[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-prostate-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-prostate-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,59,0,25,[9,55,86,108,132,159,178,206,232,255,285,308,333,360,390,418,458,489,516,545,570,598,625,647,665],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100577593","phase-1-study-of-hld-0915-in-patients-with-metastatic-prostate-cancer-100577593",false,"NCT06800313","Study of HLD-0915 (JNJ-101556143) in Patients With Metastatic Prostate Cancer","Phase 1\u002F2 Study of HLD-0915 (JNJ-101556143) in Patients With Metastatic Prostate Cancer","Patients must meet the following criteria to be eligible study participation:\n\nKey Inclusion Criteria:\n\nAll Study Arms (Phase 1 Part 1 \\& 2, Phase 2 Part 1, Part 2A, 2B, 2C \\& 2D):\n\nMales ≥ 18 years old Histological, pathological, and\u002For cytological confirmation of prostate adenocarcinoma Adequate hematological, renal, and hepatic function. Able to swallow oral medication\n\nmCRPC Arms: (Phase 1 Part 1 \\& 2, Phase 2 Part 1): Prior orchiectomy or ongoing androgen-deprivation therapy and a castrate level of serum testosterone Progressive mCRPC defined as having demonstrated PSA progression on the prior regimen\n\nSOAR Arm (Phase 2 Part 2A) mHSPC with distant metastatic disease based on conventional imaging PSA ≥0.2 ng\u002FmL, following treatment with next generation ARPI for at least 180 days and up to 365 days No evidence of radiographic or PSA progression while receiving ARPI\n\nmHSPC arms (Phase 2 Part 2B, 2C \\& 2D) serum testosterone \\>150ng\u002Fml mHSPC with distant metastatic disease based on conventional imaging and PSA \\>2.0 ng\u002FmL\n\nKey Exclusion Criteria:\n\nAll arms (Phase 1 Part 1 \\& 2, Phase 2 Part 1, Part 2A, 2B, 2C \\& 2D):\n\nHas experienced a recent major bleed or has a known bleeding disorder Tumors exhibiting neuroendocrine or small cell carcinoma component by histopathology Receiving continuous corticosteroids at prednisone-equivalent dose of \\>10 mg\u002Fday Prior or ongoing significant medical condition\n\nmCRPC arms: (Phase 1 Part 1 \\& 2, Phase 2 Part 1): Has received systemic anti-cancer therapy or investigational drugs within 2 weeks prior to first dose of study drug with certain exceptions requiring longer washout periods\n\nSOAR arm (Phase 2 Part 2A) Has received any prior cytotoxic chemotherapy for prostate cancer\n\nmHSPC arms (Phase 2 Part 2B, 2C \\& 2D) regional pelvic lymph node disease only","MALE","18 Years",{"count":20,"type":21},190,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Assessment of the safety and efficacy of HLD-0915 (JNJ-101556143) in patients with metastatic prostate cancer who have progressed on prior systemic therapies, with further evaluation in additional prostate cancer populations.",[28],"Metastatic Prostate Cancer",[30,31,32,33,34,35,36,37,38,39,40,41],"Prostate Cancer","RIPTAC","HLD-0915","Genital Neoplasms, Male","Urogenital Neoplasms, Male","Genital Diseases, Male","Urogenital Diseases, Male","Neoplasms, Glandular and Epithelial","Prostatic Neoplasms","Prostate Adenocarcinoma","Hormone Sensitive, Castrate Resistant","Metastatic Castrate Resistant Prostate Cancer","RECRUITING","2026-08-19",{"date":45,"type":46},"2026-08-20","ACTUAL",{"date":48,"type":46},"2025-02-06",{"date":50,"type":21},"2028-07-11",{"name":52,"class":53},"Janssen Research & Development, LLC","INDUSTRY",18,{"id":56,"slug":57,"hasResults":12,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":12,"sex":63,"minAge":64,"maxAge":4,"enrollmentInfo":65,"targetDuration":4,"studyType":22,"phases":67,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":85},"100572825","phase-2-cabazitaxel---carboplatin-vs-177lu-psma-617-in-metastatic-castrate-resistant-prostate-cancer-100572825","NCT06738303","Cabazitaxel +\u002F- Carboplatin vs 177Lu-PSMA-617 in Metastatic Castrate-resistant Prostate Cancer","Carboplatin and Cabazitaxel Versus 177Lu-PSMA-617 in Patients With Aggressive, Metastatic Castrate-resistant Prostate Cancer (CATCH-177)","CATCH-177","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed adenocarcinoma of prostate\n* Evidence of metastatic castrate-resistant prostate cancer that has previously been treated with an androgen receptor pathway inhibitor. Prior docetaxel exposure is recommended but not mandatory. Tissue is not mandatory, but a pathologic report is required at time of enrollment.\n* Patients must have a PSMA-positive 18F-rhPSMA-7.3 performed within 12 weeks from C1D1 with ≥1 site with SUVmax ≥10. An alternative PSMA PET tracer is permitted at baseline if performed within 8 weeks prior to randomization.\n* Eligible patients have evidence of mCRPC who have progressed on prior novel hormonal agent(s) to include at least one of the following:\n\n  * Baseline PSMA SUVmean \\\u003C10 OR\n  * ≥1 visceral metastasis OR\n  * ≥5 bone metastases OR one of the following (using Next Generation Sequencing on file within 5 years)\n  * TP53\n  * PTEN\n  * mutation.\n* Age \\> 18 years.\n* ECOG performance status of 0 to 2.\n* Participants must have adequate organ and marrow function as defined below to be suitable for the randomized treatment outlined in this\n\n  * Absolute neutrophil count \\>1000\u002FμL; platelet count \\>90 000\u002FμL; hemoglobin \\>8.5 g\u002FdL) at screening.\n  * Note: Participants must not have received any growth factors within 7 days or blood transfusions within 14 days prior to the hematologic laboratory values obtained at screening).\n  * Total bilirubin (TBIL) \\\u003C2.5 × the upper limit of normal (ULN) at screening, except participants with documented Gilbert syndrome who must have a TBIL \\\u003C3 mg\u002FdL\n  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C 5 ULN at screening\n  * Creatinine clearance ≥40 mL\u002Fmin and\u002For estimated glomerular filtration rate (eGFR) ≥30\n  * Albumin \\>30 g\u002FL (3.0 g\u002FdL) at screening\n* Participants receiving bisphosphonates or other approved bone-targeting therapy (e.g., denosumab) must be on a stable dose for at least 14 days before the start of study treatment.\n* Participants of child-producing potential agree to use highly effective contraceptive methods (i.e., barrier contraception measures such as a male condom with spermicide during intercourse) and avoid sperm donation during the study treatment and for 3 months after the last dose of study treatment. A man is considered to be of child-producing potential, unless he has had a bilateral vasectomy with documented aspermia or a bilateral orchiectomy. Partners of patients must also practice approved forms of birth control\n* Participants must have the ability to understand and the willingness to sign a written informed consent form (ICF).\n* Members of all races and ethnic groups are eligible for this trial\n\nExclusion Criteria:\n\n* Evidence of hormone-sensitive prostate cancer (HSPC)\n* Evidence of small cell prostate cancer\n* Participants receiving any other investigational agents.\n* Diagnosis of another clinically significant malignancy within the previous 2 years other than curatively treated non-melanomatous skin cancer or superficial urothelial carcinoma and other in situ or noninvasive malignancies, as determined by the PI or Co-PI.\n* Participants with brain metastases\u002Fcentral nervous system (CNS) disease that are treated prior to enrollment will be allowed in this clinical trial.\n* Known or suspected significant hypersensitivity to any components of the formulation used for Cabazitaxel, carboplatin or 177Lu-PSMA-617.\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 considered by the Investigator to limit compliance with study requirements.\n* Prior treatment toxicities not resolved to ≤ Grade 2 according to NCI CTCAE Version 5.0","ALL","19 Years",{"count":66,"type":21},44,[25],"The purpose of this study is to find out what treatment works best for participants with metastatic prostate cancer that are not responding to hormone treatment and docetaxel and are also Prostate-specific membrane antigen(PSMA) positive.",[28,70],"Metastatic Castration-resistant Prostate Cancer",[72,73,74],"Cabazitaxel","Lu-PSMA-617","Carboplatin","2026-08-13",{"date":77,"type":46},"2026-08-14",{"date":79,"type":46},"2025-07-14",{"date":81,"type":21},"2026-12",{"name":83,"class":84},"Case Comprehensive Cancer Center","OTHER",1,{"id":87,"slug":88,"hasResults":12,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":22,"phases":95,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":4},"100610163","phase-2-low-dose-naltrexone-ldn-for-management-of-fatigue-in-prostate-cancer-patients-on-androgen-deprivation-therapy-adt-100610163","NCT07224009","Low Dose Naltrexone (LDN) for Management of Fatigue in Prostate Cancer Patients on Androgen Deprivation Therapy (ADT)","Phase II Clinical Trial Evaluating the Safety and Efficacy of Low Dose Naltrexone (LDN) for the Management of Fatigue in Prostate Cancer Patients on Androgen Deprivation Therapy (ADT)","Inclusion Criteria\n\n* Histologically or cytologically confirmed biochemical recurrence and on ADT for at least 3 months. Metastatic castrate-sensitive and castrate-resistant prostate cancer on ADT with or without novel hormonal therapy like apalutamide, darolutamide, enzalutamide and abiraterone.\n* Initiation of hormonal ablative therapy within 3 months of registration.\n* ECOG performance status \\\u003C3.\n* Patients must have normal organ and marrow function as defined below:\n\n  * leukocytes \\>3,000\u002FμL\n  * absolute neutrophil count \\>1,500\u002FμL\n  * platelets \\>100,000\u002FμL\n  * total bilirubin within normal institutional limits\n  * AST(SGOT)\u002FALT(SGPT) \\\u003C2.5 X institutional upper limit of normal\n  * creatinine ≤2.5.0\n  * left ventricular ejection fraction \\>45%\n  * FACIT-F score \\\u003C 43 on screening\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria\n\n* Prior chemotherapy received in the last three months.\n* Patients currently on PARP inhibitors.\n* Currently taking or have taken within 10 days of enrollment.\n* Patients may not be receiving any other investigational agents.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Naltrexone or other agents used in the study.\n* History of other malignancies other than nonmelanoma skin cancer, unless in complete remission and off therapy for that disease for at least 5 years.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, history of congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Any Patient with acute hepatitis and liver failure are excluded.",{"count":94,"type":21},60,[25],"The study is being done to see if a small daily dose of naltrexone (LDN, 3 mg pill) can help reduce tiredness (fatigue) in men with prostate cancer. All men in this study are being treated with hormone therapy (also called androgen deprivation therapy, or ADT). Some may also be taking newer hormone medicines such as apalutamide, daralutamide, enzalutamide, or abiraterone.",[28],"NOT_YET_RECRUITING","2026-08-10",{"date":101,"type":46},"2026-08-11",{"date":103,"type":21},"2026-08",{"date":105,"type":21},"2030-01",{"name":107,"class":84},"University of Arkansas",{"id":109,"slug":110,"hasResults":12,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":22,"phases":117,"briefSummary":118,"conditions":119,"keywords":121,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":131},"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.",{"count":116,"type":21},210,[24],"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.",[120,28],"Advanced Prostate Cancer",[122],"Castration-resistant","2026-08-07",{"date":99,"type":46},{"date":126,"type":46},"2023-05-02",{"date":128,"type":21},"2027-06-30",{"name":130,"class":53},"Genentech, Inc.",26,{"id":133,"slug":134,"hasResults":12,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":22,"phases":141,"briefSummary":142,"conditions":143,"keywords":144,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":85},"100650982","sipuleucel-t-sip-t-in-combination-with-n-803-in-metastatic-androgen-pathway-modulation-resistant-mapmr-prostate-cancer-100650982","NCT07756593","Sipuleucel-T (Sip-T) in Combination With N-803 in Metastatic Androgen Pathway Modulation Resistant (mAPMR) Prostate Cancer","A Phase Ib Study Evaluating the Safety and Tolerability of Sipuleucel-T (Sip-T) in Combination With N-803 in Patients With Metastatic Androgen Pathway Modulation Resistant (mAPMR) Prostate Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed prostate adenocarcinoma.