[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Prostate Cancer Clinical Trials Consortium\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":140},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,49,61,85,114],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100053522","phase-2-a-study-of-talazoparib-with-or-without-enzalutamide-in-people-with-prostate-cancer-who-have-previously-received-abiraterone-acetate-100053522",false,"NCT06844383","A Study of Talazoparib With or Without Enzalutamide in People With Prostate Cancer Who Have Previously Received Abiraterone Acetate","A Randomized Open-label Phase 2 Study of TALazoparib With or Without ENzaluTamide in Patients With Metastatic Castration-Resistant Prostate Cancer and HRR Mutations After Progression on Abiraterone Acetate","TALENT","Inclusion Criteria\n\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* Participants ≥ 18 years of age.\n* Are willing to be randomized into either study arm and adhere to the study protocol.\n* Ability to swallow study capsules and\u002For tablets whole.\n* Are willing to remain on study treatment and to continue undergoing study imaging despite PSA progression unless clinically deteriorating.\n* Histological or cytological proof of adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features.\n* Presence of a pathogenic homologous recombination repair mutation in at least one of the following genes on tumor tissue or circulating tumor DNA testing: BRCA1, BRCA2, ATM (limited to 15% of enrolled participants), CDK12, CHEK2, PALB2, MLH1, NBN, ATR, FANCA, MRE11A, RAD51C. Assessment of HRR mutation status by germline or somatic testing. All testing must be per Clinical Laboratory Improvement Amendments (CLIA)-certified assay and may have occurred at any time prior to or at screening (not required to be completed within the screening window).\n* Metastatic castration-resistant prostate cancer (mCRPC) as demonstrated by one of the following:\n\n  * Metastatic disease documented by conventional imaging: computed tomography (CT)\u002Fmagnetic resonance imaging (MRI) chest\u002Fabdomen\u002Fpelvis and bone scan are required to be performed, but metastases do not need to be seen on both modalities. Measurable disease is not required.\n  * Unequivocal prostate-specific membrane antigen (PSMA) positron emission tomography (PET) only defined metastatic disease with negative conventional imaging. PSMA PET imaging is not required to be performed, but may be used to document metastases when relevant.\n* Received prior abiraterone acetate with prednisone for mHSPC or locally advanced disease and on which progressed via a minimum of 2 rising PSA levels with a minimum of a 1-week interval between each determination or radiographic progression by any form of imaging.\n* Progressive disease at start of treatment and in the setting of medical or surgical castration as defined by 1 or more of the following 4 criteria:\n\n  * PSA progression defined as 2 rising PSA levels, above an initial reference value, taken with a minimum of a 1-week interval. If PSA rise is the only indication of progression at start of study treatment, a minimum PSA of 1.0 ng\u002FmL is required and all measured PSA values have to be considered to make a determination of progression.\n  * Soft tissue disease progression as defined by RECIST 1.1.\n  * Bone disease progression defined by PCWG3 with 2 or more new metastatic bone lesions on a whole-body radionuclide bone scan.\n  * Appearance of newly identified, convincingly positive lesions consistent with metastatic prostate cancer on PSMA PET.\n* Surgically or medically castrated, with testosterone levels of \\\u003C50 ng\u002FdL. If the participant is medically castrated, continuous dosing with a gonadotropin-releasing hormone agonist or antagonist must be demonstrated by testosterone level of \\\u003C50 ng\u002FdL and planned to continue throughout study participation.\n* Eastern Cooperative Oncology Group (ECOG) status of ≤1 (Appendix A: Performance Status Criteria).\n* Normal organ function with acceptable initial laboratory values within 14 days of treatment start:\n\n  * Absolute neutrophil count ≥ 1,500\u002Fµl\n  * Hemoglobin ≥ 9g\u002Fdl\n  * Platelet count ≥ 100,000\u002Fµl\n  * Creatinine ≤ 1.5 x the institutional upper limit of normal (ULN)\n  * Potassium ≥ 3.5 mmol\u002FL (within institutional normal range)\n  * Bilirubin ≤ 1.3 x ULN (unless documented Gilbert's disease)\n  * Serum glutamic oxaloacetic transaminase\u002Faspartate transaminase (AST) ≤ 2.5 x ULN\n  * Serum glutamic pyruvic transaminase\u002F alanine transaminase (ALT) ≤ 2.5 x ULN\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 4 months after the last dose of study drug. Sperm donation is prohibited during the study and for 4 months 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 other active malignancy at time of first dose of study treatment or diagnosis of another malignancy within 3 years prior to first dose of study treatment that requires active treatment, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer or superficial bladder cancer.\n* Prior treatment for metastatic or non-metastatic CRPC with an ARPI other than abiraterone acetate with prednisone for ≥ 12 weeks. Prior treatment with abiraterone acetate with prednisone in the mHSPC or locally advanced setting is not exclusionary.\n* Participants who received chemotherapy for castration-sensitive prostate cancer are still eligible provided chemotherapy was completed \\>6 months prior to start of study treatment.\n* Use of investigational agents for the treatment of prostate cancer within 4 weeks of start of study treatment.\n* Prior treatment with a PARP inhibitor.\n* Concurrent treatment with crizotinib.\n* Prior platinum-based chemotherapy for the treatment of prostate cancer.\n* Current or planned use of potent P-gp inhibitors within 7 days prior to randomization. The P-gp inhibitors include: amiodarone, carvedilol, clarithromycin, cobicistat, dronedarone, erythromycin, glecaprevir\u002Fpibrentasvir, indinavir, itraconazole, ketoconazole, lapatinib, lopinavir, propafenone, quinidine, ranolazine, ritonavir, saquinavir, sofosbuvir\u002Fvelpatasvir\u002Fvoxilaprevir, telaprevir, tipranavir, valspodar, and verapamil.\n* Current use of strong cytochrome P450 2C8 (CYP2C8) inhibitors (e.g., clopidogrel, gemfibrozil) and inducers (e.g., rifampin), strong CYP3A4 inducers (e.g., carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine and St. John's Wort), moderate CYP3A4 inducers (e.g., bosentan, efavirenz, etravirine, modafinil and nafcillin), or substrates of CYP3A4 (e.g., alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus and tacrolimus), CYP2C9 (e.g., phenytoin, warfarin), or CYP2C19 (e.g., S-mephenytoin) with a narrow therapeutic index unless considered medically necessary to treat a life-threatening condition.\n* Participants treated with strong cytochrome P450 2C8 (CYP2C8) inhibitors (e.g., clopidogrel, gemfibrozil) within 7 days from randomization are not eligible.\n* Use of hormonal agents with anti-tumor activity against prostate cancer including 5-alpha reductase inhibitors, androgens (e.g., testosterone), cytoproterone acetate, progestational agents, and estrogens\u002Fdiethylstilbestrol within 28 days prior to the start of study treatment.\n* Use of herbal products or alternative therapies that may decrease PSA levels or that may have hormonal anti-prostate cancer activity (e.g., saw palmetto, PC-SPES, PC-HOPE, St. John's wort, selenium supplements, grape seed extract, etc.) within 28 days of study treatment initiation or plans to initiate treatment with these products\u002Falternative therapies during the entire duration of the study.\n* Participants receiving a blood transfusion within 14 days of randomization are not eligible.\n* History of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke, significant brain trauma). Also, history of loss of consciousness or transient ischemic attack within 12 months of randomization.\n* Medical conditions such as uncontrolled hypertension as indicated by a resting systolic blood pressure \\> 160 mm Hg or diastolic blood pressure \\> 90 mm Hg at screening, uncontrolled diabetes mellitus, and cardiac disease that would preclude participation, as determined by the investigator.\n* Untreated known or suspected brain metastases or spinal cord compression or clinically significant malignant epidural disease.\n* Use of any prohibited concomitant medications (Appendix C: Medications with the Potential for Drug-Drug Interactions) within 28 days before first dose of study treatment.\n* Grade \\>2 treatment-related toxicity from prior therapy except alopecia or peripheral neuropathy.