[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-prostate-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-prostate-cancer":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,39,67,87,112,134,165,186,229,264,291,314,338,361,393,421,453],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100544466","phase-1-prorad-5-prostate-radiation-in-5-fractions-phase-ii-five-fraction-radiotherapy-for-patients-with-advanced-prostate-cancer-100544466",false,"NCT06369246","PRORAD-5 PROstate RADiation in 5 Fractions: Phase II Five Fraction Radiotherapy for Patients With Advanced Prostate Cancer.","Inclusion Criteria:\n\n1. Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of prostate within one year of study entry. Evaluation can happen outside of MD Anderson as long as histological confirmation takes place at MD Anderson.\n\n   1. cT1c-T3a by digital exam or imaging (AJCC 8th Ed.). No cT3b-4 by digital exam or imaging (AJCC 8th Ed.)\n   2. Gleason Grade Group 2-5 (Gleason 7, 8, 9, 10).\n   3. If Gleason Grade 2, must meet definition of unfavorable intermediate risk (at least one of the following: cT2b, and\u002For ≥ 50% biopsy cores positive, and\u002For PSA \\>10 ng\u002FmL prior to starting androgen deprivation therapy (ADT).\n\n   If a participant is taking 5-alpha reductase inhibitors the measured PSA may be doubled).\n2. Node negative by conventional imaging.\n3. Be ≥ 18 years of age on the day of signing informed consent.\n4. Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both LHRH agonist and oral anti-androgen) is ≤ 185 days prior to registration; Please note: baseline PSA must be obtained prior to the start of any ADT.\n5. ECOG performance status 0-2.\n\nExclusion Criteria:\n\n1. Diagnosis of active scleroderma, lupus, or other rheumatologic disease which in the opinion of the treating radiation oncologist precludes safe RT.\n2. Prior prostatectomy, cryosurgery, or HIFU for adenocarcinoma of the prostate\n3. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation fields\n4. Distant metastatic disease on conventional imaging, which by the discretion of the treating physician cannot be treated definitively.","ALL","18 Years",{"count":18,"type":19},100,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","To look at the safety and effectiveness of stereotactic body radiation therapy (SBRT) in treating advanced or high-risk prostate cancer.",[25],"Advanced Prostate Cancer","RECRUITING","2026-08-20",{"date":29,"type":30},"2026-08-21","ACTUAL",{"date":32,"type":30},"2024-06-27",{"date":34,"type":19},"2027-09-01",{"name":36,"class":37},"M.D. Anderson Cancer Center","OTHER",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":46,"minAge":16,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":20,"phases":49,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":66},"100500777","a-study-evaluating-the-safety-pharmacokinetics-and-activity-of-ro7656594-in-participants-with-advanced-or-metastatic-prostate-cancer-100500777","NCT05800665","A Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7656594 In Participants With Advanced or Metastatic Prostate Cancer","A Phase 1, Open-Label, Multicenter, Dose-Escalation and Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7656594 in Patients With Advanced or Metastatic Prostate Cancer","Key Inclusion Criteria:\n\n1. Eastern Cooperative Oncology Group (ECOG) performance status ≤1.\n2. Metastatic prostate adenocarcinoma without small-cell carcinoma or neuroendocrine features.\n3. Prior therapy with a second-generation androgen receptor (AR)-targeted therapy (e.g., abiraterone, enzalutamide, apalutamide, darolutamide).\n4. Prior therapy with a taxane regimen or are considered ineligible for treatment with a taxane regimen or have refused treatment with a taxane regimen, unless otherwise specified.\n5. For participants with a known pathogenic breast cancer gene 1 (BRCA1) or BRCA2 mutation: prior therapy with a poly (adenosine diphosphate (ADP)-ribose) polymerase (PARP) inhibitor, or are considered ineligible for treatment with a PARP inhibitor, if such therapy is approved and available.\n\nKey Exclusion Criteria:\n\n1. Treatment with any approved systemic anti-cancer therapy within 14 days or 5 drug elimination half-lives (whichever is longer, not to exceed 28 days) prior to the first study treatment.\n2. Treatment with any investigational agent within 28 days prior to the first study treatment.\n3. Treatment with any previous AR protein degrader.\n4. Untreated central nervous system (CNS) metastases or leptomeningeal disease.\n\nNote: Other protocol specified inclusion\u002Fexclusion criteria may apply.","MALE",{"count":48,"type":19},210,[50],"PHASE1","The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary activity of RO7656594 in participants with advanced or metastatic prostate cancer. It will also identify recommended doses and regimens for RO7656594 for subsequent studies.",[25,53],"Metastatic Prostate Cancer",[55],"Castration-resistant","2026-08-07",{"date":58,"type":30},"2026-08-10",{"date":60,"type":30},"2023-05-02",{"date":62,"type":19},"2027-06-30",{"name":64,"class":65},"Genentech, Inc.","INDUSTRY",26,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":46,"minAge":16,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":20,"phases":76,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},"100636604","a-study-evaluating-the-safety-pharmacokinetics-and-preliminary-activity-of-gdc-1261-in-participants-with-advanced-or-metastatic-prostate-cancer-100636604","NCT07567846","A Study Evaluating the Safety, Pharmacokinetics, and Preliminary Activity of GDC-1261 in Participants With Advanced or Metastatic Prostate Cancer","A Phase I\u002FII Dose-escalation and Expansion Study Evaluating the Safety, Pharmacokinetics, and Preliminary Activity of GDC-1261 in Patients With Advanced or Metastatic Prostate Cancer","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of \\\u003C=1\n* Life expectancy is \\>= 3 months\n* Histologically or cytologically confirmed prostate adenocarcinoma\n* Disease progression during or following the direct prior line of therapy\n* Ongoing androgen deprivation therapy (ADT) with gonadotropin-releasing hormone (GnRH) agonist or antagonist, or have had bilateral orchiectomy\n* Metastatic disease\n* Adequate end organ function\n\nExclusion Criteria:\n\n* Treatment with any approved systemic anti-cancer therapy within 14 days or 5 drug elimination half-lives\n* Structurally unstable bone lesions suggest an impending fracture\n* Untreated central nervous system (CNS) metastases or leptomeningeal disease\n* Uncontrolled pain\n* History of malignancy within 5 years\n* Infection requiring systemic IV antibiotics within 14 days or oral antibiotics within 7 days prior to screening, or any evidence of current infection\n* Any medical condition or abnormal clinical laboratory finding that, in the investigator's judgment, would preclude the individual's safe participation in and completion of the study or could affect the interpretation of the results",{"count":75,"type":19},260,[50,22],"The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and preliminary activity of GDC-1261 in participants with advanced or metastatic prostate cancer. It's also to identify a recommended dose(s) and regimen for GDC-1261 for subsequent studies.",[25,53],"2026-08-06",{"date":58,"type":30},{"date":82,"type":30},"2026-04-29",{"date":84,"type":19},"2027-12-30",{"name":64,"class":65},5,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":46,"minAge":16,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":20,"phases":97,"briefSummary":98,"conditions":99,"keywords":100,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":4},"100649239","phase-2-study-of-xnw5004-tablets-in-advanced-prostate-cancer-100649239","NCT07730580","Study of XNW5004 Tablets in Advanced Prostate Cancer","An Open-Label, Multicenter Phase Ib\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of XNW5004 Tablets in Combination With Anti-Tumor Therapy in Participants With Advanced Prostate Cancer","XNW5004 Tablet","1. Signed written informed consent prior to initiation of any study activity\u002Fprocedure;\n2. Male, ≥18 years of age;\n3. Expected survival ≥ 3 months;\n4. ECOG performance status score of 0-1;\n5. Histologically or cytologically confirmed prostate adenocarcinoma of a single pathological type, excluding neuroendocrine carcinoma or small cell carcinoma;\n6. Bone metastatic lesions confirmed by bone scan, or soft tissue metastatic lesions confirmed by CT\u002FMRI, with at least one evaluable lesion according to RECIST 1.1 and PCWG3 criteria. \\*Note:\\* Isolated regional lymph node metastasis alone does not qualify for study participation;\n7. Continuous luteinizing hormone-releasing hormone agonist (LHRHa) or antagonist therapy (medical castration), or prior bilateral orchiectomy (surgical castration); participants who have not undergone bilateral orchiectomy must plan to maintain effective LHRHa therapy throughout the entire study period;\n8. Castrate level of testosterone at screening (≤50 ng\u002FdL or 1.7 nmol\u002FL);\n9. Disease progression at screening, defined as meeting one or more of the following three criteria while receiving castration therapy: ① PSA progression, defined as PSA \\>1 ng\u002FmL with at least 2 consecutive PSA elevations separated by ≥1 week; ② Disease progression per RECIST 1.1; ③ Bone disease progression per PCWG3 criteria, defined as ≥2 new lesions identified on bone scan;\n10. Prior antitumor therapy meets the following requirements:\n\n    1. Phase Ib:\n\n       * Cohort 1 (combination with abiraterone + prednisone for mCRPC):\\* Prior failure of novel hormonal therapy other than abiraterone acetate - defined as disease progression during treatment with novel hormonal therapy other than abiraterone (for at least 12 weeks) in the setting of mCSPC or mCRPC, or disease progression during treatment with novel hormonal therapy other than abiraterone (for at least 12 weeks) in the non-metastatic setting or within 3 months after completing such therapy; disease progression is defined as per Inclusion Criterion 9.