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
| NCT ID | NCT06952803 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | AstraZeneca |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 700 participants |
| Start Date | 2025-08-06 |
| Primary Completion | 2033-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 700 participants in total. It began in 2025-08-06 with a primary completion date of 2033-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06952803 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06952803 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 700 participants.
Is NCT06952803 currently recruiting?
Yes, NCT06952803 is actively recruiting participants. Contact the research team at information.center@astrazeneca.com for enrollment information.
Where is the NCT06952803 trial being conducted?
This trial is being conducted at Phoenix, United States, Tucson, United States, La Jolla, United States, La Jolla, United States and 11 additional locations.
Who is sponsoring the NCT06952803 clinical trial?
NCT06952803 is sponsored by AstraZeneca. The trial plans to enroll 700 participants.
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