[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mcrpc-metastatic-castration-resistant-prostate-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mcrpc-metastatic-castration-resistant-prostate-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,49,62,109,138,161,191,215,238,268,300,341,366,391],{"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":61},"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},5,{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":69,"minAge":18,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":22,"phases":72,"briefSummary":74,"conditions":75,"keywords":82,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":108},"100461030","phase-1-safety-and-tolerability-of-pb-dotam-grpr1-in-adult-subjects-with-recurrent-or-metastatic-grpr-expressing-tumors-100461030","NCT05283330","Safety and Tolerability of ²¹²Pb-DOTAM-GRPR1 in Adult Subjects With Recurrent or Metastatic GRPR-expressing Tumors","A Phase 1 Open-Label, First-in-human, Dose Escalation and Expansion Study to Determine the Safety, Tolerability, Dosimetry, Pharmacokinetics, and Preliminary Efficacy of 212Pb-DOTAM-GRPR1 in Adult Participants With Recurrent or Metastatic GRPR-expressing Tumors","1. Adult participants (age ≥ 18 years old) with any of the following advanced or metastatic solid tumors (documented history of histologically confirmed diagnosis):\n\n   1. Metastatic castration-resistant prostate cancer (mCRPC) including neuroendocrine prostate cancer (NEPC) (enrolled only in SAD and MAD Q6W)\n   2. HR+\u002FHER2- breast cancer (estrogen receptor\u002FER expression \\>10% of tumor cell nuclei stain, regardless of progesterone receptor\u002FPgR expression); HER2-negative including HER2-low (as per relevant ASCO\u002FCAP guidelines)\n   3. Colorectal cancer\n   4. Cervical cancer\n   5. Non-small-cell lung cancer (NSCLC)\n   6. Recurrent glioblastoma (only enrolled in MAD Q4W cohorts) with evidence of recurrent disease (RD) demonstrated by disease progression using modified Response Assessment in Neuro-Oncology (RANO 2.0) criteria. Note: If surgery is performed for GBM recurrence, pre-surgery MRI will be used for confirmation of RD and residual and measurable disease post-surgery is not required but surgery must have confirmed the recurrence diagnosis by MRI.\n2. Capable of giving signed informed consent\n3. All participants must have progressed on at least 2 prior systemic therapies, except for recurrent GB\n4. For participants with mCRPC: Prior orchiectomy and\u002For ongoing androgen deprivation therapy and a castrate level of serum testosterone (\\\u003C50 ng\u002FdL or \\\u003C1.7 nmol\u002FL)\n5. Presence of at least 1 measurable lesion per RECIST 1.1 as assessed by the Investigator (not applicable for GBM). At least 1 identified measurable lesion must show GRPR uptake in 203Pb-DOTAM-GRPR1 SPECT\u002FCT (uptake greater than that of the background) as assessed by the Investigator.\n6. For participants with prostate cancer that do not have measurable soft tissue disease, 203Pb-DOTAM-GRPR1 uptake in bone lesions \\> uptake in background is acceptable for eligibility.\n7. Eastern Cooperative Oncology Group (ECOG) status 0-1. Participants with ECOG status of 2 may be approved on a case-by-case basis in discussion with the Sponsor.\n8. Adequate bone marrow, hepatic, and renal function, as assessed by the following laboratory requirements:\n\n   1. White blood cell (WBC) ≥3000\u002F mm3 (≥ 3 x 109\u002FL)\n   2. Absolute neutrophil count (ANC) ≥1500\u002Fmm3 (≥1.5 x 109\u002FL)\n   3. Platelets ≥100,000\u002Fmm3 (≥ 100 x 109\u002FL)\n   4. Hemoglobin (Hb) ≥9.0 g\u002FdL\n   5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3x upper limit of normal (ULN) or ≤ 5 x ULN in the presence of liver metastases\n   6. Total bilirubin: ≤1.5 x ULN, except if documented history of Gilbert's disease who are eligible if total bilirubin ≤ 3 x ULN\n   7. Adequate renal function defined by creatinine clearance (CLCR) ≥ 60 mL\u002Fmin calculated as follows: CLCR = eGFR in ml\u002Fmin\u002F1.73 m2 calculated by the Modified Diet in Renal Disease (MDRD) x participant body surface area (BSA) in m2 ÷ 1.73\n   8. Serum amylase and\u002For lipase ≤1.5 x ULN\n9. For women of childbearing potential (WOCBP) and men with partners of childbearing potential: be willing to use highly effective methods of contraception or sexual abstinence, if part of participant's lifestyle, throughout the study and for 7 months for WOCBP, 4 months for men after the last \\[212Pb\\]Pb-DOTAM-GRPR1 administration or for 10 days following \\[203Pb\\]Pb-DOTAM-GRPR1 administration and participant is not proceeding to 212Pb-DOTAM-GRPR1 treatment, as outlined in protocol.\n\n   Participants with Recurrent Glioblastoma:\n10. Having first or second glioblastoma recurrence, after standard therapy that includes prior radiation therapy (RT) and at least 12 weeks from completion of RT prior to first administration of 212Pb-DOTAM-GRPR1. In case surgery has been performed for GBM recurrence, the surgery has to be completed at least 4 weeks prior to 212Pb-DOTAM-GRPR1 treatment start, with post-surgery recovery without any complications related to surgical procedure.\n11. Presence of 203Pb-DOTAM-GRPR1 uptake by SPECT\u002FCT scan in the tumor lesion(s).\n12. Presence of Gadolinium enhancement in the MRI in the tumor lesion(s) shown at the time of diagnosis of tumor recurrence.","ALL",{"count":71,"type":21},48,[73],"PHASE1","A Phase 1 Open-Label, First-in-human, Dose Escalation and Expansion Study to Determine the Safety, Tolerability, Dosimetry, Pharmacokinetics, and Preliminary Efficacy of 212Pb-DOTAM-GRPR1 in Adult Participants with Recurrent or Metastatic GRPR-expressing Tumors",[76,77,78,79,28,80,81],"Cervical Cancer","Breast Cancer","Colon Cancer","NSCLC","Glioblastoma","Nonsmall Cell Lung Cancer",[83,84,85,86,87,88,89,90,76,91,92,93,94,95,96,97,98],"Metastatic Cancer","Advanced Cancer","Recurrent Cancer","Prostate Cancer, Castration-Resistant","Metastatic Prostate Cancer","Breast Cancer, Hormone Receptor Positive","Non-Small Cell Lung Cancer","Colorectal Cancer","Glioblastoma, Recurrent","Radioligand Therapy","Targeted Radiation Therapy","Gastrin-Releasing Peptide Receptor or Bombesin receptor subtype-2","Targeted Alpha Therapy","Lead-212 Radiopharmaceutical Therapy","Lead-203 Radiopharmaceutical Diagnostic","SPECT\u002FCT","2026-06-09",{"date":55,"type":40},{"date":102,"type":40},"2022-12-22",{"date":104,"type":21},"2032-05",{"name":106,"class":107},"Orano Med Theranostics, SAS","INDUSTRY",8,{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":22,"phases":119,"briefSummary":120,"conditions":121,"keywords":123,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":137},"100576464","phase-1-a-phase-1b2a-study-of-pocenbrodib-as-monotherapy-and-in-combination-with-darolutamide-in-participants-with-mcrpc-100576464","NCT06785636","A Phase 1b\u002F2a Study of Pocenbrodib as Monotherapy and in Combination With Darolutamide in Participants With mCRPC","PATHWAY: A Phase 1b\u002F2a, Multicenter, Open- Label Study of Pocenbrodib as Monotherapy and in Combination With Darolutamide in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)","P300","1b \u002F 2a Inclusion Criteria:\n\n1. ≥18 years of age\n2. Histologic documentation of prostate adenocarcinoma\n3. Metastatic disease, documented by imaging. Imaging performed within 56 days prior to Screening is acceptable\n\n1b \u002F 2a Exclusion Criteria:\n\n1. Current or prior evidence of any small cell or neuroendocrine histology on the most recent prostate biopsy.\n2. Any liver metastases confirmed by biopsy or evidence of lesions \\>1 cm consistent with liver metastases on imaging.\n3. Intervention with any chemotherapy, investigational agent, or other anticancer drug, including enzalutamide, apalutamide, or darolutamide, 14 days prior to Cycle 1 Day 1 or 5 half-lives (whichever is shorter).