\n       * Cohort 2 (combination with docetaxel + prednisone for mCRPC):\\* Metastatic castration-resistant prostate cancer with prior failure of at least one novel hormonal therapy; failure of novel hormonal therapy is defined as per Cohort 1.\n    2. Phase II:\n\n       * Cohort 1 (combination with abiraterone + prednisone for mCRPC):\\* Prior failure of novel hormonal therapy other than abiraterone acetate - defined as disease progression during treatment with novel hormonal therapy other than abiraterone (for at least 12 weeks) in the setting of mCSPC or mCRPC, or disease progression during treatment with novel hormonal therapy other than abiraterone (for at least 12 weeks) in the non-metastatic setting or within 3 months after completing such therapy; disease progression is defined as per Inclusion Criterion 9.\n       * Cohort 2 (combination with abiraterone + prednisone for mCSPC):No prior systemic antitumor therapy other than androgen deprivation therapy (ADT) and first-generation antiandrogens. Prior ADT (medical or surgical castration) for up to 3 months is allowed, with no evidence of radiographic disease progression or PSA elevation prior to Cycle 1 Day 1.\n       * Cohort 3 (combination with docetaxel + prednisone for mCRPC):Metastatic castration-resistant prostate cancer with prior failure of at least one novel hormonal therapy; failure of novel hormonal therapy is defined as per Cohort 1.\n       * Cohort 4 (combination with enzalutamide for mCSPC):No prior systemic antitumor therapy other than androgen deprivation therapy (ADT) and first-generation antiandrogens. Prior ADT (medical or surgical castration) for up to 3 months is allowed, with no evidence of radiographic disease progression or PSA elevation prior to Cycle 1 Day 1.\n       * Cohort 5 (combination with other agents):Participants with advanced prostate cancer who have failed prior therapy other than the agent class of interest (to be specified via protocol amendment prior to cohort initiation).\n11. Participant laboratory values meet the following requirements:\n\n    1. Hepatic function assessment:\n\n       * Alanine aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5 × ULN for participants with liver metastases);\n       * Aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN for participants with liver metastases);\n       * Total bilirubin ≤ 1.5 × ULN (≤ 3.0 × ULN for Gilbert's syndrome).\n    2. Renal function assessment:\\*\\*\n\n       * Creatinine clearance ≥ 60 mL\u002Fmin (per Cockcroft and Gault formula, Appendix 20.3), or serum creatinine ≤ 1.5 × ULN.\n    3. Hematology assessment:\\*\\*\n\n       * Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹\u002FL (no granulocyte colony-stimulating factor \\[G-CSF\\] within 1 week, and no long-acting G-CSF within 2 weeks prior to screening CBC) - for non-docetaxel combination cohorts; Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL (no G-CSF within 1 week, and no long-acting G-CSF within 2 weeks prior to screening CBC) - for docetaxel combination cohorts;\n       * Platelets ≥ 75 × 10⁹\u002FL (no platelet transfusion and no thrombopoietin \\[TPO\\] within 1 week prior to screening CBC);\n       * Hemoglobin ≥ 8 g\u002FdL (80 g\u002FL) (no red blood cell transfusion and no erythropoietin \\[EPO\\] within 1 week prior to screening CBC).\n    4. Coagulation assessment:\n\n       * Prothrombin time (PT) \\\u003C 1.5 × ULN, or international normalized ratio (INR) \\\u003C 1.5 × ULN; if the participant is currently on anticoagulant therapy, INR ≤ 3 × ULN.\n12. Must agree to use adequate contraception from study initiation through at least 6 months after the last dose of study drug, and must refrain from sperm donation;\n13. Able to comply with all study procedures as judged by the investigator.\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will not be eligible for enrollment in this study:\n\n1. Prior antitumor therapy meets the following conditions:\n\n   1. Phase Ib:\n\n      * Cohort 1: Prior treatment with abiraterone or cytotoxic chemotherapy (including but not limited to antibody-drug conjugates \\[ADCs\\] with cytotoxic payload). \\*Note:\\* Docetaxel use during the hormone-sensitive setting is allowed, provided there was no treatment failure or disease progression during therapy or within 3 months after completion.\n      * Cohort 2: Prior cytotoxic chemotherapy (including but not limited to ADCs with cytotoxic payload) at any stage of prostate cancer. \\*Note:\\* Docetaxel use during the hormone-sensitive setting is allowed, provided there was no treatment failure or disease progression during therapy or within 3 months after completion.\n   2. Phase II:\n\n      * Cohort 1: Prior treatment with abiraterone or cytotoxic chemotherapy (including but not limited to ADCs with cytotoxic payload). \\*Note:\\* Docetaxel use during the hormone-sensitive setting is allowed, provided there was no treatment failure or disease progression during therapy or within 3 months after completion.\n      * Cohort 2:Participants must be treatment-naïve in the metastatic castration-sensitive prostate cancer (mCSPC) setting; i.e., participants must not have received any cytotoxic chemotherapy (including but not limited to ADCs with cytotoxic payload), with the exception that first-generation antiandrogen (ADT) therapy is allowed during the mCSPC stage.\n      * Cohort 3:Participants must not have received any cytotoxic chemotherapy (including but not limited to ADCs with cytotoxic payload). \\*Note:\\* Docetaxel use during the hormone-sensitive setting is allowed, provided there was no treatment failure or disease progression during therapy or within 3 months after completion.\n      * Cohort 4: Participants must be treatment-naïve in the metastatic castration-sensitive prostate cancer (mCSPC) setting; i.e., participants must not have received any cytotoxic chemotherapy (including but not limited to ADCs with cytotoxic payload), with the exception that first-generation antiandrogen (ADT) therapy is allowed during the mCSPC stage.\n2. Prior treatment with agents similar to or targeting the same pathway as the study drug (including but not limited to tazemetostat, EZH1\u002F2 inhibitors, and EED inhibitors);\n3. Received chemotherapy, immunotherapy, definitive radiotherapy, targeted therapy, anti-tumor traditional Chinese medicine, or other anti-tumor therapies within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose; palliative radiotherapy within 2 weeks prior to the first dose;\n4. Planned receipt of any other anti-tumor therapy during the study period;\n5. Received any other investigational product not yet approved in the study region within 28 days prior to the first dose of this study (i.e., last dose of investigational product within 28 days of the first study drug dose);\n6. Presence of central nervous system (CNS) metastases; history of or concurrent CNS conditions including but not limited to epilepsy, paralysis, stroke, severe brain injury, Alzheimer's disease, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, spinal cord compression, or cauda equina syndrome (with the exception of stroke that was adequately treated and stable for ≥12 months prior to first dose, or asymptomatic\u002Funtreated lacunar infarction);\n7. Severe bone damage due to tumor bone metastases as judged by the investigator, including poorly controlled severe bone pain, pathological fractures at critical sites occurring within the last 6 months or expected in the near future, and spinal cord compression;\n8. History of other malignancy within 3 years prior to enrollment that does not meet clinical cure criteria. Exceptions: basal cell carcinoma or squamous cell carcinoma of the skin that has been locally treated and cured, superficial bladder cancer, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma;\n9. Poorly