drugset / Trial / NCT06120491

Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents

NCT06120491

Phase 3 Active not recruiting 1889 enrolled AstraZeneca
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The intention of the study is to demonstrate superiority of Saruparib (AZD5305) + physician's choice NHA relative to placebo + physician's choice NHA by assessment of radiographic progression-free survival (rPFS) in participants with mCSPC.

Timeline

Start
2023-11-21
Primary completion
2027-09-30
Completion
2031-04-30

Drugs

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