\n1. Evidence of distant metastatic disease outside the pelvic lymph nodes (including osseous pelvic disease).\n2. Presence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse.\n3. Relative or absolute contraindications to radiation therapy as determined by the treating physician. These include, but are not limited to, inflammatory bowel disease, connective tissue disorders (systemic lupus erythematosus, scleroderma, etc.), and genetic disorders that risk increased sensitivity to radiation therapy.\n4. Severe, active co-morbidity, defined as follows:\n\n   1. Unstable angina and\u002For congestive heart failure requiring hospitalization within the last 3 months prior to registration.\n   2. Congestive heart failure (NYHA functional capacity class II or greater).\n   3. Transmural myocardial infarction within the last 3 months prior to registration.\n   4. History of stroke or transient ischemic attack within 3 months prior to registration.\n   5. Currently uncontrolled diabetes mellitus.\n   6. Ongoing arrhythmias of Grade \\>2 \\[National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTCAE), version 5.03\\]; chronic stable atrial fibrillation on stable anticoagulant therapy is allowed.\n   7. Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism) in the past month.\n   8. Significant vascular disease (e.g., aortic aneurysm, history of aortic dissection) or clinically significant peripheral vascular disease.\n   9. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.\n   10. Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration.\n   11. Hepatic insufficiency resulting in clinical jaundice and\u002For coagulation defects.\n   12. Acquired Immune Deficiency Syndrome (AIDS) based upon the current Centers for Disease Control and Prevention definition that is being treated with contraindicated medications, including but not limited to Atazanavir, Saquinavir, Ritonavir, Indinavir, or Nelfinavir. Note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.\n   13. Uncontrolled seizures or seizures in the past 3 months. Patients can enroll if their seizures have been well-controlled for \\>3 months on antiseizure medications.\n   14. Gastrointestinal bleeding or any other hemorrhage\u002Fbleeding event CTCAE version 5 grade 3 or greater within 30 days prior to registration.\n   15. History of a non-healing wound, ulcer, or bone fracture within 90 days (3 months) prior to registration.\n   16. Total bilirubin ≥1.5X upper limit of normal (ULN) \\[except for subjects with Gilbert's disease, in which case total bilirubin not to exceed 10X ULN\\], alanine (ALT) and aspartate (AST) aminotransferase \\>= 2.5X ULN.","30 Years",{"count":525,"type":22},140,[25],"The advent of PSMA-PET has improved sensitivity and specificity in staging prostate cancer, particularly in intermediate- and high-risk disease. This has created uncertainty in the management of patients with PSMA-positive but conventionally negative pelvic lymphadenopathy (i.e., \\\u003C1 cm in smallest diameter).\n\nThis study evaluates outcomes of enhanced androgen deprivation therapy (ADT) with abiraterone and prednisone compared to standard ADT, both in combination with radiation therapy, in patients with prostate cancer and PSMA-positive but conventionally negative pelvic lymphadenopathy.\n\nA total of 140 eligible participants will be randomized to receive either enhanced ADT with abiraterone and prednisone or standard ADT, both with concurrent radiation therapy. Participants will be followed for 5 years after completion of ADT to assess outcomes.\n\nThe primary objective is to determine whether enhanced ADT improves 5-year failure-free survival compared to standard ADT. Secondary objectives include evaluation of toxicity, quality of life, biochemical progression-free survival, cancer-specific survival, overall survival, and metastasis-free survival.\n\nExploratory objectives include evaluation of tumor growth and regression rates using PSA values and assessment of the relationship between treatment outcomes and blood-based heme oxygenase-1 (HO-1) levels.",[29],[530,29,531,532,435,533,534],"PSMA-PET","Androgen Deprivation Therapy","Abiraterone","Pelvic Lymphadenopathy","Hormone Therapy","2026-08-17",{"date":232,"type":39},{"date":538,"type":22},"2026-10-15",{"date":540,"type":22},"2033-04-03",{"name":542,"class":263},"University of