controlled bladder outlet obstruction or urinary incontinence as judged by the investigator;\n10. Impaired cardiac function or clinically significant cardiac disease, including any of the following:\n\n    1. Acute myocardial infarction or unstable angina ≤ 6 months prior to first dose;\n    2. Congestive heart failure (New York Heart Association \\[NYHA\\] Class III or IV), left ventricular ejection fraction (LVEF) \\\u003C 50%;\n    3. Uncorrected serious arrhythmia, hypertension ≥ 150\u002F100 mmHg;\n    4. Prolonged QTc interval (defined as \\>450 ms for males, \\>470 ms for females) per Fridericia's formula (see Appendix 20.4);\n    5. History of other major cardiovascular disease (e.g., valve replacement, coronary artery bypass grafting, etc.);\n11. Active systemic severe infection: a washout period of at least 2 weeks is required after completion of antifungal therapy (whether intravenous or oral); at least 1 week washout after completion of other intravenous anti-infective therapy; other oral anti-infective therapy must meet discontinuation criteria and be stopped prior to the first study dose;\n12. History of tuberculosis infection within 1 year prior to enrollment, or history of active tuberculosis infection more than 1 year ago without adequate anti-tuberculosis treatment;\n13. Known hypersensitivity to the study drug or its active ingredients or excipients;\n14. Use of known moderate or strong CYP3A inducers or inhibitors within 14 days prior to the first dose (see Appendix 20.5);\n15. Active autoimmune and inflammatory diseases, such as systemic lupus erythematosus, psoriasis requiring systemic therapy, rheumatoid arthritis, inflammatory bowel disease, and Hashimoto's thyroiditis; with the exception of Type 1 diabetes mellitus, hypothyroidism controlled solely by replacement therapy, hyperthyroidism stable on medication, and skin conditions not requiring systemic therapy (e.g., vitiligo, localized psoriasis);\n16. History of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid therapy, or any evidence of clinically active ILD;\n17. Known gastrointestinal (GI) function impairment or GI conditions that may significantly affect the absorption or metabolism of oral medications; abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to the first dose;\n18. Human immunodeficiency virus (HIV) positive, or syphilis (Anti-TP) positive (not excluded if non-treponemal syphilis test is negative and the investigator determines syphilis has been cured);\n19. Known acute or chronic active hepatitis B (HBsAg positive or HBcAb positive with HBV DNA ≥ 200 IU\u002FmL or ≥ 10³ copies\u002FmL), or acute or chronic active hepatitis C (HCV antibody positive with HCV RNA positive);\n20. Toxicities from prior anti-tumor therapy that have not resolved (not recovered to ≤ Grade 1 per NCI-CTCAE Version 6.0). Exceptions include other toxicities that the investigator deems do not affect participant safety assessment (e.g., alopecia);\n21. Symptomatic pleural effusion, ascites, or pericardial effusion that is poorly controlled despite repeated treatment;\n22. Prior allogeneic tissue or solid organ transplantation;\n23. Major surgery within 4 weeks prior to dosing, or planned major surgery during the study period (excluding procedures such as puncture or lymph node biopsy);\n24. Received live virus vaccine (including live attenuated vaccine) within 28 days prior to dosing; inactivated vaccines are allowed;\n25. Baseline bone scan showing a \"superscan\" pattern that precludes assessment of new bone metastases;\n26. Any other condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.",{"count":96,"type":19},242,[22],"Phase Ib A preliminary design of 2 cohorts is planned for this phase, with 3-6 participants to be enrolled in each cohort. A total of 6-12 participants with advanced prostate cancer are planned to be enrolled in this phase. The study will be conducted at multiple investigational sites.\n\nPhase II A preliminary design of 5 cohorts is planned for this phase. Cohorts 1, 2, and 3 are preset with 2 dose groups each, and each dose group plans to enroll 20-30 participants. Cohort 4 plans to enroll 20-50 participants. Cohort 5 will be adjusted based on results from prior study phases. A total of 140-230 participants with advanced prostate cancer are planned to be enrolled in this phase. The study will be conducted at multiple investigational sites.",[25],[101,25],"XNW5004","NOT_YET_RECRUITING","2026-07-22",{"date":105,"type":30},"2026-07-28",{"date":107,"type":19},"2026-07-13",{"date":109,"type":19},"2028-12-31",{"name":111,"class":65},"Evopoint Biosciences Inc.",{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":46,"minAge":16,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":20,"phases":121,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":133},"100641999","phase-1-dec003m-in-prostate-cancer-100641999","NCT07657806","DEC003M in Prostate Cancer","A Phase 1 Study of DEC003M, an Antibody Drug Conjugate Targeting PSMA, for Advanced Stage Prostate Cancer","Inclusion Criteria:\n\n1. At the time of informed consent, be ≥18 years of age.\n2. Histologically confirmed adenocarcinoma of the prostate.\n3. Metastatic castration-resistant prostate cancer (mCRPC) with documented disease progression despite androgen deprivation therapy.\n4. Prior orchiectomy or medical castration, or continuous treatment with luteinizing hormone releasing hormone analogues (LHRHa) .\n5. Measurable disease prior to enrollment.\n6. Testosterone at castration level.\n7. Progressed on standard therapy, or intolerant to standard therapy, or ineligible for standard therapy, or no standard therapy available.\n8. At least 1 prior Androgen Receptor Pathway Inhibitor.\n9. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n\nExclusion Criteria:\n\n1. History of other malignancies.\n2. Inadequate organ function.\n3. Active autoimmune disease.\n4. Active CNS involvement.\n5. Uncontrolled or clinically significant cardiovascular and cerebrovascular diseases.\n6. Any prior medical history of ILD\u002Fpneumonitis.\n7. Clinically significant corneal disorder or known severe dry eye.\n8. Grade 2 or higher peripheral neuropathy.\n9. Inadequate washout period for prior anticancer treatment.\n10. Any known history of or suspicion for history of clinically significant liver disease .\n11. Known hypersensitivity to any component of the DEC003M.\n12. Prior treatment with a PSMA-targeted antibody therapy.\n13. Other conditions judged by the investigator that may have effects on the patient's participation in the study.",{"count":120,"type":19},110,[50],"This is an open-label, multicenter Phase 1 study of DEC003M, in patients with advanced stage prostate cancer. The study consists of a dose-escalation phase to determine the dose for expansion, followed by a dose-expansion phase to evaluate preliminary antitumor activity, safety, and pharmacokinetics.",[25],"2026-06-17",{"date":126,"type":30},"2026-06-22",{"date":128,"type":19},"2026-08-01",{"date":130,"type":19},"2031-05-01",{"name":132,"class":65},"Hangzhou DAC Biotechnology Co., Ltd.",4,{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":46,"minAge":16,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":20,"phases":144,"briefSummary":145,"conditions":146,"keywords":4,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":38},"100641941","phase-2-study-of-psma-targeted-therapy-and-androgen-receptor-suppression-in-low-volume-metastatic-prostate-cancer-sparkle-trial-100641941","NCT07650240","Study of PSMA-targeted Therapy and Androgen Receptor Suppression in Low-volume Metastatic ProstatE Cancer: SPARKLE Trial","A Phase II Randomized Trial of Intermittent Androgen Deprivation Therapy Alone or Combined With [177Lu]Lu-PSMA-617, With or Without Abiraterone and Prednisone, in Patients With Low-Volume Metastatic Hormone-Sensitive Prostate Cancer","SPARKLE","Inclusion Criteria:\n\n* Male patients aged 18 years or older\n* Signed informed consent must be obtained prior to participation in the study\n* Histologically confirmed adenocarcinoma of the prostate\n* Prior treatment with radical prostatectomy or radiation therapy for localized disease is required\n* Prior treatment with ADT or androgen receptor pathway inhibitor (ARPI) or cytotoxic chemotherapy is permitted if:\n\n  * The last treatment \\> 12 months from enrollment on the trial\n  * The duration of treatment is less than 3 months and no evidence of disease progression on treatment\n* Disease detected on PSMA PET\u002FCT scan \\[PSMA-avid low volume metastasis (LVM)\\]. Patients with standardized uptake value maximum (SUVMax) lesion\u002Fliver \\>1 \\[molecular imaging PSMA (miPSMA) score of 2\\] or lesion\u002Fparotid \\> 1 (miPSMA score of 3) would be included. PET scanners used in the study will comply with current guidelines established by the European Association of Nuclear Medicine (EANM) Research Limited (Ltd) (EARL) for harmonizing PET\u002FCT image