Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | PHASE3 | ACTIVE NOT_RECRUITING | 496 | — | — | Mar 18, 2021 | Dec 31, 2026 | Dec 31, 2024 | 147 | United States, Australia +11 |
progression-free survival
| Arm | Type | Description |
|---|---|---|
| Treatment group A | EXPERIMENTAL | Fuzuloparib plus AA-P |
| Treatment group B | PLACEBO_COMPARATOR | Fuzuloparib Placebo plus AA-P |
| Name | Type | Description |
|---|---|---|
| Fuzuloparib , Abiraterone acetate and Prednisone | DRUG | 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 |
| Fuzuloparib Placebo， Abiraterone acetate and Prednisone | DRUG | 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 |
Inclusion Criteria 1. Able and willing to provide a written informed consent 2. A score of 0 to 1 for ECOG performance status 3. Age of ≥ 18 years old 4. Prostate adenocarcinoma confirmed 5. Disease progression of metastatic prostate cancer while the subject was on androgen deprivation therapy. 6. ...