Trial Identifiers
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Scientific Title
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
Commercial Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Summary
This is a randomised, triple-blind trial with an experimental arm and a placebo comparator arm. In the Experimental Arm, participants will receive Fuzuloparib plus Abiraterone acetate and Prednisone (AA-P). Fuzuloparib will be administered at a dose of 150mg, orally, twice a day. Abiraterone acetate will be administered at a dose of 1000mg, orally, once daily. Prednisone will be administered at a dose of 5mg, orally, twice a day. In the Placebo Comparator Arm, participants will receive a Fuzuloparib placebo plus AA-P. The Fuzuloparib placebo will be administered at a dose of 150mg, orally, twice a day. Abiraterone acetate will be administered at a dose of 1000mg, orally, once daily. Finally, Prednisone will be administered at a dose of 5mg, orally, twice a day.