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Adding saruparib to radiation and hormone therapy for high-risk prostate cancer with a BRCA mutation

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).

PHASE3 · AstraZeneca · NCT06952803

This trial will test whether adding saruparib to standard radiation and androgen‑deprivation therapy helps men with high‑risk localized or locally advanced prostate cancer who have a BRCA1 or BRCA2 mutation stay metastasis‑free longer.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment700 (estimated)
Ages18 Years and up
SexMale
SponsorAstraZeneca (industry)
Drugs / interventionschemotherapy, immunotherapy, radiation
Locations329 sites (Phoenix, Arizona and 328 other locations)
Trial IDNCT06952803 on ClinicalTrials.gov

What this trial studies

Approximately 700 men with high‑risk or very high‑risk localized/locally advanced prostate cancer and a confirmed BRCA1/2 tumor mutation will be randomized 1:1 to receive saruparib or placebo in addition to standard radiation therapy and continuous androgen‑deprivation therapy, with a subgroup also receiving abiraterone. Participants are enrolled into two cohorts based on disease status and planned systemic therapy, and must have no distant metastases on CT/MRI, bone scan, and PSMA‑PET after planned RT. The primary outcome is metastasis‑free survival, and all participants will be followed for long‑term survival with oversight by an independent data monitoring committee. Central confirmation of BRCA status and regular imaging and clinical visits are required for safety monitoring and outcome assessment.

Who should consider this trial

Good fit: Men with histologically confirmed prostate adenocarcinoma who have high‑risk or very high‑risk localized/locally advanced disease or high‑risk biochemical recurrence after prostatectomy, a centrally confirmed BRCA1 or BRCA2 tumor mutation, no distant metastases on required imaging, and who are able to receive radiation and continuous androgen‑deprivation therapy (with abiraterone in the specified cohort) are ideal candidates.

Not a fit: Patients without a BRCA1/2 mutation, those with metastatic disease on screening imaging, or those unable to tolerate the required radiation, imaging, or systemic therapies are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, adding saruparib could delay or prevent the development of metastases and extend the time men with BRCA‑mutant high‑risk prostate cancer remain metastasis‑free.

How similar studies have performed: PARP inhibitors have shown benefit in BRCA‑mutant metastatic prostate cancer, but combining a selective PARP1 inhibitor like saruparib with curative‑intent radiation plus ADT in high‑risk localized disease is a relatively novel approach that has not been proven in this setting.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Male participants with a histologically documented diagnosis of prostate adenocarcinoma.
* Newly diagnosed high-risk and very high-risk (localised/locally advanced) prostate cancer or a high-risk biochemical recurrence (BCR) following radical prostatectomy.
* Provision of a formalin fixed and paraffin embedded (FFPE) tumour tissue sample.
* Confirmed BRCA1 or BRCA2 mutation status by central tumour tissue is required for enrolment.
* Participants required to have a computed tomography (CT) or magnetic resonance imaging (MRI) and a bone scan following the completion of their planned RT. This screening scan must confirm no evidence of disease or evidence of disease confined to the pelvis (M0).
* Participants required to have a prostate-specific membrane antigen-positron emission tomography (PSMA-PET) following the completion of their planned RT. This screening scan must confirm no evidence of disease or evidence of disease confined to the pelvis (M0).
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no deterioration over the 2 weeks prior to randomization.
* Minimum life expectancy of 12 months.
* Adequate organ and bone marrow function as described in study protocol.
* All participants will have received either primary or salvage RT. Participants must be eligible for randomisation within 10 months of initial diagnosis (de novo or BCR). Radiotherapy administered to the prostate (± pelvis) either in the primary or salvage setting must be delivered with curative intent. Use of metastases-directed therapy, as part of the RT radiation plan, is permitted as localised RT treatment for a metastatic lesion(s) outside the pelvis.
* All participants will have received a planned regimen of ADT with a gonadotropin releasing hormone (GnRH) analogue.
* Participants must not father children or donate sperm from signing informed consent form (ICF), during the study intervention and for 6 months after the last dose of study intervention.
* Participants must use a condom (with spermicide - where permitted) from signing ICF, during study intervention, and for 6 months after the last dose of study drug, with all sexual partners.

Exclusion Criteria:

* Participants with a history of myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
* Participants with any known predisposition to bleeding \[e.g., active peptic ulceration, recent (within 6 months) hemorrhagic stroke, proliferative diabetic retinopathy\].
* Any history of persisting (\> 2 weeks) severe cytopenia due to any cause.
* Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of saruparib and/or abiraterone.
* History of another primary malignancy, with exceptions.
* Persistent toxicities \[Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2\] caused by previous anticancer therapy.
* Cardiac criteria, including history of arrhythmia and cardiovascular disease.
* Evidence of active and uncontrolled hepatitis B and/or hepatitis C.
* Evidence of active and uncontrolled human immunodeficiency virus (HIV) infection.
* Active tuberculosis infection.
* Any prior chemotherapy (i.e., docetaxel) or immunotherapy; any prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor.
* Prior treatment within 14 days with blood product support or growth factor support.
* Concomitant use of strong inducers and inhibitors of CYP3A4 (applies to saruparib and abiraterone) or herbal supplements within 21 days or at least 5 half-lives (whichever is longer), of randomization.
* Concomitant use of drugs that are known to prolong QT and have a known risk of Torsades de Pointes (TdP).
* Participants with a known hypersensitivity to saruparib or any excipients of these products.

Where this trial is running

Phoenix, Arizona and 328 other locations

+279 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Prostate Cancer, Localised/locally advanced prostate cancer, High-risk biochemical recurrence, Poly polymerase, Radiation therapy or radiotherapy, Breast cancer gene mutation

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.