\n* Imaging- or biopsy-proven metastatic disease. May have any type or location of metastases (bone, lymph node, visceral).\n* Prior treatment must include either orchiectomy or luteinizing hormone-releasing agonist or antagonist treatment with documented testosterone ≤ 50 ng\u002FdL.\n* Eligible for standard of care Sipuleucel-T.\n* Recovery to baseline or ≤ grade 1 from toxicities related to any prior treatments, unless AEs are clinically nonsignificant and\u002For stable on supportive therapy.\n* At least 18 years of age.\n* ECOG performance status ≤ 2\n* Adequate bone marrow and organ function as defined below:\n\n  * Absolute neutrophil count ≥ 1,500 K\u002Fcumm without granulocyte colony-stimulating factor support\n  * Platelets ≥ 100,000 K\u002Fcumm without transfusion\n  * Hemoglobin ≥ 10.0 g\u002FdL\n  * Total bilirubin ≤ 1.5 x IULN\n  * AST(SGOT) and ALT(SGPT) ≤ 2.5 x IULN\n  * Calculated creatinine clearance ≥ 50 mL\u002Fmin by Cockcroft-Gault\n* PSA ≤ 200 ng\u002FmL.\n* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants\n\nExclusion Criteria:\n\n* Rapidly progressing disease or symptomatic prostate cancer as assessed by the investigator.\n* Prior immunotherapy (e.g., anti-PD-1, anti-PD-L1, anti-CTLA4) within the 6 months prior to enrollment.\n* Prior systemic radiotherapy (such as Ra-223, Lu177-PSMA) within the 6 months prior to enrollment. Prior palliative radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before first dose of study treatment is allowed. Prior definitive radiation therapy for localized prostate cancer is allowed.\n* Prior exposure to Sipuleucel-T.\n* Ongoing systemic immune suppression (oral steroids equivalent to 10 mg daily prednisone or less are allowed; topical, inhaled, and intra-articular steroids are allowed).\n* Currently receiving any other investigational therapeutic or imaging agents.\n* Patients with known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks prior to first dose of study treatment after radiotherapy or at least 4 weeks prior to first dose of study treatment after major surgery (e.g., removal or biopsy of brain metastasis). Subjects must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of first dose of study treatment.\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to Sipuleucel-T or N-803 or other agents used in the study.\n* Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. Patients with a known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Function Classification; to be eligible for this trial, patients should be a class 2B or better.\n* HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing not required in the absence of known history of infection.\n* Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible. HBV testing not required in the absence of known history of infection.\n* History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing not required in the absence of known history of infection.\n* Uncontrolled infection with hepatitis A.",{"count":140,"type":21},30,[24],"This phase Ib single-center open-label de-escalation study uses a modified 3+3 design to determine the safety, tolerability, and recommended phase II dose (RP2D) of the combination of standard of care Sip-T and N-803 in patients with metastatic androgen pathway modulation resistant (mAPMR) prostate cancer. Patients will receive treatment for up to 8 weeks.",[30,28],[30,145,146,147,28,148,149,150],"Immunotherapy","Sipuleucel-T","IL-15","Cellular Therapy","Cytokine Therapy","Combination Trial","2026-08-06",{"date":99,"type":46},{"date":154,"type":21},"2026-11-30",{"date":156,"type":21},"2031-01-31",{"name":158,"class":84},"Washington University School of Medicine",{"id":160,"slug":161,"hasResults":12,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":22,"phases":168,"briefSummary":169,"conditions":170,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":171,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":177},"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":167,"type":21},260,[24,25],"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.",[120,28],{"date":99,"type":46},{"date":173,"type":46},"2026-04-29",{"date":175,"type":21},"2027-12-30",{"name":130,"class":53},5,{"id":179,"slug":180,"hasResults":12,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":186,"enrollmentInfo":187,"targetDuration":4,"studyType":22,"phases":189,"briefSummary":190,"conditions":191,"keywords":192,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":205},"100633671","phase-1-first-in-human-study-to-evaluate-azd8359-steap2-tce-in-participants-with-prostate-cancer-100633671","NCT07529717","First-in-Human Study to Evaluate AZD8359 STEAP2 TCE in Participants With Prostate Cancer","Phase I\u002FII Dose Escalation & Dose Optimization Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD8359, a CD8-guided T Cell-engaging Antibody That Targets STEAP2, in Adult Participants With Prostate Cancer","CRIUS-1","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of adenocarcinoma of the prostate or neuroendocrine differentiated prostate cancer\n* Surgically or medically castrated with serum testosterone levels ≤ 50 ng\u002FdL (≤ 1.75 nmol\u002FL)\n* PSA value at screening should be ≥ 1ng\u002FmL\n* Evidence of disease progression within 6 months prior to screening\n* Part A Participants should have received at least 2 prior approved systemic therapies for prostate cancer with at least one androgen receptor pathway inhibitor and at least one taxane regimen if amenable\n* Part B Participants should have received an androgen receptor pathway inhibitor for metastatic hormone sensitive prostate cancer or metastatic castration resistant prostate cancer (mCRPC). No prior taxane treatment for mCRPC is allowed for Module 1 and 2 Part B patients\n* Adequate organ function\n* Body weight ≥ 35 kg\n\nExclusion Criteria:\n\n* Any clinically relevant cardiac abnormalities such as QT prolongation or uncontrolled cardiac arrythmias\n* All prior treatment-related adverse events must have resolved to Grade ≤ 2\n* History of Grade ≥ 3 cytokine release syndrome or Grade ≥ 2 immune effector cell-associated neurotoxicity syndrome with prior therapy\n* Active or prior documented autoimmune or inflammatory disorders within the past 3 years\n* Prior exposure to any STEAP2 targeted agents or TCEs for prostate cancer","100 Years",{"count":188,"type":21},42,[24,25],"This study is being conducted to learn more about the safety, tolerability, and effectiveness of an experimental treatment for metastatic prostate cancer called AZD8359. The study is split into different modules which will look at AZD8359 delivered by different methods. The study is also further split into 2 parts, Part A which will test different dose levels and dosing schedules of AZD8359 to determine which doses are the best in terms of safety and side effects (dose escalation), and Part B will further test at least two AZD8359 doses in a larger group of participants (dose expansion).",[28],[193,194,195,196],"Prostate","STEAP2","T Cell-engaging Antibody","CD8","2026-08-05",{"date":151,"type":46},{"date":200,"type":46},"2026-05-18",{"date":202,"type":21},"2027-11-17",{"name":204,"class":53},"AstraZeneca",8,{"id":207,"slug":208,"hasResults":12,"nctId":209,"briefTitle":210,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":212,"targetDuration":4,"studyType":214,"phases":4,"briefSummary":215,"conditions":216,"keywords":218,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":4,"leadSponsor":229,"locationsCount":85},"100127142","collection-of-blood-from-patients-with-prostate-cancer-100127142","NCT00923221","Collection of Blood From Patients With Prostate Cancer","* INCLUSION CRITERIA:\n\nIndividuals 18 years of age and older are eligible.\n\nIndividuals with a diagnosis of prostate cancer are eligible.\n\nEXCLUSION CRITERIA:\n\nChildren are not eligible.",{"count":213,"type":21},1000,"OBSERVATIONAL","Background:\n\n* It is not fully understood why prostate cancer in some men becomes androgen-independent (no longer responds to anti-androgen medication), but genetics likely plays an important role.\n* Genes contain the hereditary information that is passed down from parents to children. Although everyone has the same set of genes, individuals can have different forms of the same gene.\n* Differences in genes may explain, at least in part, why some people develop a more aggressive form of prostate cancer than others.\n\nObjectives:\n\n-To obtain blood samples from patients with prostate cancer to try to identify gene differences associated with progression to the androgen independent state.\n\nEligibility:\n\n-All participants participating in NCI prostate cancer protocols.\n\nDesign:\n\n* Participants with prostate cancer are evaluated in the NCI s Medical Oncology Clinic.\n* Blood samples are collected at the initial visit or at follow-up visits.\n* DNA (genetic material) and white blood cells are extracted from these samples to be used for genotyping and establishment of cell lines.\n* Gene variations are correlated with prostate cancer prognosis and prognostic indicators.",[217,30,38,28,193],"Cancer Of Prostate",[219,38,220,221,222,223,30],"Genetic","Genotyping","Venipuncture","Polymorphism","Natural History","2026-07-25",{"date":226,"type":46},"2026-07-28",{"date":228,"type":46},"2007-02-28",{"name":230,"class":231},"National Cancer Institute (NCI)","NIH",{"id":233,"slug":234,"hasResults":12,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":238,"eligibilityCriteria":239,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":186,"enrollmentInfo":240,"targetDuration":4,"studyType":22,"phases":242,"briefSummary":243,"conditions":244,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":254},"100470307","phase-2-duration-of-androgen-receptor-pathway-inhibitor-and-adt-with-metastasis-directed-therapy-in-oligometastatic-cancer-of-the-prostate-direct-100470307","NCT05404139","Duration of Androgen Receptor Pathway Inhibitor and ADT With Metastasis Directed Therapy in Oligometastatic Cancer of the Prostate (DIRECT)","Duration of Androgen Receptor Pathway Inhibitor and ADT With Metastasis Directed Therapy in Oligometastatic Cancer of the Prostate","DIRECT","Inclusion Criteria:\n\n1. Age \\> 18 years\n2. Able to provide informed consent\n3. Histologic diagnosis of prostate adenocarcinoma\n4. ECOG performance status 0-2\n5. Stage IV castrate sensitive metachronous metastatic prostate cancer. diagnosed within 6 months of study enrollment with 1-10 metastases\n\n   1. Maximum one metastatic deposit on conventional imaging (CT or bone scan or MR)\n   2. Additional metastases can be detectable by PSMA PET only\n6. All sites of disease are amenable to and can be safely treated with radiotherapy\n7. Patients decline continuous use of ADT\n\nExclusion Criteria (for all patients):\n\n1. Significant comorbidities rendering patient not suitable for ADT, ARPI (enzalutamide or abiraterone) and SBRT\n\n   a. Patients with significant comorbidities rendering patient not suitable for atorvastatin is not an exclusion criteria, as these patients can still enroll and be randomized between Arms 1 and 3.\n2. History of malignancy within the past 5 years, excluding non-melanoma skin cancer and in-situ cancer, managed non-curatively\n3. Prior use of salvage systemic therapy\n4. Evidence of spinal cord compression\n\nExclusion Criteria (for Arm 4 only, after randomization)\n\n1. ALT\u002FAST \\> 3 x ULN\n2. History of myasthenia gravis or active myasthenia gravis\n3. History of ocular myasthenia or active ocular myasthenia",{"count":241,"type":21},352,[25],"This is a multi-centre, investigator-initiated, three-arm, randomized trial to investigate the addition on androgen receptor pathway inhibitor and atorvastatin to standard of care radiation and hormone therapy improve quality of life.