Nebraska",{"id":544,"slug":545,"hasResults":12,"nctId":546,"briefTitle":547,"officialTitle":547,"acronym":4,"eligibilityCriteria":548,"healthyVolunteers":549,"sex":17,"minAge":352,"maxAge":353,"enrollmentInfo":550,"targetDuration":4,"studyType":23,"phases":552,"briefSummary":553,"conditions":554,"keywords":556,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":561,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":566,"locationsCount":47},"100601356","impact-of-an-electronic-health-record-maintenance-alert-on-psa-screening-rates-in-a-10-hospital-integrated-health-system-100601356","NCT07109427","Impact of an Electronic Health Record Maintenance Alert on PSA Screening Rates in a 10-Hospital Integrated Health System","Eligibility Criteria:\n\n* Receive care within the BJC Health System\n* Have had at least one primary care physician appointment in the calendar year of PSA screening (primary care)\n* Be male\n* Not have a history of prostate cancer\n* Meet one of the following risk criteria:\n\n  * High Risk for Prostate Cancer\n\n    * African American, between the ages of 40 and 75 (inclusive), or\n    * Family history of prostate, breast, ovarian, and\u002For pancreatic cancer, or\n    * Known familial germline mutation OR\n  * Average Risk for Prostate Cancer\n\n    * Between the ages of 50 and 75 (inclusive)",true,{"count":551,"type":22},40000,[275],"\\- The investigators propose a clinical trial to evaluate the impact of annual shared decision making for PSA screening, supported by system-level enhancements to promote evidence-based care:\n\n* Defined referral thresholds within the health maintenance reminder, aligned with clinical risk stratification per NCCN guidelines.\n* Enhanced clinical decision support (CDS) tools to reduce provider variation and ensure guideline-concordant screening and referral practices.\n* The goal is to reduce late-stage presentation without increasing overdiagnosis-ensuring that prostate cancer screening is both accessible and clinically effective.",[29,555],"Cancer of the Prostate",[557,558,559,560],"PSA Screening","Clinically Significant Prostate Cancer","African American men","Electronic Health Record",{"date":232,"type":39},{"date":563,"type":39},"2025-08-11",{"date":565,"type":22},"2031-08-31",{"name":567,"class":263},"Washington University School of Medicine",{"id":569,"slug":570,"hasResults":12,"nctId":571,"briefTitle":572,"officialTitle":573,"acronym":574,"eligibilityCriteria":575,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":576,"targetDuration":4,"studyType":296,"phases":4,"briefSummary":578,"conditions":579,"keywords":4,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":580,"startDateStruct":581,"completionDateStruct":583,"leadSponsor":585,"locationsCount":586},"100596984","aggressive-disease-treatment-patterns-and-ctdna-hrr-evaluation-in-high-volume-metastatic-hormone-sensitive-prostate-cancer-in-russian-federation-100596984","NCT07052578","Aggressive Disease Treatment Patterns and CtDNA HRR evaluatiON in High-volume metastatiC hORmone-sensitive Prostate Cancer in Russian FeDeration","A Multicentre Observational Study on Treatment Patterns and ctDNA HRR Evaluation in Aggressive High-volume Metastatic Hormone-sensitive Prostate Cancer in Russian Federation","CONCORD","Inclusion Criteria:\n\n1. Male patients aged ≥ 18 years old;\n2. Signed ICF, including consent for blood samples ctDNA and ctDNA-based HRRm testing;\n3. Metastatic hormone-sensitive prostate cancer (mHSPC) (de novo or progressed from earlier stages);\n4. High-aggressive disease (Gleason 8-10);\n5. High-volume disease (according to CHAARTED trial criteria: presence of 4 and more (≥4) bone metastases (including at least one (≥1) outside the vertebral column\u002Fpelvis) and\u002For 1 and more (≥1) visceral metastasis);\n6. Availability of source medical documentation;\n7. Known HRRm status based on tumour sample evaluation performed in routine practice.\n\nExclusion Criteria:\n\n1. Participation in any interventional trial since the mPC diagnosis.\n2. Progression to mCRPC.",{"count":577,"type":22},400,"A multicentre observational study on treatment patterns and ctDNA HRR evaluation in aggressive high-volume metastatic hormone-sensitive prostate cancer in Russian Federation",[29],{"date":414,"type":39},{"date":582,"type":39},"2025-06-30",{"date":584,"type":22},"2028-11-30",{"name":162,"class":134},26,{"id":588,"slug":589,"hasResults":12,"nctId":590,"briefTitle":591,"officialTitle":592,"acronym":593,"eligibilityCriteria":594,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":595,"enrollmentInfo":596,"targetDuration":4,"studyType":23,"phases":598,"briefSummary":599,"conditions":600,"keywords":601,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":614,"startDateStruct":615,"completionDateStruct":617,"leadSponsor":619,"locationsCount":621},"100581820","phase-3-study-comparing-aaa817arpi-versus-standard-of-care-in-adult-participants-with-psma-positive-mcrpc-100581820","NCT06855277","Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC","A Phase III, Open-label, Multi-center, Randomized Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive Metastatic Castration Resistant Prostate Cancer","AcTFirst","Key Inclusion Criteria:\n\n* Signed informed consent must be obtained prior to participation in the study.