\n4. Any other serious underlying medical, psychiatric, psychological, familial, or geographical condition, which in the judgment of the Investigator may interfere with study participation and compliance or place the participant at high risk from treatment-related complications.\n\n2a only -key inclusion criteria:\n\n1. Must have received at least 2 cycles of PLUVICTO®\n2. 1 line of prior any ARPI therapy\n3. No prior chemotherapy for mCRPC",{"count":118,"type":21},120,[73,24],"This is a dose-finding study to assess the safety and preliminary antitumor activity of Pocenbrodib alone or with darolutamide in patients with metastatic castration-resistant prostate cancer (mCRPC)",[28,122],"Prostate Cancer",[124,125,126,127],"mCRPC, metastatic castrate resistant prostate cancer, prostate cancer,","darolutamide","Pocenbrodib","p300-CBP Transcription Factors","2026-06-05",{"date":130,"type":40},"2026-06-10",{"date":132,"type":40},"2025-02-07",{"date":134,"type":21},"2029-04-30",{"name":136,"class":107},"Pathos AI, Inc.",18,{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":22,"phases":148,"briefSummary":149,"conditions":150,"keywords":4,"overallStatus":151,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":4},"100639453","phase-2-zanzalintinib-efficacy-post-pluvicto-in-chemotherapy-nave-metastatic-castration-resistant-prostate-cancer-100639453","NCT07623460","Zanzalintinib Efficacy Post Pluvicto® in Chemotherapy Naïve Metastatic Castration Resistant Prostate Cancer","ZENITH: Zanzalintinib Efficacy Post Pluvicto® in Chemotherapy Naïve Metastatic Castration Resistant Prostate Cancer","ZENITH","Inclusion Criteria:\n\n1. Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.\n2. Age ≥ 18 years at the time of consent.\n3. ECOG Performance Status of 0-2.\n4. Metastatic Castrate Resistant Prostate Cancer (mCRPC) with histologically\u002Fcytologically confirmed adenocarcinoma without small cell histology.\n5. Prior cancer treatment must be completed at least 14 days prior to registration NOTE: Antiandrogen agent, against LHRH axis, such as Leuprolide or institutional equivalent, Relugolix, Degarelix etc. are to be continued during the course of the treatment.\n6. Must have recovered from adverse effects of any prior oncologic treatment (e.g. prior surgery, radiotherapy, or other antineoplastic therapy). CTCAE adverse events ≤ grade 1 are acceptable. CTCAE adverse events grade 2 or greater may be acceptable as determined by the treating Investigator.\n7. Patients must have had at least one dose of prior Pluvicto therapy for prostate adenocarcinoma. Patients must have received PARP inhibitor if the tumor has BRCA 1 or 2 pathogenic mutations prior to enrolling on this study unless intolerant or contraindicated per treating investigator.\n8. Demonstrate adequate organ function as defined in the table below; all screening labs to be obtained within 14 days prior to registration.\n\n   * Platelets (Plt) ≥ 100,000 \u002Fmm3 without transfusion within 14 days of sample collection\n   * Absolute Neutrophil Count (ANC) ≥ 1.5 K\u002Fmm3 without granulocyte colony-stimulating factor support within 14 days of sample collection\n   * Hemoglobin (Hgb) ≥ 9g\u002FdL without transfusion within 14 days of sample collection\n   * Serum Creatinine OR Calculated creatinine clearance (Cockcroft-Gault formula will be used to calculate creatinine clearance) ≤ 1.5 x ULN\n\n     ≥ 40 mL\u002Fmin (≥ 0.67 mL\u002Fsec)\n   * Urine protein OR Urine protein-to-creatinine ratio (UPCR) ≤ 1 mg\u002Fmg (≤ 113.2 mg\u002Fmmol) creatinine or 24-hour urine protein \\\u003C1.5 g.\n   * Total Bilirubin ≤ 1.5 × upper limit of normal (ULN) ≤ 3 × ULN for subjects with Gilbert's disease\n   * Aspartate aminotransferase (AST) ≤ 3 × ULN\n   * Alanine aminotransferase (ALT) ≤ 3 × ULN\n   * Alkaline Phosphatase (ALP) ≤ 3 × ULN; ≤ 5x ULN for subjects with documented bone metastasis; ≤ 10 x ULN for subjects with CRPC and bone metastasis if predominantly bone-specific ALP\n   * International Normalized Ratio (INR) ≤ 1.5 x upper limit of normal (ULN)\n   * Activated Partial Thromboplastin Time (aPTT) ≤ 1.2 x upper limit of normal (ULN)\n9. Males able to father a child who are sexually active with female of childbearing potential and their partners must be willing to abstain from heterosexual activity or to use an effective method(s) of contraception as outlined in Section 5.3.\n10. Ability of the subject to understand and comply with study procedures for the entire length of the study, as determined by the enrolling physician or protocol designee.\n\nExclusion Criteria:\n\n1. Receipt of chemotherapy in the mCRPC disease state. NOTE: Prior exposure and any number of lines of chemo (including docetaxel) during hormone naïve or castrate sensitive state of the cancer is allowed.\n2. Any other active malignancy or diagnosis of another malignancy within 2 years before first dose of study treatment requiring systemic treatment, except for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy.\n\n   NOTE: Patients with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial as approved by the Principal Investigator.\n3. Known central nervous system (CNS) metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 28 days before the first dose of study treatment.\n\n   NOTE: Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of registration. Base of skull lesions without definitive evidence of dural or brail parenchymal involvement are allowed.\n4. Treatment with any investigational drug within 14 days prior to registration.\n5. History of severe allergic anaphylactic reactions or hypersensitivity to zanzalintinib or any of their excipients such as Cabozantinib.\n6. Prior treatment with Zanzalintinib.\n7. Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 14 days before first dose of study treatment.\n8. Receipt of any type of cytotoxic, biologic (such as systemic Immune Checkpoint Inhibitors) or other systemic anticancer therapy (including investigational) within 28 days before the first dose of study treatment. NOTE: The antiandrogen abiraterone is permitted up to 7 days prior to the first dose of study treatment. Concomitant use of megestrol acetate or leuprolide\u002FRelugolix\u002F Degarelix\u002F Equivalent drugs such as Eligard etc. per institutional guidelines is permitted. Other types of hormonal therapies with similar use require prior approval from the sponsor-investigator.\n9. Radiation therapy for bone metastasis within 14 days, any other radiation therapy within 28 days before the first dose of study treatment. Systemic treatment with radionuclides within 42 days before the first dose of study treatment.\n10. Active treatment with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct Xa inhibitor betrixaban or platelet inhibitors (e.g., clopidogrel) within 5 days of registration. Allowed anticoagulants include: prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH), therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, apixaban. Allowed also in patients with known brain metastases who are on a stable dose of the anticoagulant for at least 1 week prior to registration without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor\n11. Uncontrolled, significant intercurrent or recent illness including, but not limited to the following conditions:\n\n    a. Unstable or deteriorating cardiovascular disorders: i. Congestive heart failure New York Heart Association Class 3 or 4, class 2 or higher, unstable angina pectoris, new-onset angina, serious cardiac arrhythmias (eg. ventricular flutter, ventricular fibrillation, Torsades de pointes).\n\n    ii. Uncontrolled hypertension defined as sustained blood pressure (BP) \\> 140 mm Hg systolic or \\> 90 mm Hg diastolic despite optimal antihypertensive treatment.\n\n    iii. Stroke (including transient ischemia attack \\[TIA\\]), myocardial infection, or other clinically significant arterial thrombotic and\u002For ischemic event within 6 months before the first dose of study treatment.\n\n    iv. Pulmonary embolism (PE) or deep vein thrombosis (DVT) or prior clinically significant venous events within 3 months before the first dose of study treatment.\n\n    NOTE: Subjects with a diagnosis of DVT within 6 months are allowed if asymptomatic and stable at screening and are on a stable dose of the anticoagulant for at least 1 week before the first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen.\n\n    NOTE: Subjects who do not require prior anticoagulation therapy may be eligible but must be discussed and approved by the sponsor-investigator.\n\n    b. Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation: i. Tumor invading the GI tract from external viscera. ii. Active peptic ulcer disease, inflammatory bowel disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, or acute pancreatitis.\n\n    iii. Acute obstruction of the bowel, gastric outlet, or pancreatic or biliary duct within 6 months before the first dose unless cause of obstruction is definitively managed and subject is asymptomatic.\n\n    iv. Abdominal fistula, gastrointestinal perforation, bowel obstruction, or intra-abdominal abscess within 6 months before the first dose. NOTE: Complete healing of an intra-abdominal abscess must be confirmed before the first dose of study treatment.\n\n    v. Known gastric or esophageal varices. vi. Ascites, plural effusion, or pericardial fluid requiring drainage in the last 28 days.\n12. Clinically significant hematuria, hematemesis, or hemoptysis of \\> 0.5 teaspoon (2.5 mL) of red blood, or other history of significant bleeding (e.g. pulmonary hemorrhage) within 84 days (12 weeks) before the first dose of study treatment.\n13. Symptomatic cavitating pulmonary lesion(s) or endobronchial disease (asymptomatic or radiated lesions allowed).\n14. Lesions invading major blood vessel including, but not limited to, inferior vena cava, pulmonary artery, or aorta. NOTE: Subjects with intravascular tumor extension (eg. Tumor thrombus in renal vein or inferior V. cava) may be eligible following sponsor-investigator approval.\n15. Other clinically significant disorders that would preclude safe study participation.\n\n    1. Active infection requiring systemic therapy. NOTE: Subjects receiving prophylactic antimicrobial treatments (antibiotics, antimycotic, antiviral) are eligible for the study.\n    2. Known infection with acute or chronic hepatitis B or C, known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness. NOTE: Subjects with HIV\u002FAIDS may be eligible if they meet all of the following criteria:\n\n    i. On stable anti-retroviral therapy ii. CD4+ T cell count ≥ 200\u002FµL iii. Undetectable viral load NOTE: To be eligible, participants taking CYP inhibitors (eg. zidovudine, ritonavir, cobicistat, didanosine) or CYP3 inducers (efavirenz) must change to a different regimen not including these drugs 7 days prior to initiation of study treatment. Anti-retroviral therapies (ART) must have been received for at least 28 days (4 weeks) prior to the first dose. CD4+ T cell counts, and viral load are monitored per standard of care by the local health care provider.\n\n    c. Serious non-healing wound\u002Fulcer\u002Fbone fracture. NOTE: non-healing wounds or ulcers are permitted if due to tumor-associated skin lesions.\n\n    d. Malabsorption syndrome. e. Pharmacologically uncompensated, symptomatic hypothyroidism. f. Moderate to severe hepatic impairment (Child-Pugh B or C). g. Requirement for hemodialysis or peritoneal dialysis. h. History of solid organ or allogenic stem cell transplant.\n16. Major surgery (eg. GI surgery, removal or biopsy of brain metastasis) within 56 days (8 weeks) prior to the first dose of treatment. Minor surgery (eg. simple excision, tooth extraction) within 5 days before the first dose of study treatment. Complete wound healing from major or minor surgery must have occurred at least prior to the first dose of study treatment.\n\n    NOTE: Fresh tumor biopsies should be performed at least 5 days before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgical procedures, including biopsies, are not eligible.\n17. Corrected QT interval calculated by the Fridericia formula (QTcF) \\> 480 ms within 14 days per electrocardiogram (ECG) before first dose of study treatment.\n\n    NOTE: Triplicate ECG evaluations will be performed and the average of these 3 consecutive results for QTcF will be used to determine eligibility.\n18. Inability to swallow tablets or ingest a suspension either orally or by a nasogastric (NG) or gastrostomy (PEG) tube.\n19. Other conditions, which in the opinion of the investigator, would compromise the safety of the patient or the patient's ability to complete the study.",{"count":147,"type":21},30,[24],"This is a multi-center single arm phase II study of zanzalintinib after Pluvicto in chemotherapy-naïve mCRPC. Subjects will receive zanzalintinib 60mg orally (PO) once daily. Zanzalintinib may continue until evidence of radiographic progression, intolerable adverse events, or withdrawal of consent. Two interim analyses will be performed; a safety interim analysis to be performed for the first 5 evaluable subjects, and a futility interim analysis to be performed for the first 15 evaluable subjects.",[28],"NOT_YET_RECRUITING","2026-05-29",{"date":154,"type":40},"2026-06-03",{"date":156,"type":21},"2026-09",{"date":158,"type":21},"2031-09",{"name":160,"class":47},"Stuthi Perimbeti",{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":22,"phases":171,"briefSummary":172,"conditions":173,"keywords":177,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":190},"100640310","phase-1-a-study-of-225acac-aky-2519-in-patients-with-metastatic-castration-resistant-prostate-cancer-100640310","NCT07581184","A Study of [225Ac]Ac-AKY-2519 in Patients With Metastatic Castration-Resistant Prostate Cancer","BActinium-1: A Phase 1b, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Intravenous Administration of B7-H3 Radiopharmaceutical ([225Ac]Ac-AKY-2519) in Metastatic Castration-Resistant Prostate Cancer","BActinium-1","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Histologic or cytologic confirmation of prostatic adenocarcinoma\n* ECOG Performance Status of 0 or 1\n* Adequate end-organ function\n* Ability to give informed consent and comply with study requirements\n* Patients with CNS metastases are eligible if they have received therapy and are neurologically stable, asymptomatic and not receiving corticosteroids\n* Castrate levels of serum testosterone (\\\u003C 50 ng\u002FdL)\n* Documented disease progression on most recent prior line of therapy, either by PSA or imaging-based progression\n* Cohort B: Received 2 or more prior doses of 177Lu-PSMA-617 (PLUVICTO)\n\nExclusion Criteria:\n\n* Prior treatment with more than 2 Androgen receptor pathway inhibitors (ARPIs) and\u002For more than 1 taxane-based therapy in the mCRPC setting\n* Prior treatment with a targeted radiotherapy\n\n  o Exception: Cohort B is required to have had at least 2 prior doses of 177Lu-PSMA-617 (PLUVICTO)\n* Prior treatment with a B7-H3 targeted therapy\n* Received an investigational agent within the previous 28 days\n* Impaired cardiac function or clinically significant cardiac disease\n* Concurrent serious medical condition that would impair study participation or impact the assessment of treatment related toxicity",{"count":170,"type":21},138,[73],"This is a Phase 1b, multi-center, open-label study to evaluate the safety, tolerability, dosimetry, and pharmacokinetics (PK) of \\[64Cu\\]Cu-AKY-2519 and\u002For \\[225Ac\\]Ac-AKY-2519, as well as the preliminary anti-tumor activity of \\[225Ac\\]Ac-AKY-2519 in participants with metastatic castration-resistant prostate cancer (mCRPC) with and without prior exposure to 177Lu-PSMA-617 (PLUVICTO™).",[174,122,28,175,176],"Castration Resistant Metastatic Prostate Cancer","mCRPC","B7H3",[178,167,179,180],"AKY-2519","AKY-2519-01","B7-H3","2026-05-06",{"date":183,"type":40},"2026-05-12",{"date":185,"type":21},"2026-07",{"date":187,"type":21},"2032-06",{"name":189,"class":107},"Aktis Oncology, Inc.",2,{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":199,"enrollmentInfo":200,"targetDuration":4,"studyType":22,"phases":202,"briefSummary":203,"conditions":204,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":214},"100627681","phase-2-shr-1701-in-combination-with-stereotactic-body-radiotherapy-in-mcrpc-100627681","NCT07451795","SHR-1701 in Combination With Stereotactic Body Radiotherapy in mCRPC","A Prospective, Randomized, Controlled Phase II Study of SHR-1701 in Combination With Stereotactic Body Radiotherapy (SBRT) for Metastatic Castration-Resistant Prostate Cancer","SHARP","Inclusion Criteria:\n\n1. Age: 18 to 80 years old.