Phase 3Recruiting
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 (EvoPAR-PR02)
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).
- Sponsor
- AstraZeneca (Industry)
- Enrolment
- 700 planned
- Conditions
- Prostate Cancer
- Interventions
- Saruparib; Placebo; Abiraterone + Prednisolone/Prednisone; Androgen Deprivation Therapy (ADT)
- Ages
- adults, older adults
- Registry
- NCT06952803, CTIS2024-513586-39-00
Full record on ClinicalTrials.gov
From the registry
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).
Primary outcomes
- Metastasis-free survival (MFS)
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered