[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-castrate-resistant-prostate-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-castrate-resistant-prostate-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"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":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100365457","phase-2-carboplatin-or-olaparib-for-brca-deficient-prostate-cancer-100365457",false,"NCT04038502","Carboplatin or Olaparib for BRcA Deficient Prostate Cancer","An Open-label, Multicenter Phase II Study to Compare the Efficacy of Carboplatin as First-line Followed by Second-line Olaparib Versus Olaparib as First-line Followed by Second-line Carboplatin in the Treatment of Patients With Castration Resistant Prostate Cancer Containing Homologous Recombination Deficiency","COBRA","Inclusion Criteria:\n\n1. Signed study informed consent form (ICF) and HIPAA authorization form\n2. Male age \\> 18 years\n3. Diagnosis of prostate cancer (pure small-cell histology or pure high-grade neuroendocrine histology are excluded; neuroendocrine differentiation is allowed)\n4. Ongoing gonadal androgen deprivation therapy with gonadotropin-releasing hormone (GnRH) analogues, antagonists or orchiectomy. Patients who have not had an orchiectomy must be maintained on effective GnRH analogue\u002Fantagonist therapy\n5. mCRPC as defined by serum testosterone \\\u003C 50 ng\u002Fml (for patients on GnRH analogues or antagonists) and at least one of the following:\n\n   * PSA level of at least 2 ng\u002Fml that has risen on at least 2 successive occasions at least 1 week apart\n   * Evaluable disease progression by modified RECIST 1.1 (Response Evaluation Criteria in Solid Tumors)\n   * Progression of metastatic bone disease on bone scan, CT or MRI with \\> 2 new lesions\n6. Prior therapy with abiraterone acetate, enzalutamide, apalutamide, or darolutamide\n7. Eastern Cooperative Oncology Group (ECOG) Performance Status of \\\u003C 2 (see Appendix 3, ECOG Grading Scale)\n8. Results of previous standard DNA testing, or previous research testing, which confirms RAD51B, RAD51C, RAD51D, or RAD54L mutations (see Introduction, Section 2 for study design and previous research on targeted therapy) from primary, metastatic tumor or circulating tumor DNA, or pathogenic\u002Flikely pathogenic germline variant as assessed by a CLIA certified laboratory level assay for DNA sequencing.\n9. Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:\n\n   * Hemoglobin \\> 10.0 g\u002FdL\n   * Absolute neutrophil count (ANC) \\> 1.5 x 109\u002FL\n   * Platelet count \\> 100 x 109\u002FL\n   * Total bilirubin \\\u003C 1.5 x institutional upper limit of normal (ULN)\n   * Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) \u002F Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) \\\u003C 2.5 x institutional upper limit of normal unless liver metastases are present in which case, they must be \\\u003C 5x ULN\n   * Patients must have creatinine clearance estimated using the Cockcroft-Gault equation of \\>51 mL\u002Fmin: Estimated creatinine clearance =(140-age \\[years\\]) x weight (kg))\u002F (serum creatinine (mg\u002FdL) x 72)\n\nExclusion Criteria:\n\n1. Currently receiving active therapy for other neoplastic disorder(s)\n2. Concurrent enrollment in another clinical investigational drug or device study\n3. Histologic evidence of small cell carcinoma (morphology alone - immunohistochemical evidence of neuroendocrine differentiation without morphologic evidence is not exclusionary)\n4. Prior treatment with platinum, mitoxantrone or PARP inhibitor for castration resistant prostate cancer\n5. Known parenchymal brain metastasis\n6. Active or symptomatic viral hepatitis or chronic liver disease AST or ALT \\> 2.5 x ULN or total bilirubin \\> ULN (unless Gilbert's syndrome is the etiology of hyperbilirubinemia)\n7. Subjects with myelodysplastic syndrome\u002Facute myeloid leukemia or with features suggestive of MDS\u002FAML\n8. Concomitant use of known strong CYP3A inhibitors (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks\n9. Concomitant use of known strong (e.g. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (e.g. bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for phenobarbital and 3 weeks for other agents\n10. Subjects unable to swallow orally administered medication and subjects with gastrointestinal disorders likely to interfere with absorption of the study medication\n11. Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of \\\u003C 35 % at baseline\n12. Treatment with an investigational therapeutic within 30 days of Cycle-1\n13. Presence of dementia, psychiatric illness, and\u002For social situations limiting compliance with study requirements or understanding HIPAA authorization and\u002For giving of informed consent\n14. Any condition(s), medical or otherwise, which, in the opinion of the Investigators, would jeopardize either the patient or the integrity of the data obtained.","MALE","18 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is an unblinded, randomized clinical study comparing the efficacy of DNA damaging chemotherapy using carboplatin, to standard of care therapy for patients who have metastatic castrate resistant prostate cancer. This trial will use olaparib or carboplatin as initial therapy with crossover to the alternate or second-line drug after first progression for patients with tumors containing BARD1, BRCA1, BRCA2, BRIP1, CHEK1, FANCL, PALB2, RAD51B, RAD51C, RAD51D, or RAD54L inactivating mutations.\n\nParticipants are randomized (1:1) and receive either carboplatin (AUC 5, IV) every 21 days, first or olaparib taken orally (300 mg), twice daily in 28 day cycles, until intolerance, complete response, or progression by Prostate Cancer Working Group 3 (PCWG3) criteria.\n\nParticipants then crossover from the first-line therapy to the second-line therapy with the opposite study medication and receive treatment to intolerance or progression (whichever is first). Enrolled participants will be allowed to crossover to second line therapy if they continue to meet initial eligibility criteria, and at least three weeks have elapsed since last administration of either carboplatin or olaparib. Throughout the study, safety and tolerability will be assessed. Progression will be evaluated with bone scan, CT of the abdomen\u002Fpelvis, or MRI and PSA as per PCWG3 criteria.",[27,28,29],"Metastatic Castrate Resistant Prostate Cancer","BARD1, BRCA1, BRCA2, BRIP1, CHEK1, FANCL, PALB2","RAD51B, RAD51C, RAD51D, or RAD54L Mutations",[31],"metastatic prostate cancer","RECRUITING","2025-08-18",{"date":35,"type":36},"2025-08-20","ACTUAL",{"date":38,"type":36},"2019-10-01",{"date":40,"type":21},"2027-08-31",{"name":42,"class":43},"VA Office of Research and Development","FED",18,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":5},"100570111","phase-1-study-of-xnw5004-tablet-in-combination-with-enzalutamide-in-subjects-with-metastatic-castration-resistant-prostate-cancer-100570111","NCT06702995","Study of XNW5004 Tablet in Combination With Enzalutamide in Subjects With Metastatic Castration-Resistant Prostate Cancer","A Phase Ib\u002FII Study of XNW5004 Tablet in Combination With Enzalutamide in Subjects With Metastatic Castration-resistant Prostate Cancer (mCRPC) Who Failed Prior Novel Hormone Therapy","Inclusion Criteria:\n\n* Patients must have the ability to understand and sign an approved informed consent form (ICF).\n* Age at the time of consent ≥ 18 years;\n* Life expectancy of ≥ 3 months;\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;\n* Prostate adenocarcinoma confirmed by histological or cytological examination, except neuroendocrine carcinoma or small cell carcinoma;\n* Metastatic prostate cancer disease, documented by CT\u002FMRI imaging\u002Fbone scan ;\n* Ongoing luteinizing hormone-releasing hormone agonist (LHRHa) or antagonist therapy (medical castration) or prior bilateral orchiectomy (surgical castration); subjects who have not undergone bilateral orchiectomy must be scheduled for Maintain effective LHRHa therapy throughout the study period;\n* Testosterone at castration level (≤50ng\u002FdL or 1.7nmol\u002FL) at screening;\n* Progressive disease in the setting of medical or surgical castration for study entry, the subject has 1 or more of the following 3 items: (1) PSA progression, defined as PSA \\> 1ng\u002Fml and at least 2 episodes of PSA level elevation ≥ 1 week apart; (2) disease progression as defined by RECIST 1.1; (3) bone disease progression as defined by PCWG3 criteria, i.e., ≥ more than 2 new lesions found on bone scan;\n* Previous anti-tumor therapy meet the following conditions： Ib and IIb: Failure of previous abiraterone acetate therapy (refers to disease progression during abiraterone acetate treatment; disease progression is defined as the same as in Article 9 of the enrollment criteria), and no next generation androgen receptor inhibitors (enzalutamide or apalutamide, etc.) have been used; IIb: Failure of previous only one approved novel hormone therapy, such as abiraterone acetate, apalutamide, darolutamide and rezvilutamide, etc., except enzalutamide；\n* Adequate hematologic and non-hematologic function during the screening.\n* Must agree to take adequate contraceptive measures from the beginning of the study to at least 3 months after the last dose of the test drug, and prohibit sperm donation;\n* Ability to comply with all procedures of the clinical trial protocol.