[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mcrpc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mcrpc":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,55,84,126,152,173,196,218,245],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100471052","phase-1-anti-tumour-activity-of-177lu-rhpsma-101-injection-100471052",false,"NCT05413850","Anti-tumour Activity of (177Lu) rhPSMA-10.1 Injection","An Open-label, Multicentre, Integrated Phase 1 & 2 Study to Evaluate the Safety, Tolerability, Radiation Dosimetry and Anti-tumour Activity of Lutetium (177Lu) rhPSMA-10.1 Injection in Men With Metastatic Castrate-resistant Prostate Cancer","Inclusion Criteria:\n\n1. Male subjects, 18 years of age or older with histologically confirmed adenocarcinoma of the prostate.\n2. Serum testosterone levels \\\u003C50 ng\u002FdL (1.73 nmol\u002FL) after surgical or continued chemical castration.\n3. Presence of disease target or non target lesions (per RECIST v1.1) on CT\u002FMRI and\u002For presence of disease on full body 99mTc bone scan performed within 28 days of screening.\n4. Positive disease expression of PSMA as confirmed on PSMA PET\u002FCT scan.\n5. At least 4 weeks or 5 half-lives (whichever is longer) elapsed between last anti-cancer treatment administration and the initiation of study treatment (except for Luteinising Hormone-releasing Hormone or GnRH).\n6. Resolution of all previous treatment related toxicities to CTCAE version 5.0 grade of ≤1 (except for chemotherapy induced alopecia and grade 2 peripheral neuropathy or grade 2 urinary frequency which are allowed).\n7. Prior major surgery must be at least 12 weeks prior to study entry.\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 with a life expectancy ≥6 months.\n9. Adequate bone marrow reserve and organ function as demonstrated by blood count, and serum biochemistry at baseline.\n10. Adequate contraception for patients and their partners.\n11. For Phase 1 mCRPC only: Subjects who have experienced disease progression on or after at least 1 NAAD (e.g. abiraterone, enzalutamide) and at least 1 course (but no more than 2 courses) of taxane-based chemotherapy. For Phase 2 mCRPC only: Subjects who have experienced disease progression on or after at least 1 NAAD (e.g. abiraterone, enzalutamide, apalutamide, darolutamide), but have not received previous taxane-based chemotherapy for the treatment of mCRPC.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to the therapeutic or diagnostic IMP or any of its constituents.\n2. Presence of significant PSMA-negative disease on ceCT\u002FMRI scan\n3. Diffuse marrow infiltration of disease ('superscan' appearance on full body 99mTc bone scan).\n4. Symptomatic spinal cord compression, or clinical or radiological findings that are indicative of impending spinal cord compression.\n5. Known history of haematological malignancy.\n6. Known history of central nervous system (CNS) metastases.\n7. Histological findings consistent with neuroendocrine phenotype of prostate cancer.\n8. Known history of other solid malignancy that may reduce life expectancy and\u002For may interfere with disease assessment.\n9. Unresolved urinary tract obstruction defined as radiographic evidence of hydronephrosis with or without ureteric stent\u002Fnephrostomy.\n10. Any uncontrolled significant medical, psychiatric, or surgical condition or laboratory finding that would pose a risk to subject safety or interfere with study participation or interpretation of individual subject results.\n11. Ongoing treatment with bisphosphonates for bone-targeted therapy.\n12. Severe urinary incontinence that would preclude safe disposal of radioactive urine.\n13. Single kidney or renal transplant or any concomitant nephrotoxic therapy that might put the subject at high risk of renal toxicity during the study in the judgement of the investigator.\n14. Clinically significant abnormalities on a single 12 lead electrocardiogram (ECG) at screening.\n15. Previously received external beam irradiation to a field that includes more than 30% of the bone marrow or kidneys.\n16. Previous treatment with any of the following: PSMA targeted radionuclide therapy, Strontium-89, Samarium-153, Rhenium 186, Rhenium-188, Radium-223, hemi-body irradiation.\n17. Subjects with bilateral hip replacements or any significant metallic implants or objects, that may affect image quality and\u002For dosimetry calculations.\n18. Transfusion of blood products for the sole purpose of meeting the eligibility criteria for this clinical study.\n19. Participation in other studies involving IMP(s) within 28 days or 5 half-lives (whichever is longer) prior to study entry and\u002For during study participation.\n20. Any history of clinically significant parenchymal lung disease e.g. interstitial lung disease or bullous emphysema.\n21. Any history of prior thoracic external beam radiotherapy.