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)
Sponsor: Fudan University
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Radiographic Progression-free Survival (rPFS)
Time frame: From randomization to radiographic progression or death from any cause, whichever occurs first, up to approximately 24 months.
Secondary Endpoints
Overall Survival (OS)
Biochemical Progression-free Survival (bPFS)
PSA Response Rate at 3 and 6 Months
Eligibility Criteria
Inclusion Criteria: 1. Male patients aged \>18 and ≤70 years, or with an estimated life expectancy \>10 years. 2. Histologically or cytologically confirmed prostate adenocarcinoma with neuroendocrine differentiation ≤10%, and no small cell or signet-ring cell carcinoma component. 3. High-volume metastatic disease according to CHAARTED definition: presence of visceral metastasis and/or ≥4 bone lesions with at least one lesion outside the axial skeleton (vertebral bodies and pelvis). 4. Newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC) who started intensified endocrine therapy within 3 months. 5. ECOG performance status 0-2. 6. Adequate bone marrow, liver, renal, and coagulation function as defined in the protocol (ANC ≥1.5×10\^9/L, hemoglobin ≥9.0 g/dL, platelets ≥80×10\^9/L; TBIL ≤1.5×ULN; AST/ALT/ALP ≤2.5×ULN; albumin ≥30 g/L; creatinine ≤2×ULN or creatinine clearance ≥30 mL/min; INR ≤1.5 in patients not receiving anticoagulation). 7. Patients voluntarily sign info…
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