NCT04691804

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 496 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Interventions

Type	Name	Description
DRUG	Fuzuloparib , Abiraterone acetate and Prednisone	1. Fuzuloparib capsules (strength: 50 mg),150mg, Bid,po 2. Abiraterone acetate tablets (strength: 250 mg) 1000mg Qd,po 3. Prednisone tablets (strength: 5 mg) 5mg, Bid po
DRUG	Fuzuloparib Placebo， Abiraterone acetate and Prednisone	1. Fuzuloparib capsules Placebo (strength: 50 mg),150mg, Bid,po 2. Abiraterone acetate tablets (strength: 250 mg)1000mg Qd,po 3. Prednisone tablets (strength: 5 mg)5mg, Bid po

Timeline

• Start date: 2021-03-18
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2020-12-31
• Last updated: 2024-12-31

Locations

147 sites across 13 countries: United States, Australia, Belgium, China, Czechia, France, Hungary, Poland, Russia, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study