drugset / Trial / NCT06527690
Race Impact on Efficacy of Niraparib Plus Abiraterone Acetate and Prednisone in Patients With Homologous Repair Deficient Castration-resistant Prostate Cancer
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is an open-label, multicenter, interventional study in racially self-identified black or ethnically self-identified hispanic and racially self-identified white or native American participants with metastatic castration-resistant prostate cancer whose tumors demonstrate molecular alterations compatible with homologous repair deficiency.
Timeline
- Start
- 2025-04-30
- Primary completion
- 2027-09-30
- Completion
- 2028-02-28
Outcome
Outcome not reported
Stopped (Enrollment): “The study aimed to include multiple countries in Latin America, but only Brazil was feasible, making the intended ethnic and racial design unviable. Activities were closed and no sites were opened for recruitment.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abiraterone acetate | Small molecule | 500 mg | — |
| Subject | Niraparib | Small molecule | 100 mg | — |
| Background | Prednisone | Other / unclassified | 5 mg | — |