\n* Participants must be adults ≥ 18 years of age.\n* Participants must have an ECOG performance status of 0 to 2.\n* Participants must have histological, and\u002For cytological confirmation of adenocarcinoma of the prostate. Participants with mixed histology (neuroendocrine) are not eligible.\n* Participants who have received taxane-based chemotherapy in mHSPC setting are eligible if they are deemed appropriate for chemotherapy, ARPI change or AAA617 as the next line of therapy in the opinion of the Investigator. Note: Participants who have received taxane-based chemotherapy for mCRPC are excluded.\n* Participants must not have received taxane-based chemotherapy in mCRPC setting (allowed in mHSPC setting).\n* Participants must have PSMA-PET positive disease using a PSMA imaging agent that is approved as per protocol.\n* Participant must have been diagnosed with mCRPC with documented progressive disease while on treatment with ARPI in mHSPC or earlier setting as their last treatment (and did not progress on more than one ARPI).\n\n  * Participants with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer, as per local testing, may be enrolled if they had prior exposure to PARPi.\n\nKey Exclusion Criteria:\n\n* Previous anti-cancer treatment with any approved or investigational radiopharmaceuticals (for example, \\[177Lu\\]Lu-PSMA, \\[177Lu\\]-DOTA, or Radium- 223.)\n* Previous treatment with any external beam radiotherapy including hemi-body radiation within 6 weeks of randomization (within 2 weeks for radiotherapy of localized metastases).\n\n  * Any prior PARP inhibitor or other systemic anticancer therapy administered for metastatic castration-resistant prostate cancer (mCRPC). Any other approved or investigational systemic therapy (including chemotherapy, immunotherapy, biologics, or monoclonal antibodies) is prohibited within 28 days or 5 half-lives (whichever is shorter) before randomization.\n\nNote: Prior ARPI administered in the mHSPC setting or earlier may continue until C1D1.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","100 Years",{"count":597,"type":22},940,[147],"The purpose of this study is to determine whether \\[225Ac\\]Ac-PSMA-617 (AAA817), given for up to 6 cycles at a dose of 10 Megabecquerel (MBq) +\u002F- 10%, plus androgen receptor pathway inhibitor (ARPI), improves the radiographic progression free survival (rPFS) compared to investigator's choice of standard of care (SOC) (ARPI change or taxane-based chemotherapy or \\[177Lu\\]Lu-PSMA-617 (AAA617)) in adult participants with PSMA-positive metastatic castration resistant prostate cancer (mCRPC) treated with another ARPI as last treatment and who have not been exposed to a taxane-containing chemotherapy in the mCRPC setting nor have received any prior PSMA-targeting radioligand therapy.",[29],[602,202,603,604,605,606,607,608,609,610,611,199,593,612,613],"Positive Metastatic Castration Resistant Prostate Cancer","PSMA-positive","AAA817","[225AC] AC-PSMA-617","Radioligand Therapy","RLT","Androgen receptor pathway inhibitor","ARPI","Taxane","Metastatic castration resistant prostate cancer","[177Lu]Lu- PSMA-617","AAA617",{"date":232,"type":39},{"date":616,"type":39},"2025-07-01",{"date":618,"type":22},"2032-11-04",{"name":620,"class":134},"Novartis Pharmaceuticals",92,{"id":623,"slug":624,"hasResults":12,"nctId":625,"briefTitle":626,"officialTitle":627,"acronym":4,"eligibilityCriteria":628,"healthyVolunteers":549,"sex":17,"minAge":352,"maxAge":629,"enrollmentInfo":630,"targetDuration":4,"studyType":23,"phases":632,"briefSummary":633,"conditions":634,"keywords":635,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":639,"startDateStruct":640,"completionDateStruct":642,"leadSponsor":644,"locationsCount":47},"100558278","veteran-peer-navigators-to-promote-shared-decision-making-for-psa-screening-100558278","NCT06549036","Veteran Peer Navigators to Promote Shared Decision Making for PSA Screening","Randomized Trial of Veteran Peer Navigators to Promote Shared Decision Making for