acquisition and reconstruction\n* Patients with hormone sensitive low volume metastatic disease (LVM); either de novo metastatic or recurrent disease. LVM, as assessed on PSMA PET\u002FCT is defined as:\n\n  * =\\\u003C 10 total metastatic spots\n\n    * Lymph nodes with short axis of =\\\u003C 2.5 cm\n    * Total tumor volume (TTV) \\\u003C 200 mL\n  * =\\\u003C 4 bone metastases\n  * No brain or liver metastases\n* Eastern Cooperative Oncology Group (ECOG) performance 0 - 2\n* Hemoglobin \\>= 9 g\u002FdL\n* Platelet count \\>= 100,000\u002Fmm\\^3\n* Absolute neutrophil count \\>= 1,500\u002Fmm\\^3\n* Serum bilirubin =\\\u003C 1.5 x upper limit of normal (ULN)\n* Alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) =\\\u003C 2.5 x ULN\n* Serum creatinine =\\\u003C 1.5 x ULN or an estimated glomerular filtration rate (eGFR) \\>= 50 mL\u002Fmin\u002F1.73m\\^2\n* Able to start therapy within 28 days of screening\n* Expected life expectancy \\> 6 months\n\nExclusion Criteria:\n\n* PSMA-undetectable disease defined as rising prostate specific antigen (PSA) with absence of PSMA-positive lesions in PSMA PET\u002FCT imaging\n* PSMA-negative disease defined as lesions detected on imaging that are deemed concerning for active cancer metastasis with PSMA SUVmax less than liver and meeting specific size criteria: lymph nodes with short axis of \\>= 2.5 cm, visceral lesions with a solid appearance (soft tissue density) \\>= 1 cm, and bone metastases with a measurable soft tissue component \\>= 1 cm\n* Patient with in-field failure (disease recurrence in prostate bed after primary definitive prostatectomy or radiotherapy)\n* Patient with spinal metastatic disease-causing cord compression\n* Patient with prior disease progression on ADT \\[castration resistance prostate cancer (CRPC)\\]\n* Prior treatment with ADT or cytotoxic chemotherapy or ARPI within less than 12 months from enrollment on the trial\n* Prior treatment with ADT or ARPI or cytotoxic chemotherapy is permitted only if more than 3 months treatment duration and no evidence of disease progression on treatment\n* Patients with severe \\[Common Terminology Criteria for Adverse Events (CTCAE) grade \\> 2\\] xerostomia\n* Patients with well documented history of myelosuppression or renal disease that might impair their participation in the trial per medical advice\n* Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, participants with a prior history of malignancy that has been adequately treated non-melanoma skin cancer, superficial bladder cancer are eligible\n* Estimated life expectancy \\\u003C 6 months\n* Concurrent serious medical co-morbidities as determined by study investigator and expected to impair participation in the study\n\n  * Subjects with female partners of reproductive potential are required to use effective, medically acceptable methods of birth control (e.g., spermicide in conjunction with a barrier such as a condom or sexual abstinence) while on this study, and for 14 weeks after the last dose of 177Lu-PSMA-617",{"count":143,"type":19},202,[22],"This phase II trial tests leuprolide acetate alone versus in combination with 177Lu-PSMA-617, with or without abiraterone acetate and prednisone, for the treatment of hormone-sensitive prostate cancer has spread to a limited number of anatomic sites at the time of initial diagnosis (de novo low volume metastasis) or that has come back after a period of improvement (recurrent). Standard of care treatment for prostate cancer usually includes androgen deprivation therapy, with or without abiraterone acetate and prednisone. Leuprolide acetate is a form of androgen deprivation therapy. It blocks the body from making testosterone (a male hormone) and estradiol (a female hormone). It may stop the growth of prostate cancer cells that need testosterone to grow. 177Lu-PSMA-617 is a type of radioconjugate drug. Upon administration, vipivotide tetraxetan targets and binds to prostate specific membrane antigen (PSMA)-expressing tumor cells. Upon binding, PSMA-expressing tumor cells are destroyed by 177Lu through the specific delivery of radiation. PSMA, a tumor-associated antigen and type II transmembrane protein, is overexpressed on prostate tumor cells. Abiraterone acetate is a type of anti-androgen drug. It blocks tissues from making androgens (male hormones), such as testosterone. This may cause the death of cancer cells that need androgens to grow. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Giving 177Lu-PSMA-617 in combination with leuprolide acetate, with or without abiraterone acetate and prednisone, may be more effective at treating patients with recurrent or de novo low volume metastatic hormone-sensitive prostate cancer than giving leuprolide acetate alone.",[147,148,149,150,151,152,153,154,53,155,25,156],"Recurrent Prostate Adenocarcinoma","Stage IVB Prostate Cancer AJCC v8","Castration-Sensitive Prostate Cancer","Metastatic Hormone-sensitive Prostate Cancer (mHSPC)","Prostate Cancer","Prostate Adenocarcinoma","Adenocarcinoma of the Prostate","Localized Prostate Carcinoma","Metastatic Prostate Adenocarcinoma","Advanced Prostate Adenocarcinoma","2026-06-15",{"date":124,"type":30},{"date":160,"type":19},"2026-07-01",{"date":162,"type":19},"2030-12-30",{"name":164,"class":37},"Mayo Clinic",{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":46,"minAge":16,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":20,"phases":174,"briefSummary":175,"conditions":176,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":38},"100608213","phase-1-a-clinical-study-of-qlc5508-andor-qlh12016-in-combination-with-other-anti-tumor-therapies-in-subjects-with-advanced-prostate-cancer-100608213","NCT07198633","A Clinical Study of QLC5508 and\u002For QLH12016 in Combination With Other Anti-tumor Therapies in Subjects With Advanced Prostate Cancer","An Open-label, Multicenter Phase Ib\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of QLC5508 and\u002For QLH12016 in Combination With Other Anti-tumor Therapies in Subjects With Advanced Prostate Cancer","Inclusion Criteria:\n\n* The subject voluntarily agrees to participate and has signed the informed consent form.\n* Male, aged ≥18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.\n* Life expectancy of at least 3 months.\n* Histologically or cytologically confirmed adenocarcinoma of the prostate.\n* Radiologically confirmed metastatic prostate cancer.\n* For subjects with mCRPC, serum testosterone must be at castrate levels, and they must have demonstrated either PSA progression or radiographic progression.\n* Must have undergone surgical castration or be willing to receive medical castration.\n* For Phase Ib, subjects must have experienced failure, intolerance, or refusal of standard therapy.\n* Adequate function of major organs as defined by the protocol.\n* Agreement to use effective contraception during the study (except for subjects who have undergone bilateral orchiectomy).\n* Sufficient blood samples must be provided during the screening period for genetic mutation testing.\n\nExclusion Criteria:\n\n* Prior treatment with the following agents: AR PROTAC, abiraterone, enzalutamide, or B7H3-targeted therapies.\n* Presence of central nervous system (CNS) metastases, leptomeningeal metastases, or spinal cord compression requiring hormonal therapy.\n* Receipt of extensive radiotherapy within 4 weeks prior to the first administration of the investigational medicinal product.\n* Treatment with other investigational drugs or major surgery within 4 weeks prior to the first administration of the investigational medicinal product.\n* Presence of factors that may affect drug administration, intake, or absorption.\n* History of epilepsy, or a condition that could provoke seizures within 12 months prior to the first administration of the investigational medicinal product.\n* Known history of substance abuse, alcoholism, or drug addiction; or prior history of significant neurological or psychiatric disorders, including dementia or hepatic encephalopathy.\n* Presence of severe cardiovascular or cerebrovascular disease.\n* Active, uncontrolled infection.\n* Clinically uncontrolled third-space fluid accumulation prior to the first administration of the investigational medicinal product.\n* History of other malignancies within 5 years prior to the first administration of the investigational medicinal product.\n* Presence of moderate to severe pulmonary disease that significantly impairs lung function.\n* For subjects receiving QLC5508, history of non-infectious interstitial lung disease (ILD) or pneumonitis.",{"count":173,"type":19},212,[50,22],"This study is an open-label, multicenter Phase Ib\u002FII clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of QLC5508 in combination with NHA (abiraterone or enzalutamide), QLC5508 in combination with QLH12016, QLC5508 in combination with QLH12016 and NHA (abiraterone or enzalutamide), and QLH12016 in combination with NHA (abiraterone or enzalutamide) in subjects with advanced prostate cancer.