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 (Jun 2026). This Phase 3 trial studies multiple treatments including Saruparib and Abiraterone + Prednisolone/Prednisone for prostate cancer.
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).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
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)
Demographics
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 →Frequently asked questions
Is NCT06952803 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior chemotherapy, immunotherapy, PARP inhibitor disqualifies patients from enrollment.
Does this trial require BRCA1?
Yes, BRCA1 mutation is a required biomarker for enrollment.
Does this trial require BRCA2?
Yes, BRCA2 mutation is a required biomarker for enrollment.
What disease stage is eligible?
Stage HIGH-RISK or VERY HIGH-RISK or LOCALISED or III or BIOCHEMICAL RECURRENCE (BCR) is required.
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages