[{"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":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,55,0,25,[9,49,83,112,146,167,191,220,230,261,283,303,333,358,379,401,420,449,475,500,529,549,573,609,635],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":28,"conditions":29,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100053507","phase-1-first-in-human-study-to-evaluate-azd8359-steap2-tce-in-participants-with-prostate-cancer-100053507",false,"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","MALE","18 Years","100 Years",{"count":22,"type":23},42,"ESTIMATED","INTERVENTIONAL",[26,27],"PHASE1","PHASE2","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).",[30],"Metastatic Prostate Cancer",[32,33,34,35],"Prostate","STEAP2","T Cell-engaging Antibody","CD8","RECRUITING","2026-07-10",{"date":39,"type":40},"2026-07-13","ACTUAL",{"date":42,"type":40},"2026-05-18",{"date":44,"type":23},"2027-11-17",{"name":46,"class":47},"AstraZeneca","INDUSTRY",8,{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":24,"phases":58,"briefSummary":59,"conditions":60,"keywords":65,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"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":57,"type":23},20,[27],"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).",[61,62,30,63,64],"Prostate Cancer","Recurrent Prostate Cancer","Prostate Cancer Recurrent","Prostate Cancer Metastatic",[66,67,68,69,70],"Prostate cancer","Low PSA","PSMA PET","BCR","Bicalutamide","NOT_YET_RECRUITING","2026-06-29",{"date":74,"type":40},"2026-07-01",{"date":76,"type":23},"2026-07-31",{"date":78,"type":23},"2027-10-31",{"name":80,"class":81},"Washington University School of Medicine","OTHER",1,{"id":84,"slug":85,"hasResults":12,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":91,"enrollmentInfo":92,"targetDuration":4,"studyType":24,"phases":94,"briefSummary":95,"conditions":96,"keywords":97,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},"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":93,"type":23},152,[26,27],"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.",[30],[98,99,100,101,102,103],"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":105,"type":40},"2026-06-30",{"date":107,"type":40},"2026-06-03",{"date":109,"type":23},"2029-09-25",{"name":46,"class":47},35,{"id":113,"slug":114,"hasResults":12,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":24,"phases":121,"briefSummary":122,"conditions":123,"keywords":124,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":145},"100577593","phase-1-study-of-hld-0915-in-patients-with-metastatic-prostate-cancer-100577593","NCT06800313","Study of HLD-0915 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",{"count":120,"type":23},190,[26,27],"Assessment of the safety and efficacy of HLD-0915 in patients with metastatic prostate cancer who have progressed on prior systemic therapies, with further evaluation in additional prostate cancer populations.",[30],[61,125,126,127,128,129,130,131,132,133,134,135],"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","2026-06-24",{"date":138,"type":40},"2026-06-26",{"date":140,"type":40},"2025-02-20",{"date":142,"type":23},"2030-04",{"name":144,"class":47},"Halda Therapeutics OpCo, Inc.",12,{"id":147,"slug":148,"hasResults":12,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":24,"phases":155,"briefSummary":156,"conditions":157,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"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":154,"type":23},60,[27],"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.",[30],"2026-06-16",{"date":160,"type":40},"2026-06-17",{"date":162,"type":23},"2026-07",{"date":164,"type":23},"2029-01",{"name":166,"class":81},"University of Arkansas",{"id":168,"slug":169,"hasResults":12,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":24,"phases":176,"briefSummary":177,"conditions":178,"keywords":179,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":183,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":190},"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":175,"type":23},32,[27],"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).",[30],[180,181,182],"Tarlatamab","Delta-like protein expression 3 (DLL3)","25-138",{"date":160,"type":40},{"date":185,"type":40},"2025-07-31",{"date":187,"type":23},"2027-08-31",{"name":189,"class":81},"Memorial Sloan Kettering Cancer Center",10,{"id":192,"slug":193,"hasResults":12,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":199,"targetDuration":4,"studyType":24,"phases":201,"briefSummary":202,"conditions":203,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":215,"completionDateStruct":216,"leadSponsor":218,"locationsCount":82},"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":200,"type":23},202,[27],"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.",[204,205,206,207,61,133,208,209,30,210,211,212],"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 Cancer","Advanced Prostate Adenocarcinoma","2026-06-15",{"date":160,"type":40},{"date":74,"type":23},{"date":217,"type":23},"2030-12-30",{"name":219,"class":81},"Mayo Clinic",{"id":221,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":222,"targetDuration":4,"studyType":24,"phases":223,"briefSummary":28,"conditions":224,"keywords":225,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":226,"startDateStruct":227,"completionDateStruct":228,"leadSponsor":229,"locationsCount":48},"100633671",{"count":22,"type":23},[26,27],[30],[32,33,34,35],{"date":158,"type":40},{"date":42,"type":40},{"date":44,"type":23},{"name":46,"class":47},{"id":231,"slug":232,"hasResults":12,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":236,"eligibilityCriteria":237,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":238,"enrollmentInfo":239,"targetDuration":4,"studyType":24,"phases":241,"briefSummary":242,"conditions":243,"keywords":244,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":260},"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":240,"type":23},177,[26,27],"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.",[30],[245,246,247,248,249,250,251],"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","2026-06-11",{"date":254,"type":40},"2026-06-12",{"date":256,"type":40},"2025-10-01",{"date":258,"type":23},"2029-01-18",{"name":46,"class":47},52,{"id":262,"slug":263,"hasResults":12,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":4,"eligibilityCriteria":267,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":268,"targetDuration":4,"studyType":24,"phases":270,"briefSummary":271,"conditions":272,"keywords":273,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":275,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":282},"100500777","phase-1-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":269,"type":23},210,[26],"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.",[211,30],[274],"Castration-resistant",{"date":213,"type":40},{"date":277,"type":40},"2023-05-02",{"date":279,"type":23},"2027-06-30",{"name":281,"class":47},"Genentech, Inc.",26,{"id":284,"slug":285,"hasResults":12,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":290,"targetDuration":4,"studyType":24,"phases":292,"briefSummary":293,"conditions":294,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":295,"lastUpdatePostDateStruct":296,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":302},"100636604","phase-1-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":291,"type":23},260,[26,27],"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.",[211,30],"2026-06-09",{"date":252,"type":40},{"date":298,"type":40},"2026-04-29",{"date":300,"type":23},"2027-12-30",{"name":281,"class":47},2,{"id":304,"slug":305,"hasResults":12,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":309,"eligibilityCriteria":310,"healthyVolunteers":12,"sex":311,"minAge":19,"maxAge":4,"enrollmentInfo":312,"targetDuration":4,"studyType":24,"phases":313,"briefSummary":315,"conditions":316,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":82},"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.","ALL",{"count":57,"type":23},[314],"EARLY_PHASE1","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.",[317,30,318,319,320,321,322,323],"Metastatic Breast Cancer","GRPR-Targeted Molecular Imaging","Theranostic Radiopharmaceuticals","Cancer","Active Cancer","Theranostic","Radiopharmaceutical","2026-06-08",{"date":326,"type":40},"2026-06-10",{"date":328,"type":40},"2026-05-28",{"date":330,"type":23},"2029-05-31",{"name":332,"class":81},"Integrated Haematology and Oncology Network",{"id":334,"slug":335,"hasResults":12,"nctId":336,"briefTitle":337,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":339,"targetDuration":4,"studyType":341,"phases":4,"briefSummary":342,"conditions":343,"keywords":345,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":353,"completionDateStruct":4,"leadSponsor":355,"locationsCount":82},"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":340,"type":23},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.",[344,61,132,30,32],"Cancer Of Prostate",[346,132,347,348,349,350,61],"Genetic","Genotyping","Venipuncture","Polymorphism","Natural History","2026-06-05",{"date":324,"type":40},{"date":354,"type":40},"2007-02-28",{"name":356,"class":357},"National Cancer Institute (NCI)","NIH",{"id":359,"slug":360,"hasResults":12,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":364,"eligibilityCriteria":365,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":366,"targetDuration":4,"studyType":24,"phases":368,"briefSummary":369,"conditions":370,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":371,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":302},"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:\n\n1. Significant comorbidities rendering patient not suitable for ADT, enzalutamide and SBRT\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",{"count":367,"type":23},132,[27],"This is a multi-centre, investigator-initiated, two-arm, randomized trial to investigate the addition on androgen receptor pathway inhibitor 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) or standard of care radiation and hormone (ADT) therapy plus oral abiraterone for 8-9 months (Arm 3). Participants will be routinely follow-up in clinic or remotely for up to 5 years.",[30],{"date":372,"type":40},"2026-06-04",{"date":374,"type":40},"2023-05-24",{"date":376,"type":23},"2031-02",{"name":378,"class":81},"University Health Network, Toronto",{"id":380,"slug":381,"hasResults":12,"nctId":382,"briefTitle":383,"officialTitle":384,"acronym":385,"eligibilityCriteria":386,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":387,"targetDuration":4,"studyType":24,"phases":389,"briefSummary":391,"conditions":392,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":82},"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":388,"type":23},200,[390],"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.",[30],"2026-06-01",{"date":107,"type":40},{"date":396,"type":40},"2023-11-09",{"date":398,"type":23},"2028-11-30",{"name":400,"class":81},"University of Utah",{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":4,"eligibilityCriteria":407,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":408,"targetDuration":4,"studyType":24,"phases":410,"briefSummary":411,"conditions":412,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":413,"startDateStruct":414,"completionDateStruct":416,"leadSponsor":418,"locationsCount":82},"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":409,"type":23},30,[26],"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.",[30,61],{"date":393,"type":40},{"date":415,"type":40},"2026-03-16",{"date":417,"type":23},"2030-10-31",{"name":419,"class":81},"University