drugset / Trial / NCT06952803
A Study of Metastases Free Survival With Saruparib vs Placebo Added to a Standard RT/ADT in Men With High-risk Prostate Cancer With a BRCA Mutation
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of the study is to demonstrate superiority of Saruparib (AZD5305) relative to placebo added to a standard radiation therapy (RT) + androgen deprivation therapy (ADT) regimen by assessment of metastases-free survival in participants with high-risk and very high-risk localised/locally advanced prostate cancer with a breast cancer gene mutation (BRCAm).
Timeline
- Start
- 2025-08-06
- Primary completion
- 2033-03-31
- Completion
- 2036-04-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Saruparib | Small molecule | — | Oral |
| Background | Abiraterone acetate | Small molecule | — | Oral |
| Background | Prednisolone | Other / unclassified | — | — |
| Background | Prednisone | Other / unclassified | — | — |