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
试验速览
- 阶段
- 3 期
- 状态
- 进行中(未招募)
- 入组人数
- 496
- 试验地点
- 147
- 主要终点
- rPFS by blinded independent central review (BICR) using RESIST1.1 and PCWG3
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Treatment group A
Fuzuloparib plus AA-P
干预措施: Fuzuloparib , Abiraterone acetate and Prednisone (Drug)
Treatment group B
Fuzuloparib Placebo plus AA-P
干预措施: Fuzuloparib Placebo, Abiraterone acetate and Prednisone (Drug)
结局指标
主要结局
rPFS by blinded independent central review (BICR) using RESIST1.1 and PCWG3
时间窗: up to 3 years
progression-free survival
次要结局
- ORR(up to 3 years)
- Time to PSA progression(up to 3 years)
- OS(up to 4 years)
- Time to skeletal-related events(up to 4 years)