of California, San Francisco",{"id":421,"slug":422,"hasResults":12,"nctId":423,"briefTitle":424,"officialTitle":425,"acronym":4,"eligibilityCriteria":426,"healthyVolunteers":12,"sex":311,"minAge":19,"maxAge":4,"enrollmentInfo":427,"targetDuration":4,"studyType":24,"phases":429,"briefSummary":431,"conditions":432,"keywords":433,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":440,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":446,"locationsCount":448},"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":428,"type":23},50,[430],"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).",[317,30],[434,435,436,437,438],"Chronotherapy","breast cancer","prostate cancer","endocrine therapy","metastatic cancer","2026-05-25",{"date":441,"type":40},"2026-05-27",{"date":443,"type":40},"2026-02-02",{"date":445,"type":23},"2033-03",{"name":447,"class":81},"Ottawa Hospital Research Institute",3,{"id":450,"slug":451,"hasResults":12,"nctId":452,"briefTitle":453,"officialTitle":453,"acronym":454,"eligibilityCriteria":455,"healthyVolunteers":12,"sex":311,"minAge":19,"maxAge":4,"enrollmentInfo":456,"targetDuration":4,"studyType":24,"phases":458,"briefSummary":460,"conditions":461,"keywords":462,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":467,"lastUpdatePostDateStruct":468,"startDateStruct":469,"completionDateStruct":471,"leadSponsor":473,"locationsCount":82},"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":457,"type":23},54,[459],"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.",[317,30],[463,30,317,464,465,466],"Circulating Tumor Cell","CellSearch®","Parsortix®","SmartCatch®","2026-05-22",{"date":441,"type":40},{"date":470,"type":40},"2025-08-14",{"date":472,"type":23},"2026-11",{"name":474,"class":81},"Institut Claudius Regaud",{"id":476,"slug":477,"hasResults":12,"nctId":478,"briefTitle":479,"officialTitle":480,"acronym":481,"eligibilityCriteria":482,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":483,"targetDuration":4,"studyType":24,"phases":484,"briefSummary":485,"conditions":486,"keywords":488,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":492,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":498,"locationsCount":82},"100624846","phase-1-actinium-in-castrate-resistant-prostate-cancer-after-lutetium-100624846","NCT07414940","ACTinium in Castrate-RESistant Prostate Cancer After LUTEtium","A Multi-site, Prospective, Open-label Phase I\u002FII Trial of Actinium (225Ac) rhPSMA 10.1 to Evaluate Safety and Anti-tumour Activity in Men With Metastatic Castrate-resistant Prostate Cancer (mCRPC) Including Those Who Have Previously Responded to Lutetium-PSMA","ACT-RESoLUTE","Phase I 177Lu-PSMA requirement:\n\nThe first 3 participants treated at each dose level may be 177Lu-PSMA treatment naïve or may have previously received 177Lu-PSMA treatment. Additional participants recruited at any dose level must have received prior 177Lu-PSMA treatment and had a response to therapy, as judged by the treating physician.\n\nPhase II 177Lu-PSMA requirement:\n\nAll participants must have received prior 177Lu-PSMA and had a response to therapy, as judged by the treating physician.\n\nInclusion Criteria:\n\n1. Age ≥ 18 years at time of providing informed consent.\n2. Histologically- or cytologically-confirmed diagnosis of prostate adenocarcinoma, which may include small cell or neuroendocrine features.\n3. Castration-resistant prostate cancer, defined as a rising PSA despite surgical castration or ongoing medical castration, with serum testosterone ≤ 0.5ng\u002FmL or \\\u003C1.7 nmol\u002FL.\n4. Progressive mCRPC with rising PSA level, as defined by PCWG3 criteria, or by radiological progression, and must demonstrate a sequence of rising values above baseline at a minimum of 1-week intervals and PSA \\> 1 ng\u002FmL.\n5. PSMA-avid disease on screening PSMA-PET-CT scan\n6. Prior treatment with at least one second-generation androgen receptor pathway inhibitor (ARPI)\n7. Prior treatment with at least one but no more than two lines of taxane therapy for prostate cancer, or been deemed ineligible or refused taxane therapy on consultation with their treating physician.\n8. At least 4 weeks or 5 half-lives (whichever is longer) elapsed between last anti-cancer treatment administration and the initiation of trial treatment. Anti-cancer treatment includes ARPIs and PARP inhibitors but excludes ADT (e.g. luteinising hormone releasing hormone (LHRH) analogue or gonadotropin-releasing hormone treatment), which should be continued. Prednisone up to 10 mg daily (or equivalent) is also permitted.\n9. Prior treatment with 177Lu-PSMA-targeted radiopharmaceutical therapy (e.g. 177Lu-PSMA-617, 177Lu PSMA-I\\&T) up to a maximum of 6 cycles and with response to therapy as judged by the treating physician.\n\n   Exception: in Phase I, the first 3 participants treated at each dose level may be 177Lu-PSMA naïve Note: last treatment with 177Lu-PSMA must be more than 10 weeks prior to study enrolment.\n10. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.\n11. Estimated life expectancy \\> 12 weeks.\n12. Grade ≤ 1 xerostomia symptoms at time of trial enrolment.\n13. Adequate bone marrow, renal, and hepatic function\n14. Resolution of all previous treatment-related toxicities to CTCAE v5.0 Grade ≤ 1, except for chemotherapy-induced alopecia, Grade 2 peripheral neuropathy, and Grade 2 urinary frequency, which are permitted.\n15. Adequate contraception for participants and their partners.\n16. Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression.\n2. Active metastatic central nervous system (CNS) disease, including leptomeningeal disease.