\n2. Diagnosis: Histologically or cytologically confirmed adenocarcinoma of the prostate, clinically staged as metastatic prostate cancer based on conventional imaging (bone scan or CT\u002FMRI).\n3. Biopsy: Whenever possible, patients should undergo a pre-treatment image-guided biopsy of a lesion; alternatively, archived biopsy tissue obtained within 30 days prior to enrollment is acceptable.\n4. Prior Therapy: Failure of at least one prior next-generation hormone therapy (NHT), such as abiraterone acetate, rezivilutamide, enzalutamide, apalutamide, or darolutamide.\n5. Chemotherapy History: Prior treatment with docetaxel, or documentation of intolerance to or refusal of chemotherapy.\n6. Disease Progression: Evidence of disease progression defined by: PSA progression: At least two consecutive increases in PSA levels, measured at least 1 week apart, with a screening PSA value ≥ 1 ng\u002FmL; OR Radiographic progression in soft tissue per RECIST v1.1 (with or without PSA progression); OR Bone progression per PCWG3 criteria (occurrence of ≥ 2 new bone lesions on bone scan).\n7. Castration Status: Maintenance of effective and continuous luteinizing hormone-releasing hormone analog (LHRHa) therapy throughout the study period, or prior bilateral orchidectomy; serum testosterone must be maintained at castrate levels (\\\u003C 50 ng\u002FdL).\n8. Performance Status: ECOG Performance Status score of 0 to 2.\n9. Life Expectancy: ≥ 6 months.\n10. Hematologic Function: Absolute neutrophil count (ANC) ≥ 1.5 ×10\\^9\u002FL; Platelets ≥ 75 ×10\\^9\u002FL; Hemoglobin ≥ 90 g\u002FL; White blood cell (WBC) count ≥ 3.0 ×10\\^9\u002FL.\n11. Hepatic Function (Transaminases): Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN); for patients with liver metastases, ALT\u002FAST ≤ 5 × ULN.\n12. Hepatic Function (Bilirubin): Total bilirubin ≤ 1.5 × ULN, or total bilirubin \\> 1.5\n\n    × ULN if direct bilirubin ≤ ULN.\n13. Coagulation Function: INR ≤ 1.5, Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN, and Prothrombin time (PT) \\\u003C ULN + 4 seconds.\n14. Cardiac Function: Left ventricular ejection fraction (LVEF) ≥ 50%; QTc \\\u003C 450 ms for males; serum potassium ≥ 3.5 mmol\u002FL.\n15. Blood Pressure: Systolic BP \\\u003C 160 mmHg and diastolic BP \\\u003C 95 mmHg; patients with stable BP after appropriate clinical management are eligible.\n16. Renal Function: Serum creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL\u002Fmin.\n17. Contraception: Sexually active patients with ejaculatory potential must agree to use effective contraception and refrain from sperm donation from the first dose until 3 months after the last dose of study treatment.\n18. Informed Consent: Ability to understand and willingness to sign a written Informed Consent Form (ICF).\n19. Compliance: Ability to comply with the study visit schedule and other protocol requirements.\n\nExclusion Criteria:\n\n1. Concurrent Therapy: Plan to receive any other anti-tumor therapy during the study treatment period.\n2. Brain Metastasis: Presence of brain metastases.\n3. Prior Immunotherapy: Previous treatment with immune checkpoint inhibitors (including PD-1, PD-L1, CTLA-4 inhibitors, etc.) or any anti-tumor agents targeting T-cells or activating the immune system.\n4. Other Malignancies: Known other malignancies that are progressing or require active treatment within the past 3 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ that have undergone potentially curative therapy.\n5. Autoimmune Disease\u002FInfection: Active autoimmune disease or active infection (including tuberculosis) requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within the past 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroid replacement for adrenal\u002Fpituitary insufficiency) is not considered systemic treatment.\n6. Immunosuppression: Diagnosis of immunodeficiency or receipt of chronic systemic steroid therapy (doses exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 14 days prior to the first dose.\n7. Pneumonitis: History of (non-infectious) pneumonitis requiring steroid treatment or current non-infectious pneumonitis.\n8. Prior Radiation\u002FHormonal Washout: Receipt of radiotherapy or radionuclide therapy (e.g., Radium-223) within 28 days prior to the first dose; or abiraterone within 1 week, or other anti-androgen therapy within 2 weeks prior to the first dose.\n9. Hypersensitivity: Hypersensitivity or intolerance to the active ingredients or any excipients of the PD-L1 monoclonal antibody.\n10. Neuropsychiatric Disorders: Known history of significant neurological or psychiatric disorders, such as dementia, epilepsy, or seizure-prone conditions.\n11. Concomitant Conditions: Any concurrent medical condition (e.g., severe diabetes, thyroid disease, or psychiatric illness) that, in the investigator's judgment, poses a severe risk to subject safety or interferes with study completion; or any unstable medical\u002Fpsychiatric condition (including laboratory abnormalities) that compromises safety or the ability to provide informed consent; or any psychological, familial, social, or geographical conditions that may affect protocol compliance and follow-up.\n12. Investigator's Discretion: Any other reason that the investigator deems the patient unsuitable for participation in this clinical trial.","80 Years",{"count":201,"type":21},66,[24],"The aim of this study is to evaluate the efficacy of SHR-1701 in combination with SBRT in patients with metastatic castration-resistant prostate cancer. Dr. Yao Zhu from Fudan University Shanghai Cancer Center is the co-leading PI of this study.",[122,28],"2026-04-29",{"date":207,"type":40},"2026-04-30",{"date":209,"type":40},"2026-03-02",{"date":211,"type":21},"2028-12-31",{"name":213,"class":47},"Fudan University",3,{"id":216,"slug":217,"hasResults":11,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":4,"eligibilityCriteria":221,"healthyVolunteers":11,"sex":69,"minAge":18,"maxAge":4,"enrollmentInfo":222,"targetDuration":4,"studyType":22,"phases":224,"briefSummary":225,"conditions":226,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":237},"100607712","phase-1-a-study-of-mhb048c-in-patients-with-advanced-solid-tumors-100607712","NCT07192120","A Study of MHB048C in Patients With Advanced Solid Tumors","A Phase I\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MHB048C for Injection in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily agrees to participate in the study and signs the informed consent form.\n2. Age ≥ 18 years, no restriction on gender.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n4. Estimated life expectancy ≥ 3 months.\n5. Histologically or cytologically confirmed advanced solid tumors that are refractory to standard therapy, intolerant to standard therapy, or have no standard treatment options.\n6. At least one measurable lesion per RECIST v1.1 criteria or one bone.\n7. Adequate bone marrow reserve and organ function. -\n\nExclusion Criteria:\n\n1. History of ≥2 primary malignancies within 5 years prior to informed consent.\n2. Received chemotherapy within 3 weeks, radiotherapy within 4 weeks, or biologic, endocrine, or immunotherapy within 4 weeks before first study dose.\n3. Medication of other unmarketed investigational drugs or therapies within 4 weeks before the first dose of investigational drug.\n4. Brain metastases, bone marrow metastases, leptomeningeal disease, brainstem metastases, or spinal cord compression.