Clinical Trial

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study of Fuzuloparib Combined With Abiraterone Acetate and Prednisone (AA-P) Versus Placebo Combined With AA-P as First-Line Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer

Active, Not Recruiting Phase 3
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Summary
To evaluate whether Fuzuloparib plus AA-P is superior to placebo plus AA-P as first-line treatment by assessment of radiographic progression-free survival (rPFS) in mCRPC subjects unselected for deoxyribonucleic acid (DNA) damage repair deficiencies (DRD) status (Cohort 1) to evaluate whether Fuzuloparib plus AA-P is superior to placebo plus AA-P as first-line treatment by assessment of rPFS in mCRPC subjects harboring DRD (Cohort 2).
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2020-12-30; most recent amendment 2024-12-30.
Status change: Recruiting → Active, Not Recruiting 2024-12-30
Status change: Not Yet Recruiting → Recruiting 2021-12-09
Trial Details
NCT Number NCT04691804
Lead Sponsor Jiangsu HengRui Medicine Co., Ltd.
Conditions Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Enrollment 496 participants
Start Date 2021-03-18
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-12-31