\n3. Receipt of 177Lu-PSMA treatment within 10 weeks of trial enrolment.\n4. Prior radiotherapeutic treatment for metastatic prostate cancer (e.g. Radium-223) with the exception of 177Lu-PSMA.\n\n   Note: prior radiotherapeutic treatment for other cancers is permitted (e.g. radioactive iodine for thyroid cancer).\n5. Receipt of transfused blood products or erythropoietin stimulating agents within 4 weeks of trial enrolment.\n6. Major surgery within 12 weeks of trial enrolment.\n7. Other current malignancy, or malignancy diagnosed\u002Frelapsed within the past 5 years (other than non melanomatous skin cancer, stage 0 melanoma in situ, or non-muscle invasive bladder cancer that has undergone curative intent therapy).\n8. Sjogren's disease or any other medical conditions that in the judgement of the investigator puts the participant at increased risk of xerostomia.\n9. Single kidney, renal transplant or any nephrotoxic condition or concomitant therapy that in the judgement of the investigator could put the participant at risk of unacceptable renal toxicity during the trial.\n10. Severe urinary incontinence or any other conditions that in the judgement of the investigator would preclude safe disposal of radioactive urine.\n11. Any structural kidney\u002Frenal tract disease that in the judgement of the investigator could affect excretion of the trial agent (e.g. hydronephrosis), unless addressed with intervention (e.g. ureteric stent insertion with normalisation of renal function).\n12. Clinically significant abnormalities on a single 12-lead electrocardiogram (ECG) during screening evaluation.\n13. Concurrent serious conditions that in the judgement of the investigator would pose a safety risk or impair trial participation.\n14. Radiation therapy within 2 weeks before trial enrolment.\n15. Hypersensitivity to the investigational product or any of its constituents.\n16. Current participation in another trial with ongoing receipt of an investigational agent.\n17. Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the trial protocol and follow-up schedule, or that would pose a risk to the participant's safety.",{"count":154,"type":23},[26,27],"Advanced metastatic castration-resistant prostate cancer is a medical condition for which additional effective and tolerable treatments are urgently needed in order to improve patient outcomes and quality of life.\n\nThe goal of this clinical trial is to learn more about Actinium (225Ac) radiohybrid prostate-specific membrane antigen-10.1 (rhPSMA-10.1) injection in men with prostate cancer that has spread and progressed after previous treatments, particularly after Lutetium-PSMA.\n\nActinium (225Ac) rhPSMA-10.1 is an injectable radioactive medication that aims to attach to prostate cancer cells in the body and destroy them using ionising radiation. It is a new medication that has not yet been studied in humans.\n\nParticipants will receive a dose of Actinium (225Ac) rhPSMA-10.1 every 6 weeks, to a maximum of 6 doses. They will be reviewed regularly by the trial researchers to monitor side effects and safety signals. A range of medication doses will be administered so that researchers can find out what doses of the medication are safe for men with prostate cancer. The trial will also aim to determine how effective this medication is for treating advanced prostate cancer.",[487,30,61],"Metastatic Castration-resistant Prostate Cancer",[489,490,61],"PSMA","mCRPC","2026-05-05",{"date":493,"type":40},"2026-05-08",{"date":495,"type":40},"2026-04-13",{"date":497,"type":23},"2031-12-30",{"name":499,"class":81},"University College, London",{"id":501,"slug":502,"hasResults":12,"nctId":503,"briefTitle":504,"officialTitle":505,"acronym":4,"eligibilityCriteria":506,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":507,"targetDuration":4,"studyType":24,"phases":509,"briefSummary":510,"conditions":511,"keywords":513,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":520,"lastUpdatePostDateStruct":521,"startDateStruct":523,"completionDateStruct":525,"leadSponsor":527,"locationsCount":82},"100549115","remotely-monitored-exercise-interventions-in-patients-with-mcspc-undergoing-adt-prostate-006-100549115","NCT06429813","Remotely Monitored Exercise Interventions in Patients With mCSPC Undergoing ADT (Prostate 006)","A Feasibility Study to Examine the Impact of Remotely Monitored Exercise Interventions on Cardiorespiratory\u002FMuscular Fitness and Fatigue in Patients With Metastatic Castrate-sensitive Prostate Cancer (mCSPC) Undergoing Treatment With Androgen-deprivation Therapy (ADT) Intensification","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male, aged ≥18 years old\n4. Diagnosis of mCSPC (defined as either biopsy-proven metastatic prostate cancer or elevated PSA (Prostate Specific Antigen) in the setting of imaging findings typical of prostate cancer spread; patients can either have de novo metastatic disease or recurrent metastatic disease after prior definitive therapy to the primary tumor with either surgery or radiation)\n5. Planned treatment with ADT (LHRH \\[Luteinizing hormone-releasing hormone\\] agonist such as leuprolide or LHRH antagonist such as degarelix), or recent administration, ≤14 days prior to enrollment.\n6. Planned intensification with ARSI (abiraterone\u002Fprednisone, enzalutamide, apalutamide, or darolutamide).\n7. Oncologist clearance for exercise training after taking into account functional status and co-morbid conditions that may limit ability to participate.\n8. Ability to take oral medication and willing to adhere to the study intervention regimen\n9. Ability to read, speak, and understand English.