EvoPAR Prostate 02
Research type
Research Study
Full 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)
IRAS ID
1012279
Contact name
Adesola Obunge
Contact email
Sponsor organisation
AstraZeneca AB
Clinicaltrials.gov Identifier
Research summary
Prostate cancer is a big health concern for men around the world. It's the second most common cancer in men and the fifth leading cause of cancer deaths in men.
BRCA genes are in everyone’s body. BRCA genes produce proteins that help prevent rapid cell growth and repair DNA damage. Mutations in BRCA genes can impair this function, increasing the risk of prostate cancer.
Saruparib is a PARP1 inhibitor, a drug that blocks the PARP1 enzyme involved in cell repair and growth. By inhibiting PARP1, saruparib may prevent cancer cells from repairing themselves, potentially leading to the cancer cells’ death.
There are 2 cohorts in the study:
• Cohort A: Saruparib or placebo + ADT, where participants continue receiving the same ADT treatment that they were taking before the study.
• Cohort B: Saruparib or placebo + ADT + abiraterone (and prednisone/prednisolone), where participants continue receiving the ADT and abiraterone treatment they were taking before the study.The study is randomised, meaning participants and researchers will not know what treatment each participant is receiving. Participants have a 1 in 2 chance of receiving saruparib in either cohort.
The study treatment, saruparib or placebo, will be supplied as tablets and will be taken by mouth every day. Study treatment is given in monthly (28-day) cycles. Treatment duration will be up to 24 months and participants will remain on the study for up to 5 years.
Doctors will monitor participants’ health and disease progress during the trial and participants will be asked to report their symptoms.Participants may not directly benefit from taking part in this study as efficacy of saruparib is unknown, but they may help patients in the future by improving the knowledge of and possible treatment regimens for these diseases.
The trial will include approximately 700 participants aged 18 years or older across 300 sites in 26 countries.
REC name
London - London Bridge Research Ethics Committee
REC reference
25/LO/0641
Date of REC Opinion
3 Oct 2025
REC opinion
Further Information Favourable Opinion