[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613607":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":29,"centralContacts":48,"locations":58,"responsibleParty":74,"collaborators":29,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":29,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":100,"overallStatus":108,"whyStopped":29,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Fudan University","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Systemic Therapy Alone","ACTIVE_COMPARATOR","Participants with high-volume metastatic hormone-sensitive prostate cancer (mHSPC) who achieve \"conversion success\" after induction systemic therapy will be randomized to this arm at either the 6-month or 12-month evaluation. Conversion success is defined based on PSMA PET\u002FCT as all metastatic lesions showing no obvious uptake (SUVmax lower than liver SUVmean or blood pool SUVmean) and fulfilling all predefined clinical and radiological criteria for randomization.\n\nPatients randomized to Arm A will continue standard systemic therapy alone without local prostate surgery or radiotherapy. Systemic therapy consists of androgen deprivation therapy (ADT) using LHRH agonists or antagonists (e.g., goserelin, leuprolide, triptorelin, degarelix) combined with second-generation androgen receptor signaling inhibitors (such as rezvilutamide, enzalutamide, apalutamide, darolutamide, or abiraterone), with or without docetaxel and other systemic agents (e.g., PARP inhibitors such as olaparib), admini",[13,14,15],"Drug: Androgen Deprivation Therapy (ADT)","Drug: Docetaxel","Drug: PARP Inhibitors and Other Systemic Agents",{"label":17,"type":18,"description":19,"interventionNames":20},"Systemic Therapy Plus Local Prostate Treatment (Arm B)","EXPERIMENTAL","Participants with high-volume metastatic hormone-sensitive prostate cancer (mHSPC) who achieve \"conversion success\" after induction systemic therapy will be randomized to this arm at either the 6-month or 12-month evaluation. Conversion success is defined based on PSMA PET\u002FCT as all metastatic lesions showing no obvious uptake (SUVmax lower than liver SUVmean or blood pool SUVmean) and fulfilling all predefined clinical and radiological criteria for randomization.\n\nPatients randomized to Arm B will receive local prostate treatment in addition to continued standard systemic therapy. Systemic therapy consists of ADT using LHRH agonists or antagonists (e.g., goserelin, leuprolide, triptorelin, degarelix) combined with second-generation androgen receptor signaling inhibitors (such as rezvilutamide, enzalutamide, apalutamide, darolutamide, or abiraterone), with or without docetaxel and other systemic agents (e.g., PARP inhibitors such as olaparib), administered according to approved labels",[13,14,15,21,22],"Procedure: Radical Prostatectomy","Radiation: Prostate Radiotherapy",[24,30,34,38,43],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Androgen Deprivation Therapy (ADT)","Androgen deprivation therapy using LHRH agonists or antagonists (e.g., goserelin, leuprolide, triptorelin, degarelix) according to local prescribing information and CSCO guideline recommendations. The specific drug, dose, and schedule are determined by the investigator and may be adjusted based on tolerability and adverse events.",[9,17],null,{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"Docetaxel","Intravenous docetaxel may be combined with ADT plus second-generation ARSis in selected patients according to contemporary guideline recommendations and investigator judgment. Dose and schedule follow approved labels and may be modified based on toxicity and tolerability.",[9,17],{"type":25,"name":35,"description":36,"armGroupLabels":37,"otherNames":29},"PARP Inhibitors and Other Systemic Agents","Other systemic agents, including PARP inhibitors such as olaparib, may be used in combination with ADT and second-generation ARSis according to approved indications, molecular testing results, guideline recommendations, and investigator judgment.",[9,17],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":29},"PROCEDURE","Radical Prostatectomy","Radical prostatectomy with bilateral seminal vesicle removal and, when appropriate, pelvic lymph node dissection, performed by experienced urologic surgeons via open, laparoscopic, or robot-assisted approach, in patients randomized to Arm B who have achieved conversion success on PSMA PET\u002FCT",[17],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":29},"RADIATION","Prostate Radiotherapy","Definitive external-beam radiotherapy to the prostate delivered according to institutional standards and guideline recommendations, as an alternative local prostate treatment for patients randomized to Arm B who have achieved conversion success on PSMA PET\u002FCT and are not undergoing radical prostatectomy",[17],[49,54],{"name":50,"role":51,"phone":52,"phoneExt":29,"email":53},"Dingwei Ye, MD.","CONTACT","86-21-64175590","dwyeli@163.com",{"name":55,"role":51,"phone":56,"phoneExt":29,"email":57},"Xiaojian Qin, MD.","+86 18017317217","q@urocancer.org",[59],{"facility":60,"status":29,"city":61,"state":29,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Fudan University Shanghai Cancer