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)
Objective
To demonstrate the superiority of adjuvant saruparib relative to placebo added to standard ADT therapy in participants with high-risk and very high-risk (localised/locally advanced) prostate cancer with a BRCA1/2 mutation receiving either primary or salvage RT (Cohort A) by assessment of MFS using standard clinical imaging, by BICR.
To demonstrate the superiority of adjuvant saruparib relative to placebo added to standard ADT therapy plus abiraterone in participants with localised very high-risk prostate cancer with a BRCA1/2 mutation receiving primary RT (Cohort B) by assessment of MFS using standard clinical imaging, by BICR.
To demonstrate the superiority of adjuvant saruparib relative to placebo added to standard ADT therapy for participants in Cohort A by assessment of OS.
To demonstrate the superiority of adjuvant saruparib relative to placebo added to standard ADT therapy plus abiraterone for participants in Cohort B by assessment of OS.
