[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"psma-positive-progressive-metastatic-castration-resistant-prostate-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:psma-positive-progressive-metastatic-castration-resistant-prostate-cancer":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,55],{"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":31,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100643460","phase-1-dual-target-psmapsca-car-nk-cells-in-advanced-prostate-cancer-100643460",false,"NCT07641049","Dual-target PSMA\u002FPSCA CAR-NK Cells in Advanced Prostate Cancer","A Phase 1, Open-Label, Multicenter, Dose-Escalation and Dose-Expansion Study of ETB-DualNK-01, an Allogeneic Dual-target PSMA\u002FPSCA CAR-NK Cell Product, in Adults With Metastatic Castration-Resistant Prostate Cancer","DUAL-NK-PC","Inclusion Criteria:\n\n* Male participant age 18 years or older.\n* Histologically or cytologically confirmed prostate adenocarcinoma with metastatic castration-resistant disease.\n* Disease progression by PCWG3 while maintaining castrate testosterone (\\\u003C50 ng\u002FdL) with ongoing androgen deprivation therapy or prior orchiectomy.\n* Documented PSMA and\u002For PSCA expression by a validated tumor assay; PSMA PET may support target confirmation when applicable.\n* Prior progression on at least one androgen receptor pathway inhibitor such as abiraterone, enzalutamide, apalutamide, or darolutamide; prior taxane, PARP inhibitor, radioligand therapy, or checkpoint inhibitor is allowed.\n* ECOG performance status 0 or 1.\n* Adequate hematologic, renal, hepatic, cardiac, and pulmonary function per protocol laboratory thresholds.\n* At least one measurable lesion by RECIST 1.1 or evaluable bone-predominant disease by PCWG3.\n* Life expectancy of at least 12 weeks.\n* Ability to understand and sign informed consent and willingness to provide required blood and tissue samples.\n\nExclusion Criteria:\n\n* Active central nervous system metastases or leptomeningeal disease.\n* Dominant small-cell or neuroendocrine prostate cancer histology.\n* Prior gene-modified cellular therapy within 6 months before lymphodepletion, or prior allogeneic transplant requiring ongoing systemic immunosuppression.\n* Active autoimmune disease requiring systemic treatment or chronic immunosuppression; systemic corticosteroid use greater than 10 mg prednisone equivalent daily within 7 days of lymphodepletion.\n* Uncontrolled infection, including uncontrolled hepatitis B, hepatitis C, or HIV infection.\n* Clinically significant cardiovascular disease, symptomatic arrhythmia, recent myocardial infarction, or uncontrolled heart failure.\n* Unresolved grade 2 or higher toxicity from prior anticancer therapy, except alopecia, stable endocrinopathy, or other protocol-approved exceptions.\n* Another active malignancy requiring systemic treatment.\n* Any medical, psychiatric, or laboratory abnormality that, in the investigator's judgment, would increase risk or interfere with study interpretation.","MALE","18 Years",{"count":20,"type":21},36,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This example Phase 1 study is designed to evaluate the safety, tolerability, feasibility, and preliminary anti-tumor activity of ETB-DualNK-01, an allogeneic dual-target PSMA\u002FPSCA CAR-NK cell therapy, in adults with metastatic castration-resistant prostate cancer (mCRPC). Part A uses dose escalation to determine the maximum tolerated dose and\u002For recommended Phase 2 dose. Part B expands at the selected dose in biomarkerconfirmed disease.",[27,28,29,30],"Metastatic Castration-resistant Prostate Cancer","Advanced Prostate Adenocarcinoma","PSCA-positive Prostate Cancer","PSMA-Positive Progressive Metastatic Castration-Resistant Prostate Cancer",[32,33,34,35,36,37,38,39,40,41],"CAR-NK","dual-target","PSMA","PSCA","mCRPC","metastatic prostate cancer","cell therapy","immunotherapy","dose escalation","dose expansion","RECRUITING","2026-06-06",{"date":45,"type":46},"2026-06-11","ACTUAL",{"date":48,"type":46},"2026-03-02",{"date":50,"type":21},"2028-06-17",{"name":52,"class":53},"Beijing Biotech","INDUSTRY",1,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":62,"targetDuration":4,"studyType":22,"phases":64,"briefSummary":66,"conditions":67,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":54},"100616905","phase-3-a-phase-iii-study-comparing-hrs-4357-with-novel-androgen-receptor-pathway-inhibitors-in-patients-with-progressive-psma-positive-metastatic-castration-resistant-prostate-cancer-100616905","NCT07311694","A