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

Summary

Objectives

Approximately 1800 adult participants with mCSPC will be assigned to one of two cohorts
(550 HRRm and 1250 non-HRRm) and randomized in a 1:1 ratio to receive either Saruparib
(AZD5305) with NHA or placebo with NHA. They will receive their assigned treatment and
regular tumor evaluation scans until disease progression, or until treatment is stopped
for another reason.

All patients will be followed for survival until the end of the study. Independent data
monitoring committee (DMC) composed of independent experts will be convened to confirm
the safety and tolerability of Saruparib (AZD5305) + physicians choice NHA.