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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
Sponsor: AstraZeneca
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).
Official title: 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).
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
700
Start Date
2025-08-06
Completion Date
2036-04-30
Last Updated
2026-03-10
Healthy Volunteers
No
Conditions
Interventions
Saruparib
Saruparib will be administered orally.
Placebo
Matching placebo to saruparib will be administered orally.
Abiraterone + Prednisolone/Prednisone
Abiraterone will be administered orally in combination with prednisone/prednisolone.
Androgen Deprivation Therapy (ADT)
Standard of care ADT will be administered.
Locations (328)
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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La Jolla, California, United States
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La Jolla, California, United States
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Los Angeles, California, United States
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San Luis Obispo, California, United States
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Lakewood, Colorado, United States
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Greenwood, Indiana, United States
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Rochester, Minnesota, United States
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Diyarbakır, Turkey (Türkiye)
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