\n22. Presence of abnormal PSMA PET uptake in the lung parenchyma above expected physiological levels, as determined by local assessment.","MALE","18 Years",{"count":19,"type":20},82,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","To determine the dose, safety, radiation dosimetry and efficacy of 177Lu-rhPSMA-10.1 in participants with PSMA-expressing metastatic castrate resistant prostate cancer.",[27,28,29,30,31,32],"Prostate Cancer","Metastatic Castration-resistant Prostate Cancer","mCRPC","Urogenital Neoplasms","Prostatic Neoplasms","Prostatic Diseases",[34,29,35,36,37,38,39,40,41],"PSMA","Prostate cancer","177Lu rhPSMA-10.1","18F-rhPSMA-7.3","BET-PSMA-121","Blue Earth Therapeutics Limited","Radiohybrid","Radiopharmaceuticals","RECRUITING","2026-05-12",{"date":45,"type":46},"2026-05-14","ACTUAL",{"date":48,"type":46},"2022-07-20",{"date":50,"type":20},"2028-03-31",{"name":52,"class":53},"Blue Earth Therapeutics Ltd","INDUSTRY",21,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":21,"phases":65,"briefSummary":66,"conditions":67,"keywords":71,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":83},"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":64,"type":20},138,[23],"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™).",[68,27,69,29,70],"Castration Resistant Metastatic Prostate Cancer","mCRPC (Metastatic Castration-resistant Prostate Cancer)","B7H3",[72,61,73,74],"AKY-2519","AKY-2519-01","B7-H3","2026-05-06",{"date":43,"type":46},{"date":78,"type":20},"2026-07",{"date":80,"type":20},"2032-06",{"name":82,"class":53},"Aktis Oncology, Inc.",2,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":21,"phases":94,"briefSummary":95,"conditions":96,"keywords":99,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":125},"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":93,"type":20},144,[23],"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.",[28,97,98,29,69],"Metastatic Castration-Resistant Prostate Cancer Patients","Metastatic Castration-resistant Prostate Cancer, mCRPC",[29,100,101,102,103,104,105,106,107,108,109,110,111,31,30,112,113,114,115],"Metastatic Castration-Resistant Prostate Cancer","castration-resistant prostate cancer","NSD2 inhibitor","efficacy","safety","pharmacokinetics","pharmacodynamics","Darolutamide","NUBEQA","Metastatic Disease","Neoplasms","prostatic Diseases","Neoplasms by Site","Urogenital Diseases","Male Urogenital Diseases","Epigenetics","2026-03-19",{"date":118,"type":46},"2026-03-23",{"date":120,"type":46},"2025-11-21",{"date":122,"type":20},"2028-09",{"name":124,"class":53},"K36 Therapeutics, Inc.",13,{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":133,"enrollmentInfo":134,"targetDuration":4,"studyType":21,"phases":136,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":151},"100622866","early-phase-1-safety-and-preliminary-efficacy-evaluation-of-lc-k76-plus-anti-pd-1-therapy-in-patients-with-metastatic-castration-resistant-prostate-cancer-mcrpc-100622866","NCT07389187","Safety and Preliminary Efficacy Evaluation of LC-K76 Plus Anti-PD-1 Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)","An Open-Label, Single-Arm, Exploratory Study to Evaluate the Safety and Preliminary Efficacy of LC-K76 Plus Anti-PD-1 Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)","Inclusion Criteria:\n\n1. Male, aged 18 to 85 years.\n2. Histologically confirmed prostate adenocarcinoma, without small cell carcinoma components.\n3. Metastatic Castration-Resistant Prostate Cancer (mCRPC) with disease progression after at least one novel endocrine therapy (e.g., abiraterone or enzalutamide) and\u002For docetaxel chemotherapy.\n4. Evidence of bone metastasis on PSMA-PET-CT or bone scan (ECT).\n5. Serum testosterone at castration levels (\\\u003C 50 ng\u002FdL or 1.75 nmol\u002FL).\n6. ECOG performance status ≤ 2.\n7. Life expectancy \\> 6 months.\n8. Adequate bone marrow, hepatic, and renal function.\n9. Willing to undergo biopsies before and during treatment\n\nExclusion Criteria:\n\n1. Lack of pathological evidence for prostate cancer.\n2. Other primary malignant tumors active or requiring treatment within the past 3 years.\n3. Has visceral metastases.\n4. Poorly controlled diabetes after continuous insulin therapy.\n5. Significant abnormalities in laboratory values at randomization (Hb \\\u003C 90 g\u002FL; Neutrophils \\\u003C 1.5x10\\^9\u002FL; Platelets \\\u003C 75x10\\^9\u002FL; ALT\u002FAST \\> 2.5xULN; Bilirubin \\> 1.5xULN; eGFR \\\u003C 60 mL\u002Fmin\u002F1.73m\\^2) .\n6. Severe cardiopulmonary disease or high-risk conditions.\n7. Prior therapy with any immune checkpoint inhibitors (e.g., anti-PD-1\u002FPD-L1).\n8. Intolerance to anti-PD-1 monoclonal antibody or dandelion extracts.\n9. History of severe drug allergies.\n10. Factors affecting drug intake\u002Fabsorption (e.g., swallowing difficulty, chronic diarrhea).\n11. Concurrent psychiatric or neurological conditions","85 Years",{"count":135,"type":20},10,[137],"EARLY_PHASE1","This open-label, single-arm study evaluates the safety and preliminary efficacy of LC-K76 combined with Tislelizumab and ADT in 10 patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) who progressed on prior therapies. Participants will receive oral LC-K76 and intravenous Tislelizumab for a 24-week treatment period.",[29],"NOT_YET_RECRUITING","2026-02-03",{"date":143,"type":46},"2026-02-05",{"date":145,"type":20},"2026-02",{"date":147,"type":20},"2028-06",{"name":149,"class":150},"Shanghai Changzheng Hospital","OTHER",1,{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":21,"phases":161,"briefSummary":162,"conditions":163,"keywords":4,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":151},"100600988","phase-1-study-of-tyk-00540-combined-with-enzalutamide-in-patients-with-metastatic-castration-resistant-prostate-cancermcrpc-100600988","NCT07104643","Study