\n\nParticipants will either receive standard of care radiation and hormone (ADT) therapy (Arm 1), standard of care radiation and hormone (ADT) therapy plus oral abiraterone for 8-9 months (Arm 3) or standard of care radiation and hormone (ADT) therapy plus oral abiraterone for 8-9 months plus atorvastatin for 2 years (Arm 4). Participants will be routinely follow-up in clinic or remotely for up to 5 years.",[28],"2026-07-23",{"date":247,"type":46},"2026-07-27",{"date":249,"type":46},"2023-05-24",{"date":251,"type":21},"2031-02",{"name":253,"class":84},"University Health Network, Toronto",2,{"id":256,"slug":257,"hasResults":12,"nctId":258,"briefTitle":259,"officialTitle":259,"acronym":260,"eligibilityCriteria":261,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":22,"phases":263,"briefSummary":265,"conditions":266,"keywords":269,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":85},"100644944","early-phase-1-response-with-interim-psma-pet-in-metastatic-castration-sensitive-prostate-cancer-for-optimization-of-adaptive-metastasis-directed-radiotherapy-delivery-100644944","NCT07674771","Response With Interim PSMA PET in Metastatic Castration-sensitive Prostate Cancer for Optimization of Adaptive Metastasis-directed Radiotherapy Delivery","RIPCORD","Inclusion Criteria:\n\n1. History of pathologically confirmed prostate cancer.\n2. Age \\>=18 years.\n3. Performance status ECOG 0-2.\n4. Staging 68Ga PMSA-11 PET\u002FCT showing 4-20 sites of metastasis from prostate cancer within \\\u003C=90 days prior to registration. This scan ideally should be performed before initiation of androgen deprivation therapy (ADT).\n5. At the discretion of the treating investigator, it is believed that it is safe to treat all sites of disease using SABR.\n6. All men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of standard of care SABR and for a period of time of 6 months thereafter as per standard guidelines. Should a patient's partner become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n7. Ability to understand and the willingness to sign a written informed consent.\n8. Planned for standard systemic therapy for metastatic prostate cancer to include androgen deprivation therapy (ADT). Upfront Docetaxel should not be planned (See section 4.1.2).\n\nExclusion Criteria:\n\n1. Prior radiotherapy to any metastases currently targeted for therapy or overlapping regions.\n2. Patient with metastatic lesions involving the gastrointestinal tract, specifically, invading esophagus, stomach, or intestines will be excluded. Patients with ultra-central metastatic lesions defined as 1 cm from the trachea and main bronchi will be excluded.\n3. Serious medical co-morbidities precluding safe delivering of radiotherapy to poly-metastatic sites. This includes interstitial lung disease for patients undergoing SABR to thoracic sites and ulcerative colitis or Crohn's disease requiring systemic immunosuppressive therapy for patients undergoing SABR to GI sites.\n4. Subjects may not be receiving any other PSMA-directed investigational agents for the treatment of the cancer under study.\n5. History of allergic reactions to PMSA-11 68Ga imaging agent.\n6. Uncontrolled intercurrent illness or psychiatric illness\u002Fsocial situations that, in the opinion of the investigator, would limit compliance with study requirements.",{"count":140,"type":21},[264],"EARLY_PHASE1","The purpose of this study is to characterize the reduction in PSMA-avid tumor volume and metastasis-directed radiotherapy treatment intensity facilitated by PET PSMA-response adapted SABR for poly-metastatic castration sensitive prostate cancer.",[30,267,28,268],"Castration Sensitive Prostate Cancer","Adaptive Radiotherapy",[270,271,272,273,274,275,276],"prostate cancer","castration sensitive","stereotactic ablative radiotherapy","stereotactic body radiotherapy","metastatic prostate cancer","metastasis","adaptive radiotherapy","2026-07-21",{"date":245,"type":46},{"date":280,"type":21},"2026-07-15",{"date":282,"type":21},"2029-06-15",{"name":284,"class":84},"University of Texas Southwestern Medical Center",{"id":286,"slug":287,"hasResults":12,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":291,"eligibilityCriteria":292,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":293,"targetDuration":4,"studyType":22,"phases":295,"briefSummary":296,"conditions":297,"keywords":298,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":299,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":307},"100440137","phase-2-high-dose-testosterone-for-atm-cdk12-or-chek2-altered-prostate-cancers-100440137","NCT05011383","High Dose Testosterone for ATM, CDK12 or CHEK2 Altered Prostate Cancers","High-dose Testosterone in Men With Metastatic Castration-resistant Prostate Cancer and ATM or CDK12 Deficiency","VA-BAT","Inclusion Criteria:\n\n* Signed informed consent form (ICF) providing agreement to adhere to the dosing schedule, report for all trial visits and authorization, use and release of health and research trial information\n* Histologically or cytologically confirmed adenocarcinoma of the prostate\n* Ongoing gonadal androgen deprivation therapy with gonadotropin-releasing hormone (GnRH) analogues, antagonists or orchiectomy. Patients who have not had an orchiectomy must be maintained on effective GnRH analogue\u002Fantagonist therapy\n* Castration resistant prostate cancer as defined by serum testosterone \\\u003C 50 ng\u002Fml and one of the following:\n\n  * PSA level of at least 2 ng\u002Fml that has risen on at least 2 successive occasions at least 1 week apart.\n  * Evaluable disease progression by modified RECIST 1.1 (Response Evaluation Criteria in Solid Tumors)\n  * Progression of metastatic bone disease on bone scan with \\> 2 new lesions\n* Presence of metastatic disease on bone or CT scan\n* Patients must have progressed on 1 next-generation AR-signaling inhibitor (e.g. abiraterone, enzalutamide, apalutamide, darolutamide, etc.).\n* Asymptomatic or minimal cancer related symptoms\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of \\\u003C 2\n* Presence of inactivating mutations in ATM, CDK12 or CHEK2 as determined by a CLIA level assay for DNA sequencing.\n\nExclusion Criteria:\n\n* Currently receiving active therapy for other neoplastic disorders will not be eligible.\n* Histologic evidence of small cell carcinoma (morphology alone - immunohistochemical evidence of neuroendrocrine differentiation without morphologic evidence is not exclusionary)\n* Known parenchymal brain metastasis\n* Liver metastases\n* Active or symptomatic viral hepatitis or chronic liver disease AST or ALT \\> 2.5 x ULN or total bilirubin \\> ULN (unless Gilbert's syndrome is the etiology of hyperbilirubinemia).\n* Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of \\\u003C35 % at baseline\n* Patients with pain attributable to their prostate cancer and requiring the use of opioids.\n* Tumor causing urinary outlet obstruction that requires catheterization for voiding. Patients that require catheterization to void secondary to benign strictures or other non-cancer causes will be permitted to enroll.\n* Presence of dementia, psychiatric illness, and\u002For social situations limiting compliance with study requirements or understanding and\u002For giving of informed consent.\n* Any condition(s), medical or otherwise, which, in the opinion of the investigators, would jeopardize either the patient or the integrity of the data obtained.",{"count":294,"type":21},51,[25],"This study will determine whether the presence of DNA repair deficiency in the form of alterations in the genes ATM, CDK12 or CHEK2 predicts for a high likelihood of responding to the use of intermittent high dose testosterone. This therapy may result in responses in tumors which are genetically unstable because of DNA repair deficiency and this is a prospective study to test that hypothesis",[28],[38],{"date":245,"type":46},{"date":301,"type":46},"2021-08-31",{"date":303,"type":21},"2027-08-31",{"name":305,"class":306},"VA Office of Research and Development","FED",17,{"id":309,"slug":310,"hasResults":12,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":4,"eligibilityCriteria":314,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":315,"targetDuration":4,"studyType":22,"phases":317,"briefSummary":318,"conditions":319,"keywords":320,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":326,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":332},"100648437","phase-2-18ffluorthanatrace---positron-emission-tomography-ftt-pet-and-ctdna-to-predict-response-to-parp-inhibitor-therapy-in-metastatic-prostate-cancer-mpc-100648437","NCT07723651","[18F]Fluorthanatrace - Positron Emission Tomography (FTT-PET) and ctDNA to Predict Response to PARP Inhibitor Therapy in Metastatic Prostate Cancer (mPC)","Integration of FTT-PET and ctDNA to Predict Response to PARP Inhibitor Therapy in Metastatic Prostate Cancer (mPC)","Inclusion Criteria:\n\n* Adult male patients 18 years of age or older\n* mCRPC with confirmed germline or somatic HRR (such as ATM, ATR, BRCA1, BRCA2, CDK12, CHEK2, FANCA, MLH1, MRE11A, NBN, PALB2, or RAD51C for Talazoparib\u002Fenzalutamide and ATMm, BRCA1m, BRCA2m, BARD1m, BRIP1m, CDK12m, CHEK1m, CHEK2m, FANCLm, PALB2m, RAD51Bm, RAD51Cm, RAD51Dm, RAD54Lm; gBRCA1m, gBRCA2m; ATMm, BRCA1m, BRCA2m for Olaparib +\u002F- abiraterone) mutations who are scheduled for SOC PARPi therapy.\n* Lesion size of at least 1.0 cm in longest dimension by imaging. If non-measurable, lesion needs to be clearly detected on other imaging studies such as bone scintigraphy, FDG-PET, PSMA-PET or MRI.\n* On continuous androgen deprivation therapy (ADT) with appropriately suppressed castrate testosterone levels of \\\u003C 50 ng\u002FdL, or prior bilateral orchiectomy.\n* Serum PSA of 2 ng\u002FmL or greater.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* Able to give informed consent\n\nExclusion Criteria:\n\n* Receipt of prior PARP inhibitor therapy in any disease setting.\n* Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer that is active at the time of enrollment.\n* Unable to tolerate approximately 30 min (total time) of PET\u002FCT imaging.",{"count":316,"type":21},75,[25],"This multicenter center, open-label, baseline-controlled diagnostic imaging study designed to assess the use of Fluorthanatrace-Positron Emission tomography (FTT-PET) as a PARP inhibitor (PARPi) therapy predictive imaging biomarker and the use of EnhanceAR-Seq (ctDNA) in predicting response to therapy and to identify genomic alterations associated with resistance. Furthermore, to correlate changes in ctDNA and imaging (FTT-PET and standard of care imaging) to understand the dynamics of tumor response.",[28,30],[321,322,323,324],"PARP","FTT","PET","Prostate cancer","2026-07-19",{"date":245,"type":46},{"date":328,"type":21},"2026-09-01",{"date":330,"type":21},"2032-03-31",{"name":158,"class":84},3,{"id":334,"slug":335,"hasResults":12,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":4,"eligibilityCriteria":339,"healthyVolunteers":12,"sex":63,"minAge":18,"maxAge":4,"enrollmentInfo":340,"targetDuration":4,"studyType":22,"phases":342,"briefSummary":344,"conditions":345,"keywords":347,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":352,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":332},"100612372","phase-4-evaluating-dose-timing-morning-vs-evening-of-endocrine-based-therapies-in-metastatic-breast-and-prostate-cancers-100612372","NCT07252726","Evaluating Dose Timing (Morning vs Evening) of Endocrine-based Therapies in Metastatic Breast and Prostate Cancers","A Randomised, Multicentre Trial Evaluating the Dose Timing (Morning vs Evening) of Endocrine-based Therapies in Metastatic Breast and Prostate Cancers (REaCT-CHRONO-MetBP Pilot Study)","Cohort A (Breast Cohort) Inclusion Criteria\n\n* Patients with metastatic hormonal receptor positive breast cancer\n* Plan to receive endocrine therapy and a CDK4\u002F6 inhibitor (either Ribociclib or Palbociclib) in the first-line metastatic setting\n* Age ≥18 years\n* Able to provide oral consent\n* Willing and able to complete questionnaires as per study protocol\n\nCohort A (Breast Cohort) Exclusion Criteria\n\n* Any contraindication in taking endocrine therapy and CDK4\u002F6 inhibitor in the morning or evening\n* Plan to receive abemaciclib (as this requires twice a day dosing)\n\nCohort B (Prostate Cancer) Inclusion Criteria\n\n* Patients with metastatic castrate sensitive prostate cancer\n* Plan to receive androgen receptor pathway inhibitor (either enzalutamide, apalutamide or abiraterone acetate) in combination with androgen deprivation therapy\n* Age ≥18 years\n* Able to provide oral consent\n* Willing and able to complete questionnaires as per study protocol\n\nCohort B (Prostate Cancer) Exclusion Criteria\n\n* Any contraindication in taking androgen receptor pathway inhibitor in the morning or evening\n* Plan to receive darolutamide (as this requires twice a day dosing)\n* Plan to receive docetaxel in combination with androgen receptor pathway inhibitor",{"count":341,"type":21},50,[343],"PHASE4","The REaCT-CHRONO-MetBP Pilot study will compare morning and evening administration of endocrine-based therapy in metastatic breast and prostate cancers.