drugset / Trial / NCT06392841
Niraparib, Abiraterone Acetate and Prednisone for mHSPC With Deleterious Homologous Recombination Repair Alterations
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is an open label, phase II trial in subjects with treatment naïve, metastatic hormone sensitive prostate cancer (mHSPC) with deleterious homologous recombination repair (HRR) alteration(s). These include pathologic alterations in BRCA 1/2, BRIP1, CHEK2, FANCA, PALB2, RAD51B, and/or RAD54L. A total of 64 people will be enrolled to the study.
Timeline
- Start
- 2025-10
- Primary completion
- 2028-01-31
- Completion
- 2029-01-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abiraterone acetate | Small molecule | 1000 mg | Oral |
| Subject | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Subject | Niraparib | Small molecule | 200 mg | Oral |
| Background | Prednisone | Other / unclassified | 5 mg | Oral |