\n5. Severe bone damage caused by bone metastasis of prostate cancer.\n6. Has adverse reactions from previous anti-tumor treatment that have not recovered to ≤ CTCAE 5.0 Grade 1.\n7. Severe lung disease affecting pulmonary function.\n8. Vaccinated within 4 weeks before dosing.\n9. Active systemic infection requiring treatment within 7 days before dosing.\n10. Serious cardiovascular or cerebrovascular diseases.\n11. Uncontrolled third-space effusions not suitable for enrollment.\n12. Significant bleeding, bleeding tendency, or non-healing wounds within 1 month before first dose.\n13. Known hypersensitivity or delayed allergic reaction to the investigational product or its components.\n14. Drug abuse or other medical\u002Fpsychiatric condition that may interfere with study participation or results.\n15. Known alcohol or drug dependence.\n16. Pregnant or breastfeeding women, or individuals planning to conceive. -",{"count":223,"type":21},200,[73,24],"This is a first-in-human, open-label, multicenter Phase I\u002FII study of MHB048C in patients with advanced solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB048C monotherapy.",[28,227],"Advanced Malignant Solid Tumor","2026-04-08",{"date":230,"type":40},"2026-04-09",{"date":232,"type":40},"2026-01-16",{"date":234,"type":21},"2029-10",{"name":236,"class":107},"Minghui Pharmaceutical (Hangzhou) Ltd",1,{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":245,"targetDuration":4,"studyType":22,"phases":247,"briefSummary":248,"conditions":249,"keywords":250,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":261,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":108},"100577664","phase-1-phase-1-study-of-ace-232-to-treat-patients-with-metastatic-castration-resistant-prostate-cancer-100577664","NCT06801236","Phase 1 Study of ACE-232 to Treat Patients With Metastatic Castration-Resistant Prostate Cancer","A Phase 1 Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ACE-232 in Patients With Metastatic Castration-Resistant Prostate Cancer (CRPC)","Inclusion Criteria:\n\n* Provide written informed consent\n* Metastatic Castration-resistant Prostate Cancer with ongoing androgen - deprivation therapy (ADT) or have bilateral orchiectomy\n* Difficult to treat or intolerant to standard treatment (post at least 1 line of NHA and taxane-based chemo in mHSPC or mCRPC), suitable for investigational treatment;\n* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Has a life expectancy of at least 6 months\n* Adequate organ function and bone marrow function\n\nExclusion Criteria:\n\n* Receiving any anti-cancer drugs or other treatment, major surgery, extensive radiation therapy, or local radiation therapy within protocol-defined wash-out period;\n* Concomitant use of medications or herbal supplements known to be moderate to strong CYP3A4 inhibitors\u002Finducers, or P-gp inhibitors, known to prolong the QT interval.\n* Any previous treatment-related toxicities have not recovered.\n* Spinal cord compression or known brain metastases or leptomeningeal carcinomatosis.\n* Severe cardiovascular disorders.\n* Known gastrointestinal (GI) disorder or GI procedure\n* History of gastric and duodenal perforation.\n* History of pituitary dysfunction.\n* Poorly controlled diabetes mellitus.\n* Active or uncontrolled autoimmune disease\n* Active infections, or a known history of HIV infection, or a known active hepatitis B or C, or a known active tuberculosis.\n* Other malignancies requiring treatment within 3 years prior to the first dose of study drug\n* Known allergy or hypersensitivity to any of the excipients of ACE-232.\n* Has other medical conditions that at the discretion of the investigator interfere with safety or efficacy evaluation, or treatment compliance.",{"count":246,"type":21},67,[73],"This is an open label, phase I, multi-center study aiming to assess the safety and tolerability in patients with metastatic castration resistant prostate cancer (mCRPC).",[27,28],[251,252,253,254,255,256,257,258,259,260],"ACE-232","castration-resistant prostate cancer","CRPC","Hormone Antagonists","Hormone Substitutes","Antineoplastic Agents","Prostatic Neoplasms","Castration-Resistant","prostate cancer","CYP11A1",{"date":230,"type":40},{"date":263,"type":40},"2025-05-12",{"date":265,"type":21},"2028-08-01",{"name":267,"class":107},"Acerand Therapeutics (Hong Kong) Limited",{"id":269,"slug":270,"hasResults":11,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":4,"eligibilityCriteria":274,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":275,"targetDuration":4,"studyType":22,"phases":277,"briefSummary":278,"conditions":279,"keywords":284,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":299},"100530754","phase-1-gedatolisib-in-combination-with-darolutamide-in-metastatic-castration-resistant-prostate-cancer-100530754","NCT06190899","Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer","A Phase 1\u002F2, Open-Label, Randomized, Dose Finding and Dose Expansion Study of Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)","Inclusion Criteria\n\n1. Adult males ≥18 years of age\n2. Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate without a small cell component and with \\\u003C10% neuroendocrine type cells\n3. Subjects must have metastatic castration-resistant prostate cancer (mCRPC; i.e., developed progression of metastases following surgical castration or during medical androgen ablation therapy)\n4. Metastatic disease identified by conventional imaging: computed tomography (CT), magnetic resonance imaging (MRI), or technetium 99m-methyl diphosphonate (99mTc-MDP) bone scintigraphy. Measurable and non-measurable disease are allowed, but metastases visible only on prostate-specific membrane antigen (PSMA) positron emission tomography (PET) will not be allowed for eligibility purposes.\n5. Progressive mCRPC based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 with modifications as specified in Prostate Cancer Working Group 3 (PCWG3) criteria as defined by at least one of the following criteria:\n\n   5.1. 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. A minimum PSA of 1.0 ng\u002FmL is required for study entry.\n\n   5.2. Soft-tissue progression defined as an increase ≥20% in the sum of the longest diameter (LD) of all target lesions based on the smallest sum LD since treatment started or the appearance of one or more new lesions. 5.3. Progression of bone disease (measurable disease) or 2 or more new bone lesions by bone scan.\n6. Continued primary androgen deprivation with luteinizing hormone-releasing hormone (LHRH) analog (agonist or antagonist) if the subject has not undergone bilateral orchiectomy\n7. Eastern Cooperative Oncology Group (ECOG) performance status score ≤1\n8. Progression during treatment with one next-generation androgen receptor signaling inhibitor for metastatic disease (e.g., abiraterone, enzalutamide, apalutamide, darolutamide)\n9. Completion of prior treatment with an androgen receptor inhibitor (ARi) ≥4 weeks before the first dose of the study drug\n10. At least 2 weeks beyond treatment with a targeted therapy or major surgery and at least 3 weeks beyond any other systemic anticancer therapy and\u002For radiation therapy, and resolution of all toxicities related to prior therapies or surgical procedures to baseline (except alopecia, Grade 1 peripheral neuropathy)\n11. Adequate bone marrow, hepatic, renal and coagulation function\n\nExclusion Criteria\n\n1. History of malignancies other than adequately treated non-melanoma skin cancer or other solid tumors curatively treated with no evidence of disease for ≥3 years\n2. Adenocarcinoma of the prostate with a small cell component, and with ≥10% neuroendocrine type cells\n3. Prior treatment with a phosphoinositide 3-kinase (PI3K) inhibitor, a protein kinase B (AKT) inhibitor, or a mechanistic target of rapamycin (mTOR) inhibitor\n4. Prior treatment with chemotherapy or radiopharmaceutical therapy for mCRPC (except prior chemotherapy plus ADT for castration-sensitive disease, including docetaxel plus darolutamide).