\n\nParticipants with metastatic breast or prostate cancer will be randomly placed in one of two groups: a morning group and an evening group. The group assignment will determine whether they take their endocrine therapy in the morning or the evening. The primary outcome of this pilot study is to evaluate the feasibility of study procedures in order to conduct a larger definitive trial in the future. The secondary outcomes include comparing quality of life, tolerability, and efficacy outcomes between the morning and evening groups for each of the two cancer cohorts (metastatic breast and prostate cancer).",[346,28],"Metastatic Breast Cancer",[348,349,270,350,351],"Chronotherapy","breast cancer","endocrine therapy","metastatic cancer",{"date":353,"type":46},"2026-07-17",{"date":355,"type":46},"2026-02-02",{"date":357,"type":21},"2033-03",{"name":359,"class":84},"Ottawa Hospital Research Institute",{"id":361,"slug":362,"hasResults":12,"nctId":363,"briefTitle":364,"officialTitle":365,"acronym":366,"eligibilityCriteria":367,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":368,"enrollmentInfo":369,"targetDuration":4,"studyType":22,"phases":371,"briefSummary":372,"conditions":373,"keywords":374,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":389},"100606869","phase-1-study-of-azd0516-as-monotherapy-and-in-combination-in-participants-with-metastatic-prostate-cancer-100606869","NCT07181161","Study of AZD0516 as Monotherapy and in Combination in Participants With Metastatic Prostate Cancer","A Modular Phase I\u002FIIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AZD0516 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Metastatic Prostate Cancer","SEACLIFF","Main Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of metastatic adenocarcinoma of the prostate. Focal high grade neuroendocrine features are permitted.\n* Measurable PSA ≥ 1 μg\u002FL (≥ 1 ng\u002FmL).\n* Surgically or medically castrated with serum testosterone levels ≤ 50 ng\u002FdL (≤ 1.75 nmol\u002FL) within ≤ 28 days before treatment allocation. Ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone (GnRH) modulator for participants who have not undergone bilateral orchiectomy must be initiated at least 2 weeks prior to consent and must continue throughout the study.\n* Eastern cooperative oncology group (ECOG) performance status of 0 or 1.\n* Adequate organ and marrow function in the absence of blood transfusion or growth factor support (within 21 days prior to the scheduled first dose of study intervention).\n* Provision of baseline archival or newly obtained formalin-fixed paraffin-embedded (FFPE) tumour sample is mandatory.\n* Documented current evidence of metastatic prostate cancer\n* Life expectancy of at least 12 weeks in the opinion of the investigator\n* Documented mCRPC progression at screening as assessed by the investigator with at least one of the following criteria:\n\n  1. PSA progression defined by a minimum of 3 rising PSA levels with an interval of ≥ 1 week between each determination. The PSA value at the screening visit should be ≥ 1 μg\u002FL (1 ng\u002FmL).\n  2. Radiographic disease progression in soft tissue based on response evaluation criteria in solid tumors (RECIST) v1.1 criteria with or without PSA progression as per prostate cancer working group 3 (PCWG3).\n  3. Radiographic disease progression in bone defined as the appearance of 2 or more new bone lesions on a bone scan as per PCWG3 with or without PSA progression.\n\nMain Exclusion Criteria:\n\n* Cancer related spinal cord compression, or brain metastases unless asymptomatic, treated and stable and not requiring continuous corticosteroids at a dose of \\> 10 mg prednisone\u002Fday or equivalent for at least 4 weeks prior to study enrolment.\n* History of leptomeningeal carcinomatosis.\n* Unresolved toxicities of Grade ≥ 2 (National Cancer Institute Common Terminology Criteria for Adverse Events v5.0) from prior therapy (excluding vitiligo, alopecia, and endocrine disorders that are controlled with replacement hormone therapy).\n* Uncontrolled intercurrent illness within the last 12 months.\n* Cardiovascular disorder (History of arrhythmia, uncontrolled hypertension, symptomatic hypotension, history of brain perfusion problems, symptomatic heart failure, prior or current cardiomyopathy, severe valvular heart disease)\n* History of malignancy\n* History of non-infectious interstitial lung disease (ILD)\u002Fpneumonitis\n* Active infection exclusions, including tuberculosis and infections with Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV).\n* Any known predisposition to bleeding\n* Clinically severe pulmonary compromise\n* Participants with Myelodysplastic syndrome (MDS)\u002FAcute Myeloid Leukemia (AML) or with features suggestive of MDS\u002FAML.\n* Previous treatment with a STEAP2 targeting modality, chemotherapeutic agent that inhibits topoisomerase activity or metabolic enzymes.","130 Years",{"count":370,"type":21},177,[24,25],"The main purpose of this study is to assess the safety and tolerability of AZD0516 as monotherapy and\u002For in combination with other anti-cancer agents for treatment of metastatic prostate cancer.",[28],[375,376,377,378,379,380,381],"Metastatic Castration-Resistant Prostate Cancer","Dose escalation study","Anti-cancer agents","Antibody-drug conjugate","Anti-Six-transmembrane epithelial antigen of the prostate 2 (anti-STEAP2)","Metastatic castration resistant prostate cancer (mCRPC)","AZD0516","2026-07-14",{"date":280,"type":46},{"date":385,"type":46},"2025-10-01",{"date":387,"type":21},"2029-01-18",{"name":204,"class":53},52,{"id":391,"slug":392,"hasResults":12,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":4,"eligibilityCriteria":396,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":397,"targetDuration":4,"studyType":22,"phases":399,"briefSummary":400,"conditions":401,"keywords":402,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":417},"100471019","phase-1-study-of-oric-944-in-patients-with-metastatic-prostate-cancer-100471019","NCT05413421","Study of ORIC-944 in Patients With Metastatic Prostate Cancer","An Open-Label, Phase 1\u002F1b Study of ORIC-944 as a Single Agent or in Combination With an Androgen Receptor Pathway Inhibitor in Patients With Metastatic Prostate Cancer","Inclusion Criteria:\n\n* Patients with metastatic prostate cancer\n* Must have undergone bilateral orchiectomy or be willing to continue GnRH analogue or antagonist to maintain castrate levels of testosterone\n* Prior therapies:\n\nPart I (single agent ORIC-944 dose escalation): Any number of prior therapies are allowed, but must have progressed after at least one line of next generation ARPI (abiraterone, apalutamide, darolutamide, or enzalutamide) and must not have received more than 2 chemotherapy regimens in the mCRPC setting\n\nPart II (ARPI combination dose escalation): Must have received only 1 prior line of ARPI (abiraterone, apalutamide, darolutamide, or enzalutamide) in any setting; may have also received up to 1 prior line of chemotherapy in the mCSPC setting\n\nPart III (ARPI combination dose optimization): In addition to up to 1 prior line of chemotherapy in the mCSPC setting:\n\n* Cohorts A and B: received only one 1 prior line of abiraterone in any setting\n* Cohorts C and D: received only one 1 prior line of apalutamide, darolutamide, or enzalutamide in any setting:\n\n  * Evidence of progressive disease by PCWG3 criteria for study entry\n\n    * rising PSA, defined as a minimum of 2 rising values obtained a minimum of one week apart with the latest result being at least 2.0 ng\u002FmL (or 1.0 ng\u002FmL if PSA rise is the only indication of progression), or\n    * confirmation of 2 new bone lesions on last systemic therapy, or\n    * soft tissue progression per RECIST 1.1\n  * Measurable and\u002For evaluable disease by RECIST 1.1\n  * Agreement and ability to undergo on-study punch skin biopsies and core tumor biopsies\n  * ECOG performance status of 0 or 1\n  * Adequate organ function\n\nExclusion Criteria:\n\n* History or presence of CNS metastases, unless previously treated and stable\n* History of class III or IV congestive heart failure or severe non-ischemic cardiomyopathy, unstable or poorly controlled angina, myocardial infarction, or ventricular arrhythmia within the previous 6 months\n* Known, symptomatic human immunodeficiency virus (HIV) infection\n* Active symptomatic Hepatitis B or C infection; patients with well controlled disease are eligible\n* Active gastrointestinal disease (eg, Crohn's disease, ulcerative colitis, short gut syndrome, etc) or other malabsorption syndromes that would reasonably impact drug absorption per investigator judgement\n* Any other condition or circumstance (eg, clinical, psychological, familial, sociological, inability to swallow oral study drug) that, in the opinion of the investigator, may interfere with protocol compliance or contraindicates participation in the study",{"count":398,"type":21},275,[24],"The purpose of this study is to establish the safety and preliminary antitumor activity of ORIC-944 as a single agent and in combinations with ARPIs in patients with metastatic prostate cancer.",[28],[403,404,405,406,407],"PRC2 dysregulation","EED","CRPC","mCRPC","ARPI","2026-07-07",{"date":410,"type":46},"2026-07-09",{"date":412,"type":46},"2022-06-01",{"date":414,"type":21},"2028-04",{"name":416,"class":53},"ORIC Pharmaceuticals",27,{"id":419,"slug":420,"hasResults":12,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":424,"eligibilityCriteria":425,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":426,"targetDuration":428,"studyType":214,"phases":4,"briefSummary":429,"conditions":430,"keywords":433,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":450,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":456,"locationsCount":85},"100647042","prostate-radiotherapy-and-metastasis-directed-therapy-in-synchronous-oligometastatic-prostate-cancer-100647042","NCT07686016","Prostate Radiotherapy and Metastasis-Directed Therapy in Synchronous Oligometastatic Prostate Cancer","Outcomes and Patterns of Failure After Definitive Prostate-Directed Radiotherapy and Metastasis-Directed Therapy in Patients With Synchronous De Novo Prostate Cancer and Up to 10 Metastases: An Ambispective Multicenter Real-World Evidence Registry","SynSABR-PC","Inclusion Criteria:\n\n* Histologically confirmed adenocarcinoma of the prostate.\n* Male sex.\n* Age 18 years or older.\n* Synchronous de novo metastatic prostate cancer diagnosed at initial presentation or within 6 months of primary prostate cancer diagnosis.\n* Up to 10 extraregional metastatic lesions on staging imaging used for clinical decision-making.\n* Treatment with definitive prostate-directed radiotherapy, including external-beam radiotherapy alone, external-beam radiotherapy with brachytherapy boost, or definitive prostate brachytherapy monotherapy in selected patients.\n* Treatment with SBRT or another ablative metastasis-directed radiotherapy approach to all identified extraregional metastatic lesions.\n* Availability of sufficient clinical, imaging, radiotherapy, systemic therapy, follow-up, adverse event, and survival data for outcome assessment.\n* For prospectively enrolled patients, ability to provide informed consent where required by local ethics and regulatory procedures.\n\nExclusion Criteria:\n\n* More than 10 extraregional metastatic lesions at baseline staging.