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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
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).
Details
| Lead sponsor | Jiangsu HengRui Medicine Co., Ltd. |
|---|---|
| Phase | PHASE3 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 496 |
| Start date | Thu Mar 18 2021 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Thu Dec 31 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Interventions
- Fuzuloparib , Abiraterone acetate and Prednisone
- Fuzuloparib Placebo， Abiraterone acetate and Prednisone
Countries
France, Russia, Belgium, Taiwan, United Kingdom, Hungary, Poland, South Korea, Australia, China, United States, Spain, Czechia