PSA Screening","Inclusion Criteria:\n\nVeteran patient participants:\n\n* Veteran\n* Male\n* Attending VANYHHS-Manhattan for routine primary care appointment\n\nProviders:\n\n* Primary care provider at VA New York Harbor Healthcare System (VANYHHS)\n* Caring for patients that fit inclusion criteria\n\nExclusion Criteria:\n\nVeteran Patients:\n\n* Patients seen within 9 months of other PSA tests\n* Patients seen within 180 days after primary diagnosis of urinary obstruction, prostatitis, hematuria, other disorder of prostate, unexplained weight loss, or lumbar back pain\n* Patients with a prior diagnosis of prostate cancer (ICD-10-CM C61)\n* Patients visiting their provider for any indication other than a well-visit appointment\n\nProviders:\n\n\\- Providers who do not treat adult male patients (e.g. OB\u002FGyns, pediatricians)","69 Years",{"count":631,"type":22},228,[275],"The project will investigate the efficacy of a Veteran-peer-navigator-led decision coaching (PDC) program to promote Shared Decision Making (SDM) for prostate cancer screening among Veterans at the Veterans Health Administration (VA). Prostate cancer is commonly screen detected using PSA, a non-specific test which has led to modest population-level survival benefits at the cost of over-detection of low-risk disease. This trade off in outcomes is ideally addressed using SDM which can be challenging to implement in time constrained primary care office visits. The investigators propose the evaluation of a PDC intervention to promote SDM for PSA screening to improve both access and quality of care for Veterans. The investigators results will enhance understanding of the efficacy, cost-effectiveness, and sustainability of PDC interventions for SDM promotion across communication formats in the VA. Lessons learned through this proposal will not only improve quality of care for PSA screening but also will suggest a paradigm for dissemination of SDM across preventive services.",[29],[636,637,638],"prostate cancer","Prostate-Specific Antigen","shared decision making",{"date":232,"type":39},{"date":641,"type":22},"2026-10-05",{"date":643,"type":22},"2028-08-31",{"name":645,"class":646},"VA Office of Research and Development","FED",{"id":648,"slug":649,"hasResults":12,"nctId":650,"briefTitle":651,"officialTitle":652,"acronym":4,"eligibilityCriteria":653,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":654,"targetDuration":4,"studyType":23,"phases":656,"briefSummary":657,"conditions":658,"keywords":4,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":660,"startDateStruct":661,"completionDateStruct":663,"leadSponsor":665,"locationsCount":47},"100522672","phase-1-a-pilot-presurgical-trial-of-regn5678-anti-psma-x-cd28-in-patients-with-high-risk-localized-prostate-cancer-followed-by-radical-prostatectomy-100522672","NCT06085664","A Pilot Presurgical Trial of REGN5678 (Anti-PSMA x CD28) in Patients With High-risk, Localized Prostate Cancer Followed by Radical Prostatectomy","A Pilot Presurgical Trial of REGN5678 (Anti-PSMA X CD28) in Patients With High-Risk, Localized Prostate Cancer Followed by Radical Prostatectomy","Inclusion Criteria:\n\n* Men ≥ 18 years of age\n* Histologically documented Gleason 8 or greater prostatic adenocarcinoma in at least 3 biopsy cores and at least 8 mm of disease on a single core of Gleason 8 or greater. Prostate biopsy within 3 months of screening is allowed for entry requirements. Prostate biopsy must be reviewed at MD Anderson Cancer Center. Patients with small cell, neuroendocrine, or transitional cell carcinomas or mixed histologies are not eligible\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) grade of 0 or 1\n* No evidence of metastatic disease as documented by technetium-99m (99mTc) bone scan and by computed tomography (CT) or magnetic resonance imaging (MRI) scans. Imaging may be obtained up to 60 days prior to enrollment\n* Localized or locally advanced disease deemed by the surgeon to be resectable. Patients must be appropriate candidates for radical prostatectomy plus pelvic lymph node dissection\n* No prior treatment for prostate cancer including prior surgery (excluding transurethral resection of the prostate \\[TURP\\]), cryoablation, pelvic lymph node dissection, radiation therapy, hormonal therapy or chemotherapy\n* Hemoglobin ≥ 11 g\u002FdL\n* Absolute neutrophil count ≥ 1.5 x 10\\^9\u002FL\n* Platelet count ≥ 100 x 10\\^9\u002FL\n* Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or estimated glomerular filtration rate \\> 50 mL\u002Fmin\u002F1.73 m\\^2. A 24-hour urine