\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.","MALE","18 Years",{"count":20,"type":21},126,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The purpose of this study is to find out whether talazoparib in combination with enzalutamide or talazoparib alone delays cancer progression in people with metastatic castration-resistant prostate cancer (mCRPC) who have homologous recombination repair (HRR) mutations and have previously received abiraterone acetate.",[27,28],"Prostate Cancer (Adenocarcinoma)","mCRPC (Metastatic Castration-resistant Prostate Cancer)",[30,31,32,15,33,34,35],"talazoparib","enzalutamide","PARP inhibitor","androgen receptor signaling inhibitor (ARSI)","Prostate Cancer Clinical Trials Consortium, LLC (PCCTC)","c24-349","RECRUITING","2026-07-10",{"date":39,"type":40},"2026-07-13","ACTUAL",{"date":42,"type":40},"2026-05-05",{"date":44,"type":21},"2030-03",{"name":46,"class":47},"Prostate Cancer Clinical Trials Consortium","OTHER",7,{"id":50,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":25,"conditions":53,"keywords":54,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":59,"leadSponsor":60,"locationsCount":5},"100580982",{"count":20,"type":21},[24],[27,28],[30,31,32,15,33,34,35],"2026-06-11",{"date":57,"type":40},"2026-06-15",{"date":42,"type":40},{"date":44,"type":21},{"name":46,"class":47},{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":17,"minAge":68,"maxAge":4,"enrollmentInfo":69,"targetDuration":71,"studyType":72,"phases":4,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},"100297409","international-registry-for-men-with-advanced-prostate-cancer-ironman-100297409","NCT03151629","International Registry for Men With Advanced Prostate Cancer (IRONMAN)","IRONMAN","• Willing and able to provide written informed consent and privacy authorization for the release of personal health information.\n\nNOTE: Privacy authorization may be either included in the informed consent or obtained separately.\n\n* Males 21 years of age and above\n* Histological or cytological confirmed prostate adenocarcinoma from TRUS biopsy, radical prostatectomy or TURP Or Documented histopathology or cytopathology of prostate adenocarcinoma from a biopsy of a metastatic site Or Metastatic disease typical of prostate cancer (i.e., involving bone or pelvic lymph nodes or para-aortic lymph nodes) AND a serum concentration of PSA \\>20ng\u002FmL at the time of initial prostate cancer diagnosis\n* No previous diagnosis of a second, non-prostate malignancy that requires additional systemic therapy except cancer in situ of bladder and basal cell cancer of skin","21 Years",{"count":70,"type":21},5000,"5 Years","OBSERVATIONAL","Our intent is to establish the International Registry to Improve Outcomes in Men with Advanced Prostate Cancer (IRONMAN) as a prospective, international cohort of minimum 5,000 men with advanced cancer, including men with mHSPC and M0\u002FM1 CRPC. The goal is to establish a population-based registry and recruit patients across academic and community practices from Australia, Barbados, Brazil, Canada, Ireland, Jamaica, Kenya, Nigeria, Norway, Spain, South Africa, Sweden, Switzerland, the United Kingdom (UK), and the United States (US). Target accrual number and number of participating sites are subject to change based on accrual, funding, and interest in participation by other international sites. This cohort study will facilitate a better understanding of the variation in care and treatment of advanced prostate cancer across countries and across academia and community based practices.\n\nDetailed data will be collected from patients at study enrollment and then during follow-up, for a minimum of five years. Patients will be followed prospectively for overall survival, clinically significant adverse events, comorbidities, changes in cancer treatments, and PROMs.\n\nPROMs questionnaires will be collected at enrollment and every three months thereafter.\n\nPhysician Questionnaires will be collected from all participating sites at patient enrollment, time of first change in treatment and\u002For one year follow-up, at each subsequent change of treatment, and discontinuation of treatment.