\n\nExclusion Criteria:\n\n1. Castrate-resistant prostate cancer (defined as prostate cancer previously treated with a backbone of ADT hormonal therapy with either progression of disease on imaging PSA progression with PSA increase of \\> 25% and 2 ng\u002FmL above nadir, confirmed at 2 time points at least 3 weeks apart, in the setting of testosterone level \\\u003C 50)\n2. Patients with prostate cancer with biochemical recurrence (e.g., received prior definitive therapy with subsequent PSA \\[Prostate-Specific Antigen\\] rise) but radiographic imaging is negative for metastatic disease\n3. Metastatic bone lesion(s) in the proximal femur, bone lesion causing impending fracture, or other metastatic site deemed unsafe for walking by treating physician\n4. Medical\u002Forthopedic comorbidities that preclude stationary cycling or walking\n5. Significant cardiac\u002Frenal\u002Fhepatic\u002Fhematological\u002Fpulmonary disease precluding exercise training\n6. Unstable angina or myocardial infarction within 4-weeks prior to treatment\n7. Complex ventricular arrhythmias or New York Heart Association class IV symptoms\n8. Symptomatic severe aortic stenosis\n9. Acute pulmonary embolus\n10. Acute myocarditis\n11. Untreated high-risk proliferative retinopathy\n12. Recent retinal hemorrhage\n13. Uncontrolled hypertension (systolic blood pressure \\> 180 mm Hg or diastolic blood pressure \\> 120 mm Hg)\n14. Severe baseline electrolyte abnormalities (e.g. potassium) that may predispose patient to arrhythmias in the opinion of the treating investigator\n15. Uncontrolled metabolic disease (diabetes with fasting blood sugar \\>300 mg\u002Fdl, thyrotoxicosis, myxedema)\n16. Symptomatic peripheral vascular disease\n17. Prior treatment with taxane- or platinum- based chemotherapy\n18. Prior treatment with PARP \\[Poly (ADP-ribose) polymerase\\] inhibitors\n19. Prior treatment with radium-223 or lutetium-177",{"count":508,"type":23},24,[459],"This study consists of two home-based exercise programs: a stationary exercise bicycle intervention (Arm A), and a walking intervention (Arm B). The study will enroll 24 patients who are starting ADT (Androgen Deprivation Therapy)\u002FARSI (Androgen-Receptor Signaling Inhibitors) therapy for newly diagnosed metastatic castrate-sensitive prostate cancer (mCSPC). All participants will be asked to complete 1-2 training sessions at UVA prior to starting the exercise. All participants will be asked to complete aerobic and strength testing before and after the exercise program. Participants will be asked to answer questionnaires throughout the program. The at-home exercise will last for 12 weeks.",[512,30],"Castrate Sensitive Prostate Cancer",[514,515,516,436,517,518,519],"prostate","metastatic prostate cancer","metastatic castrate-sensitive prostate cancer","exercise","ADT","ARSI","2026-04-27",{"date":522,"type":40},"2026-05-04",{"date":524,"type":40},"2024-07-26",{"date":526,"type":23},"2027-11",{"name":528,"class":81},"Paul Viscuse",{"id":530,"slug":531,"hasResults":12,"nctId":532,"briefTitle":533,"officialTitle":534,"acronym":535,"eligibilityCriteria":536,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":91,"enrollmentInfo":537,"targetDuration":4,"studyType":341,"phases":4,"briefSummary":539,"conditions":540,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":541,"lastUpdatePostDateStruct":542,"startDateStruct":544,"completionDateStruct":546,"leadSponsor":548,"locationsCount":82},"100636017","promet-br---molecular-profiling-of-metastatic-prostate-cancer-a-brazilian-cohort-100636017","NCT07560215","PROMET-BR - Molecular Profiling of Metastatic Prostate Cancer: a Brazilian Cohort","A Retrospective and Prospective Study Aiming to Characterize Molecular Alterations and Clinical Outcomes of Metastatic Prostate Cancer in a Real-world Cohort of Patients Eligible to Palliative Systemic Therapy at Oncoclínicas & Co Group","PROMET-BR","Inclusion Criteria:\n\n* Adult patients age \\>= 18 years; clinical diagnosis of metastatic prostate cancer (irrespective of hormone-sensitivity or castration-resistance status); eligible to palliative therapy for metastatic prostate cancer at Oncoclínicas \\& Co in 2023 onwards; sufficient FFPE tissue available for molecular profiling. For the subset of patients prospectively selected to liquid biopsy cohort, clinical or radiological evidence of disease progression at the sample collection, and with at least 14 days of treatment interval from last dose of systemic anticancer therapy or radiotherapy to liquid biopsy.\n\nExclusion Criteria:\n\n* No tissue FFPE tissue available for molecular profiling (except in prospective liquid biopsy cohort); less than 3 months follow-up from start of palliative therapy for metastatic prostate cancer at Oncoclínicas \\& Co.",{"count":538,"type":23},100,"PROMET-BR is an observational, retrospective and prospective real-world study in Brazil designed to characterize clinically relevant molecular alterations in metastatic prostate cancer and explore their association with patient outcomes in routine practice. The study will be conducted within Oncoclínicas \\& Co and will integrate centralized biomarker testing performed at OC Precision Medicine laboratories with retrospectively assembled clinical data from electronic health records (EHRs) from participating sites. Treatments are not assigned by the protocol; patients receive standard-of-care palliative systemic therapy at the discretion of their treating physicians.",[30],"2026-04-24",{"date":543,"type":40},"2026-05-01",{"date":545,"type":23},"2026-04-30",{"date":547,"type":23},"2027-03-31",{"name":46,"class":47},{"id":550,"slug":551,"hasResults":12,"nctId":552,"briefTitle":553,"officialTitle":554,"acronym":555,"eligibilityCriteria":556,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":557,"targetDuration":4,"studyType":24,"phases":559,"briefSummary":560,"conditions":561,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":562,"lastUpdatePostDateStruct":563,"startDateStruct":565,"completionDateStruct":567,"leadSponsor":569,"locationsCount":572},"100549836","phase-3-platinum-and-taxane-chemo-in-met-castration-resistant-prostate-cancer-patients-with-alterations-in-dna-damage-response-genes-100549836","NCT06439225","Platinum and Taxane Chemo in Met Castration Resistant Prostate Cancer Patients With Alterations in DNA Damage Response Genes","A Randomized Phase III Trial Investigating Platinum and Taxane Chemotherapy in Metastatic Castration Resistant Prostate Cancer Patients With Alterations in DNA Damage Response Genes","OPTION-DDR","Inclusion Criteria:\n\n* Histologic diagnosis of adenocarcinoma of the prostate. The presence of neuroendocrine or small cell carcinoma will be exclusionary\n* Prior treatment with any ARPI, such as abiraterone, enzalutamide, apalutamide, or darotlutamide, is required.