Center","Shanghai","200032","China","CN",{"type":66,"coordinates":67},"Point",[68,69],121.45806,31.22222,{"lat":69,"lon":68},[72],{"name":73,"role":51,"phone":52,"phoneExt":29,"email":53},"Dingwei Ye",{"type":75,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"PRINCIPAL_INVESTIGATOR","Ding-Wei Ye","Fudan University Shanghai Cancer Center (Fudan University Shanghai Cancer Hospital)","100613607","phase-2-convert-hb1-radical-prostatectomy-after-systemic-therapy-for-high-volume-metastatic-hormone-sensitive-prostate-cancer-100613607",false,"NCT07268794","CONVERT-HB1: Radical Prostatectomy After Systemic Therapy for High-volume Metastatic Hormone-sensitive Prostate Cancer","A Multicenter, Prospective, Randomized Controlled Phase II Clinical Trial of Prostatectomy After Conversion Therapy With Second-generation Antiandrogen Agents Plus ADT in Patients With High-volume mHSPC(CONVERT-HB1)","CONVERT-HB1","Inclusion Criteria:\n\n1. Male patients aged \\>18 and ≤70 years, or with an estimated life expectancy \\>10 years.\n2. Histologically or cytologically confirmed prostate adenocarcinoma with neuroendocrine differentiation ≤10%, and no small cell or signet-ring cell carcinoma component.\n3. High-volume metastatic disease according to CHAARTED definition: presence of visceral metastasis and\u002For ≥4 bone lesions with at least one lesion outside the axial skeleton (vertebral bodies and pelvis).\n4. Newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC) who started intensified endocrine therapy within 3 months.\n5. ECOG performance status 0-2.\n6. Adequate bone marrow, liver, renal, and coagulation function as defined in the protocol (ANC ≥1.5×10\\^9\u002FL, hemoglobin ≥9.0 g\u002FdL, platelets ≥80×10\\^9\u002FL; TBIL ≤1.5×ULN; AST\u002FALT\u002FALP ≤2.5×ULN; albumin ≥30 g\u002FL; creatinine ≤2×ULN or creatinine clearance ≥30 mL\u002Fmin; INR ≤1.5 in patients not receiving anticoagulation).\n7. Patients voluntarily sign informed consent and are willing and able to comply with study procedures.\n\nExclusion Criteria:\n\n1. History of hypersensitivity or intolerance to any study drugs.\n2. mCRPC (metastatic castration-resistant prostate cancer).\n3. Oligometastatic mHSPC intended for upfront radical prostatectomy.\n4. History of seizure, medications that may lower seizure threshold, or conditions predisposing to seizures (e.g., TIA, stroke, significant head trauma with loss of consciousness requiring hospitalization) within 12 months before starting study treatment.\n5. Major surgery within 4 weeks prior to starting study treatment.\n6. Significant cardiovascular or cerebrovascular disease within 6 months (e.g., unstable angina, myocardial infarction, NYHA class III or higher heart failure, stroke, clinically significant arrhythmia requiring treatment).\n7. Conditions affecting drug intake or absorption (e.g., inability to swallow, chronic diarrhea, intestinal obstruction).\n8. Active infection (e.g., HIV positive, HBsAg positive, HCV positive) which in the investigator's opinion may affect safety or efficacy assessment.\n9. Other malignancies within the past 3 years, except adequately treated basal cell carcinoma of the skin.\n10. Known brain metastases or leptomeningeal disease.\n11. Concurrent participation in another interventional clinical trial or receiving other investigational drugs\u002Fdevices.\n12. Poor compliance or inability to adhere to study procedures and follow-up.\n13. Any other severe uncontrolled comorbidities (e.g., poorly controlled hypertension, severe diabetes, neurologic or psychiatric disorders) or conditions that may interfere with study conduct or interpretation, as judged by the investigator.","MALE","18 Years","70 Years",{"count":90,"type":91},112,"ESTIMATED","INTERVENTIONAL",[94],"PHASE2","This is a prospective, randomized, open-label, phase II multicenter clinical trial evaluating the efficacy and safety of radical prostatectomy in patients with high-volume metastatic hormone-sensitive prostate cancer (mHSPC) who achieve good response after systemic therapy with androgen deprivation therapy (ADT) plus second-generation antiandrogens such as rezvilutamide. All eligible patients will receive 6 months of induction systemic therapy (ADT plus second-generation androgen receptor signaling inhibitors, with or without docetaxel or other systemic agents). Patients who achieve PSMA PET\u002FCT \"conversion success\" (no metabolically active lesions; all metastases with SUVmax below liver background or blood pool) will be randomized 1:1 to continue systemic therapy alone (control arm) or receive local prostate treatment (radical prostatectomy or radiotherapy) plus systemic therapy (experimental arm). The primary endpoint is radiographic progression-free survival (rPFS). Key secondary endpoints include overall survival (OS), biochemical progression-free survival (bPFS), PSA response rate, quality of life, conversion success rate, and safety.",[97,98,99],"Metastatic Prostate Cancer","Prostate Cancer (Adenocarcinoma)","Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)",[101,102,103,104,105,106,107],"High-volume mHSPC","Androgen deprivation therapy","Second-generation antiandrogens","Rezvilutamide","Radical prostatectomy","Radiotherapy","Conversion therapy","NOT_YET_RECRUITING","2025-12-05",{"date":111,"type":112},"2025-12-08","ACTUAL",{"date":114,"type":91},"2025-11-30",{"date":116,"type":91},"2027-12-30",{"name":5,"class":6},1]