Saruparib is a new pill that blocks PARP1, a protein cancer cells use to repair DNA. Laboratory and early‑phase studies indicated 60 mg once a day as the recommended dose. Adding saruparib might hold the cancer in check for longer.
Phase 3 Trial of Saruparib (AZD5305) With Standard Hormone Therapy After Radiotherapy for BRCA‑Mutated, High‑Risk Prostate Cancer
Why Is This Study Needed?
- Prostate cancer is the most common cancer in men. About 1.4 million men were diagnosed in 2020
- Men whose tumors carry BRCA1 or BRCA2 gene changes often get faster-growing cancer and are more likely to have it spread.
- The usual care for high-risk disease is external‑beam radiotherapy plus at least 2 years of androgen‑deprivation therapy (ADT). Very high-risk patients may also take the hormone-blocking drug abiraterone. One‑third of men still go on to develop metastatic cancer.
How The Trial Works:
- Sponsor / ID: AstraZeneca – D9727C00001 (EvoPAR Pro2)
- Phase/design: Phase 3, double blind, placebo-controlled, randomized
- Participants: ~700 men (≈ 400 in Cohort A, 300 in Cohort B) in about 300 centers across ~26 countries*
- Core treatment: All men keep receiving ADT for 24 months; Cohort B also receives abiraterone + low-dose prednisone for 24 months
- Study drug: Either 60 mg saruparib or a matching placebo tablet once daily
- Visits & tests: Clinic visits every 4 weeks for exams and blood counts, PSA testing every 3 months
- Follow up: Safety visit ~30 days after last dose, then PSA testing continues every 3 months, and once PSA rises, imaging scans (CT/MRI, bone and PSMA-PET) are performed and then repeated every 6 months
*Site and country counts are based on the current internal plan; individual centers will open in stages.
Who Can Participate?
Men ≥ 18 years who
- Have a confirmed BRCA1/2‑mutated high-risk or very high-risk prostate adenocarcinoma (newly diagnosed or high-risk biochemical recurrence after prostatectomy).
- Finished curative‑intent radiotherapy.
- Are already on continuous ADT (± abiraterone for very high‑risk cases).
Men cannot take part if they have another active cancer within 3 years, recent major surgery or palliative radiation, serious heart/liver/kidney disease, prior PARP‑inhibitor use, or other listed medical issues.
What Will I Do In The Study?
- Take three tablets of saruparib or a placebo each day.
- Keep receiving hormone shots or implants for 24 months (and abiraterone + prednisone if in Cohort B).
- Record tablets and symptoms in an electronic diary.
- Attend short clinic visits and routine scans. If the side effects become too hard, you can choose to stop, or the global study will end.
Possible Patient Benefits
- May delay or prevent the spread of cancer.
- Close monitoring by prostate cancer experts.
- All study tests and medicines are free.
Possible Patient Risks
- Saruparib can cause tiredness, nausea, or low blood counts, like other PARP inhibitors.
- Side effects could be higher when combined with hormone therapy.
- Unknown or rare risks can emerge in any clinical trial.
Want to learn more?
Speak with your oncologist or search “NCT06952803” on ClinicalTrials.gov. You can also visit AstraZenecaClinicalTrials.com and look for D9727C00001 (EvoPAR‑Prostate02). Staff will explain every detail before you decide.
Organization:
- AstraZeneca
- If interested, visit AstraZenecaClinicalTrials.com
ClinicalTrials.gov Information
- NCT Number: NCT06952803
- Title: 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)
Use the “clinical trials glossary” and “dictionary” for words, phrases, and treatments that you may not understand.
Register your interest or comments about this trial with PHEN
Please note: This information is provided for educational and awareness purposes. A decision on clinical trial participation is to be made between the patient and his doctor.
Glossary of Key Terms
ADT (Androgen deprivation therapy): Medicines or injections that lower testosterone and other male hormones to slow prostate cancer growth.
Abiraterone: An oral drug that blocks hormone production in the adrenal glands; taken with low-dose prednisone.
BRCA1 / BRCA2: Genes that normally repair DNA. When faulty, they raise the risk of breast, ovarian, and aggressive prostate cancer.
Cohort: A predefined group inside a trial that follows a specific treatment plan.
CT / MRI / PSMA PET / Bone scan: Imaging tests that look for cancer inside the body or bones.
Double-blind: Neither patients nor doctors know who receives the real drug or placebo.
Metastasis-free survival: Time from randomization until the cancer spreads outside of the pelvic region or the patient dies of any cause.
PARP1 inhibitor: A drug class that blocks the PARP1 enzyme so cancer cells cannot repair DNA damage.
Placebo: An inactive tablet that looks like the real medicine; used for fair comparison.
Prednisone/Prednisolone: Low-dose steroid given with abiraterone to prevent side effects.
Radiotherapy (RT): High-energy X-ray treatment aimed at the prostate (and sometimes the pelvic lymph nodes).
Randomized: Participants are assigned to study groups by chance, not by choice.
Saruparib (AZD5305): An investigational, highly selective PARP1 inhibitor taken as a pill once daily.