\n* Participants must have recovered to ≤ grade 1 from all reversible toxicity related to prior systemic or radiation therapy, with the exception of chemotherapy induced alopecia and grade 2 peripheral neuropathy, and have adequate washout as follows:\n* Longest of one of the following:\n\n  * Two weeks for oral therapies (such as abiraterone, apalutamide, enzalutamide, darolutamide and olaparib)\n  * Standard cycle of standard IV or IM therapies (such as radium 223 or Lu-177-PSMA-617\n  * 2 weeks, 5 half lives, or standard cycle length (whichever is longer) for investigational agents\n* Previous major surgery is permitted provided that surgery occurred at least 28 days prior to participant enrollment and that wound healing has occurred\n* Prior external beam radiation is permitted provided a minimum of 7 days have elapsed between the last dose of radiation and date of enrollment\n* Radiologically documented presence of metastatic disease within 28 days prior to randomization\n* Disease progression after ARPI therapy as assessed by the investigator with at least one of the following:\n* PSA progression with a minimum of two rising PSA values at least 1 week apart, at least 25% and 2ug\u002FL above baseline\u002Fnadir.\n* Radiographic progression of soft tissue disease by RECIST 1.1 criteria or bone metastases by PCWG3 criteria.\n* Medical or surgical castration with serum testosterone levels \\\u003C50ng\u002FdL or \\\u003C1.7mmol\u002FL\n* Qualifying Tier I or Tier II (clinically significant\u002Flikely clinically significant or pathogenic \u002F likely pathogenic) germline or somatic alterations involving one or more of the following DDR genes: BRCA1, BRCA2, ATM, ATR, BRIP1, BARD1, CDK12, CHEK1, CHEK2, ERCC2, FANCA, FANCC, FANCD2, FANCL, PALB2, RAD51B, RAD51C, RAD51D, RAD54L. Monoallelic gene deletions in isolation will not be eligible.\n* Age 18 years or older.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2\n* Participants must have adequate organ and marrow function measured within 14 days prior to enrolment\n* Life expectancy \\> 12 weeks.\n* If the participant and the participant's partner are of childbearing potential, they must agree to use medically accepted methods of contraception (e.g., barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 6 months after the last dose of study drug.\n* Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life and health utility questionnaires in either English or French\n* Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant must sign a consent form prior to enrollment in the trial to document their willingness to participate.\n* Participants must be accessible for treatment and follow-up. Investigators must assure themselves the participants enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.\n* In accordance with CCTG policy, protocol treatment is to begin within 2 working days after participant enrolment.\n\nExclusion Criteria:\n\n* Received prior platinum chemotherapy (i.e. carboplatin, cisplatin, oxaliplatin, satraplatin) or prior taxane chemotherapy (docetaxel, paclitaxel, cabazitaxel) at any time for the treatment of prostate cancer with the exception of docetaxel for mCSPCor adjuvant therapy after curative intent treatment for localized prostate cancer, as long as it was no more than 6 cycles and at least 12 months have elapsed from their last treatment to the date of enrollment. If the participant received prior platinum or taxane chemotherapy for other cancers, then please contact the CCTG office to discuss this further with the trial team.\n* Active anticancer systemic therapy or investigational agents within 14 days of randomization.\n* Uncontrolled intercurrent illness including, but not limited to: active infection, symptomatic congestive heart failure (NYHA Class III or IV heart disease), unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Participants with myelodysplastic syndrome\u002Facute myeloid leukemia.\n* Malignancy within the previous 2-years with a \\> 30% probability of recurrence within 12 months, with the exception of non-melanoma skin cancer, and in-situ or superficial bladder cancer.\n* Participants with known symptomatic brain metastasis. However, participants with asymptomatic, treated brain metastases that have been stable for at least 12 weeks are eligible for study entry.\n* Participants with symptomatic or impending cord compression unless appropriately treated beforehand and clinically stable and asymptomatic.\n* Presence of a condition or situation, which, in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with participation in the study.\n* Live attenuated vaccination administered within 30 days prior to randomization.\n* For patients with known immunodeficiency virus (HIV) infection, the HIV viral load must be undetectable on effective anti-retroviral therapy within 6 months of enrollment.