NCT06120491

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

A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of Saruparib (AZD5305) in Combination With Physician's Choice New Hormonal Agents in Patients With HRRm and Non-HRRm Metastatic Castration-Sensitive Prostate Cancer (EvoPAR-Prostate01)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,800 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: Male
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Metastatic Castration-Sensitive Prostate Cancer

Interventions

Type	Name	Description
DRUG	Saruparib	Oral
DRUG	Placebo	Oral
DRUG	Abiraterone Acetate	Oral
DRUG	Darolutamide	Oral
DRUG	Enzalutamide	Oral

Timeline

• Start date: 2023-11-21
• Primary completion: 2028-01-11
• Completion: 2031-04-30
• First posted: 2023-11-07
• Last updated: 2026-04-03

Locations

410 sites across 27 countries: United States, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Finland, France, Germany, Hungary, India, Italy, Japan, Malaysia, Netherlands, Peru, Poland, Puerto Rico, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study