Overview

A 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 (mCRPC)

Status:
Not yet recruiting

Trial end date:
2026-12-31

Target enrollment:

Participant gender:

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).

Phase:

Phase 3

Details

Lead Sponsor:

Jiangsu HengRui Medicine Co., Ltd.

Treatments:

Abiraterone Acetate
Prednisone