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

A Randomised, Double-blind, Placebo-controlled, Phase III Study of Adjuvant Saruparib (AZD5305) in Patients With BRCAm Localised High-Risk Prostate Cancer Receiving Radiotherapy With Androgen Deprivation Therapy (EvoPAR-Prostate02).

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 700 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Approximately, 700 adult participants with localised/locally advanced prostate cancer will be randomized in a 1:1 ratio to receive saruparib or placebo with ADT (+ abiraterone) in one of the following two cohorts: Cohort A: 400 adult participants with newly diagnosed high-risk and very high-risk (localised/locally advanced) prostate cancer who have received primary RT and are receiving continuous ADT, and participants with high-risk biochemical recurrence (BCR) \[including prostate-specific antigen (PSA) persistence\] following a radical prostatectomy who have received salvage RT are receiving continuous ADT. Cohort B: 300 adult participants with newly diagnosed very high-risk (locally advanced) prostate cancer who have received primary RT and who are receiving continuous ADT and abiraterone. All participants will be followed for survival until the end of the study. Independent data monitoring committee (DMC) composed of experts will be convened to confirm the safety and efficacy of Saruparib + ADT (+ abiraterone).

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Saruparib	Saruparib will be administered orally.
DRUG	Placebo	Matching placebo to saruparib will be administered orally.
DRUG	Abiraterone + Prednisolone/Prednisone	Abiraterone will be administered orally in combination with prednisone/prednisolone.
DRUG	Androgen Deprivation Therapy (ADT)	Standard of care ADT will be administered.

Timeline

• Start date: 2025-08-06
• Primary completion: 2033-03-31
• Completion: 2036-04-30
• First posted: 2025-05-01
• Last updated: 2026-03-10

Locations

328 sites across 28 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Finland, France, Germany, Hungary, India, Israel, Italy, Japan, Malaysia, Netherlands, Peru, Poland, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study