\n\nAs such, this registry will help identify the treatment sequences or combinations that optimize overall survival and PROMs for men with mHSPC and M0\u002FM1 CRPC. By collecting blood at enrollment, time of first change in treatment and\u002For one year follow-up (plasma, cell free DNA, buffy coat \u002F RNA), this registry will further identify and validate molecular phenotypes of disease that predict response and resistance to specific therapeutics. Additionally, every effort will be made to collect blood specimen at each subsequent change in treatment due to progression of disease. When feasible, existing tumor tissue may be collected for correlation with described blood based studies. All samples will be used for future research. This cohort study will provide the research community with a unique biorepository to identify biomarkers of treatment response and resistance.",[75],"Prostate Cancer","2026-05-19",{"date":78,"type":40},"2026-05-22",{"date":80,"type":40},"2017-07-21",{"date":82,"type":21},"2032-01",{"name":46,"class":47},121,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":22,"phases":95,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":4},"100637431","phase-2-a-study-of-mevrometostat-with-enzalutamide-in-people-with-prostate-cancer-who-have-previously-received-androgen-receptor-pathway-inhibitor-therapy-100637431","NCT07592910","A Study of Mevrometostat With Enzalutamide in People With Prostate Cancer Who Have Previously Received Androgen Receptor Pathway Inhibitor Therapy","A Phase 2, Open-label, Single-Arm Study of Mevrometostat Plus Enzalutamide in Metastatic Castration-Resistant Prostate Cancer Following Prior Androgen Receptor Pathway Inhibitor Therapy (MOMENT)","MOMENT","Inclusion Criteria:\n\n* Willing and able to provide written informed consent\n* Age 18 years or older\n* Diagnosis of prostate cancer (adenocarcinoma) confirmed by tissue sample, without neuroendocrine or small cell features\n* Currently taking or recently treated with enzalutamide, darolutamide, or apalutamide (within 30 days of screening) and willing to switch to or restart enzalutamide for this study\n* Cancer has spread to bone or soft tissue (metastatic disease), confirmed by imaging\n* ECOG performance status of 0, 1, or 2 (able to care for self and up and about more than 50% of waking hours)\n* Testosterone level less than 50 ng\u002FdL at screening, with ongoing hormone deprivation therapy or prior surgical castration\n* If receiving bone-protective therapy (e.g., denosumab or bisphosphonates), must be on a stable dose for at least 4 weeks\n* Evidence of cancer progression while on enzalutamide, darolutamide, or apalutamide, shown by rising PSA, worsening disease on imaging, or new bone lesions\n* Adequate organ function based on blood tests within 28 days of starting treatment, including adequate blood counts, kidney function, and liver function\n* Willing to use acceptable birth control during the study and for 30 days after the last dose\n\nExclusion Criteria:\n\n* History of myelodysplastic syndrome, acute myeloid leukemia, or other prior cancer (exceptions: non-melanoma skin cancer, carcinoma in situ, cancers more than 3 years ago with no recurrence, or early-stage cancers with low risk of recurrence)\n* Any medical or psychiatric condition, including active infection or recent suicidal ideation, that may make study participation unsafe\n* History of seizure or conditions that may increase seizure risk (e.g., prior stroke, significant brain trauma), or loss of consciousness or transient ischemic attack within 12 months\n* Untreated brain metastases, spinal cord compression, or clinically significant epidural disease\n* Use of 5-alpha reductase inhibitors, herbal medications, or supplements known to alter PSA levels within 4 weeks of starting treatment\n* AIDS-related illness or active hepatitis B or C (well-controlled HIV is allowed)\n* Known history of chronic liver disease (e.g., alcoholic liver disease, primary biliary cirrhosis, autoimmune hepatitis, Wilson's disease, hemochromatosis)\n* Known history of active inflammatory gastrointestinal disease, chronic diarrhea, or prior gastric resection or lap-band surgery\n* Clinically significant cardiovascular disease within the past 6 months (e.g., heart attack, unstable angina, stroke, heart failure NYHA Class III\u002FIV, pulmonary embolism, significant arrhythmias), cardiac pacemaker, or QTcF greater than 480 msec on screening ECG\n* Prior or current use of PARP inhibitors and\u002For AKT inhibitors\n* Prior cancer progression on abiraterone (stopping abiraterone due to side effects is allowed)\n* Known allergy to any study drug\n* Blood transfusion within 28 days prior to screening blood tests\n* Use of another investigational drug within 4 weeks before starting study treatment\n* Any other condition