of TYK-00540 Combined With Enzalutamide in Patients With Metastatic Castration-resistant Prostate Cancer（mCRPC）","A Phase Ib\u002FII Clinical Study to Evaluate the Safety and Efficacy of TYK-00540 Combined With Enzalutamide in the Treatment of Metastatic Castration-resistant Prostate Cancer (mCRPC) That Has Failed Previous Novel Endocrine Therapy","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Metastatic castration-resistant prostate adenocarcinoma confirmed by pathology (with no neuroendocrine or small cell features indicated by the initial pathological examination), if pathological examination is performed in the subsequent CRPC stage, the accompanying other pathological types should not exceed 10%. Those with only pelvic lymph node metastasis or local recurrence and metastasis (such as in the bladder, rectum, etc.) cannot be included.\n3. At the time of screening, testosterone levels were at castration levels (≤50ng\u002FdL or 1.70nmol\u002FL). If the patient had not previously undergone bilateral orchiectomy, they must be undergoing and voluntarily continue to receive LHRH agonists\u002Fantagonists for androgen deprivation therapy throughout the study treatment period.\n4. During screening, if the disease progresses, that is, the subject experiences one or more of the following three conditions; PSA progression is defined as no PSA \\> 1ng\u002Fml and at least two elevated PSA levels with an interval of ≥1 week. ② Disease progression as defined in RECIST 1.1; ③ Bone disease progression as defined by the PCWG3 standard refers to the discovery of ≥2 new lesions on bone scans.\n5. Previous anti-tumor treatment must meet the following requirements: having failed in only one approved and marketed novel endocrine therapy in the past (referring to disease progression during the process of novel endocrine therapy; The definition of disease progression is the same as that in inclusion criterion 4), such as abiraterone acetate, apatamide, darotamide or rivelutamide, etc., and no treatment with enzalutamide has been received.\n6. ECOG score ≤1, no deterioration in the two weeks prior to study enrollment, and an expected survival period of ≥3 months\n7. Have good organ functions, including:\n\n   1. Liver function Total bilirubin (TBIL) ≤ 1.5×ULN (except for documented Gilbert syndrome), alanine aminotransferase (ALT) ≤ 2.5×ULN, and aspartate aminotransferase (AST) ≤ 2.5×ULN (for patients with liver metastasis, ALT\u002FAST≤5×ULN), albumin ≥3.0g\u002FL;\n   2. Renal function enhancement: Serum creatinine (Cr) ≤ 1.5×ULN, or creatinine clearance rate ≥50 mL\u002Fmin;\n   3. \\\u003CS:1\\> Blood routine: PLT ≥ 100×109\u002FL, ANC ≥ 1.5×109\u002FL, WBC≥ 3.5×109\u002FL and Hb ≥ 90g\u002FL;\n   4. The international normalized ratio (INR) is ≤1.5, and the activated partial prothrombin time (APTT) is ≤1.5×ULN;\n8. The patient agrees to maintain abstinence (control heterosexual sexual intercourse) or take contraceptive measures, and agrees not to donate sperm;\n9. Understand and voluntarily sign the written ICF, and have the willingness and ability to complete regular visits, treatment plans, laboratory tests and other experimental processes.\n\nExclusion Criteria:\n\n1. Subjects with the following treatments:\n\n   1. Those who have previously received selective CDK2, CDK4 inhibitors, CDK4\u002F6 inhibitors (e.g., Palbociclib, Ribociclib, Abemaciclib, Trilaciclib\u002FG1T38, SHR6390, pirociclib) for treatment;\n   2. Previously received enzalutamide or two or more novel endocrine therapies for prostate cancer;\n   3. Isotope therapy with strontium-89, samarium or radium-223 was received within 12 weeks prior to the first administration;\n   4. Systemic treatment for prostate cancer (anti-androgen therapy, chemotherapy, targeted therapy, immunotherapy, or other interventional clinical trial drugs, except castration therapy drugs) has been received within 4 weeks prior to the first medication.\n   5. Systemic treatment for prostate cancer (anti-androgen therapy, chemotherapy, targeted therapy, immunotherapy, or other interventional clinical trial drugs, except castration therapy drugs) has been received within 4 weeks prior to the first medication.\n   6. The patient has received blood transfusion, albumin infusion or used hematopoietic growth factor within 2 weeks before the first administration;\n   7. Major surgery was performed within 28 days before the first administration of the drug , or surgery was performed when the surgical effect had not yet recovered at the time of screening or during the planned enrollment for treatment;\n   8. Has received allogeneic transplants such as stem cell transplantation, bone marrow transplantation or liver transplantation in the past;\n   9. Palliative radiotherapy was received within 2 weeks before the first administration;\n   10. The first administration was within no more than five half-lives from the implantation of radioactive particles;\n   11. The first administration was within no more than five half-lives from the implantation of radioactive particles.