\n\nThe study consists of two stages:\n\nPhase Ib: is the combination dose-escalation stage, during which the recommended Phase II dose (RP2D) will be determined.\n\nPhase II is the efficacy exploration stage, in which, based on the RP2D established in Phase Ib, the therapeutic efficacy will be further evaluated in the target indication.",[25],"2026-06-01",{"date":179,"type":30},"2026-06-02",{"date":181,"type":30},"2025-11-05",{"date":183,"type":19},"2027-12",{"name":185,"class":65},"Qilu Pharmaceutical Co., Ltd.",{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":192,"eligibilityCriteria":193,"healthyVolunteers":11,"sex":46,"minAge":16,"maxAge":4,"enrollmentInfo":194,"targetDuration":4,"studyType":196,"phases":4,"briefSummary":197,"conditions":198,"keywords":201,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":228},"100593295","lab-research-using-mini-tumors-to-study-prostate-cancer-treatments-100593295","NCT07004582","Lab Research Using Mini-tumors to Study Prostate Cancer Treatments","Preclinical ex Vivo Patient-derived 3D Cultures for the Prediction of Prostate Cancer Treatment Response","PR3DICT","Inclusion Criteria:\n\n* Patients aged 18 years or older\n* Patients with prostate cancer\n* Patients planned for HDR brachytherapy treatment for high-risk or recurrent prostate cancer or transperineal prostate biopsy with MRI-suspected metastatic prostate cancer with at least clinical stage T3-4.\n\nExclusion Criteria:\n\n* Patients younger than 18 years\n* Patients of whom it is not possible to obtain left-over tissue as part of the normal clinical treatment procedure (e.g., if all tumor material is required for the pathologist to make a diagnosis, to stage the patient or to perform a molecular diagnosis).",{"count":195,"type":19},600,"OBSERVATIONAL","For men with an aggressive form of prostate cancer, finding the right and effective treatment right away is challenging. Many of these men face a high risk of cancer recurrence: about half experience a relapse after surgery, and more than a third after undergoing radiation therapy. Men with metastatic prostate cancer have particularly poor prognoses, with a five-year survival rate of only 30% to 50%. In short, it is difficult to predict which treatment, or combination of treatments, will lead to longer survival for this group of men with aggressive (metastatic) prostate cancer.\n\nIn the laboratory, it is possible to grow small samples of tumors into 3D mini-tumors. These mini-tumors retain the characteristics of the patient's original tumor tissue. Various treatments can be tested on these 3D mini-tumors to determine which therapy is most effective for each individual case. There are currently two techniques available for creating these 3D mini-tumors in the lab. In this project, we aim to investigate which of these two techniques works best in order to test and personalize treatments.",[151,199,200,25],"Prostate Cancer Metastatic Disease","Prostate Cancer Recurrent",[202,203,204,205,206,207,208,209,210,211,212,213,214,215,216,217,218],"Advanced prostate cancer","Metastatic prostate cancer","Prostate cancer","Patient-tailored treatment","Precision Medicine","Ex vivo prediction platform","Personalized medicine","Drug Screening Assays","Three-Dimensional Culture Techniques","Organoids","Tumoroids","Tumor replicas","Prostatic Neoplasms","Neoplasm Metastasis","Advanced Cancer","Treatment Outcome","Human Tissue Culture Techniques","2026-04-20",{"date":221,"type":30},"2026-04-23",{"date":223,"type":30},"2026-03-15",{"date":225,"type":19},"2031-12-30",{"name":227,"class":37},"Maastricht Radiation Oncology",3,{"id":230,"slug":231,"hasResults":11,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":235,"eligibilityCriteria":236,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":237,"targetDuration":4,"studyType":20,"phases":239,"briefSummary":241,"conditions":242,"keywords":247,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":38},"100558781","engage-psychosocial-intervention-for-cancer-symptoms-100558781","NCT06555588","Engage Psychosocial Intervention for Cancer Symptoms","Engage: A Randomized Controlled Trial Testing the Efficacy of a Telehealth-Delivered Psychosocial Intervention to Decrease Symptom Interference in Patients With Advanced Cancer","Engage","Inclusion Criteria:\n\n* Receiving cancer care at 1) a Duke Cancer Network (DCN) clinic; or 2) the Duke Cancer Institute (DCI) and live in a rural county at least 60 miles from Duke\n* Oncologist confirmed Stage IV breast, prostate, lung, or colorectal cancer\n* Worst pain, fatigue, or distress rated at \\>\u002F= 3 out of 10 in the past 7 days for at least 2 symptoms\n* MD Anderson Symptom Inventory (MDASI) Interference with Daily Living Scale average score of \\>\u002F= 3 out of 10 in the past 7 days\n* Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower\n* At least 18 years old\n* Ability to speak and read English\n* Hearing and vision that allows for successful completion of telehealth sessions\n\nExclusion Criteria:\n\n* Significant cognitive impairment indicated in medical chart or during telephone screening on a mental status questionnaire\n* Serious psychiatric condition (e.g., schizophrenia, suicidal intent) that would contraindicate safe study participation\n* Participation in the last 6 months in Cognitive-Behavioral Therapy or Acceptance and Commitment Therapy for cancer symptom management\n* Enrollment in hospice at screening",{"count":238,"type":19},190,[240],"NA","The goal of this clinical trial is to test the efficacy a new psychosocial symptom management intervention called ENGAGE for patients with Stage IV breast, prostate, lung, or colorectal cancer. Participants will be randomized to ENGAGE or a Supportive Care intervention. Patient-reported outcomes will be assessed at baseline, 2 months, and 4 months.",[243,25,244,245,246],"Advanced Breast Cancer","Advanced Lung Cancer","Advanced Colorectal Carcinoma","Advanced Colorectal Adenocarcinoma",[248,249,250,251,252,253,254],"Acceptance and Commitment Therapy","Cognitive Behavioral Therapy","Pain management","Fatigue management","Symptom management","Telehealth","Psychosocial intervention","2026-03-12",{"date":257,"type":30},"2026-03-16",{"date":259,"type":30},"2025-06-11",{"date":261,"type":19},"2028-11",{"name":263,"class":37},"Duke University",{"id":265,"slug":266,"hasResults":11,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":4,"eligibilityCriteria":270,"healthyVolunteers":11,"sex":46,"minAge":16,"maxAge":271,"enrollmentInfo":272,"targetDuration":4,"studyType":20,"phases":274,"briefSummary":275,"conditions":276,"keywords":278,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":289,"locationsCount":4},"100628094","phase-2-a-study-investigating-the-pharmacokinetics-pharmacodynamics-efficacy-and-safety-of-teverelix-dp-a-gonadotropin-releasing-hormone-gnrh-antagonist-in-patients-with-advanced-prostate-cancer-100628094","NCT07457164","A Study Investigating the Pharmacokinetics, Pharmacodynamics, Efficacy and Safety of Teverelix DP, a Gonadotropin-releasing Hormone (GnRH) Antagonist, in Patients With Advanced Prostate Cancer","A Phase 2, Open-Label, Single-Arm, Multicentre Study Investigating the Pharmacokinetics, Pharmacodynamics, Efficacy and Safety of Teverelix DP, a Gonadotropin-releasing Hormone (GnRH) Antagonist, in Patients With Advanced Prostate Cancer","Inclusion Criteria:\n\n* Is male, aged ≤85 years (≥18 years) at the beginning of the treatment period (Day 1)\n* Has histologically proven advanced adenocarcinoma of the prostate (metastatic or non metastatic, hormone-sensitive, non-curative), suitable for androgen deprivation therapy\n* Is treatment naïve for GnRH analogues\n* Agrees to practice contraception during the entire study treatment period and for 3 months after the last dose of IMP is administered:\n\n  * Either by using double barrier contraception,\n  * or, is truly sexually abstinent, when this is in line with the preferred and usual lifestyle of the patient\n\nNote: Periodic abstinence \\[e.g. calendar, ovulation, symptothermal, postovulation methods for the female partner with childbearing potential\\] and withdrawal are not acceptable methods of contraception.\n\n• Has provided written (personally signed and dated) informed consent before completing any study-related procedure, which means any assessment or evaluation that would not have formed a part of his normal medical care\n\nExclusion Criteria:\n\n* Has abnormal screening and\u002For baseline laboratory values that suggest a clinically significant underlying disease, or the following laboratory values:\n\n  * Liver function test (aspartate aminotransferase \\[ASAT\u002FSGOT\\], alanine aminotransferase \\[ALAT\u002FSGPT\\]), exceeding \\>2X the ULN range\n  * Total bilirubin exceeding \\>1.5X the ULN range\n  * Creatinine twice the ULN range\n  * Uncontrolled diabetes (HbA1c \\>7.5%) or previously undiagnosed diabetes mellitus with HbA1c \\>6.5%\n  * An estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin, based on creatinine clearance calculation by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation normalized to an average surface area of 1.73m2, at the screening visit.