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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
496
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
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
Alaska Oncology and Hematology LLC
Anchorage, Alaska, United States
Urological Associates of Southern Arizona PC
Tucson, Arizona, United States
Desert Hematology Oncology Medical Group Inc
Rancho Mirage, California, United States
San Bernardino Urological Associates Medical Group
San Bernardino, California, United States
UF College of Medicine - Jacksonville
Jacksonville, Florida, United States
rPFS by blinded independent central review (BICR) using RESIST1.1 and PCWG3
progression-free survival
Time frame: up to 3 years
OS
time from randomization to death due to any cause
Time frame: up to 4 years
ORR
The percentage of subjects with measureable disease at baseline who achieved a complete or partial response in their soft tissue disease using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria
Time frame: up to 3 years
Time to PSA progression
Time from randomisation to the first time of PSA progression according to the criterion of PCGW3
Time frame: up to 3 years
Time to skeletal-related events
Time from randomisation to the first occurrence of a fracture or treatment for the fracture. The skeletal-related event is defined as the occurrence of either pathological or clinical fracture, spinal cord compression, bone-related radiotherapy or surgery.
Time frame: up to 4 years
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Hematology Oncology Clinic
Baton Rouge, Louisiana, United States
VA Maryland Health Care System
Baltimore, Maryland, United States
Johns Hopkins
Baltimore, Maryland, United States
Henry Ford Health System
Detroit, Michigan, United States
GU Research Network LLC
Omaha, Nebraska, United States
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