\n2. In addition to prostate cancer, there are other malignant tumors at the same time (excluding basal cell carcinoma or squamous cell carcinoma of the skin that can be treated locally and have been cured, superficial bladder cancer, cervical carcinoma in situ, ductal carcinoma of the breast and papillary thyroid carcinoma, etc.); Excluding those with other malignant tumors who have been cured of radical treatment for ≥5 years;\n3. In addition to prostate cancer, there are other malignant tumors at the same time (excluding basal cell carcinoma or squamous cell carcinoma of the skin that can be treated locally and have been cured, superficial bladder cancer, cervical carcinoma in situ, ductal carcinoma of the breast and papillary thyroid carcinoma, etc.); Excluding those with other malignant tumors who have been cured of radical treatment for ≥5 years;\n4. Known to be allergic to any excipients of TYK-00540 tablets, or allergic to enzalutamide and its excipients;\n5. Patients whose progression of bone and soft tissue lesions cannot be evaluated, that is, those who simultaneously meet the following two criteria:\n\n   1. The bone scan shows a super bone imaging.\n   2. According to RECIST1.1 criteria, there are no assessable soft tissue lesions (measurable or unmeasurable).\n6. The patient has any unstable or other disease or medical condition that may affect its safety or compliance with the study, any serious or uncontrolled systemic disease, including uncontrolled hypertension (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥95 mmHg), uncontrolled diabetes, active bleeding, ocular lesions Other serious diseases of the mental, nervous and other systems;\n7. Clinically obvious digestive tract abnormalities during screening may affect drug intake, transport or absorption (such as dysphagia, uncontrollable nausea and vomiting, active gastric ulcers, ulcerative colitis, Crohn's disease, chronic diarrhea, intestinal obstruction, etc.);\n8. Severe bone injury caused by tumor bone metastasis, with pathological fractures of important parts or spinal cord compression expected to occur in the near future within 6 months prior to knowledge;\n9. There is cancerous meningitis or untreated central nervous system metastasis. Those who have previously received systemic or radical treatment for brain metastases (radiotherapy or surgery), and whose stability has been maintained for at least one month as confirmed by imaging, and who have stopped systemic hormone therapy (with a dose greater than 10mg\u002F day prednisone or other equivalent dose hormones) for more than two weeks and have no clinical symptoms, can be included;\n\n9\\. There is cancerous meningitis or untreated central nervous system metastasis. Those who have previously received systemic or radical treatment for brain metastases (radiotherapy or surgery), and whose stability has been maintained for at least one month as confirmed by imaging, and who have stopped systemic hormone therapy (with a dose greater than 10mg\u002F day prednisone or other equivalent dose hormones) for more than two weeks and have no clinical symptoms, can be included 10.Patients with clinically symptomatic third space effusion (such as pleural effusion, ascites, pericardial effusion) who require puncture and drainage, or those who have received puncture and drainage within 2 weeks before the first medication; 11. At the time of screening, the toxicity of previous treatments had not yet recovered. According to CTCAE v5.0, there were still grade ≥2 AES (excluding special toxicities such as alopecia, fatigue, increased GGT, and increased ALP).\n\n12\\. Have serious cardiovascular diseases, including but not limited to:\n\n1. At rest, the 12-lead electrocardiogram examination showed that the QTcF was ≥470ms.\n2. There are severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, II-III degree atrioventricular block, etc.\n3. Acute coronary syndrome, congestive heart failure (New York Heart Association (NYHA)) cardiac function grade ≥2, aortic dissection or other grade 3 cardiovascular events occurred within 6 months before the first administration.\n4. Left ventricular ejection fraction (LVEF) \\\u003C50%; 13. There is a history of thromboembolism or cerebrovascular events within 6 months before the first administration, including transient ischemic attack, cerebrovascular accident, deep vein thrombosis or pulmonary embolism, etc; 14. There was evidence of radiation pneumonitis, interstitial lung disease or interstitial pneumonia (ILD) requiring hormone therapy during the screening period, or drug-induced ILD, or any active ILD (such as acute exacerbation or progressive pneumonia\u002Fpulmonary fibrosis at baseline). Or pulmonary symptoms that the researchers consider unsuitable for enrollment, or high-risk factors that make it unsuitable for enrollment due to the possibility of interstitial lung disease; 15.Severe infection occurred within 4 weeks before the first administration, including but not limited to bacteremia and severe pneumonia that require hospitalization; There was an active infection of CTCAE grade ≥2 that required systemic antibiotic treatment within 2 weeks before the first administration (except for local chronic infections or prophylactic antibiotic use that the investigator determined did not require treatment).\n\n   16\\. Those with a history of active pulmonary tuberculosis infection within 6 months prior to the first administration; 17. People infected with active human immunodeficiency virus (HIV), syphilis, hepatitis C virus (HCV) or hepatitis B virus (HBV). Active HBV, HCV and HIV infections are defined as:\n\na.positive HBsAg and HBV DNA ≥500cps\u002Fml\u002FHBV DNA ≥1000u\u002Fml; b.Anti-hcv antibody and HCV RNA positive; c.HIV antibody positive. 