\n5. Subjects with uncontrolled type 1 or type 2 diabetes\n\n9\\. Known and untreated, or active, brain or leptomeningeal metastases. Subjects with previously treated central nervous system (CNS) metastases may be enrolled in the study if they meet the following criteria: do not require supportive therapy with steroids; do not have seizures and do not exhibit uncontrolled neurological symptoms; stable disease confirmed by radiographic assessment within at least 4 weeks prior to randomization 10. History of clinically significant cardiovascular abnormalities 11. Gastrointestinal tract disease resulting in an inability to absorb oral medication as well as history of inflammatory bowel disease 12. Unable to swallow oral medication tablets\u002Fcapsules",{"count":276,"type":21},54,[73,24],"This is a Phase 1\u002F2, open-label, randomized, dose finding and dose expansion study to evaluate the safety, preliminary efficacy, and PK of gedatolisib in combination with darolutamide in subjects with mCRPC.",[28,280,281,282,283,122],"Genital Diseases, Male","Urogenital Diseases, Male","Prostatic Disease","Prostatic Neoplasms, Castration-Resistant",[285,286,287,288,289,122,283,282,281,280],"Gedatolisib","PI3K","Protein Kinase Inhibitors","mCRPC (metastatic castration-resistant prostate cancer)","Darolutamide","2026-04-07",{"date":292,"type":40},"2026-04-13",{"date":294,"type":40},"2024-01-01",{"date":296,"type":21},"2030-01",{"name":298,"class":107},"Celcuity Inc",13,{"id":301,"slug":302,"hasResults":11,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":306,"eligibilityCriteria":307,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":308,"targetDuration":4,"studyType":22,"phases":310,"briefSummary":311,"conditions":312,"keywords":316,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":333,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":299},"100600863","phase-1-a-clinical-study-of-ktx-2001-in-subjects-with-metastatic-castration-resistant-prostate-cancer-strike-001-100600863","NCT07103018","A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001)","Phase 1, Dose-Escalation Study of KTX2001 (an NSD2 Inhibitor) Alone and in Combination With Darolutamide for Metastatic Castration-Resistant Prostate Cancer","STRIKE-001","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.\n3. Male participants with mCRPC as defined by PCWG3 criteria.\n4. Metastatic disease documented using bone scan for bone metastases (PCWG3 criteria) or by computed tomography (CT) or magnetic resonance imaging (MRI) for soft-tissue metastases. Evidence of metastasis on prostate-specific membrane antigen positron emission tomography alone will not be sufficient for confirmation of metastatic disease.\n5. Willingness to undergo a baseline and on-treatment biopsy of a metastatic site if safe and feasible. If tissue from a biopsy of a metastatic site (including bone) obtained within the previous 6 months (prior to treatment start) is available, this tissue may be used, and the baseline biopsy may be omitted.\n6. Participants should have progressed on or after receiving an ARPI (eg, abiraterone, enzalutamide, darolutamide, or apalutamide).\n7. Adequate renal function (creatinine clearance \\>50 mL\u002Fmin by serum creatinine).\n8. Adequate hepatic function (total bilirubin ≤1.5× ULN, total bilirubin \\\u003C3× ULN for participants with documented Gilbert's syndrome, AST and ALT ≤2.5× ULN). In case of liver metastases, AST and ALT \\\u003C5× ULN is allowed.\n9. Adequate hematological function (neutrophils \\>1 × 109\u002FL, platelet count \\>100 × 109\u002FL, hemoglobin \\>9 g\u002FdL) with no prior transfusions within 2 weeks.\n\nExclusion Criteria:\n\n1. Presence of symptomatic or uncontrolled brain metastases unless adequately treated, not requiring steroids and stable for the last 28 calendar days before signing the ICF. Participants with leptomeningeal disease are excluded without exception.\n2. Symptomatic or impending cord compression that has not been treated or stabilized.\n3. Life-threatening illness, medical condition, active uncontrolled infection, or organ system dysfunction (such as coagulopathy or encephalopathy), or other reasons which, in the investigator's opinion, could compromise the participant's safety or interfere with or compromise the integrity of the study outcomes.\n4. Presence of a drug-related toxicity from prior cancer therapy that has not resolved to Grade ≤1 (with the exception of alopecia and Grade 2 neuropathy) according to NCI-CTCAE Version 5.0.\n5. Active, uncontrolled, bacterial, fungal, or viral infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS)-related illness. In equivocal cases, participants with a negative viral load may be eligible. Eligibility criteria for HIV-positive participants currently on highly active antiretroviral therapy should be evaluated and discussed with the medical monitor and will be based on current and past CD4 and T cell counts, history (if any) of AIDS-defining conditions (eg, opportunistic infections), and status of HIV treatment. Participants with previously treated HBV and HCV with negative viral load are eligible.\n6. A significant history of renal, neurologic, psychiatric, pulmonary, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease that, in the opinion of the investigator, would adversely affect participation in this study.\n\n   1. QT interval corrected by Fridericia's formula \\>470 msec at screening.\n   2. Unstable cardiovascular function defined as:\n   3. Symptomatic ischemia, or\n   4. Uncontrolled clinically significant conduction abnormalities (ie, ventricular tachycardia on antiarrhythmic agents are excluded; first-degree atrioventricular block or asymptomatic left anterior fascicular block\u002Fright bundle branch block are not excluded), or\n   5. Congestive heart failure New York Heart Association Class ≥3, or\n   6. Myocardial infarction within 3 months of the screening visit.\n   7. Hypertension that cannot be controlled (persistent \\>150\u002F90 mmHg despite optimal medical therapy).\n7. Current use or anticipated need for food or drugs that are known strong CYP3A inducers or inhibitors, including their administration within 10 days or 5 half-lives of the CYP3A inhibitor, whichever is longer prior to first dose of study drug.\n8. Treatment with anticancer therapies including radiotherapy or AR-targeted therapy\u002Fandrogen biosynthesis inhibitor) within 2 weeks prior to initial study drug dose or within 4 weeks for systemic chemotherapy, radioligand therapy, or other systemic anticancer therapies.\n9. Treatment with another investigational agent in the 4 weeks prior to the initial dose of study drug.\n10. Major surgical procedures ≤28 days prior to the initial dose of study drug. Participants must have recovered from any of the effects of any major surgery. No waiting period is required following central venous access placement, biopsy collection, or minor surgeries as long as the investigator assesses the impact on study participation.\n11. Initiation of hormonal agents with antitumor activity against prostate cancer including 5alpha reductase inhibitors, androgens (eg, testosterone), cytoproterone acetate, etc during study participation (from the time of consent to off-study); however, stable use of 5-alpha reductase inhibitors is permitted, if continuous use for ≥6 months.\n12. Use of herbal products or alternative therapies that may decrease PSA levels or that may have hormonal anti-prostate cancer activity (eg, saw palmetto, PC-SPES, PC-HOPE, St. John's wort, selenium supplements, grape seed extract, etc) within 4 weeks of study drug initiation or plans to initiate treatment with these products\u002Falternative therapies at any point during the study.