\n* Incomplete metastasis-directed therapy, defined as treatment of selected metastatic lesions only while leaving other known baseline extraregional metastatic sites untreated.\n* Prostate-directed radiotherapy delivered with palliative rather than definitive intent.\n* Missing key dates preventing outcome determination, including prostate-directed radiotherapy, brachytherapy, metastasis-directed SBRT dates, or follow-up information.\n* Prior definitive treatment of prostate cancer before diagnosis of synchronous metastatic disease.\n* Histology other than adenocarcinoma of the prostate.",{"count":427,"type":21},700,"3 Years","This is an ambispective, multicenter, observational real-world registry of patients with synchronous de novo oligometastatic prostate cancer, defined as prostate cancer with up to 10 extraregional metastatic lesions diagnosed at initial presentation or within 6 months of the primary diagnosis.\n\nThe study will evaluate outcomes after comprehensive local and metastasis-directed treatment. Eligible patients receive definitive prostate-directed radiotherapy, which may include external-beam radiotherapy, external-beam radiotherapy with brachytherapy boost, or definitive prostate brachytherapy monotherapy in selected patients, together with stereotactic body radiotherapy to all identified extraregional metastatic lesions. Systemic therapy is given according to routine clinical practice and local multidisciplinary decisions.\n\nThe registry is non-interventional. Participants are not assigned to treatment by the study protocol, and no experimental treatment, randomization, or protocol-mandated imaging schedule is used. The study collects de-identified data from routine medical records, including baseline disease characteristics, imaging, radiotherapy details, systemic therapy, radiographic progression, patterns of failure, subsequent treatments, adverse events, and survival.\n\nThe study includes historical retrospective data, prospective follow-up of previously treated eligible patients, and prospective enrollment of newly eligible patients from the registry activation date. The main goal is to describe where and when prostate cancer progresses after comprehensive treatment of the prostate and all visible metastatic lesions, and to identify clinical and treatment-related factors associated with disease control and adverse events.",[30,28,431,432],"Oligometastatic Prostate Cancer","Synchronous Oligometastatic Prostate Cancer",[434,435,273,436,437,438,439,440,441,442,443,444,445,446,447,448],"synchronous de novo oligometastatic prostate cancer","metastasis-directed therapy","definitive prostate radiotherapy","prostate brachytherapy","SBRT","brachytherapy boost","PSMA PET","up to 10 metastases","patterns of failure","radiographic progression","polymetastatic progression","real-world evidence","ambispective registry","prospective registry","adverse events","2026-07-02",{"date":451,"type":46},"2026-07-06",{"date":453,"type":46},"2026-06-26",{"date":455,"type":21},"2029-12-30",{"name":457,"class":84},"Affidea Nu-med Center of Oncological DIagnostics and Therapy",{"id":459,"slug":460,"hasResults":12,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":464,"eligibilityCriteria":465,"healthyVolunteers":466,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":467,"targetDuration":468,"studyType":214,"phases":4,"briefSummary":469,"conditions":470,"keywords":472,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":484,"startDateStruct":485,"completionDateStruct":486,"leadSponsor":488,"locationsCount":85},"100646430","psma-pet-guided-progression-directed-radiotherapy-for-oligoprogressive-prostate-cancer-100646430","NCT07691697","PSMA PET-Guided Progression-Directed Radiotherapy for Oligoprogressive Prostate Cancer","Outcomes After PSMA PET-Guided Progression-Directed Radiotherapy, Including SBRT and Brachytherapy, for Oligoprogressive Prostate Cancer: An Ambispective Multicenter Real-World Evidence Cohort Study","PSMA-OLIGO-PRO","Inclusion Criteria:\n\n* Age 18 years or older.\n* Diagnosis of prostate cancer.\n* Metastatic hormone-sensitive prostate cancer or metastatic castration-resistant prostate cancer.\n* Receiving active systemic therapy at the time of oligoprogression.\n* Oligoprogression defined as up to five new and\u002For regrowing lesions detected on PSMA PET\u002FCT or PSMA PET\u002FMR, with other known disease sites remaining controlled.\n* Planned or completed PSMA PET-guided progression-directed radiotherapy to all clinically relevant oligoprogressive lesions as part of routine clinical care.\n* Radiotherapy may include stereotactic body radiotherapy, moderately hypofractionated external beam radiotherapy, brachytherapy, combined external beam radiotherapy and brachytherapy, or mixed-modality radiotherapy, when clinically appropriate.\n* Availability of baseline clinical, imaging, treatment, and follow-up data sufficient for registry endpoints.\n\nExclusion Criteria:\n\n* Polymetastatic progression not consistent with an oligoprogressive state at the time of index radiotherapy.\n* More than five new or regrowing lesions at the index oligoprogression episode.\n* Radiotherapy delivered with purely palliative symptom-control intent rather than progression-directed local control intent.\n* Lack of sufficient clinical, imaging, treatment, or follow-up information for endpoint assessment.\n* Any condition that, in the opinion of the treating physician or investigator, makes registry inclusion inappropriate.",true,{"count":213,"type":21},"5 Years","PSMA-OLIGO-PRO is a multicenter ambispective observational real-world registry evaluating outcomes after PSMA PET-guided progression-directed radiotherapy for oligoprogressive prostate cancer. The registry includes retrospectively identified patients treated before June 26, 2026 and prospectively enrolled patients from June 26, 2026 onward.\n\nEligible patients have metastatic hormone-sensitive or castration-resistant prostate cancer, are receiving active systemic therapy, and develop a limited number of new or regrowing lesions while the remaining disease sites are controlled. Oligoprogression is primarily defined by PSMA PET\u002FCT or PSMA PET\u002FMR, with MRI used when clinically appropriate, particularly for intraprostatic, local, or prostate-bed progression.\n\nParticipants are not assigned to treatment by the registry protocol. All imaging, systemic therapy, radiotherapy modality, dose, fractionation, and follow-up decisions are made by treating physicians as part of routine clinical care. Progression-directed radiotherapy may include stereotactic body radiotherapy for nodal, bone, visceral, or local lesions, moderately hypofractionated external beam radiotherapy when clinically selected, and brachytherapy when appropriate for intraprostatic, prostate-bed, or selected metastatic oligoprogressive lesions.\n\nThe registry evaluates whether treating all identifiable oligoprogressive lesions can delay escalation to a new systemic therapy line, preserve the oligometastatic state, maintain local control, and provide acceptable safety in contemporary PSMA PET-guided practice.",[471,28],"Oligoprogressive Prostate Cancer",[440,473,30,474,475,476,477,478,479,480,481,482,483],"Oligoprogression","Progression-Directed Radiotherapy","Stereotactic Body Radiotherapy","Brachytherapy","Metastasis-Directed Therapy","Castration-Resistant Prostate Cancer","Hormone-Sensitive Prostate Cancer","Time to Next Systemic Therapy","Real-World Evidence","Ambispective Registry","Prospective Registry",{"date":410,"type":46},{"date":453,"type":46},{"date":487,"type":21},"2031-12-30",{"name":457,"class":84},{"id":490,"slug":491,"hasResults":12,"nctId":492,"briefTitle":493,"officialTitle":494,"acronym":4,"eligibilityCriteria":495,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":496,"targetDuration":4,"studyType":22,"phases":498,"briefSummary":499,"conditions":500,"keywords":504,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":508,"lastUpdatePostDateStruct":509,"startDateStruct":511,"completionDateStruct":513,"leadSponsor":515,"locationsCount":85},"100640146","phase-2-prostate-specific-membrane-antigen-psma-imaging-for-detection-of-residual-and-metastatic-prostate-cancer-100640146","NCT07593079","Prostate Specific Membrane Antigen (PSMA) Imaging for Detection of Residual and Metastatic Prostate Cancer","Optimizing PSMA Imaging for Enhanced Detection of Residual and Metastatic Prostate Cancer in Low PSA Recurrence (OPERA) Study","Inclusion Criteria:\n\n* Histologically or cytologically confirmed biochemically recurrent prostate cancer, with original diagnosis no more than 2 years from date of consent.\n* Intermediate unfavorable or high-risk prostate cancer.\n* All patients under consideration for radiation therapy, either at the time of first recurrence or in salvage radiation therapy will be included.\n* Patients who have started bicalutamide up to a maximum of 3 days prior to randomization will be allowed to be on protocol. Otherwise, a washout period of at least 42 days will be required.\n* Biological males, at least 18 years of age.\n* Prostate specific antigen (PSA) \\\u003C 1.0 ng\u002FmL.\n* Agreement to adhere to Lifestyle Considerations throughout study duration\n* Ability to understand and willingness to sign an IRB approved written informed consent document.\n\nExclusion Criteria:\n\n* Patients currently on androgen deprivation therapy (ADTs).\n* Currently receiving any other investigational agents.\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to POSLUMA, furosemide, bicalutamide, or other agents used in the study.",{"count":497,"type":21},20,[25],"This is a randomized, open-label, pilot study assessing the impact of a short course of bicalutamide on PSMA expression in patients with prostate cancer belonging to the intermediate unfavorable or high risk group, who have low levels of PSA. Adult patients with biochemically recurrent prostate cancer (BCR PCa) who have a PSA of less than 1.0 ng\u002FmL and who have undergone complete prostatectomy and\u002For will be undergoing radiotherapy, in combination with standard of care bicalutamide, will be recruited to this study. Patients will be randomized in a 1:1 ratio into Group A (baseline PSMA PET\u002FCT only with bicalutamide standard of care) or Group B (baseline PSMA PET\u002FCT and an additional PSMA PET\u002FCT after 2 weeks of bicalutamide).",[30,501,28,502,503],"Recurrent Prostate Cancer","Prostate Cancer Recurrent","Prostate Cancer Metastatic",[324,505,440,506,507],"Low PSA","BCR","Bicalutamide","2026-06-29",{"date":510,"type":46},"2026-07-01",{"date":512,"type":21},"2026-07-31",{"date":514,"type":21},"2027-10-31",{"name":158,"class":84},{"id":517,"slug":518,"hasResults":12,"nctId":519,"briefTitle":520,"officialTitle":521,"acronym":522,"eligibilityCriteria":523,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":524,"enrollmentInfo":525,"targetDuration":4,"studyType":22,"phases":527,"briefSummary":528,"conditions":529,"keywords":530,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":508,"lastUpdatePostDateStruct":537,"startDateStruct":539,"completionDateStruct":541,"leadSponsor":543,"locationsCount":544},"100638391","phase-1-phase-ibii-platform-study-of-multiple-anti-cancer-agents-in-participants-with-metastatic-prostate-cancer-100638391","NCT07590934","Phase Ib\u002FII Platform Study of Multiple Anti-Cancer Agents in Participants With Metastatic Prostate Cancer","A Phase Ib\u002FII, Open-label, Multi-centre, Platform Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of Multiple Anti-Cancer Agents in Metastatic Prostate Cancer","PROSPECTOR","Inclusion Criteria:\n\n1. Participants with a diagnosis of histologically confirmed adenocarcinoma of the prostate (no small cell, neuroendocrine, sarcomatoid, spindle or signet cell).\n2. Minimum life expectancy of 3 months or more.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of O or 1 at screening, with no deterioration.\n4. PCWG3 (Prostate Cancer Working Group 3) modified RECIST Version 1.1 evaluable disease.\n5. Must have received at least one novel androgen receptor pathway inhibitor (ARPI), such as enzalutamide or darolutamide or apalutamide or abiraterone acetate.