18. Known history of alcohol or drug abuse or dependence; Mental disorder; Or the researcher believes that there is a history of other serious systemic diseases or other reasons that make the participants unsuitable for this study (such as not meeting the most beneficial treatment for the subjects, subject compliance, etc.)",{"count":160,"type":20},48,[23,24],"This study is to evaluate the safety, and preliminary antitumor activity of TYK-00540 combined with Enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) that have failed novel endocrine therapy",[29],"2025-07-29",{"date":166,"type":46},"2025-08-05",{"date":168,"type":20},"2025-08",{"date":170,"type":20},"2026-11",{"name":172,"class":53},"TYK Medicines, Inc",{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":21,"phases":182,"briefSummary":183,"conditions":184,"keywords":185,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":195},"100600333","phase-1-a-study-of-177lu-lu-psma-xt-injection-in-patients-with-metastatic-prostate-cancer-100600333","NCT07096128","A Study of [177Lu] Lu-PSMA-XT Injection in Patients With Metastatic Prostate Cancer","A Phase I Study to Assess the Safety, Tolerability, Radiation Dosimetry and Efficacy of [177Lu] Lu-PSMA-XT in Patients With Metastatic Prostate Cancer","Inclusion Criteria:\n\n1. Patients must have the ability to understand and sign an approved informed consent form (ICF).\n2. Patients must be \\>= 18 and \\\u003C＝80 years of age.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. Patients must have a life expectancy \\>6 months.\n5. Patients must have histological, pathological, and\u002For cytological confirmation of prostate cancer.\n6. Patients must be PSMA Positron Emission Tomography (PET)\u002FComputed Tomography (CT) scan positive。\n7. Patients must have a castrate level of serum\u002Fplasma testosterone (\\\u003C50 ng\u002FdL or \\\u003C1.7 nmol\u002FL).\n8. Patients must have received at least one NAAD (such as enzalutamide and\u002For abiraterone)； patients must have been previously treated undergone at least 1-2 prior taxane-based chemotherapy regimens or be unsuitable for taxane therapy (unsuitability includes contraindications, investigator-determined ineligibility, or patient refusal) in mCRPC stage.\n9. Patients must have progressive mCRPC.\n10. Patients must have adequate organ function。\n11. Subjects of childbearing potential voluntarily use an effective method of contraception, such as condoms, oral or injectable contraceptives, Intra-uterine device（IUD）,etc., during treatment and within 6 months of the last use of the trial drug.\n\nExclusion Criteria:\n\n1. Previous treatment with any of the following within 6 months of enrollment: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation. Previous PSMA-targeted radioligand therapy is not allowed.\n2. Known other malignancies.\n3. Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy within 28 days prior to day of enrollment.\n4. Known hypersensitivity to the components of the study therapy or its analogs.\n5. A superscan as seen in the baseline bone scan.\n6. Patients with a history of Central Nervous System (CNS) metastases.\n7. Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, cardiac arrhythmia, or other severe complications.",{"count":181,"type":20},36,[23],"This was a multicenter, open-label, phase I study to evaluate the safety, tolerability, radiation dosimetry and efficacy of \\[177Lu\\] Lu-PSMA-XT injection in patients with metastatic prostate cancer .",[29],[29,186,34],"177Lu",{"date":188,"type":46},"2025-07-31",{"date":190,"type":46},"2024-08-20",{"date":192,"type":20},"2027-04-30",{"name":194,"class":150},"Jinming Zhang",3,{"id":197,"slug":198,"hasResults":11,"nctId":199,"briefTitle":200,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":202,"enrollmentInfo":203,"targetDuration":4,"studyType":21,"phases":205,"briefSummary":206,"conditions":207,"keywords":208,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":151},"100600159","phase-2-efficacy-and-safety-of-disitamab-vedotin-plus-abiraterone-for-metastatic-castration-resistant-prostate-cancera-phase-ii-study-100600159","NCT07093866","Efficacy and Safety of Disitamab Vedotin Plus Abiraterone for Metastatic Castration-Resistant Prostate Cancer：a Phase II Study","Inclusion Criteria:\n\n* Patients are able to understand and voluntarily sign the informed consent form (ICF); judged by the investigator to be capable of complying with the protocol.\n* Male patients of ≥18 years or older at the time of ICF signature.\n* Patients with ECOG performance status 0-1.\n* Patients with an expected survival of 3months or more.\n* Patients who are histologically or cytologically confirmed prostatic adenocarcinoma with HER2 expression (IHC 1+, 2+ or 3+) in archival or fresh tumour tissue.\n* Patients with documented castration-resistant prostate cancer (CRPC): serum testosterone \\\u003C1.73 nmol\u002FL (50 ng\u002FdL) at screening; patients on medical castration must continue LHRH agonist\u002Fantagonist therapy throughout the study.\n* Patients with evidence of metastatic disease by bone scan (bone lesions) and\u002For CT\u002FMRI (soft-tissue lesions).