Phase III Study Comparing HRS-4357 With Novel Androgen Receptor Pathway Inhibitors in Patients With Progressive, PSMA-Positive Metastatic Castration-Resistant Prostate Cancer","A Phase III, Randomized, Open-Label, Multicenter Study Comparing HRS-4357 With Novel Androgen Receptor Pathway Inhibitors in Patients With Progressive, PSMA-Positive Metastatic Castration-Resistant Prostate Cancer","Inclusion Criteria:\n\n1. Be willing to participate in this clinical trial, understand the study procedures, and be able to sign the informed consent form in writing;\n2. Male, aged ≥ 18 years;\n3. ECOG performance status score of 0-1;\n4. Expected survival time of no less than 6 months;\n5. Prostate adenocarcinoma confirmed by histology and\u002For cytology, and diagnosed as mCRPC (metastatic castration-resistant prostate cancer) with reference to current clinical guidelines;\n6. Presence of at least one metastatic lesion confirmed by imaging examinations (CT\u002FMRI and\u002For bone scan) within 4 weeks before randomization;\n7. Confirmation of at least one PSMA-positive lesion and no PSMA-negative lesions by PSMA PET\u002FCT;\n8. Serum testosterone at castration level (\\\u003C 50 ng\u002Fdl or \\\u003C 1.7 nmol\u002FL) at the screening visit; continuous luteinizing hormone-releasing hormone analog (LHRHA) therapy (medical castration) or previous bilateral orchiectomy (surgical castration); subjects who have not undergone bilateral orchiectomy must plan to maintain effective LHRHA therapy throughout the study period;\n9. Previous treatment with second-generation ARPIs, with only one episode of disease progression during treatment; and assessed by the investigator as suitable for switching to another ARPI (suitable for receiving abiraterone or enzalutamide);\n10. Disease progression at the time of enrollment. Disease progression is defined as the occurrence of at least one of the following while the subject's serum testosterone is at a stable castration level: ① PSA progression: PSA value \\> 1 ng\u002FmL, with two consecutive increases in PSA at intervals of at least 1 week; ② Radiographic progression: occurrence of clearly new lesions; appearance of 2 or more new bone lesions on bone scan; lesion progression indicated by CT or MRI (per RECIST v1.1);\n\nExclusion Criteria:\n\n1. Received any of the following treatments before randomization:\n\n   1. Any radionuclide therapy or hemi-body radiotherapy within 6 months.\n   2. Any PSMA-targeted radiopharmaceutical therapy.\n   3. Surgery, radiotherapy, or any local therapy within 4 weeks.\n   4. Any other investigational drug intervention within 4 weeks.\n2. Known hypersensitivity to the components of the study drug or its analogs.\n3. History of malignancy (other than prostate cancer) within 5 years before randomization that is expected to alter life expectancy or may interfere with disease assessment, excluding cured malignancies with low risk of metastasis and mortality (5-year survival rate \\> 90%), such as non-metastatic basal cell carcinoma of the skin, superficial squamous cell carcinoma of the skin, and low-grade superficial bladder cancer.\n4. Occurrence of severe infection (CTCAE \\> Grade 2) within 4 weeks before randomization.\n5. Failure to recover from adverse events of previous treatments (NCI-CTCAE Version 5.0 Grade \\> 1) before randomization, as judged by the investigator.\n6. Presence of poorly controlled clinical cardiac symptoms or cardiac diseases.\n7. History of physical or psychiatric illnesses\u002Fconditions that may interfere with the study objectives and assessments (including epilepsy and dementia).",{"count":63,"type":21},370,[65],"PHASE3","This study is a randomized, open-label, controlled, multicenter phase III clinical trial, which plans to randomly enroll 370 subjects with advanced metastatic castration-resistant prostate cancer (mCRPC). The efficacy of HRS-4357 versus novel androgen receptor pathway inhibitors (ARPI) in the treatment of PSMA-positive advanced metastatic castration-resistant prostate cancer (mCRPC) will be evaluated based on radiographic progression-free survival (rPFS) assessed by the BIRC.",[30],"2026-02-03",{"date":70,"type":46},"2026-02-04",{"date":72,"type":46},"2026-02-02",{"date":74,"type":21},"2028-12",{"name":76,"class":53},"Jiangsu HengRui Medicine Co., Ltd."]