\n* Has any contraindication to the use of teverelix DP\n* Has a life expectancy of less than 1 year\n* Has T levels \\\u003C1.5 ng\u002FmL at screening\n* Has a medical history of bilateral orchidectomy\n* Any other IMP (within 3 months of enrolment)\n* GnRH analogues (subjects must be treatment naïve to GnRH analogues)\n* Using any of the following prohibited treatments:\n\n  * Within 25 weeks prior to screening: dutasteride\n  * Within 12 weeks prior to screening: finasteride and others\n* Current use of any of the following:\n\n  o Anti-androgen therapy, including T replacement therapy and 5α-reductase inhibitor treatment etc. within 3 months of enrolment (Spironolactone is a permitted concomitant treatment)\n* Any other medication or herbal product that may affect hormone levels and might, therefore, confound interpretation of the study results (e.g. St. John's wort, red reishi, licorice, white peony, green tea, spearmint, black cohosh, chaste tree, saw palmetto, etc) (within 3 months of enrolment)\n* Has neurological disease, psychiatric disease, drug or alcohol abuse, which could interfere with the patient's proper compliance\n* Has a history of myocardial infarction, unstable symptomatic ischaemic heart disease, any ongoing cardiac arrhythmias of grade \\>2 (chronic stable atrial fibrillation on stable anticoagulant therapy is allowed), thromboembolic events (e.g. deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or any other significant cardiac condition (e.g. pericardial effusion, restrictive cardiomyopathy) within the 6 months prior to screening\n* Has congenital long QT syndrome or ECG abnormalities at screening of:\n\n  * Q-wave infarction, unless identified ≥6 months before screening\n  * Fridericia corrected QT interval (QTcF interval) \\>480 msec. If QTcF is prolonged in a patient with a pacemaker, the patient may be enrolled in the study upon discussion with the project clinician\n  * If the QTcF interval is 450-480 msec, inclusive, in a patient with current use of medications with known effects on QT interval, the patien may be enrolled in the study following discussion with the Medical Lead\n* Note: Cardiac arrhythmia grading:\n\n  * Bradyarrhythmias (HR \\\u003C60\u002Fmin)\n  * Tachyarrhythmias (HR \\>100\u002Fmin)\n  * Supraventricular arrhythmias - arrhythmias that originate in the sinoatrial node, atrial myocardium or atrioventricular node (regular QRS complex)\n  * Ventricular arrhythmias - arrhythmias that originate below the atrioventricular node (wide QRS complex)\n* Has known or suspected severe renal impairment\n* Has a medical history of diagnosis of, or treatment for, another malignancy within the 2 years prior to administration of the first dose of IMP, or previous diagnosis of another malignancy with evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection\n* Is currently using Class IA (e.g. quinidine, procainamide) or Class III (e.g. amiodarone, sotalol) antiarrhythmic medications\n* Has uncontrolled hypertension despite appropriate medical therapy (sitting blood pressure \\[BP\\] of \\>180 millimetres of mercury \\[mmHg\\] systolic and \\>95 mmHg diastolic at 2 separate measurements taken no more than 60 minutes apart during the screening visit). Patients with isolated systolic BP measurements \\>180 mmHg may be rescreened. Patients with isolated systolic BP measurements 141 to 180 mmHg or isolated diastolic BP measurements ≥95 mmHg, although eligible, should be referred for further management of hypertension if indicated\n* Has known, previously diagnosed HIV infection, active chronic hepatitis B or C, life-threatening illness unrelated to prostate cancer, or any serious medical condition that could, in the investigator's opinion, potentially interfere with participation in this study. Specific screening for chronic viral illness is at the discretion of the site and\u002For local Institutional Review Board (IRB)\n* Has been exposed to another investigational drug within the 3 months prior to screening\n* Has anticipated non-availability for study visits\u002Fprocedure\n* Plans to undergo surgery during the study period\n* Known presence of hepatic metastases","85 Years",{"count":273,"type":19},40,[22],"The purpose of this clinical trial is to test the effectiveness of a dosing regimen of Teverelix DP castration rate defined as the cumulative probability of testosterone suppression to \\\u003C 0.5 ng\u002FmL with the lower bound of the 95% confidence interval (CI) being \\> 90% to meet the evaluation criteria for efficacy.\n\nThe main question it aims to answer is:\n\n•Is the dosing regimen of Teverelix DP in this study effective at achieving the required testosterone suppression to castrate levels.\n\nParticipants will\n\n* Receive a single loading dose consisting of 3 injections of teverelix DP (180 mg IM + 2x 180 mg SC) on Day 1.\n* Receive a maintenance dose consisting of 2 injections (2X 180 mg SC) from week 4 (Day 29) and every 6 weeks up to Week 16 (Day 113).\n* The first 30 enrolled participants will have 24-hour continuous Holter monitoring performed and 24-hour PK samples will be drawn.\n\nThe results of this study are intended to support dose selection and provide supportive safety and PK\u002FPD data to enable advancement into a subsequent Phase 3 clinical study in patients with advanced prostate cancer who are at high cardiovascular risk.",[25,277],"GnRH Antagonist",[279,280,281,282,283],"Teverelix","Pharmacokinetics","Pharmacodynamics","Prostatic Diseases","Urogenital Diseases","2026-03-10",{"date":255,"type":30},{"date":287,"type":19},"2026-07",{"date":183,"type":19},{"name":290,"class":65},"Antev Ltd.",{"id":292,"slug":293,"hasResults":11,"nctId":294,"briefTitle":295,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":11,"sex":46,"minAge":16,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":20,"phases":299,"briefSummary":300,"conditions":301,"keywords":302,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":38},"100541903","dual-psma-and-fdg-pet-imaging-for-patients-with-advanced-prostate-cancer-100541903","NCT06335914","Dual PSMA and FDG PET Imaging for Patients With Advanced Prostate Cancer","Inclusion Criteria:\n\n* Male, age ≥ 18 years\n* Histologically or cytologically confirmed prostate cancer (adenocarcinoma)\n* Poor risk patients with mCSPC at study enrollment\n* De novo or recurrent high volume mCSPC as per conventional imaging (CT chest abdomen pelvis, or MRI, plus bone scan) prior to starting ADT and ARPI\n* High or low volume mCSPC plus PSA ≥4.0 after 6-8 months of initiating ADT\n* Willing to undergo study PET scans and remain under the care of medical oncology, radiation oncology or urology physician at Princess Margaret Cancer Center.\n* No prior PSMA or FDG PET imaging within the last 60 days at each specified time point on study\n* Patients enrolled in clinical trials are eligible if they satisfy all other criteria of eligibility\n\nExclusion Criteria:\n\n* Under a randomized-controlled trial with unknown allocation of systemic therapy\n* Inability to undergo or successfully complete PSMA PET and FDG PET imaging exams\n* Unable to provide written consent by patient and their legal representatives\n* In the opinion of the treating physician:\n* conditions which would significantly impair the patient's ability to comply with study procedures and follow up\n* Significant uncontrolled comorbidity, which may negatively impact the safety or interpretability of study PET imaging\n\n  * another active malignancy\n  * patient on dialysis\n  * another radioisotope or investigational systemic agent within 5 half-lives prior to PET imaging",{"count":298,"type":19},30,[240],"This study will use Prostate Specific Membrane Antigen (PSMA) and (18)F-Fluorodeoxyglucose Positron Emission Tomography (FDG PET) imaging in patients with advanced prostate cancer to learn about tumor biology across disease stages and during treatment. This may help with treatment selection and potential response monitoring in the future.",[25],[303,304],"Prostate Specific Membrane Antigen","Positron Emission Tomography","2026-02-09",{"date":307,"type":30},"2026-02-12",{"date":309,"type":30},"2025-04-03",{"date":311,"type":19},"2029-09-04",{"name":313,"class":37},"University Health Network, Toronto",{"id":315,"slug":316,"hasResults":11,"nctId":317,"briefTitle":318,"officialTitle":319,"acronym":4,"eligibilityCriteria":320,"healthyVolunteers":11,"sex":46,"minAge":16,"maxAge":4,"enrollmentInfo":321,"targetDuration":4,"studyType":20,"phases":323,"briefSummary":324,"conditions":325,"keywords":326,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":38},"100601818","phase-1-phase-ib-study-of-hs-20093hrs-5041-in-patients-with-advanced-prostate-cancer-100601818","NCT07115446","Phase Ib Study of HS-20093+HRS-5041 in Patients With Advanced Prostate Cancer","A Phase Ib Study to Explore the Safety, Tolerability, and Pharmacokinetics of HS-20093 Combination With HRS-5041 in Patients With Advanced Prostate Cancer","Inclusion Criteria:\n\n* Men greater than or equal to 18 years.