OncoMatch/Clinical Trials/NCT06952803

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

Is NCT06952803 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Saruparib and Abiraterone + Prednisolone/Prednisone for prostate cancer.

Phase 3RecruitingAstraZenecaNCT06952803Data as of May 2026

Treatment: Saruparib · Abiraterone + Prednisolone/Prednisone · Androgen Deprivation Therapy (ADT) — The purpose of the study is to demonstrate superiority of Saruparib (AZD5305) relative to placebo added to a standard radiation therapy (RT) + androgen deprivation therapy (ADT) regimen by assessment of metastases-free survival in participants with high-risk and very high-risk localised/locally advanced prostate cancer with a breast cancer gene mutation (BRCAm).

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Extracted eligibility criteria

Cancer type

Prostate Cancer

Biomarker criteria

Required: BRCA1 mutation

Required: BRCA2 mutation

Disease stage

Required: Stage HIGH-RISK, VERY HIGH-RISK, LOCALISED, III, BIOCHEMICAL RECURRENCE (BCR)

Newly diagnosed high-risk and very high-risk (localised/locally advanced) prostate cancer or a high-risk biochemical recurrence (BCR) following radical prostatectomy

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: radiation therapy — primary or salvage

All participants will have received either primary or salvage RT. Radiotherapy administered to the prostate (± pelvis) either in the primary or salvage setting must be delivered with curative intent.

Must have received: androgen deprivation therapy (gonadotropin releasing hormone (GnRH) analogue)

All participants will have received a planned regimen of ADT with a gonadotropin releasing hormone (GnRH) analogue.

Cannot have received: chemotherapy (docetaxel)

Any prior chemotherapy (i.e., docetaxel) or immunotherapy

Cannot have received: immunotherapy

Any prior chemotherapy (i.e., docetaxel) or immunotherapy

Cannot have received: PARP inhibitor

any prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor

Lab requirements

Blood counts

Adequate organ and bone marrow function as described in study protocol

Kidney function

Adequate organ and bone marrow function as described in study protocol

Liver function

Adequate organ and bone marrow function as described in study protocol

Adequate organ and bone marrow function as described in study protocol

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

Research Site · Phoenix, Arizona
Research Site · Tucson, Arizona
Research Site · La Jolla, California
Research Site · La Jolla, California
Research Site · Los Angeles, California

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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