\n6. Must have one or more unresectable metastatic lesions.\n7. Must have had prior orchiectomy and\u002For ongoing androgen deprivation therapy, and a castrate level of serum testosterone (\\\u003C50ng\u002FdL or \\\u003Cl.7nmol\u002FL).\n8. Progressive metastatic castration-resistant prostate cancer (mCRPC) following the most recent treatment at time of study entry.\n9. Adequate organ and marrow function.\n10. Non sterilised participants who are sexually active with a partner of childbearing potential must use a condom (plus spermicide, if available), must refrain from fathering a child, freezing or donating sperm, and it is recommended for the partner to also use a highly effective contraceptive method.\n\nInclusion Criteria for Sub study 1:\n\n1. Must have received a single line of ARPI, such as enzalutamide, darolutamide, apalutamide or abiraterone acetate.\n2. PSMA positive mCRPC by computed tomography positron emission tomography, obtained with PSMA ligand defined as at least 1 PSMA positive metastatic lesion with tracer uptake greater than liver, and no PSMA negative lesions. All measurable or intraprostatic lesions must be PSMA positive.\n3. Capable of self-administering oral formulations.\n\nExclusion Criteria:\n\n1. Any evidence of non adenocarcinomatous forms of prostate cancer (including small cell, spindle cell, signet cell, neuroendocrine, sarcomatous).\n2. Known, unresolved urinary tract obstruction.\n3. Participants with a history of central nervous system metastases.\n4. Symptomatic malignant spinal cord compression or findings indicative of impending cord compression.\n5. Participants with a history of leptomeningeal carcinomatosis.\n6. Previous or concurrent cancer distinct from the cancer under investigation in primary site or histology .\n7. Concurrent serious medical conditions.\n8. Previous history of interstitial lung disease or non-infectious pneumonitis.\n9. Participants with a history or clinical\u002Flaboratory features suggestive of myelodysplastic syndrome or acute myeloid leukaemia.\n10. Persistent toxicities caused by previous therapy.\n11. Participants unable to swallow orally administered medications or with gastrointestinal disorders likely to interfere with absorption.\n12. Active infection, including tuberculosis, hepatitis C virus, and hepatitis B virus infection.\n13. Known hypersensitivity to study intervention or any of their excipients.\n\nExclusion Criteria for Sub study 1:\n\n1. History of uncontrolled seizures or requirement for \\>2 antiepileptic drugs.\n2. History of severe brain injury or stroke.\n3. Skeletal metastases demonstrating a superscan appearance on bone scan.\n4. Participants have received prior therapy with AZD9574 or more than 1 prior line of any other Poly-ADP-ribose polymerase inhibitor (PARPi)-based regimen (either as a treatment or as maintenance).","99 Years",{"count":526,"type":21},152,[24,25],"The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of multiple anti-cancer agents in participants with metastatic prostate cancer.",[28],[531,532,533,534,535,536],"Metastatic castration resistant prostate cancer","Prostate-specific membrane antigen-targeted radioligand therapy","Alpha particle therapy","Poly ADP-ribose polymerase 1 (PARP1) inhibitor therapy","Combination therapy","Docetaxel therapy",{"date":538,"type":46},"2026-06-30",{"date":540,"type":46},"2026-06-03",{"date":542,"type":21},"2029-09-25",{"name":204,"class":53},35,{"id":546,"slug":547,"hasResults":12,"nctId":548,"briefTitle":549,"officialTitle":550,"acronym":4,"eligibilityCriteria":551,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":552,"targetDuration":4,"studyType":22,"phases":554,"briefSummary":555,"conditions":556,"keywords":557,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":561,"lastUpdatePostDateStruct":562,"startDateStruct":564,"completionDateStruct":566,"leadSponsor":567,"locationsCount":569},"100601516","phase-2-a-study-of-tarlatamab-for-people-with-prostate-cancer-100601516","NCT07111507","A Study of Tarlatamab for People With Prostate Cancer","TIDAL: Phase 2 Study of Tarlatamab in Patients With Delta-like Protein 3 (DLL3) Positive Metastatic Prostate Cancer","Inclusion Criteria:\n\n* To be included in this study, participants should complete all screening procedures and meet all of the following criteria:\n* Willing and able to provide, or have a legally authorized representative provide, written informed consent and privacy authorization for the release of personal health information. A signed informed consent must be obtained before screening procedures are performed.\n\nNOTE: Privacy authorization may be either included in the informed consent or obtained separately.\n\n* 18 years of age and above\n* Resting oxygen saturation of ≥ 90% on room air.\n* Histologically confirmed prostate cancer. Any histologic subtype of prostate cancer is allowed.\n* Documented metastatic disease based on conventional imaging (soft tissue disease on computed topography (CT)\u002Fmagnetic resonance imaging (MRI), or at least 2 lesions as found on bone scan) obtained during Screening. Metastatic disease as seen only on PET scan is exclusionary. Metastatic disease may include pelvic lymph nodes above and\u002For below the aortic bifurcation.\n\nNote: Measurable disease by RECIST 1.1 criteria is not required; however, a minimum of 50% of participants enrolled must have measurable disease by RECIST 1.1 criteria.\n\n* Serum testosterone ≤ 50 ng\u002FdL with ongoing androgen-deprivation therapy (ADT) or de novo small cell NEPC (neither testosterone levels nor ADT are required in participants with de novo small cell NEPC).\n* Progression on at least one line of therapy in the metastatic setting based on at least one of the following criteria:\n\n  1. Prostate-specific antigen (PSA) progression defined as a minimum of 2 rising PSA levels with a minimum of a 1-week interval between each determination. There is no minimum PSA level required.\n  2. Nodal or visceral progression as defined by RECIST 1.1 with PCWG3 modifications\n  3. Progression of bone disease with two or more new bone lesions on bone scan (i.e., PCWG3)\n* Participants with de novo small cell NEPC are required to have received prior platinum-based chemotherapy or be ineligible for this treatment.\n* No more than two prior lines of cytotoxic chemotherapy in the metastatic castration-resistant disease setting or the de novo small cell NEPC setting\n* DLL3 positive disease as defined by archival or fresh tumor biopsy with positive DLL3 expression using a CLIA certified assay (50% or more of tumor cells with DLL3 expression by IHC). DLL3 testing may be obtained at any point prior to study enrollment\n* Participants with brain metastases are eligible provided definitive treatment completed at least two weeks prior to C1D1, no concurrent steroids for the treatment of central nervous system (CNS) disease, and no progression noted on CNS imaging obtained during screening obtained following completion of definitive treatment.\n* ECOG status of ≤ 2\n* Normal organ function with acceptable initial laboratory values within 14 days of treatment start. Red blood cell transfusions during screening may be allowed if laboratory values initially fall outside of the following ranges:\n\n  * Absolute neutrophil count (ANC) ≥ 1,500\u002Fμ\n  * Hemoglobin ≥9g\u002FdL\n  * Platelet count ≥75,000\u002Fμl\n  * Bilirubin ≤ 1.5 upper limit of normal (ULN) or \\\u003C 2 if liver metastases or Gilbert's disease\n  * SGOT (AST) \\\u003C 3 x ULN or \\\u003C 5 if liver metastases\n  * SGPT (ALT) \\\u003C 3 x ULN or \\\u003C 5 if liver metastases\n  * Adequate renal function CrCl ≥ 30mL\u002Fmin using Cockroft Gault or MDRD calculation\n* Participants must agree to use a medically acceptable method of birth control (e.g., spermicide in conjunction with a barrier such as a condom) or sexual abstinence for the duration of the study, including 60 days after the last dose of study drug. Sperm donation is prohibited during the study and for 60 days after the last dose of study drug. Female partners must use hormonal or barrier contraception unless postmenopausal or abstinent.\n\nExclusion Criteria:\n\n* Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessments in the judgment of the site Principal Investigator (PI).\n* Medical conditions such as uncontrolled hypertension (sustained SBP \\> 160 mm Hg or diastolic BP \\> 100 mm Hg), any history of seizure, or major cardiovascular event (myocardial infarction), stroke or transient ischemia event within 6 months prior to study entry, or NYHA class ≥ III congestive heart failure, or uncontrolled cardiac arrhythmia.\n* Active hepatitis B or C infection (defined as positive HBsAg or positive HBV DNA in participants who are HBV core Ab +; detectable HCV RNA by PCR). Prior treatment for HBV or HCV is allowed.\n* Active human immunodeficiency (HIV) infection on antiviral therapy as measured by a detectable viral load.\n* History of leptomeningeal disease.\n* Active autoimmune disease requiring systemic treatment within the past 2 years or Grade \\> 2 autoimmune adverse effect from prior immune checkpoint inhibition (exception: any grade endocrine disorders on replacement treatment are allowed). Prednisone or equivalent at doses of up to 10 mg\u002Fday along with oral weekly methotrexate are allowed. No other immunosuppressive medications are allowed\n* History of interstitial lung disease and\u002For Grade ≥ 2 pneumonitis at the time of study entry\n* Diagnosis of immunodeficiency or receiving systemic steroid therapy (prednisone \\> 10 mg\u002Fday or equivalent) within 7 days of C1D1\n* Presence of infection requiring IV antibiotics within 7 days of C1D1\n* Prior DLL3-targeting treatment\n* Systemic anti-cancer treatment (other than LHRH analog) within 14 days or 5 half-lives, whichever is shorter, prior to C1D1\n* Receipt of another investigational therapeutic agent within 14 days or 5 half-lives, whichever is shorter, prior to C1D1\n* Major surgical procedure within 28 days prior to C1D1\n* Palliative radiotherapy if \\\u003C 1 week prior to C1D1\n* Use of any prohibited concomitant medications (Appendix C: Medications With the Potential for Drug-Drug Interactions) within two weeks prior to C1D1.\n* Grade \\> 2 treatment-related adverse event related to prior therapy that is ongoing at the start of study treatment.\n* Known allergy to any of the compounds under investigation\n* Any other condition which, in the opinion of the Investigator, would preclude participation in this trial",{"count":553,"type":21},32,[25],"The researchers are doing this study to find out whether tarlatamab is an effective treatment for Delta-like Protein 3 (DLL3)-positive prostate cancer that has spread to other parts of your body (metastasized) and has either come back after treatment (relapsed) or not responded to treatment (refractory).",[28],[558,559,560],"Tarlatamab","Delta-like protein expression 3 (DLL3)","25-138","2026-06-16",{"date":563,"type":46},"2026-06-17",{"date":565,"type":46},"2025-07-31",{"date":303,"type":21},{"name":568,"class":84},"Memorial Sloan Kettering Cancer Center",10,{"id":571,"slug":572,"hasResults":12,"nctId":573,"briefTitle":574,"officialTitle":575,"acronym":576,"eligibilityCriteria":577,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":578,"targetDuration":4,"studyType":22,"phases":580,"briefSummary":581,"conditions":582,"keywords":4,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":591,"lastUpdatePostDateStruct":592,"startDateStruct":593,"completionDateStruct":594,"leadSponsor":596,"locationsCount":85},"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":579,"type":21},202,[25],"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.",[583,584,585,586,30,39,587,588,28,589,120,590],"Recurrent Prostate Adenocarcinoma","Stage IVB Prostate Cancer AJCC v8","Castration-Sensitive Prostate Cancer","Metastatic Hormone-sensitive Prostate Cancer (mHSPC)","Adenocarcinoma of the Prostate","Localized Prostate Carcinoma","Metastatic Prostate Adenocarcinoma","Advanced Prostate Adenocarcinoma","2026-06-15",{"date":563,"type":46},{"date":510,"type":21},{"date":595,"type":21},"2030-12-30",{"name":597,"class":84},"Mayo Clinic",{"id":599,"slug":600,"hasResults":12,"nctId":601,"briefTitle":602,"officialTitle":603,"acronym":604,"eligibilityCriteria":605,"healthyVolunteers":12,"sex":63,"minAge":18,"maxAge":4,"enrollmentInfo":606,"targetDuration":4,"studyType":22,"phases":607,"briefSummary":608,"conditions":609,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":616,"lastUpdatePostDateStruct":617,"startDateStruct":619,"completionDateStruct":621,"leadSponsor":623,"locationsCount":85},"100643060","early-phase-1-first-in-human-diagnostic-imaging-profile-of-the-theranostic-pair-68gaga-dota-str-17126-and-low-dose-177lu-lu-dota-str-17126-in-patients-with-advanced-or-metastatic-cancer-100643060","NCT07608848","First-in-human Diagnostic Imaging Profile of the Theranostic Pair [68Ga]Ga-DOTA-STR-17126 and Low Dose [177Lu] Lu-DOTA-STR-17126 in Patients With Advanced or Metastatic Cancer","An Open-label, First-in-human, Exploratory Imaging Study of the DOTA-STR-17126 Theranostic Pair [68Ga]Ga-DOTA-STR-17126 and Low-dose [177Lu]Lu-DOTA-STR-17126 in Patients With Advanced or Metastatic Cancer","DOTA-STR-17126","Inclusion Criteria:\n\nInclusion criteria refer to the enrolment of participants for the PET\u002FCT and SPECT\u002FCT imaging with the radioligands; PET imaging tracer \\[68Ga\\]Ga-DOTA-STR-17126 and with the SPECT imaging tracer \\[177Lu\\]Lu-DOTA-STR-17126. Participants must meet all of the following inclusion criteria to be eligible for enrolment.