\n* Voluntarily to participate, Signed and dated Informed Consent Form.\n* Patients with metastatic castration-resistant prostate cancer (mCRPC) who progressed after at least one type of novel hormonal therapy (standard treatment).\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\\~1.\n* Estimated life expectancy ≥ 12 weeks.\n* Men should use adequate contraceptive measures throughout the study, up to 3 months after the last dose of HRS-5041 or 4.5 months after the last dose of HS-20093 (whichever is later).\n\nExclusion Criteria:\n\n* Treatment with any of the following:\n\n  a. Previous or current treatment with B7-H3 targeted therapy. b. Previous treatment with AR PROTAC. c. Any cytotoxic chemotherapy, investigational agents and anticancer drugs within 21 days prior to the first scheduled dose of HS-20093+HRS-5041. d. brain metastases.\n* Any unresolved toxicities from prior therapy greater than Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0.\n* History of other primary malignancies.\n* Inadequate bone marrow reserve or organ dysfunction.\n* Severe, uncontrolled or active cardiovascular diseases.\n* Severe or uncontrolled diabetes.\n* The presence of active infectious diseases.\n* Any known or suspected interstitial lung disease.\n* History of serious neuropathy or mental disorders.\n* History of severe hypersensitivity reaction, severe infusion reaction.\n* Hypersensitivity to any ingredient of HS-20093.\n* Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator.\n* Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments.",{"count":322,"type":19},63,[50],"HS-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. HRS-5041 is a Proteolysis Targeting Chimeras (PROTAC) targeting androgen receptors.\n\nThis is a phase Ib, open-label, multi-center study to evaluate the safety, tolerability, and pharmacokinetics (PK) of HS-20093 combination with HRS-5041 in patients with advanced prostate cancer.",[25],[202,327,328],"B7H3","HS-20093","2025-11-28",{"date":331,"type":30},"2025-12-05",{"date":333,"type":30},"2025-08-19",{"date":335,"type":19},"2028-12",{"name":337,"class":65},"Hansoh BioMedical R&D Company",{"id":339,"slug":340,"hasResults":11,"nctId":341,"briefTitle":342,"officialTitle":343,"acronym":4,"eligibilityCriteria":344,"healthyVolunteers":11,"sex":46,"minAge":16,"maxAge":4,"enrollmentInfo":345,"targetDuration":4,"studyType":20,"phases":346,"briefSummary":347,"conditions":348,"keywords":350,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":353,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":360},"100520913","phase-1-pilot-study-for-detection-of-psma-low-crpc-ne-tumors-with-fluciclovine-petct-100520913","NCT06062745","Pilot Study for Detection of PSMA-Low CRPC-NE Tumors With Fluciclovine PET\u002FCT","A Pilot Study for Detection of PSMA-Low Castration Resistant and Neuroendocrine Prostate Cancer With 18F-fluciclovine PET\u002FCT Imaging","Inclusion Criteria:\n\n* Participants must have histologically confirmed prostate cancer that is metastatic and one of the following: CRPC with PSMA-low disease defined by whole-body SUVmean ≤ 10 determined by standard-of-care 68Ga-PSMA-11 PET\u002FCT imaging with at least 5 metastatic lesions OR NEPC pathology based on tumor biopsy. This may include morphology consistent with small cell carcinoma or mixed adenocarcinoma\u002FNE features and\u002For IHC staining for NE markers. Participants should have at least 5 metastatic lesions.\n* Must have either already had standard of care 68Ga-PSMA PET\u002FCT scan or be planned for 68Ga-PSMA PET\u002FCT scan before or after the planned 18F-fluciclovine-PET\u002FCT.\n* Age ≥18 years. Since no dosing or adverse event data are currently available on the use of 18F-fluciclovine in participants \\\u003C18 years of age, and most prostate cancer occurs in the adult population, children are excluded from this study but will be eligible for future pediatric trials.\n* ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)\n* Ability and willingness to comply with the study procedures.\n* The effects of 18F-fluciclovine on the developing human fetus are unknown. For this reason and because radiopharmaceuticals may be teratogenic, men must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for 24 hours after the PET\u002FCT scan is completed.\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Participants with other known malignancy requiring treatment\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-fluciclovine.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Contraindications for PET\u002FCT including:\n\n  * Severe claustrophobia\n* Any past or current condition that in the opinion of the study investigators would confound the results of the study or pose additional risk to the patient by their participation in the study.",{"count":298,"type":19},[50],"This research study is studying a positron emission tomography (PET) agent called 18F-fluciclovine to evaluate how well 18F-fluciclovine-PET scans determine the extent of advanced prostate cancer that either has low prostate-specific membrane antigen (PSMA) expression or has neuroendocrine features.\n\nThe name of the study interventions are:\n\n* 18F-fluciclovine-PET\u002FCT scan\n* Two research blood collections",[25,53,349],"Metastatic Prostate Neuroendocrine Carcinoma",[25,53,349,351],"PSMA-Low Castration Resistant Prostate Cancer","2025-11-04",{"date":181,"type":30},{"date":355,"type":30},"2024-02-01",{"date":357,"type":19},"2028-09-01",{"name":359,"class":37},"Brigham and Women's Hospital",2,{"id":362,"slug":363,"hasResults":11,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":367,"eligibilityCriteria":368,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":369,"targetDuration":4,"studyType":20,"phases":371,"briefSummary":372,"conditions":373,"keywords":378,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":38},"100575218","phase-1-hs-10502-combination-treatment-in-patients-with-advanced-solid-tumors-100575218","NCT06769425","HS-10502 Combination Treatment in Patients With Advanced Solid Tumors","A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10502 Combination Treatment in Subjects With Advanced Solid Tumors","HS-10502","Inclusion Criteria:\n\n* Males or females aged 18 years or older (≥18 years).\n* Patients diagnosed with pathologically confirmed advanced solid tumors.\n* Subjects have at least one target lesion as assessed per the RECIST 1.1.\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 1 and no deterioration within 2 weeks before the first dose.\n* Have a life expectancy of at least 12 weeks.\n* Female subjects of childbearing potential are willing to take appropriate contraceptive measures and should not breastfeed from signing the informed consent until 6 months after the last dose; male subjects must agree to use barrier contraception (i.e. condoms) from signing the informed consent to 6 months after the last dose.\n* Female subjects must have a negative pregnancy test within 7 days prior to the first dose (for subjects with tumor related abnormal elevation of human chorionic gonadotropin \\[HCG\\], an ultrasound of uterus and appendages should be performed within 7 days prior to the first dose to rule out pregnancy), or demonstrate no risk for pregnancy.\n* Subject must be voluntarily enrolled in this clinical trial, be able to understand the study procedures and to sign written informed consent.\n\nExclusion Criteria:\n\n* Have received or is currently receiving the following treatment: PARPi\u002FB7-H4\u002FB7-H3-targeted therapies;\n* Have received or is currently receiving the following treatment: PARPi\u002FB7-H4\u002FB7-H3-targeted therapies;\n* Have received any of cytotoxic chemotherapy drugs, investigational drugs, anti-tumor traditional Chinese medicines or other anti-tumor drugs within 14 days prior to the first dose of study drug; or need to continue these drugs during the study.\n* Presence of Grade ≥ 2 toxicities as per Common Terminology Criteria for Adverse Events due to prior anti-tumor therapy.\n* Presence of pleural\u002Fabdominal effusion requiring clinical intervention.\n* Known history of other primary malignancy.\n* Evidence of brain metastasis and\u002For cancerous meningitis\n* Inadequate bone marrow reserve or hepatic\u002Frenal functions.\n* Cardiological examination abnormality.\n* Severe, uncontrolled or active cardiovascular disorders.\n* Serious or poorly controlled diabetes.\n* Serious or poorly controlled hypertension.\n* Clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose of study treatment.\n* Serious infections within 4 weeks prior to the first dose.