\n* Patients with adequate organ function as defined below:\n\n  * Absolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL\n  * Platelet count (PLT) ≥100 × 10⁹\u002FL\n  * Hemoglobin (Hb) ≥100 g\u002FL\n  * Total bilirubin (TBIL) ≤1.5 × upper limit of normal (ULN); ≤2 × ULN if liver metastases present\n  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5 × ULN; ≤2 × ULN if liver metastases present\n  * Serum creatinine (Cr) ≤1.5 × ULN or calculated creatinine clearance (CrCl) ≥60 mL\u002Fmin (Cockcroft-Gault formula; calculate only if Cr \\>1.5 × ULN)\n  * Urinalysis protein \\\u003C2+; if ≥2+, 24-h urine protein must be \\\u003C1 g or urine protein\u002Fcreatinine ratio \\\u003C0.5\n  * For patients not on anticoagulation: INR and aPTT ≤1.5 × ULN; patients on stable-dose anticoagulation are eligible\n  * Left ventricular ejection fraction (LVEF) ≥50% or ≥local lower limit of normal (LLN), whichever is lower\n  * QTcF interval \\\u003C470 ms\n* Male patients with partners of child-bearing potential must use a medically acceptable contraceptive method from the first study dose until 3 months after the last dose.\n\nExclusion Criteria:\n\n* Patients who are known hypersensitivity to any component of disitamab vedotin or abiraterone.\n* Patients with other malignancies within 3 years before screening, except early-stage malignancies considered clinically cured (carcinoma in situ or stage I tumors), e.g., basal-cell or squamous-cell skin carcinoma or superficial bladder cancer.\n* Patients with central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Patients with treated brain metastases may enroll if lesions have been stable for ≥1 month, there is no evidence of new or enlarging CNS disease, and systemic corticosteroids have been discontinued ≥3 days before the first study dose.\n* Patients who are clinically significant pericardial effusion, or pleural\u002Fperitoneal\u002Fpelvic effusions that are poorly controlled or require drainage within 2 weeks before the first dose.\n* Patients with major surgical intervention (any grade 3 or 4 procedure per the 2009 Chinese Regulation on Clinical Application of Medical Technologies) within 4 weeks before the first dose, or incomplete post-operative recovery that, in the investigator's judgment, poses a risk to trial participation.\n* Patients who are prior PSMA-targeted therapy.\n* Patients within 4 weeks (6 weeks for nitrosoureas or mitomycin C) before the first dose: any antineoplastic chemotherapy (except castration therapy), radiotherapy (\\>1 week of local palliative radiotherapy permitted), endocrine therapy (estrogens or anti-androgens; bicalutamide or nilutamide require 6-week washout), targeted therapy, immunotherapy, or participation in another interventional clinical trial (observational studies or post-trial follow-up are allowed).\n\n  * Patients with stable-dose denosumab or bisphosphonates for bone metastases are permitted.\n  * mCRPC patients must not have used PSA-lowering herbal agents (e.g., saw palmetto) or systemic corticosteroids (except short courses for allergy prophylaxis\u002Ftreatment) within 4 weeks before the first dose, nor plan to use such agents during the study.\n* Patients with use of antineoplastic traditional Chinese medicine (TCM) prescriptions or proprietary TCM within 1 week, or receipt of blood transfusion\u002Fblood products, hematopoietic growth factors, or other agents to correct blood cell counts within 2 weeks before first study dose.\n* Patients with toxicities from prior antineoplastic therapy that have not resolved to baseline, CTCAE v5.0 grade 0-1 (except alopecia and pigmentation), or to the levels specified in the inclusion\u002Fexclusion criteria; unhealed wounds. Irreversible toxicities not expected to worsen with study drug (e.g., hearing loss) are permitted.\n* Patients with unexplained fever \\>38.5 °C (tumor-related fever may be allowed per investigator judgment); active or persistent infection; HIV antibody positive; HBsAg positive with HBV DNA \\> site ULN, or HBsAg-negative\u002FHBcAb-positive with HBV DNA \\> site ULN after treatment; HCV antibody positive with HCV RNA \\> site ULN; active syphilis (except adequately treated, cured, or stable syphilis).\n* NYHA class III\u002FIV congestive heart failure; uncontrolled arrhythmia despite treatment\u002Fintervention; risk of QT prolongation or use of drugs known to prolong QT; refractory hypertension (hypertension controlled to \\\u003C140\u002F90 mmHg on medication is allowed).\n* Patients with clinically significant vascular events within 6 months before first dose, including acute arterial\u002Fvenous thromboembolism, thrombotic arteritis, thrombophlebitis, acute pulmonary embolism, acute coronary syndrome (MI, unstable angina, etc.), acute cerebrovascular events, or disseminated intravascular coagulation.\n* Patients with tumor metastases with clear invasion of major arteries posing a high bleeding risk.\n* Patients with interstitial pneumonitis, pulmonary fibrosis, or other severe pulmonary disease requiring treatment; hemoptysis \\>2.5 mL per episode within 3 weeks before first dose.\n* Patients with active gastro-intestinal ulcer, perforation, and\u002For fistula requiring treatment within 6 months; GI bleeding (hematemesis, melena, or hematochezia) within 3 months without endoscopic\u002Fcolonoscopic evidence of complete healing.\n* Patients with uncontrolled concurrent disease \\>CTCAE v5.0 grade 2 (e.g., diabetes).