A Study of the PARP Inhibitor Saruparib Added to Standard Treatment for High Risk BRCA-Positive Prostate Cancer (EvoPAR PR02)
https://www.facingourrisk.org/research-clinical-trials/study/369/a-study-of-the-parp-inhibitor-saruparib-added-to-standard-treatment-for-high-risk-brca1-positive-prostate-cancer
Clinicaltrials.gov identifier:
NCT06952803 (https://clinicaltrials.gov/show/NCT06952803)
Treatment
Phase 3 treatment study for BRCA-positive high-risk prostate cancer
Study Contact Information:
AstraZeneca Clinical Study Information Center
📞 1‑877‑240‑9479
📧 [email protected]
About the Study
This study is testing a new medication called saruparib (AZD5305) to see if it can help people with prostate cancer that is high risk for getting worse or spreading to other parts of the body. Saruparib is a type of targeted therapy known as a PARP inhibitor. The study is open to people with a BRCA1 or BRCA2 mutation. The goal of this study is to find out if adding saruparib after radiation treatment can lower the chances of the cancer coming back or spreading.
What the Study Involves
Everyone in the study will receive standard treatment for prostate cancer, including hormone therapy. Some participants may also receive abiraterone plus prednisone, depending on their cancer features.
Participants are then randomly assigned to receive either:
- Saruparib (the study drug), or
- A placebo (a pill with no active medicine)
Neither the participant nor the study doctor will know which treatment is being given. Treatment with saruparib or placebo can last up to 2 years. Participants will be followed after treatment is complete.
Researchers will measure how long participants live without the cancer returning or spreading. This is called "metastasis-free survival." They will also track how long study participants live overall, as well as any side effects of the medication(s).
This Study is Open To:
You may be able to join if you have all of the following:
- Are 18 or older
- Have high‑risk or very high‑risk prostate cancer that:
- Has not spread outside the pelvis, or
- Came back after prostate surgery (biochemical recurrence)
- Have a confirmed BRCA1 or BRCA2 mutation found on tumor testing
- Have had or are currently having radiation therapy
- Are receiving hormone therapy (ADT)
- Are able to carry out most daily activities
This Study is Not Open To:
You cannot join if you:
- Have already received chemotherapy or a PARP inhibitor
- Have certain serious medical conditions
- Have another active cancer (with some exceptions)
About FORCE
FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.