\n\n1. Ability to understand and willingness to provide informed consent\n2. Adults ≥ 18 years of age\n3. Must have the following histologically or cytologically confirmed diagnosis of advanced or metastatic i. breast cancer ii. prostate cancer\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1\n5. Participant must have clinical or radiological documented tumour progression as established by the Investigator within 30 days of signing consent for the study\n6. Participants who have exhausted standard-of-care systemic therapies in their metastatic setting. At least one detectable by conventional imaging tumour lesion with any diameter of ≥ 1 cm in size\n7. Participants must have adequate organ and bone marrow function, defined as follows:\n\n   i. Absolute neutrophil count (ANC) ≥ 1000 cells\u002Fmm3 ii. Platelet count ≥ 100,000\u002Fmm3 iii. Haemoglobin ≥ 9.0 g\u002FdL iv. AST, ALT, alkaline phosphatase ≤ 3 times upper limit of normal (ULN) if there is no evidence of liver metastases or ≤5 ULN in the presence of liver metastases v. Total bilirubin ≤ 2 times upper limit of normal (ULN) vi. Creatinine ≤ 2 times ULN and creatinine clearance (CrCL) ≥ 60mL\u002Fmin using the Cockcroft Gault equation (Appendix 2)\n8. Able to remain still for up to 60 minutes per scan\n9. Any other condition which, in the opinion of the Investigator, would preclude participation in this study Optional: Participants that have available archival tissue (at least 15 consecutive, unstained, formalin-fixed, paraffin embedded (FFPE) slides or 1 FFPE block), or a fresh tumour biopsy sample that opt to provide samples will be used for GRPR analysis (histology staining or RNA measurements). Participants without any archival tissue or fresh biopsy sample, or who refuse to provide archival tissue are still eligible for the study.\n\nExclusion Criteria:\n\nParticipants must not be enrolled into the trial if one or more of the following criteria are met. Participants must NOT meet any of the following Exclusion criteria to be eligible for enrolment:\n\n1. Known hypersensitivity to the investigational medicinal products (DOTA-STR-17126) or any of the excipients.\n2. Participants with Class 3 or 4 New York Heart Association (NYHA) Congestive Heart Failure.\n3. Average QTc (using the Fridericia correction calculation) \\> 470 msec for females and QTcF \\>450 msec for males on screening ECG or history of congenital long QT syndrome.\n4. Clinically significant bleeding within two weeks prior to trial entry (i.e., gastrointestinal bleeding, intracranial bleeding).\n5. Pregnant or lactating women. i. For female participants of childbearing potential or male participants with female partner of childbearing potential, who are not willing to practice highly effective contraception during the trial and for at least 6 months after \\[177Lu\\] Lu-DOTA-STR-17126 administration ii. Sexually active males must use a condom during intercourse while taking the drug and for 4 months after stopping treatment and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid. Female partners of childbearing potential should use highly effective contraceptive methods during and up to 6 months after stopping treatment.\n6. Have any medical condition that impairs complete bladder emptying. Participants with permanent urinary indwelling catheter (IDC) or nephrostomy may be allowed to enrol on a case-by-case basis in discussion with Principal Investigator, if it is determined not to put the patient at an increased risk of adverse drug effects and\u002For interfere with the integrity of study outcome.\n7. Major surgery, defined as any surgical procedure that involves general anaesthesia and a significant incision (i.e., larger than what is required for placement of a central venous access, percutaneous feeding tube, or biopsy) within 30 days before study day 1 or anticipated surgery within the subsequent 43 days (6 weeks).\n8. Has an additional active malignancy requiring therapy within the past 2 years.\n9. History of another malignancy within 3 years before study enrolment. A subject with the following malignancies is allowed if considered cured or unlikely to recur within 3 years:\n\n   i. Carcinoma of the skin without melanomatous features ii. Curatively treated cervical carcinoma in situ iii. Bladder tumours considered superficial such as non-invasive (T1a) and carcinoma in situ (T1s), thyroid papillary cancer with prior treatment\n10. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy within 30 days prior to trial enrolment.\n11. Psychiatric illness\u002Fsocial situations that would interfere with compliance with study requirements.\n12. Cannot undergo PET\u002FCT scanning because of weight limits (350 lbs or 160 kg).\n13. Prior exposure to any other GRPR-targeting therapeutic agents.\n14. Prior treatment with any systemic anti-cancer therapy including chemotherapy, immunotherapy, biological therapy, radiation therapy, biologic, hormonal or herbal therapy, or any investigational therapy or investigational device, unless:\n\n    i. Standard of care or maintenance therapy such as, luteinizing hormone-releasing hormone (LHRH) or gonadotropin releasing hormone (GnRH) for patients with prostate cancer; selective estrogen receptor modulators or aromatase inhibitors or GnRH inhibitors for breast cancer, ii. Within more than 30 days of chemotherapy, herbal therapies and monoclonal antibodies, iii. Within more than 5 half-lives for biologic\u002Fnon-cytotoxic targeted agents, iv. Within more than 8 weeks prior radiation therapies External Beam Radiotherapy (EBRT) and\u002For Radioligand Therapy (RLT). Focal palliative radiotherapy given within 8 weeks prior to the low dose of \\[177Lu\\] Lu-DOTA-STR-17126 may be approved on a case-by-case basis, if it is determined not to put the participant at an increased risk of adverse drug effects and\u002For interfere with the integrity of study outcome, v. For participants who received radiotherapy (EBRT and\u002For RLT) more than 8 weeks prior to the low dose of 177Lu-DOTA-STR-17126, efforts should be made to calculate the prior radiation absorbed dose to each critical organ such as the kidneys, liver, lungs, and bone marrow.\n15. Patients with a history of inflammatory disease which according to the investigator may interfere with correct evaluation of radioactive uptake, especially those affecting the thoraco-abdominal cavities (i.e., autoimmune, granulomatous disease).\n16. Any clinically significant toxicity (with the exception of alopecia) related to prior anti-tumour therapy not resolved to Grade 1 or baseline.",{"count":497,"type":21},[264],"This is an open-label, first-in-human, exploratory Phase 0 study evaluating the safety and diagnostic imaging performance of the DOTA-STR-17126 theranostic pair in patients with advanced or metastatic breast or prostate cancer. The study investigates \\[68Ga\\]Ga-DOTA-STR-17126 for PET imaging and, in patients with positive GRPR uptake, a low dose of \\[177Lu\\]Lu-DOTA-STR-17126 for SPECT imaging and dosimetry.\n\nThe primary objective is to assess safety and tolerability. Secondary objectives include evaluation of imaging quality, biodistribution, pharmacokinetics, and radiation dosimetry. Exploratory objectives assess correlations between GRPR expression in tumour tissue and imaging uptake.\n\nThe study is conducted at a single centre in Australia, with 12 evaluable participants (up to 20 enrolled), and supports the development of a GRPR-targeted theranostic approach for personalised cancer management.",[346,28,610,611,612,613,614,615],"GRPR-Targeted Molecular Imaging","Theranostic Radiopharmaceuticals","Cancer","Active Cancer","Theranostic","Radiopharmaceutical","2026-06-08",{"date":618,"type":46},"2026-06-10",{"date":620,"type":46},"2026-05-28",{"date":622,"type":21},"2029-05-31",{"name":624,"class":84},"Integrated Haematology and Oncology Network",{"id":626,"slug":627,"hasResults":12,"nctId":628,"briefTitle":629,"officialTitle":630,"acronym":631,"eligibilityCriteria":632,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":633,"targetDuration":4,"studyType":22,"phases":635,"briefSummary":637,"conditions":638,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":639,"lastUpdatePostDateStruct":640,"startDateStruct":641,"completionDateStruct":643,"leadSponsor":645,"locationsCount":85},"100524765","phase-3-creatine-supplementation-and-resistance-training-to-preserve-muscle-mass-and-attenuate-cancer-progression-100524765","NCT06112990","Creatine Supplementation and Resistance Training to Preserve Muscle Mass and Attenuate Cancer Progression","Creatine Supplementation and Resistance Training to Preserve Muscle Mass and Attenuate Cancer Progression: A Double-Blind Randomized Controlled Trial","CREATINE-52","Inclusion Criteria:\n\n* Subject age ≥ 18 years old.\n* Metastatic castration-sensitive prostate cancer patients who have not met criteria for disease progression (per Prostate Cancer Working Group guidelines) on current systemic therapy\n* Currently treated with surgical castration or medical castration with Gonadotropin-releasing hormone (GnRH) agonists\u002Fantagonists, and\u002For an androgen receptor pathway inhibitor (ARPI)) aka novel hormone therapy (e.g., abiraterone, enzalutamide, apalutamide, darolutamide). Must have started the current regimen at least 12 weeks prior to enrollment.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2\n* Not currently adhering to national physical activity guidelines for resistance training, as defined as participating in structured resistance training (e.g., time set aside in your day to workout) ≥ two days per week.\n* Regular access to an electronic device with internet service and ability for video calls (e.g., computer, smart phone, iPad, tablet, etc).\n* Access to an active MyChart account or the willingness to create an account for the purposes of the trial.\n* Willingness to engage in a home-based resistance exercise program two days per week.\n* Willingness to take creatine monohydrate supplementation or placebo for the duration of the 52 week trial and to avoid taking additional creatine-containing supplementation or other nutritional supplementation during the study period.\n* Willingness to complete and submit weekly supplementation logs to study personnel throughout the duration of the 52-week study via email, text, in person, or verbally verified over the phone.\n* Willingness to complete three in-person assessment sessions (baseline, 24-, and 52-weeks).\n* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.\n\nExclusion Criteria:\n\n* Treatment with cytotoxic chemotherapy within 12 weeks prior to enrollment.\n* Estimated Glomerular Filtration Rate (eGFR) \\\u003C 30 ml\u002Fmin\u002F1.73m2.\n* ECOG Performance Status ≥ 3",{"count":634,"type":21},200,[636],"PHASE3","The goal of this clinical trial is to test the use of creatine monohydrate supplementation with resistance training to preserve muscle mass and help lessen prostate cancer progression.