\n* Have received systemic glucocorticoid therapy for more than 7 days within 28 days prior to the first dose study treatment, or require chronic (≥ 7 days) use of systemic glucocorticoids during the study, or have other acquired, congenital immunodeficiency disorders, or a history of organ transplantation.\n* Presence of active infectious diseases such as hepatitis B, hepatitis C, tuberculosis, syphilis, or human immunodeficiency virus infection, etc.\n* Current hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Class B or more severe cirrhosis.\n* Any moderate or severe lung diseases that may interfere with the detection and treatment of drug-related pulmonary toxicity or may seriously affect respiratory function.\n* History of severe neurological or psychiatric disorder.\n* Pregnant or breast-feeding women or women who intend to become pregnant during the study.\n* Attenuated live vaccination within 4 weeks prior to the first dose.\n* Subjects with autoimmune disease that is active or is likely to recur.\n* Subjects with gastrointestinal fistula, visceral fistula, gastrointestinal perforation, or abdominal abscess, or with symptoms\u002Fsigns of intestinal obstruction within 6 months prior to the first dose of study drug.\n* Subjects unlikely to comply with study procedures, restrictions and requirement as determined by the investigator.\n* Subjects with any condition that jeopardizes the safety of the patient or interferes with the assessment of the study, as judged by the investigator.",{"count":370,"type":19},157,[50],"HS-10502 is a PARP1-specific selective inhibitor. The purpose if this study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of HS-10502 Combination Treatment in subjects with advanced solid tumors.",[374,375,243,376,25,377],"Recurrent Ovarian Cancer","HER2-negative","TNBC","Advanced Gastric Cancer",[379,367,380,381,376,382,383],"Poly(ADP-ribose) polymerase-1 inhibitor","ovarian cancer","breast cancer","prostate cancer","gastric cancer","2025-06-18",{"date":386,"type":30},"2025-06-24",{"date":388,"type":30},"2025-05-07",{"date":390,"type":19},"2026-08-31",{"name":392,"class":65},"Jiangsu Hansoh Pharmaceutical Co., Ltd.",{"id":394,"slug":395,"hasResults":11,"nctId":396,"briefTitle":397,"officialTitle":397,"acronym":398,"eligibilityCriteria":399,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":400,"targetDuration":4,"studyType":196,"phases":4,"briefSummary":402,"conditions":403,"keywords":408,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":228},"100584894","whole-body-mri-in-oncology-100584894","NCT06895291","Whole Body MRI in Oncology","ONCO-MRI","Inclusion Criteria:\n\n* Patients candidate to WB-MRI according to clinical practice belonging to the study groups listed above.\n* Participant is willing and able to give informed consent for participation in the study.\n* Male or Female, aged ≥ 18 years.\n* Life expectancy greater than 3 months.\n\nExclusion Criteria:\n\n* Patients with MRI-unsafe prostheses and devices.\n* Patients whose tests are of suboptimal quality, or whose test has been suspended, or is incomplete.",{"count":401,"type":19},1000,"Multicenter, observational, prospective, study. All patients will be treated and monitored according to the local clinical practice. No additional procedures\u002Fpatient visits in comparison with the usual clinical practice are planned for the study.",[404,25,243,405,406,407],"Lymphoma","Monoclonal Gammopathy of Undetermined Significance","Smoldering Multiple Myeloma","Multiple Myeloma",[405,409,410,243,25,404,411],"Smoldering multiple myeloma","Multiple myeloma","Whole Body-Magnetic Resonance Imaging","2025-03-25",{"date":414,"type":30},"2025-03-30",{"date":416,"type":30},"2023-10-26",{"date":418,"type":19},"2031-10",{"name":420,"class":37},"Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS",{"id":422,"slug":423,"hasResults":11,"nctId":424,"briefTitle":425,"officialTitle":425,"acronym":426,"eligibilityCriteria":427,"healthyVolunteers":11,"sex":46,"minAge":16,"maxAge":4,"enrollmentInfo":428,"targetDuration":429,"studyType":196,"phases":4,"briefSummary":430,"conditions":431,"keywords":433,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":444,"startDateStruct":446,"completionDateStruct":448,"leadSponsor":450,"locationsCount":452},"100582705","european-registry-of-next-generation-imaging-in-advanced-prostate-cancer-100582705","NCT06866782","European Registry of Next Generation Imaging in Advanced Prostate Cancer","RING","Inclusion Criteria:\n\n1. Adult male patients (≥18 years with no upper age limit).\n2. Histologically proven prostate cancer.\n3. Patients who require imaging exploration (conventional, Next-Generation Imaging (NGI), or their combination) at high risk for harbouring metastatic deposits at the hormone-sensitive stage, either at the diagnostic workout of a \"naïve\" patient or at biochemical relapse\u002Fprogression after local treatment.\n4. Patients who authorize their participation in the study by signing a written informed consent form (ICF).\n\nExclusion Criteria:\n\n1. Patients participating in other interventional or non-interventional study which requires NGI as a triage test for metastatic assessment.\n2. Patients with evidence of any other clinically significant disease or condition which in the opinion of the investigator discourages their participation in the study.\n3. Patients who will not be able to complete the study.",{"count":195,"type":19},"24 Months","The RING study is a European registry collecting real-world data on advanced prostate cancer (APC) imaging. It aims to evaluate the role of next-generation imaging (NGI), such as PET\u002FCT and whole-body MRI, in detecting and monitoring the disease compared to conventional imaging.\n\nMen aged 18 or older with histologically confirmed prostate cancer are eligible to participate in the study if they require imaging to assess potential metastases, either at diagnosis or after relapse and sign a consent form.\n\nPatients will receive standard care with no experimental treatments. Imaging and treatment decisions will follow routine clinical practice. Data will be collected from medical records and analysed for research. This study will help doctors understand when NGI should be used, how it affects treatment decisions, and its impact on patient outcomes.",[151,25,432],"Metastatic Prostate Cancer (mPC)",[382,434,435,436,53,437,438,439,440,441,442],"advanced prostate cancer","new generation imaging","conventional imaging","Magnetic Resonance Imaging","PET\u002FCT PSMA","Prostate-Specific Membrane Antigen","Imaging Biomarkers","bone scan","CT","2025-03-08",{"date":445,"type":30},"2025-03-11",{"date":447,"type":30},"2024-09-17",{"date":449,"type":19},"2026-12-23",{"name":451,"class":37},"Fundacio Puigvert",24,{"id":454,"slug":455,"hasResults":11,"nctId":456,"briefTitle":457,"officialTitle":458,"acronym":4,"eligibilityCriteria":459,"healthyVolunteers":11,"sex":46,"minAge":16,"maxAge":460,"enrollmentInfo":461,"targetDuration":4,"studyType":20,"phases":462,"briefSummary":463,"conditions":464,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":465,"lastUpdatePostDateStruct":466,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":472,"locationsCount":38},"100511635","phase-1-study-of-hrs-5041-in-patients-with-metastatic-castration-resistant-prostate-cancer-mcrpc-100511635","NCT05942001","Study of HRS-5041 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)","A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HRS-5041 in Subjects With Metastatic Castration-resistant Prostate Cancer","Inclusion Criteria:\n\n1. Able and willing to provide a written informed consent.\n2. Age 18-80 years old, gender unlimited.\n3. The physical status score of the Eastern Tumor Cooperative Group (ECOG) was 0 \\~ 1.\n4. Predicted survival ≥12 weeks.\n5. Histological or cytological confirmed adenocarcinoma of the prostate.\n6. Patients progressed on taxane chemotherapy and at least one prior secondary hormonal therapy.\n\nExclusion Criteria:\n\n1. Prior treatment with an androgen receptor (AR) degrader.\n2. Plan to receive any other antitumor therapy during this trial.\n3. Receiving other investigational drugs or treatments that are not on the market within 4 weeks prior to the initial administration of the study.\n4. Patients with known brain metastases.\n5. Any significant medical condition, such as uncontrolled infection, laboratory abnormality, or psychiatric illness.","80 Years",{"count":18,"type":19},[50],"The purpose of this study is to assess the safety, tolerability and preliminary efficacy of HRS-5041 in men with progressive metastatic castration resistant prostate cancer. The objective of this study was to determine the dose-limiting toxicity, maximum tolerance and recommended dose of HRS-5041 in phase II study.",[25],"2025-02-15",{"date":467,"type":30},"2025-02-19",{"date":469,"type":30},"2023-08-03",{"date":471,"type":19},"2025-08-31",{"name":473,"class":65},"Jiangsu HengRui Medicine Co., Ltd."]