drugset / Trial / NCT07711002

Saruparib in Combination With Physician's Choice of ARPI in Patients With mHSPC Previously Treated With Docetaxel or 177Lu-PSMA Therapy Without Disease Progression and PSA ≥ 0.2 ng/mL (EvoPAR-PR05)

NCT07711002

Phase 3 Not yet recruiting 1330 enrolled AstraZeneca
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of this study is to measure efficacy of saruparib + physician's choice of ARPI compared with placebo + ARPI in men with metastatic hormone-sensitive prostate cancer (mHSPC) who have previously received docetaxel chemotherapy or a prostate-specific membrane antigen (PSMA)-directed lutetium-177 radioligand therapy with no evidence of disease progression and PSA ≥ 0.2 ng/mL.

Timeline

Start
2026-10-01
Primary completion
2031-06-17
Completion
2033-06-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Saruparib Small molecule 60 mg Oral
Background Abiraterone acetate Small molecule
Background Darolutamide Other / unclassified
Background Enzalutamide Other / unclassified