\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Unable to obtain provincial reimbursement of carboplatin and docetaxel",{"count":558,"type":23},236,[390],"The usual approach for most patients who are not in a study is treatment with docetaxel.\n\nThis study is being done to answer the following question: Can the chance of prostate cancer growing or spreading be lowered by adding a drug to the usual approach?\n\nThis study is being done to find out if this approach is better or worse than the usual approach for prostate cancer. The usual approach is defined as the care most people get for prostate cancer.",[487,30],"2026-04-15",{"date":564,"type":40},"2026-04-16",{"date":566,"type":40},"2024-12-30",{"date":568,"type":23},"2030-03-31",{"name":570,"class":571},"Canadian Cancer Trials Group","NETWORK",14,{"id":574,"slug":575,"hasResults":12,"nctId":576,"briefTitle":577,"officialTitle":578,"acronym":579,"eligibilityCriteria":580,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":581,"targetDuration":4,"studyType":24,"phases":583,"briefSummary":584,"conditions":585,"keywords":589,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":599,"lastUpdatePostDateStruct":600,"startDateStruct":602,"completionDateStruct":604,"leadSponsor":606,"locationsCount":57},"100422969","phase-2-veterans-affairs-seamless-phase-iiiii-randomized-trial-of-standard-systemic-therapy-with-or-without-pet-directed-local-therapy-for-oligometastatic-prostate-cancer-100422969","NCT04787744","Veterans Affairs Seamless Phase II\u002FIII Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer","Veterans Affairs Seamless Phase II\u002FIII Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for OligoRecurrenT Prostate Cancer (VA STARPORT)","VA STARPORT","Inclusion Criteria:\n\nAge 18 years. Ability to provide Informed Consent for participation in the study ECOG Performance Status 2 at time of enrollment. Prostate cancer, confirmed histologically or cytologically. If original documentation of histology and cytology are not available, documentation of prostate cancer satisfies these criteria. If recurrent, prior curative-intent local therapy to all sites of prostate cancer with either upfront radiotherapy or prostatectomy with or without post-operative radiotherapy.\n\nIf recurrent, PSA suspicious for biochemical recurrence after local therapy, with lab value(s) taken prior to start of SST (if current SST has already started) or within 90 days prior to enrollment if not already on SST, and meeting one of the three below categories:\n\nPSA 0.2 ng\u002Fml x 2 after prostatectomy +\u002F- post-operative radiotherapy; Elevation of PSA 2 ng\u002Fml above the nadir after definitive radiotherapy; Or Two consecutively elevated PSAs with evidence of metastasis on the imaging Studies.\n\n-Serum testosterone obtained prior to randomization based on one of the criteria below:\n\nFor patients who have a history of a prior episode of therapy with SST agents for prostate cancer, a total testosterone 100 ng\u002Fdl after completion of the prior episode of SST and before the start of current SST or within 30 days of starting current SST if the patient has already started SST for recurrence.\n\nFor patients who have no prior history of an episode of therapy with SST agents and have already started SST for recurrence, this pre-SST testosterone is not required.\n\nCT or MRI abdomen\u002Fpelvis performed prior to start of SST (if current SST has already started) or within 90 days prior to enrollment if not already on SST. The results from the CT component of the PET\u002FCT can be used to fulfill this criterion. This is optional for patients who have a PSMA PET\u002FCT. Yechnetium (Tc99m-MDP) or sodium fluoride (NaF) bone scan (sodium fluoride preferred) performed prior to start of SST (if current SST has already started), or within 90 days prior to enrollment if not already on SST. This is optional for patients who have a PSMA PET\u002FCT. Prostate PET\u002FCT (currently PSMA, Fluciclovine, choline) performed prior to start of SST (if current SST has already started), or within 90 days prior to enrollment if not already on SST.\n\n1-10 lesions suspicious for nodal recurrence or metastasis from prostate cancer as determined by the investigator based on the above imaging studies.\n\nHas already undergone NPOP sequencing or a plan is in place for NPOP sequencing for prostate cancer.\n\nFor participants on SST at the time of enrollment only:\n\nHas been on SST for 180 days. For participants with local recurrence after curative-intent local therapy on imaging :\n\nPatients with local recurrence in the prostate, SV, or prostate bed are eligible as long as there is at least 1 nodal or distant metastatic recurrence. Biopsy must confirm local recurrence for patients who have had prior curative-intent radiation to the prostate, SV, or prostate bed.\n\nCandidate for salvage local therapy (refer to Section 10.4) as determined by a urologist or radiation oncologist (depending on the respective modality to be used to treat the local recurrence).\n\nFor participants with de novo prostate cancer:\n\nCandidate for prostate-directed radiation.\n\nExclusion Criteria:\n\n* Any current or prior evidence of castration-resistant prostate cancer, defined as two consecutive rises in serum PSA, obtained at a minimum of 1-week interval, with the final PSA value \\>\u002F= 1 ng\u002Fml, while having a total testosterone \\\u003C 50 ng\u002Fdl).\n* Prior malignancy, except the following:\n\n  * Adequately treated non-melanomatous skin cancer;\n  * Adequately treated Stage 0, I, or II cancer from which the patient is currently in complete remission; or\n  * Any other cancer from which the patient has been disease free for three years.\n* Presence of a symptomatic metastasis that requires palliative radiotherapy.