\n\nFor Part B only (KTX-2001 + darolutamide): Current use or anticipated need for drugs that are known as combined P-glycoprotein (P-gp) and strong or moderate CYP3A4 inducers including their administration within 10 days or 5 half-lives of the combined Pgp\u002FCYP3A4 inducer, whichever is longer prior to first dose of darolutamide.",{"count":309,"type":21},144,[73],"Study K36-MCRPC-001 is the first in human clinical trial testing KTX-2001 alone and with darolutamide in men with metastatic castration-resistant prostate cancer. The study aims to assess whether the drug is safe, increasing doses alone and in combination with darolutamide, whether it is effective in treating metastatic castration-resistant prostate cancer, and measuring how the drug(s) behaves in the body.",[313,314,315,175,28],"Metastatic Castration-resistant Prostate Cancer","Metastatic Castration-Resistant Prostate Cancer Patients","Metastatic Castration-resistant Prostate Cancer, mCRPC",[175,317,252,318,319,320,321,322,289,323,324,325,326,257,327,328,329,330,331],"Metastatic Castration-Resistant Prostate Cancer","NSD2 inhibitor","efficacy","safety","pharmacokinetics","pharmacodynamics","NUBEQA","Metastatic Disease","Neoplasms","prostatic Diseases","Urogenital Neoplasms","Neoplasms by Site","Urogenital Diseases","Male Urogenital Diseases","Epigenetics","2026-03-19",{"date":334,"type":40},"2026-03-23",{"date":336,"type":40},"2025-11-21",{"date":338,"type":21},"2028-09",{"name":340,"class":107},"K36 Therapeutics, Inc.",{"id":342,"slug":343,"hasResults":11,"nctId":344,"briefTitle":345,"officialTitle":345,"acronym":346,"eligibilityCriteria":347,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":348,"targetDuration":4,"studyType":22,"phases":350,"briefSummary":352,"conditions":353,"keywords":354,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":237},"100616219","four-timepoint-multi-tracer-pet-imaging-to-characterize-metastatic-prostate-cancer-heterogeneity-100616219","NCT07302763","Four-Timepoint Multi-tracer PET Imaging to Characterize Metastatic prOstate Cancer Heterogeneity","4TMPO","Inclusion Criteria:\n\n1. Assign male at birth, any gender ≥ 18 years old;\n2. Histologically or cytologically proven adenocarcinoma of the prostate;\n3. Metastatic disease documented by at least 3 metastatic active lesions\\*, \\*\\* on whole body bone scan and\u002For measurable soft tissue on CT-scan (lymph nodes and visceral lesions);\n4. CRPC \\& post-androgen receptor pathway inhibitor (ARPI) defined by progression under continuous castration (measured serum testosterone ≤50 ng\u002FdL \\[1.73 nM\\]) AND an ARPI (darolutamide, apalutamide, enzalutamide or abiraterone acetate);\n5. Eligible for taxane chemotherapy or PSMA-radioligand therapy (before imaging); 6-Able and willing to provide signed informed consent and to comply with protocol requirements.\n\n   * Metastatic lesions on imaging are defined either: ≥ 10 mm on CT scan or caliper (for lymph nodes, see below), ≥ 20 mm on chest X-ray, lymph node ≥ 10 mm or having grown by ≥ 5 mm from baseline CT, any metastasis described on bone scan counts as a lesion. Of note: A bone lesion that has been treated by radiation is excluded from the lesions counted in the criterion of ≥ 3 lesions.\n\n     * The reference imaging (scan with 3 metastases) confirming eligibility must be done either: 1) after biochemical progression on treatment OR 2) ≥ 90 days after last treatment has begun if imaging was performed while patient was still responding (to avoid disappearance of metastasis due to response).\n\nExclusion Criteria:\n\n* 1\\. Another non-cutaneous malignancy or melanoma diagnosed in the past 5 years; 2. Currently under a randomized controlled trial with unknown allocation; 3-Any disease or condition limiting the patient's capacity to execute the study procedures, based on the investigators' opinion;",{"count":349,"type":21},45,[351],"NA","Imaging modalities currently used in the clinics do not image cancer, but the effect ofncancer on bone (bone scan) or on the anatomy (CT-scan). Bone scan and CT-scan are therefore named conventional imaging (CI) modalities. Positron Emission Tomography (PET) is an imaging technique that uses tracers to measure cancer activity in each lesion and is therefore quantitative. Usually, treatment changes in metastatic prostate cancers are based on the appearance of new lesions on CI, named metastases. Prostate cancer metastases have been shown to be clonal, which means that there are several cancers within each patient, potentially with divergent behaviors under therapy. In other words, some metastases might be resistant to a systemic therapy like chemotherapy, while others might be sensitive. The study proposes here to use molecular imaging by positron emission tomography to image and quantify the activity of prostate cancer cells in each metastasis before start, after 3 months and after progression during systemic therapy.\n\nEach metastasis will then be measured to assess whether there is an increase (resistance) or a decrease (response) in prostate cancer cell activity. The analysis will determine how many metastases progress or remain stable when new metastases appear on conventional imaging (polyclonal resistance), as well as the impact of a change in therapy on metastases that were previously stable when cancer progressed elsewhere. In addition, the genes expressed in responding and non-responding metastases will be analyzed to identify gene expression patterns associated with resistance and\u002For response. Overall, this study aims to characterize metastatic prostate cancer clonal resistance mechanisms using serial PET molecular imaging and imaging-guided genomics.",[28],[355,356],"oncology","molecular imaging tracers","2025-12-11",{"date":359,"type":40},"2025-12-24",{"date":361,"type":40},"2025-11-04",{"date":363,"type":21},"2030-12-31",{"name":365,"class":47},"Frederic Pouliot",{"id":367,"slug":368,"hasResults":11,"nctId":369,"briefTitle":370,"officialTitle":371,"acronym":4,"eligibilityCriteria":372,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":373,"targetDuration":4,"studyType":22,"phases":375,"briefSummary":376,"conditions":377,"keywords":379,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":389,"locationsCount":190},"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":374,"type":21},307,[73,24],"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.",[378,28],"Metastatic Castrate-Resistant Prostate Cancer",[380,381],"XNW5004","Enzalutamide","2025-04-17",{"date":384,"type":40},"2025-04-20",{"date":386,"type":40},"2023-04-19",{"date":388,"type":21},"2026-07-19",{"name":390,"class":107},"Evopoint Biosciences Inc.",{"id":392,"slug":393,"hasResults":11,"nctId":394,"briefTitle":395,"officialTitle":396,"acronym":175,"eligibilityCriteria":397,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":398,"targetDuration":4,"studyType":22,"phases":400,"briefSummary":402,"conditions":403,"keywords":4,"overallStatus":151,"whyStopped":4,"lastUpdateSubmitDate":406,"lastUpdatePostDateStruct":407,"startDateStruct":409,"completionDateStruct":411,"leadSponsor":413,"locationsCount":237},"100575128","phase-3-phase-iii-study-of-abiraterone-acetate-ii-versus-abiraterone-acetate-in-patients-with-mcrpc-100575128","NCT06768255","Phase III Study of Abiraterone Acetate (II) Versus Abiraterone Acetate in Patients with MCRPC","A Multicenter, Randomized Controlled Trial of Abiraterone Acetate (II) Combined with ADT Versus Abiraterone Acetate Combined with ADT in Patients with Metastatic Castration-resistant Prostate Cancer","Inclusion Criteria:\n\n1. Age≧ 18 years old, male;\n2. Physical condition ECOG score 0\\~1 points;\n3. Expected survival of at least 6 months;\n4. Prostate adenocarcinoma confirmed by histological or cytological examination, and no diagnosis of neuroendocrine carcinoma or small cell carcinoma;\n5. Ongoing luteinizing hormone-releasing hormone-releasing hormone (LHRHA) therapy (medical castration) or prior bilateral orchiectomy (surgical castration); Subjects who have not undergone bilateral orchiectomy must plan to maintain effective LHRHA therapy throughout the study;\n6. Testosterone at castration level (≦50 ng\u002FdL or 1.73 nmol\u002FL) at screening;\n7. Disease progression at the time of study enrollment. Disease progression is defined as the occurrence