Clinical trial · Interventional
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
NCT04691804CI-TRIAL-00084243active not recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Castration-Resistant Prostate Cancer (mCRPC) | Castration-Resistant Prostate Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fuzuloparib , Abiraterone acetate and Prednisone | Drug | — | UNRESOLVED |
| Fuzuloparib Placebo， Abiraterone acetate and Prednisone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment group A
- description
- Fuzuloparib plus AA-P
- interventionNames
- Drug: Fuzuloparib , Abiraterone acetate and Prednisone
- type
- PLACEBO_COMPARATOR
- label
- Treatment group B
- description
- Fuzuloparib Placebo plus AA-P
- interventionNames
- Drug: Fuzuloparib Placebo， Abiraterone acetate and Prednisone
Primary outcomes (1)
- measure
- rPFS by blinded independent central review (BICR) using RESIST1.1 and PCWG3
- timeFrame
- up to 3 years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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. The functional level of the organs must meet the requirements 7. Blood and tumor tissue samples are provided during screening to determine the DRD status Exclusion Criteria 1. Prior treatment with any PARP inhibitor 2. Have received any systemic anti-tumor treatment during the mCRPC stage or non-metastatic CRPC stage 3. Have used any CYP3A4 inducers or inhibitors within 14 days prior to the first dose 4. Plan to receive any other anti-tumor treatment 5. Presence of radiologically confirmed tumor lesions in the brain 6. Contraindications to the use of Prednisone 7. History of uncontrolled pituitary or adrenal dysfunction 8. Uncontrolled hypertension 9. Presence of active heart diseases 10. Human immunodeficiency virus-positive 11. Presence of dysphagia, chronic diarrhea, intestinal obstruction, or other factors affecting drug intake and absorption 12. Active HBV or HCV infection 13. Presence of concomitant diseases
References
Publications (0)
Data not yet available
No reference posted for this study.