that, in the opinion of the investigator, would prevent safe participation\n* Current use or anticipated need for strong CYP3A4\u002F5 inhibitors or inducers (other than enzalutamide) within 10 days or 5 half-lives prior to treatment start",{"count":94,"type":21},60,[24],"The purpose of this study is to find out whether mevrometostat in combination with enzalutamide delays cancer progression in people with metastatic castration-resistant prostate cancer (mCRPC) who have previously received enzalutamide, darolutamide, or apalutamide in the metastatic castration-sensitive prostate cancer (mCSPC) or non-metastatic castration-resistant prostate cancer (nmCRPC) setting but have not previously progressed on abiraterone.",[98,27],"Metastatic Castrate Resistant Prostate Cancer (mCRPC)",[100,101,102,103,91,104,75],"Mevrometostat","EZH2 inhibitor","Enzalutamide","ARPI resistance","mCRPC","NOT_YET_RECRUITING","2026-05-11",{"date":108,"type":40},"2026-05-18",{"date":110,"type":21},"2026-08",{"date":112,"type":21},"2029-08",{"name":46,"class":47},{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":120,"targetDuration":122,"studyType":72,"phases":4,"briefSummary":123,"conditions":124,"keywords":125,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},"100438892","promise-registry-a-prostate-cancer-registry-of-outcomes-and-germline-mutations-for-improved-survival-and-treatment-effectiveness-100438892","NCT04995198","PROMISE Registry: A Prostate Cancer Registry of Outcomes and Germline Mutations for Improved Survival and Treatment Effectiveness","Inclusion Criteria:\n\n* Have prostate cancer (any stage of disease or survivorship) diagnosed or documented through one of the following:\n\n  * tissue biopsy, and\u002For\n  * PSA greater than 100 ng\u002FdL (1ng\u002Fml), and\u002For\n  * clear radiographic evidence of disease\n* Live in the United States (including Puerto Rico, Guam, American Samoa, US Virgin Islands, Northern Mariana Islands)\n\nExclusion Criteria:\n\n* Unable or unwilling to provide all of the necessary information for eligibility\n* Incomplete inclusion criteria",{"count":121,"type":21},500,"15 Years","PROMISE aims to create a comprehensive nationwide registry of prostate cancer patients with germline pathogenic variants by prospectively screening approximately 5,000 subjects with a confirmed prostate cancer diagnosis, either through tissue biopsy, PSA greater than 100 ng\u002FdL and\u002For radiographic evidence of disease and receiving systemic therapy for prostate cancer. Patients at all stages of disease will be welcome to participate in the PROMISE Registry.\n\nParticipants will be recruited \\& screened over a five-year period. Study participants will be asked to provide a saliva sample to be tested for germline cancer risk variants through Color Health. If the results identify a pathogenic or likely pathogenic variant, an appointment with a genetic counselor from Color Health will be scheduled to discuss the results.\n\nParticipants will complete a baseline demographic survey that includes self-reported health history, family history of cancer and standardized patient reported outcome (PRO) measures.\n\nPROMISE Registry staff will request medical records from the participant's cancer care provider(s) for the purpose of obtaining clinical data.\n\nParticipants will receive bi-annual newsletters offering information on new developments in treatment and research opportunities, including clinical trials, associated with genetic variants.\n\nEligible participants (those with target germline mutations) will be followed every 6 months to obtain updated health records data and patient-reported outcomes data. Participants will be followed for a minimum of 15 years.\n\nThe PROMISE registry will help identify prostate cancer patients with pathogenic variants to learn more about how these variants affect patient outcomes. Ultimately, we hope to help patients learn more about their disease and the treatments that they may derive the most benefit from, including the germline genetic biomarker-based clinical trials they may be eligible for.\n\nFor more information, visit the study website at: prostatecancerpromise.org",[75],[75,126,127,128,129,130],"Genetics","Registry","Germline Mutation","Genetic Testing","Germline Testing","2024-08-05",{"date":133,"type":40},"2024-08-07",{"date":135,"type":40},"2021-05-03",{"date":137,"type":21},"2036-02-26",{"name":46,"class":47},3,""]