\n* Any known brain metastases, presence of leptomeningeal disease, malignant spinal cord compression, or malignant cauda equina syndrome.\n* Prior nodal, bone, or visceral metastasis after curative-intent therapy other than those identified on the enrollment imaging studies which make the patient ineligible for PET-directed local therapy (per investigator discretion).\n* Prior radiation therapy to any sites requiring PET-directed local therapy or salvage local therapy that will lead to prohibitively high risk of toxicity from subsequent local therapy, as determined by the treating radiation oncologist (if radiation is intended as the study local therapy) or surgeon\u002Furologist (if surgery is intended as the study local therapy).\n* Any other previous or current condition, which, in the judgement of the LSI, is likely to interfere with any STARPORT treatments or assessments.",{"count":582,"type":23},464,[27,390],"This is a prospective, open-label, multi-center seamless phase II to phase III randomized clinical trial designed to compare SST with or without PET-directed local therapy in improving the castration-resistant prostate cancer-free survival (CRPC-free survival) for Veterans with oligometastatic prostate cancer. Oligometastasis will be defined as 1-10 sites of metastatic disease based on the clinical determination of the LSI which incorporates all imaging, clinical, and pathologic data available.",[61,586,587,62,30,588],"Oligometastasis","Oligorecurrence","De Novo Prostate Cancer",[61,590,587,591,592,593,586,594,595,596,62,597,489,598],"Metastasis","PET-directed local therapy","Standard Systemic Therapy","SBRT","Oligorecurrent","Metastasis-directed therapy","Salvage Local Therapy","Fluciclovine","Choline","2026-04-02",{"date":601,"type":40},"2026-04-08",{"date":603,"type":40},"2021-07-01",{"date":605,"type":23},"2029-03-30",{"name":607,"class":608},"VA Office of Research and Development","FED",{"id":610,"slug":611,"hasResults":12,"nctId":612,"briefTitle":613,"officialTitle":614,"acronym":615,"eligibilityCriteria":616,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":91,"enrollmentInfo":617,"targetDuration":4,"studyType":341,"phases":4,"briefSummary":619,"conditions":620,"keywords":621,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":626,"lastUpdatePostDateStruct":627,"startDateStruct":629,"completionDateStruct":631,"leadSponsor":633,"locationsCount":82},"100615258","real-world-use-of-lutetium-177lu-vipivotide-tetraxetan-in-chinapsmareal-cn-100615258","NCT07290270","Real-world Use of Lutetium (177Lu) Vipivotide Tetraxetan in China(PSMAreal CN)","Real-world Use of Lutetium (177Lu) Vipivotide Tetraxetan Injection in Metastatic Prostate Cancer: an Observational, Multicenter, Prospective Cohort Study in China (PSMAreal CN)","PSMAreal","Inclusion Criteria:\n\nAdult male patients diagnosed with mCRPC or mHSPC Initiating lutetium (177Lu) vipivotide tetraxetan treatment by treating physician as per local label. After treatment decision enrollment is allowed before date of cycle 1 or within 2 weeks after the date of cycle 1 Written ICF must be obtained prior to any data collection Participants must have adequate organ function following Society of Nuclear Medicine and Molecular Imaging (SNMMI) consensus (Hope et al., 2023)\n\nExclusion Criteria:\n\nSimultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with lutetium (177Lu) vipivotide tetraxetan during the study period\n\nOther protocol-defined inclusion \u002F exclusion criteria may apply",{"count":618,"type":23},170,"This non-interventional, observational, multicenter, prospective cohort study is designed to investigate the treatment patterns of mPC patients treated with lutetium (177Lu) vipivotide tetraxetan, as well as their clinical outcomes, real-world characteristics, and quality of life during the treatment period and up to one year after treatment completion.",[30],[30,245,622,623,624,625],"Metastatic Hormone-Sensitive Prostate Cancer","Lutetium (177Lu) vipivotide tetraxetan Injection","Non-interventional Study","China","2026-03-25",{"date":628,"type":40},"2026-03-30",{"date":630,"type":40},"2026-02-04",{"date":632,"type":23},"2029-08-31",{"name":634,"class":47},"Novartis Pharmaceuticals",{"id":636,"slug":637,"hasResults":12,"nctId":638,"briefTitle":639,"officialTitle":640,"acronym":641,"eligibilityCriteria":642,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":643,"targetDuration":4,"studyType":341,"phases":4,"briefSummary":645,"conditions":646,"keywords":647,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":648,"startDateStruct":650,"completionDateStruct":652,"leadSponsor":654,"locationsCount":4},"100630176","pulse-registry-for-patients-receiving-lutetium-177lu-vipivotide-tetraxetan-100630176","NCT07484269","PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan","Understanding Drug Utilisation, Treatment Patterns, Clinical Outcomes, and Profile of the Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan for the Treatment of Metastatic Prostate Cancer: a Multicountry, AI-powered Registry (PULSE)","PULSE","Inclusion criteria:\n\nAge ≥ 18 years at index date\n\n* Diagnosis of mPC\n* PSMA positive\n* Received at least one dose of lutetium (177Lu) vipivotide tetraxetan on or after mPC diagnosis date\n\nExclusion criterion:\n\n• Current or prior participation in an investigational study within the 30-day period immediately prior to and including the index date, or within five half-lives of the investigational product (whichever is longer)",{"count":644,"type":23},753,"The primary objective of the study is to describe real-world drug utilisation of lutetium (177Lu) vipivotide tetraxetan among patients with metastatic prostate cancer",[30],[66,515],{"date":649,"type":40},"2026-03-20",{"date":651,"type":23},"2026-08-01",{"date":653,"type":23},"2031-07-31",{"name":634,"class":47}]