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Clinical Trials in the UK / NCT06952803
Recruiting Phase 3

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

NCT06952803 · tracked via the Priya Life Science UK tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2025-08-06
Last updated
2026-08-21

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

SaruparibPlaceboAbiraterone + Prednisolone/PrednisoneAndrogen Deprivation Therapy (ADT)

Saruparib: Saruparib will be administered orally.

Placebo: Matching placebo to saruparib will be administered orally.

Abiraterone + Prednisolone/Prednisone: Abiraterone will be administered orally in combination with prednisone/prednisolone.

Androgen Deprivation Therapy (ADT): Standard of care ADT will be administered.

Study 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

Sex
MALE
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (346)

FacilityCityRegionStatus
Research Site Phoenix Arizona Recruiting
Research Site Tucson Arizona Withdrawn
Research Site La Jolla California Recruiting
Research Site La Jolla California Recruiting
Research Site Los Angeles California Recruiting
Research Site San Diego California Recruiting
Research Site San Luis Obispo California Recruiting
Research Site Lakewood Colorado Recruiting
Research Site Hialeah Florida Recruiting
Research Site Jacksonville Florida Recruiting
Research Site Tallahassee Florida Withdrawn
Research Site Tampa Florida Recruiting
Research Site Newnan Georgia Recruiting
Research Site Chicago Illinois Recruiting
Research Site Chicago Ridge Illinois Recruiting
Research Site Lake Barrington Illinois Withdrawn
Research Site Greenwood Indiana Recruiting
Research Site Jeffersonville Indiana Withdrawn
Research Site Bethesda Maryland Withdrawn
Research Site Towson Maryland Recruiting
Research Site Plymouth Massachusetts Recruiting
Research Site Rochester Minnesota Recruiting
Research Site Hackensack New Jersey Recruiting
Research Site Voorhees Township New Jersey Recruiting
Research Site Albany New York Withdrawn
Research Site New York New York Recruiting
Research Site Syracuse New York Recruiting
Research Site Columbus Ohio Recruiting
Research Site Springfield Oregon Recruiting
Research Site Hershey Pennsylvania Recruiting
Research Site Lancaster Pennsylvania Recruiting
Research Site Pittsburgh Pennsylvania Recruiting
Research Site Providence Rhode Island Recruiting
Research Site Myrtle Beach South Carolina Recruiting
Research Site Nashville Tennessee Recruiting
Research Site Austin Texas Recruiting
Research Site Austin Texas Recruiting
Research Site Houston Texas Recruiting
Research Site San Antonio Texas Recruiting
Research Site Spring Texas Recruiting

+ 306 more sites — see the full list on the official registry below.

More AstraZeneca trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06952803 on ClinicalTrials.gov ↗ ← All trials in the UK