\n\nUncontrolled concurrent disease \\>CTCAE v5.0 grade 2 (e.g., diabetes).\n\n* Patients with CTCAE v5.0 grade \\>2 peripheral neuropathy, prior epilepsy, psychiatric disorders; history of drug abuse within 6 months or alcohol abuse within 3 months (alcohol abuse defined as \\>14 units\u002Fweek: 1 unit = 285 mL beer, 25 mL spirits, or 80 mL wine).\n* Patients with autoimmune disease, immunodeficiency, or organ transplantation.\n* Patients with any condition, therapy, or laboratory abnormality that, in the investigator's opinion, could confound results, interfere with trial participation, or be not in the subject's best interest.","75 Years",{"count":204,"type":20},20,[24],"This is an open-label，prospective，single-arm，phase 2 trial aims to evaluate the efficacy and safety of disitamab vedotin combined with abiraterone in patients with metastatic castration-resistant prostate cancer.",[29],[29],"2025-07-22",{"date":211,"type":46},"2025-07-30",{"date":213,"type":20},"2025-07-20",{"date":215,"type":20},"2027-12-30",{"name":217,"class":150},"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School",{"id":219,"slug":220,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":225,"targetDuration":4,"studyType":21,"phases":227,"briefSummary":229,"conditions":230,"keywords":231,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":244},"100566803","the-radium-select-study-100566803","NCT06659926","The Radium-select Study","68Ga-PSMA-PET\u002FCT and Genomic Alterations for Future Selection of Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) for Radium-223 Treatment.","Inclusion Criteria:\n\n* Histologically confirmed adenocarcinoma of the prostate.\n* Progressive disease after previous treatment defined as a rise in serum (Prostate Specific Antigen) PSA (PCWG3 criteria(22), see appendix 1) and\u002For progression on conventional imaging (PCWG3).\n* A positive bone scan (osteoblastic bone metastases), with at least two metastases.\n* Hemoglobin concentration \\>10 g\u002Fdl (6.2 mmol\u002Fl) and thrombocytes \\>100 109\u002FI at baseline.\n* Each patient will need to (continue to) receive adequate bone protective agents (e.g. bisphosphonates) and androgen deprivation therapy (ADT) according to current clinical guidelines.\n\nExclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance score \\>2\n* Life expectancy \\\u003C 6 months.\n* Detected extra-skeletal metastases or lymph node metastases (\\>3 cm short axis) as identified by conventional imaging (ceCT thorax\u002Fabdomen)",{"count":226,"type":20},60,[228],"NA","Radium-223 is an established radionuclide therapy for patients with metastatic castration resistant prostate cancer (mCRPC) and symptomatic bone metastasis. Patients are eligible for this treatment when they have mCRPC and bone metastases; limited extraskeletal lesions (local prostate, lymph nodes \\\u003C3 cm) on conventional contrast enhanced CT (ceCT) were allowed in the registration trial(1). Previous research revealed that extraskeletal disease on ceCT and bone scans correlates with a poor response. Meanwhile, 68Ga-PSMA-PET\u002FCT emerged as more sensitive imaging strategy that increases the detection of extraskeletal prostate cancer metastases. It is unclear whether these extraskeletal lesions harbour any predictive value in the treatment of mCRPC patients with Radium-223.",[29,114],[29,232,233,234],"68Ga-PSMA-PET\u002FCT","Radium-223","Bone only-disease","2025-07-04",{"date":237,"type":46},"2025-07-08",{"date":239,"type":46},"2025-02-24",{"date":241,"type":20},"2029-07-01",{"name":243,"class":150},"The Netherlands Cancer Institute",5,{"id":246,"slug":247,"hasResults":11,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":21,"phases":254,"briefSummary":256,"conditions":257,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":151},"100351117","phase-3-a-trial-evaluating-the-efficacy-and-safety-of-hc-1119-soft-capsules-in-patients-with-metastatic-castration-resistant-prostate-cancer-mcrpc-100351117","NCT03851640","A Trial Evaluating the Efficacy and Safety of HC-1119 Soft Capsules in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC).","A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of HC-1119 Soft Capsules in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Have Failed Treatments with Abiraterone Acetate and Docetaxel.","Inclusion Criteria:\n\n1. Males aged ≥18 years at screening and voluntary to participate in the study and sign the informed consent form.\n2. Subjects with histologically or cytologically confirmed prostate adenocarcinoma, with no small cell features.\n3. In the case of medical or surgical castration, during or after the last treatment before screening, there are signs of progressive disease determined according to the PCWG3 criteria, defined as satisfying one or more of the following 3 criteria:\n\n   1. PSA progression; at least 2 episodes of increased PSA levels that are measured ≥1 week apart; PSA ≥ 1 μg\u002FL (1 ng\u002FmL) in the screening period;\n   2. Progression of soft tissue lesions as defined by RECIST 1.1;\n   3. The progression of bone lesions is defined as at least two new lesions discovered by bone scan; ambiguous results can be confirmed using another imaging technique (e.g., CT or MRI).