creatinine collection may substitute for the calculated creatinine clearance to meet eligibility criteria\n* Total bilirubin ≤ 1.5 x ULN\n\n  * NOTES: Patients with Gilbert's syndrome do not need to meet total bilirubin requirements provided their total bilirubin is not greater than their historical level. Gilbert's syndrome must be documented appropriately as past medical history\n* Aspartate aminotransferase (AST) ≤ 2.5 x ULN\n* Alanine aminotransferase (ALT) ≤ 2.5 x ULN\n* Alkaline phosphatase (ALP) ≤ 2.5 x ULN\n* Consent to MD Anderson laboratory protocol PA13-0291\n* Willing and able to comply with clinic visits and study-related procedures\n* Provide informed consent signed by study patient\n* To avoid risk of drug exposure through the ejaculate (even men with vasectomies), subjects must use a condom during sexual activity while on study drug and for 3 months following the last dose of study drug. If the subject is engaged in sexual activity with a woman of childbearing potential, a condom is required along with another effective contraceptive method consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies and their partners. Donation of sperm is not allowed while on study drug and for 3 months following the last dose of study drug\n\nExclusion Criteria:\n\n* Prior hormone therapy for prostate cancer including orchiectomy, antiandrogens, ketoconazole, or estrogens (5-alpha reductase inhibitors allowed), or luteinizing hormone-releasing hormone (LHRH) agonists\u002Fantagonists\n* Currently enrolled in another interventional study\n* Concurrent treatment with systemic corticosteroids (prednisone dose \\> 10 mg per day or equivalent) or other immunosuppressive drugs \\\u003C 14 days prior to treatment initiation. Steroids that are topical, inhaled, nasal (spray), or ophthalmic solution are permitted\n* History of or known or suspected autoimmune disease (exception\\[s\\]: subjects with vitiligo, resolved childhood atopic dermatitis, hypothyroidism, or hyperthyroidism that is clinically euthyroid at screening are allowed)\n* Known evidence of an active infection requiring systemic therapy such as human immunodeficiency virus (HIV), active hepatitis, or fungal infection. Patients with known HIV infection which is well-controlled (undetectable viral load by HIV ribonuclecid acid \\[RNA\\] polymerase chain reaction \\[PCR\\]) and CD4 counts greater than 350 are permitted to participate\n* History of clinically significant cardiovascular disease including, but not limited to:\n\n  * Myocardial infarction or unstable angina ≤ 6 months prior to treatment initiation\n  * Clinically significant cardiac arrhythmia\n  * Deep vein thrombosis, pulmonary embolism, stroke ≤ 6 months prior to treatment initiation\n  * Congestive heart failure (New York Heart Association class III-IV)\n  * Pericarditis\u002Fclinically significant pericardial effusion\n  * Myocarditis\n  * Endocarditis\n* History of major implant(s) or device(s), including but not limited to:\n\n  * Prosthetic heart valve(s)\n  * Artificial joints and prosthetics placed ≤ 12 months prior to treatment initiation\n  * Current or prior history of infection or other clinically significant adverse event associated with an exogenous implant or device that cannot be removed\n* Other prior malignancy (exceptions: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) ≤ 2 years prior to enrollment\n* Has received major surgery within 14 days of first administration of study drug\n* Encephalitis, meningitis, neurodegenerative disease (with the exception of mild dementia that does not interfere with activities of daily living \\[ADLs\\]) or uncontrolled seizures in the year prior to first dose of study therapy\n* Known history of, or any evidence of interstitial lung disease, or active, non-infectious pneumonitis (past 5 years)\n* Receipt of a live vaccine within 4 weeks of planned start of study medication\n* Prior allogeneic stem cell transplantation or recipients of organ transplants at any time, or autologous stem cell transplantation within 12 weeks of the start of study treatment\n* Any medical, psychological or social condition that in the opinion of the investigator, would preclude participation in this study",{"count":655,"type":22},42,[59,25],"To learn about the safety and effects of a drug called REGN5678 when it is given to patients with high-risk prostate cancer.",[29,659],"Radical Prostatectomy",{"date":232,"type":39},{"date":662,"type":39},"2023-12-04",{"date":664,"type":22},"2028-06-30",{"name":666,"class":263},"M.D. Anderson Cancer Center"]