\n\nThe main question it aims to answer is if this treatment will help maintain muscle mass to help in reducing fatigue and improving physical function, independence, and quality of life.\n\nParticipants will be asked to participate in a 52-week exercise intervention consisting of a twice weekly telehealth resistance training program.",[28],"2026-06-01",{"date":540,"type":46},{"date":642,"type":46},"2023-11-09",{"date":644,"type":21},"2028-11-30",{"name":646,"class":84},"University of Utah",{"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":22,"phases":655,"briefSummary":656,"conditions":657,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":620,"lastUpdatePostDateStruct":658,"startDateStruct":659,"completionDateStruct":661,"leadSponsor":663,"locationsCount":85},"100604104","phase-1-177lu-psma-617-with-liver-directed-therapy-in-metastatic-castration-resistant-prostate-cancer-100604104","NCT07145177","177Lu-PSMA-617 With Liver Directed Therapy in Metastatic Castration Resistant Prostate Cancer","A Phase 1b Study of 177Lu-PSMA-617 Combined With Liver Directed Therapy in Metastatic Castration Resistant Prostate Cancer","Inclusion Criteria:\n\n1. Histologically confirmed prostate cancer.\n2. Progressive disease by PCWG3 criteria at study entry.\n3. Male participants who are at least 18 years of age on the day of signing informed consent.\n4. Castrate level of serum testosterone at study entry (\\\u003C 50 ng\u002FdL). Note: Participants without prior bilateral orchiectomy are required to remain on Luteinizing hormone-releasing hormone (LHRH) analogue treatment for duration of study treatment.\n5. Prior progression on at least one second generation androgen signaling inhibitor including abiraterone, apalutamide, darolutamide, and\u002For enzalutamide.\n6. Adverse events related to prior anti-cancer treatment (excluding LHRH analogs) must have recovered to Grade ≤ 1 (except for any grade alopecia and grade ≤ 2 neuropathy).\n7. Prior external beam radiotherapy is allowed if the last radiotherapy treatment was greater than 2 weeks from start of study treatment on Cycle 1 Day 1 (C1D1). Note: Participants must have recovered from all radiation-related toxicities. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease.\n8. At least one PSMA-avid extrahepatic lesion on screening PSMA Positron Emission Tomography (PET). A positive lesion is defined as uptake above background liver. Hepatic lesions may be PSMA PETnegative or positive.\n9. Availability of archival mCRPC tissue, or presence of a metastatic lesion that is amenable to fresh biopsy and willingness to undergo biopsy during screening if no archival mCRPC tissue available.\n10. The presence of one or more liver metastases amenable to liver-directed therapy in the judgment of the treating interventional radiologist. Liver metastases may be detected by CT or magnetic resonance imaging (MRI), and biopsy confirmation is not required.\n11. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 or Karnofsky ≥ 50%.\n12. Demonstrates adequate organ function as defined below:\n\n    1. Absolute neutrophil count ≥ 1,500\u002F microliter (mcL).\n    2. Platelets ≥ 100,000\u002FmcL.\n    3. Hemoglobin \\> 9.0 g\u002FdL.\n    4. Total bilirubin ≤ 1.5 x upper limit of normal (ULN). In participants with known or suspected Gilbert's disease, direct bilirubin ≤ ULN.\n    5. aspartate aminotransferase (AST)\u002Fserum glutamic-oxaloacetic transaminase (SGOT) ≤ 5 x institutional upper limit of normal.\n    6. alanine aminotransferase (ALT)\u002Fserum glutamic-pyruvic transaminase (SGPT) ≤ 5 x institutional upper limit of normal.\n    7. Prothrombin time ≤ 1.5 x institutional upper limit of normal (unless on medical therapy known to prolong prothrombin time).\n    8. Albumin ≥ 2.8 g\u002FdL\n    9. Creatinine clearance Glomerular filtration rate (GFR) ≥ 30 mL\u002Fmin\u002F1.73 m2, calculated using the Cockcroft-Gault equation or 24 hour urine collection.\n13. Participants with previously treated brain metastases are eligible provided the following criteria are all met:\n\n    1. Last treatment was \\> 28 days prior to C1D1\n    2. No evidence of new\u002Fprogressive brain metastases is observed on MRI obtained during the Screening window\n14. Participants must use appropriate methods of contraception during study treatment and for at least 6 months after last study treatment. Note: Participants who are sexually active should consider their female partner to be of childbearing potential if she has experienced menarche and is not postmenopausal (defined as amenorrhea \\> 24 consecutive months) or has not undergone successful surgical sterilization. Even women who use contraceptive hormones (oral, implanted, or injected), an intrauterine device, or barrier methods (diaphragms, condoms, spermicide) should be considered to be of childbearing potential. Participants who have undergone vasectomy themselves should also be considered to be of childbearing potential. Acceptable methods of contraception include continuous total abstinence, or double barrier method of birth control (e.g., condoms used with spermicide, or condoms used with oral contraceptives). Periodic abstinence and withdrawal are not acceptable methods of contraception.\n15. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. De novo small cell neuroendocrine prostate cancer.\n2. One or more extrahepatic soft tissue lesions (lymph nodes \\> 1.5 cm in short axis, visceral\u002Fsoft tissue lesions \\> 1 cm) on screening CT that is negative on PSMA PET. Non- PSMA avid liver lesions are allowed.\n3. Recipient of other systemic anti-cancer therapies administered within 14 days, or 5 half lives, whichever is shorter, prior to initiation of study treatment. Note: LHRH analogues are the exception and are permitted\n4. Recipient of prior PSMA-directed radioligand treatment.\n5. Recipient of \\> 2 lines of prior taxane-based chemotherapy administered in the castration-resistant setting. Prior taxane in the castration sensitive setting does not count towards this limit. If platinum chemotherapy is added to taxane this does not count as a separate line of treatment.\n6. Previous bilio-enteric anastomosis, ampulla of Vater sphincterotomy, biliary stent, or biliary drain passing through the ampulla of Vater.\n7. Currently participating in a study of an investigational therapeutic agent or has used an investigational device within 4 weeks prior to the first dose of study treatment on C1D1. Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.\n8. Clinically significant cardiovascular disease including, but not limited to:\n\n   1. Uncontrolled or any New York Heart Association Class 3 or 4 congestive heart failure.\n   2. Uncontrolled angina, history of myocardial infarction, unstable angina, or stroke within 6 months before study entry.\n   3. Clinically significant arrhythmias not controlled by medication. Note: Chronic rate-controlled or paroxysmal atrial fibrillation\u002Fflutter is not an exclusion to study participation.\n9. Major surgery within 28 days of study treatment. Note: If participant received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting study treatment on C1D1. Minor procedures (e.g., biopsy, cataract surgery, stent placement, endoscopy) are not considered major surgery.\n10. Has a secondary malignancy requiring active treatment at study entry (except for carcinoma-in-situ, non-muscle invasive bladder cancer, and non-melanoma skin cancer).\n11. Has an active infection requiring intravenous antibiotics within 7 days prior to C1D1.\n12. Has a known history of Hepatitis B infection (Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus infection (HCV RNA \\[qualitative\\] detected, with the following exceptions:\n\n    1. Participants who are HbsAg positive are eligible if they have received hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to study entry.\n    2. Participants with history of HCV infection are eligible if HCV viral load is undetectable at screening. Participants must have completed curative anti-viral therapy at least 4 weeks prior to study entry.\n13. Not a candidate for liver-directed therapy on the basis of any of the following:\n\n    1. History of bleeding diathesis and currently on anti-coagulation therapy that cannot be safely discontinued for liver directed therapy.\n    2. Clinically significant ascites including requiring more than one paracentesis in the 28 days prior to C1D1.\n14. Unable or unwilling to follow radiation safety precautions following each dose of radioligand therapy or liver directed therapy.\n15. Any condition that, in the opinion of the Principal Investigator, would impair the participant's ability to comply with study procedures.",{"count":140,"type":21},[24],"This is an open label, single arm, phase 1b study to determine the safety of combining sequential Prostate-Specific Membrane Antigen (PSMA)-targeted 177Lu-PSMA-617 radionuclide therapy with liver-directed therapy in metastatic castrate-resistant prostate cancer (mCRPC) patients with liver metastases amenable to liver-directed therapy who have progressed on at least one prior androgen pathway inhibitor.",[28,30],{"date":639,"type":46},{"date":660,"type":46},"2026-03-16",{"date":662,"type":21},"2030-10-31",{"name":664,"class":84},"University of California, San Francisco",{"id":666,"slug":667,"hasResults":12,"nctId":668,"briefTitle":669,"officialTitle":669,"acronym":670,"eligibilityCriteria":671,"healthyVolunteers":12,"sex":63,"minAge":18,"maxAge":4,"enrollmentInfo":672,"targetDuration":4,"studyType":22,"phases":674,"briefSummary":676,"conditions":677,"keywords":678,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":683,"lastUpdatePostDateStruct":684,"startDateStruct":686,"completionDateStruct":688,"leadSponsor":690,"locationsCount":85},"100585612","comparison-of-different-methods-of-capture-of-circulating-tumour-cells-ctc-in-patients-with-metastatic-breast-or-prostate-cancer-100585612","NCT06904625","Comparison of Different Methods of CAPTure of Circulating Tumour Cells (CTC) in Patients With Metastatic Breast or Prostate Cancer","CAPT CTC","Inclusion Criteria:\n\n1. Patient with breast cancer (whatever the immunohistochemical subtype: triple-negative, RH+\u002FHER2-negative or HER2-positive) or prostate cancer, multi-metastatic, eligible for a new line of treatment.\n2. Patient not yet initiated on a new specific treatment for breast or prostate cancer at inclusion.\n3. Age ≥ 18 years and WHO ≤ 2\n4. Patient affiliated to Social Security scheme in France.\n5. Patient having signed informed consent prior to inclusion in the study and prior to any study-specific procedures.\n\nExclusion Criteria:\n\n1. Associated pathology(ies) likely to prevent the study procedure from running smoothly\n2. Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and\u002For procedures stipulated in the study protocol.\n3. Patient deprived of liberty or under legal protection (guardianship, legal protection)\n4. Patient who has had another solid tumor (excluding carcinoma in situ of the breast or cervix) within 5 years.",{"count":673,"type":21},54,[675],"NA","This trial is a pilot, prospective, single-center study conducted in a population of patients with metastatic breast cancer (whatever the immunohistochemical subtype) or metastatic prostate cancer. The aim of this exploratory study is to compare the sensitivity of three different techniques (CellSearch®, Parsortix® and SmartCatch®) in detecting circulating tumor cells (CTCs). After the patient's agreement, and before starting anti-tumor treatment, a blood sample will be taken using the 3 different CTC detection techniques.\n\nEach patient will participate in the study for one day.\n\nA total of 54 evaluable patients (36 patients with metastatic breast cancer and 18 patients with metastatic prostate cancer) will be included in this interventional study.",[346,28],[679,28,346,680,681,682],"Circulating Tumor Cell","CellSearch®","Parsortix®","SmartCatch®","2026-05-22",{"date":685,"type":46},"2026-05-27",{"date":687,"type":46},"2025-08-14",{"date":689,"type":21},"2026-11",{"name":691,"class":84},"Institut Claudius Regaud"]