\n4. Metastatic diseases confirmed by imaging examinations during the screening period (the status of metastasis refers to the presence of metastatic lesions confirmed by bone scan and\u002For CT\u002FMRI scan).\n5. For patients who have undergone orchiectomy or are being treated by medical castration therapy, their androgen blockade therapy is maintained by luteinizing hormone-releasing hormone agonists or antagonists during the study period (including the follow-up period), and their serum testosterone levels are ≤ 1.73 nmol\u002FL (50 ng\u002FdL) during screening visits.\n6. Patients who have failed previous treatments of prostate cancer with abiraterone acetate or who are intolerant to treatments with abiraterone acetate.\n7. Patients who have failed previous chemotherapy of prostate cancer with docetaxel or who are intolerant to treatments with docetaxel, or who are not suitable for docetaxel treatment during screening. Patients who are not suitable for docetaxel treatment during screening and do not plan to use cytotoxic chemotherapy within 6 months after the informed discussion are eligible.\n8. Expected survival of ≥ 3 months.\n9. ECOG performance status score of 0-2.\n10. Laboratory tests must meet the following criteria:\n\n    1. Blood routine examination: Hemoglobin (Hb) ≥ 85 g\u002FL; white blood cell (WBC) ≥ 3.0 x 109\u002FL; platelet (PLT) ≥ 75 x 109\u002FL;\n    2. Liver function: Total bilirubin (TBIL) ≤ 1.5 x ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN (for patients without liver metastasis) or ≤ 5 x ULN (for patients with liver metastasis); albumin (ALB) ≥ 25 g\u002FL;\n    3. Renal function: serum creatinine (SCr) ≤ 1.5 x ULN.\n11. Willing to use reliable contraceptive measures (such as condoms) and not to donate sperms throughout the study period and within 3 months after the last dose.\n\nExclusion Criteria:\n\nSubjects with any of the following conditions should not be enrolled:\n\n1. Received any anti-prostate cancer treatment within 4 weeks before randomization, including chemotherapy, immunotherapy, targeted therapy, estrogen therapy, anti-androgen therapy, systemic radiotherapy, treatments with traditional Chinese medicines for anticancer, or treatments with interventional drugs of other clinical trials; palliative radiotherapy or surgery for bone metastatic or soft tissue lesions should be completed \\>14 days prior to baseline imaging examinations; the lesions treated by palliative radiotherapy should not be the targeted lesions of subsequent RECIST 1.1 assessment. Androgen blockade therapy that is maintained by a luteinizing hormone releasing hormone agonist or antagonist.\n2. Previously received any of novel androgen receptor inhibitors (e.g., Enzalutamide, Apalutamide, Darolutamide, SHR3680, Proxalutamide, or HC-1119).\n3. Patients with brain or central nervous system metastases are known (if a brain or central nervous system metastasis is suspected, a CT\u002FMRI scan of the head is required)\n4. Patients with known serious cardiovascular diseases, including any of the following:\n\n   1. A myocardial infarction or thrombotic event occurred in the past 6 months;\n   2. Known unstable angina;\n   3. Heart failure of Grade III or IV according to the New York Heart Association (NYHA) criteria;\n   4. QT interval of \\> 500 ms during screening visits;\n   5. Resting systolic blood pressure of \\>170 mmHg or diastolic blood pressure of \\>105 mmHg suggesting uncontrolled hypertension during screening visits.\n5. The toxicity of previous treatment has not been eliminated before the start of the study treatment; toxic reaction of grade 2 or above (except for hair loss) according to the CTCAE 5.0 grading scale remains.\n6. Clinically significant gastrointestinal abnormalities that may affect the intake, transport or absorption of drugs (for example, inability to swallow, chronic diarrhea or intestinal obstruction, and patients had total gastrectomy).\n7. Patients with a history of serious diseases in the central nervous system. Patients with a history of epilepsy or any history of diseases that may induce epilepsy, including unexplained loss of consciousness or transient ischemic attack.\n8. Patients who have been diagnosed in the past 5 years with other malignant tumors in addition to prostate cancer, except patients with cured basal or squamous cell skin cancer and superficial bladder tumors (Ta, Tis, and T1).\n9. Patients with a history of allogeneic bone marrow or organ transplantation who require continued medical treatment.\n10. Patients with known congenital or acquired immunodeficiency, active hepatitis, active tuberculosis or other active infections.\n11. Patients known to be allergic to androgen receptor inhibitors.\n12. The investigator believes that the patients are unfit for this study (e.g., the treatments will not benefit the patients the most, inadequate patient compliance, etc.).",{"count":253,"type":20},417,[255],"PHASE3","This is a multicenter, randomized, double-blind, placebo-controlled, Phase 3 clinical study evaluating the efficacy and safety of HC-1119 soft capsules versus placebo in mCRPC patients who have failed or become intolerant to the treatments with both abiraterone acetate and docetaxel, or who are not suitable for docetaxel treatment.",[258],"MCRPC","2025-03-10",{"date":261,"type":46},"2025-03-12",{"date":263,"type":46},"2019-04-12",{"date":265,"type":20},"2025-09",{"name":267,"class":53},"Hinova Pharmaceuticals Inc."]