\n\nExclusion Criteria:\n\n* Previous anti-tumor therapy meet the following conditions： Ib and IIb: previously received any next generation androgen receptor antagonists (such as enzalutamide, apalutamide, proxalutamide and rezvilutamide, etc.) ； IIa: previously received with enzalutamide or more than 1 novel hormone therapy;\n* Prior chemotherapy for castration resistant disease (including but not limited to ADCs);\n* Prior exposure to EZH2 inhibitor(s) (including but not limited to tazemetostat and EZH1\u002F2 inhibitors);\n* Subjects who received anti-tumor therapies including chemotherapy, immunotherapy, radical radiotherapy, major surgery, targeting therapy and other anti-tumor therapies within 4 weeks or 5 half-lives of the drug (whichever is shorter) before the first dose; or received palliative radiotherapy within 2 weeks before the first dose;\n* Plan to receive any other anti-tumor therapy during this trial;\n* Subjects who participated in any other clinical trial of anti-tumor therapy within 28 days before the first dosing, and the last dose of other anti-tumor trial drug is within 28 days prior to the first administration of study drug in this trial;\n* Central nervous system metastasis or disease;\n* Severe bone injury caused by tumor bone metastasis judged by the investigator, including severe bone pain with poor control, pathological fractures of important sites and spinal cord compression that occurred in the past 6 months or are expected to occur in the near future, etc.;\n* Subjects who have a history of other malignancies within 3 years prior to enrollment and do not meet the criteria for clinical cure. This exclusion criterion does not apply to skin basal cell carcinoma or squamous cell carcinoma with local treatment methods available and has been cured, superficial bladder cancer, intraductal breast carcinoma in situ, and papillary thyroid carcinoma;\n* Subjects who experienced stroke or other serious cerebrovascular diseases within 12 months prior to enrollment;\n* Subjects who have impaired heart functions or clinically serious heart disease；\n* Have severe systemic active infection;\n* Have a history of tuberculosis within 1 year before enrollment, or had an active TB infection more than 1 year before but not received adequate anti-TB treatment;\n* Subjects known to be allergic to the study drug or its active ingredients or excipients;\n* Subjects taking known moderate or strong inducers and inhibitors of CYP3A within 14 days before the first administration;\n* Active autoimmune and inflammatory diseases, such as: systemic lupus erythematosus, psoriasis requiring systemic therapy, rheumatoid arthritis, inflammatory bowel disease, and Hashimoto's thyroiditis, etc., except type I diabetes, Hypothyroidism that can be controlled by replacement therapy alone, hyperthyroidism that is stable under drug control, skin diseases that do not require systemic therapy (eg, vitiligo, psoriasis);\n* Past medical history of interstitial lung disease (ILD), history of drug-induced ILD, history of radiation pneumonitis requiring steroid therapy, or evidence of any clinically active ILD;\n* Known impaired gastrointestinal (GI) function or GI diseases that may significantly affect the absorption or metabolism of oral drugs; abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before the first administration;\n* Human immunodeficiency virus (HIV) positive, syphilis (Anti-TB) positive;\n* Known acute or chronic active hepatitis B (HBsAg positive or HBcAb positive, and HBV DNA ≥ 200 IU\u002FmL or ≥ 103 copies\u002FmL) or acute or chronic active hepatitis C (HCV antibody positive and positive for HCV RNA test);\n* Subjects who experienced toxicity events during previous anti-tumor treatment and the toxicity has not resolved (the toxicity events has not been graded as ≤ level 1 according to NCI-CTCAE 5.0). Other toxicities that the investigator does not think it will affect the safety assessment of the subject (such as hair loss, etc.) will be allowed;\n* Subjects who have clinically symptomatic and uncontrollable pleural or pericardial effusions after multiple times of treatments;\n* Subjects who have an allogeneic tissue\u002F solid organ transplantation;\n* Subjects who underwent major surgery within 4 weeks prior to the start of the study treatment, or who are scheduled to undergo a major surgery during the study period (procedures such as puncture or lymph node biopsy is allowed);\n* Subjects who have received live vaccines (including attenuated live vaccines) within 28 days prior to the administration of study drug. Inactivated vaccines are permitted.\n* A superscan as seen in the baseline bone scan；\n* Subjects who are considered unsuitable for the study judged by the investigator.",{"count":53,"type":21},307,[55,24],"PHASE1","In this phase Ib\u002FII study, participants with metastatic castration-resistant prostate cancer (mCRPC) who failed prior novel hormone therapy will be treated with XNW5004 in combination with enzalutamide.",[58,59],"Metastatic Castrate-Resistant Prostate Cancer","mCRPC (Metastatic Castration-resistant Prostate Cancer)",[61,62],"XNW5004","Enzalutamide","2025-04-17",{"date":65,"type":36},"2025-04-20",{"date":67,"type":36},"2023-04-19",{"date":69,"type":21},"2026-07-19",{"name":71,"class":72},"Evopoint Biosciences Inc.","INDUSTRY"]