of one or more of the following 3 items while the subject is receiving castration therapy: (1) PSA progression, defined as PSA \\> 1 ng\u002FmL with a PSA interval of 1 week, 2 consecutive episodes of \\>50% increase from the baseline value; In patients treated with flutamide or bicalutamide, PSA must also progress after discontinuation (≧ 4 weeks and ≧6 weeks, respectively); (2) disease progression as defined in RECIST 1.1; (3) Bone disease progression as defined by PCWG3 criteria, i.e., more than ≧2 new lesions found on bone scan;\n8. Subjects who have been treated with one endocrine drug and\u002For one cytotoxic chemotherapeutic drug in the hormone-sensitive stage, such as novel androgen receptor antagonists (such as enzalutamide, apalutamide, ODM-201, revilutamide, HC-1119 and proxalutamide) or ADT (such as goserelin), etc., subjects who have been treated ≤with more than one treatment (bicalutamide for 4 weeks in the mCRPC stage can be included, and subjects who are on a triple regimen of new endocrine therapy combined with docetaxel can be included, Dual subjects with docetaxel in combination with ADT may be included);\n9. Metastatic lesions confirmed by CT\u002FMRI or radioactive bone scan (99mTc) imaging examination;\n10. The functional level of the organ must meet the following requirements (no blood transfusion or hematopoietic growth factor therapy within 2 weeks prior to routine blood screening):\n\n    * ANC≧1.5×10\\*9\u002FL；\n    * PLT≧100×10\\*9\u002FL；\n    * Hb≧80 g\u002FL；\n    * TBIL≦1.0×ULN；\n    * ALT and AST ≦2.5×ULN;\n    * BUN and Cr≦1.5×ULN.\n11. As judged by the investigator, be able to comply with the test protocol;\n12. Male subjects whose partner is a female of childbearing potential, should be surgically sterile or agree to use effective contraception during the trial and for at least 3 weeks after the last administration of abiraterone acetate tablets (Ecente) or abiraterone acetate (II), sperm donation is not allowed during the study;\n13. Voluntarily participate in this clinical trial, understand the study procedures and have signed informed consent.\n\nExclusion Criteria:\n\n1. Previous treatment with abiraterone acetate for prostate cancer;\n2. Have received ≥2-line systemic drug therapy in the hormone-sensitive stage in the past;\n3. Prior treatment with novel androgen receptor antagonists (such as enzalutamide, apalutamide, ODM-201, revilutamide, HC-1119 and proxalutamide), any cytotoxic chemotherapy drug therapy, molecularly targeted therapy (patients with HRR mutations who refuse or are unable to use PARP inhibitors can be enrolled) or immunotherapy in the mCRPC stage;\n4. The washout period of any prior anti-tumor therapy (including radiotherapy, surgery, molecularly targeted therapy, immunotherapy, and first-generation androgen receptor antagonists) to the end of the randomization date of this study is \\\u003C 4 weeks (except for the bicalutamide washout period \\\u003C 6 weeks);\n5. Participate in other drug clinical trials as subjects, and the last test drug administration is within 4 weeks from the randomization date of the drug in this study;\n6. Plan to receive any other anti-tumor therapy during this trial;\n7. Known untreated central nervous system (CNS) metastases. Patients with a history of surgery or radiotherapy for brain metastases, if the disease has been stable for at least 8 weeks after treatment prior to enrollment and corticosteroid-free for at least 2 weeks prior to enrollment;\n8. Severe bone injury caused by tumor bone metastasis judged by the investigator, including severe bone pain with poor control, pathological fractures and spinal cord compression of important parts that occurred in the past 6 months or are expected to occur in the near future;\n9. Presence of contraindications to prednisone (corticosteroid) use, such as active infection or other conditions;\n10. Presence of any chronic condition requiring treatment with corticosteroids administered at doses greater than \"prednisone 5 mg, BID\";\n11. Habitual constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease; Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to the first dose of the drug; Those with abnormal gastrointestinal function, which may affect drug absorption as judged by the investigator;\n12. Have a history of epilepsy, or have had diseases that can induce seizures within 12 months before C1D1 (including a history of transient ischemic attack, cerebral stroke, traumatic brain injury with impaired consciousness requiring hospitalization);\n13. Uncontrolled hypertension. Subjects with a history of hypertension are allowed to participate in this study if they can effectively control their blood pressure through antihypertensive therapy;\n14. Presence of active cardiac disease within 6 months prior to the randomization date of the study, including: severe\u002Funstable angina, myocardial infarction, symptomatic congestive heart failure, left ventricular ejection fraction \\\u003C50%, and ventricular arrhythmias requiring medication;\n15. Other malignant tumors within 5 years before the randomization date of the study (except for carcinoma in situ that has been in complete remission and malignant tumors that have been judged to have progressed slowly by the investigator);\n16. Patients with active HBV or HCV infection (HBV virus copy number≧ 10\\*4 copies\u002FmL, HCV virus copy number≧10\\*3 copies\u002FmL);\n17. History of immunodeficiency (including HIV test positive, other acquired and congenital immunodeficiency diseases) or organ transplantation;\n18. Presence of inability to swallow, chronic diarrhea, intestinal obstruction or other factors affecting drug taking and absorption;\n19. Known allergy or intolerance to abiraterone acetate or its excipients;\n20. According to the judgment of the investigator, there are concomitant diseases (such as severe diabetes, peripheral neuropathy, thyroid diseases and psychiatric disorders, etc.) or any other conditions that seriously endanger the safety of the patient or affect the completion of the study.",{"count":399,"type":21},400,[401],"PHASE3","Acetate abiraterone tablets (II) is a modified new drug launched in China, prepared using nanocrystal technology and supplemented with SNAC as an absorption enhancer, working together to promote the gastrointestinal absorption of Abiraterone, improve its oral bioavailability, and reduce its pharmacokinetic variability within individuals, as well as the impact of food on its pharmacokinetics. According to preliminary research results, the exposure to 300mg acetate abiraterone tablets (II) under fasting conditions is not less than the exposure to the original Zeke® 1000mg, and the food effect of acetate abiraterone tablets (II) is small, allowing for medication without dietary restrictions. The registration study uses steady-state serum testosterone levels as the primary pharmacodynamic indicator, comparing the efficacy of 300mg acetate Abiraterone tablets (II) and 1000mg Zeke® in mCRPC patients to be equivalent, with a safety advantage.This study is a non-inferior phase III, open-label, randomized controlled, multicenter trial. The study planned to enroll 400 mCRPC subjects and randomly assign them to the experimental group or the control group in a 1:1 ratio. The experimental group was treated with abiraterone acetate tablets (II.) combined with prednisone, and the control group was treated with abiraterone acetate tablets combined with prednisone, and the primary endpoints were PSA50 response rate and safety.To assess whether the efficacy (PSA50) of Abiraterone Acetate Tablets (II) is statistically non-inferior to that of Abiraterone Acetate Tablets, and whether there is a significant reduction in the incidence of grade 3 and above TEAEs.",[404,405],"Abiraterone Acetate","MCRPC (metastatic Castration-resistant Prostate Cancer)","2025-01-06",{"date":408,"type":40},"2025-01-10",{"date":410,"type":21},"2025-01-30",{"date":412,"type":21},"2029-06-30",{"name":414,"class":47},"Ding-Wei Ye"]