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Looking for participantsPhase3

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

Sponsor: AstraZeneca

NCT ID: NCT06952803

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Saruparib (drug), Placebo (drug), Abiraterone + Prednisolone/Prednisone (drug), Androgen Deprivation Therapy (ADT) (drug)
How long the study runs
Study runs about 128 months (dates as stated)
About the drug or intervention
Saruparib — drug: Saruparib will be administered orally. · Placebo — drug: Matching placebo to saruparib will be administered orally. · Abiraterone + Prednisolone/Prednisone — drug: Abiraterone will be administered orally in combination with prednisone/prednisolone. · Androgen Deprivation Therapy (ADT) — drug: Standard of care ADT will be administered.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
Male
Number of participants
700
Started
2025-08-06
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for prostate cancer
  • • Phase3 - 700 participants
  • • 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)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with prostate cancer
  • • Male only

Where?

  • • Aberdeen - Research Site
  • • Bristol - Research Site
  • • Cambridge - Research Site
  • • Edinburgh - Research Site
  • • +12 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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).

More detail

Approximately, 700 adult participants with localised/locally advanced prostate cancer will be randomized in a 1:1 ratio to receive saruparib or placebo with ADT (+ abiraterone) in one of the following two cohorts: Cohort A: 400 adult participants with newly diagnosed high-risk and very high-risk (localised/locally advanced) prostate cancer who have received primary RT and are receiving continuous ADT, and participants with high-risk biochemical recurrence (BCR) \[including prostate-specific antigen (PSA) persistence\] following a radical prostatectomy who have received salvage RT are receiving continuous ADT. Cohort B: 300 adult participants with newly diagnosed very high-risk (locally advanced) prostate cancer who have received primary RT and who are receiving continuous ADT and abiraterone. All participants will be followed for survival until the end of the study. Independent data monitoring committee (DMC) composed of experts will be convened to confirm the safety and efficacy of Saruparib + ADT (+ abiraterone).

Prostate Cancer

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: Male only

Biomarkers mentioned

BRCA1BRCA2

Treatment history

Treatments you must have had:

  • ✓ for enrolment

What the study is looking for

  • ✓Male participants with a histologically documented diagnosis of prostate adenocarcinoma.
  • ✓Newly diagnosed high-risk and very high-risk (localised/that has grown locally) prostate cancer or a high-risk biochemical...
  • ✓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.
  • ✓activity scale (ECOG) performance status of 0 or 1 with no deterioration over the 2 weeks prior...

Who cannot take part

  • ✗Participants with a history of myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML) or with features...
  • ✗Participants with any known predisposition to bleeding \[e.g., active peptic ulceration, recent (within 6 months)...
  • ✗Any history of persisting (\> 2 weeks) severe cytopenia due to any cause.
  • ✗History of another primary cancer, with exceptions.
  • ✗Persistent toxicities \[Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2\] caused by previous...
See the full 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 Is This Study? (16 UK sites)

Research Site

Aberdeen AB25 2ZN, United Kingdom

Recruiting

Research Site

Bristol BS2 8ED, United Kingdom

Recruiting

Research Site

Cambridge CB2 0QQ, United Kingdom

Recruiting

Research Site

Edinburgh EH4 2XU, United Kingdom

Recruiting

Research Site

Exeter EX2 5DW, United Kingdom

Recruiting

Research Site

Glasgow G12 0YN, United Kingdom

Recruiting

Research Site

Greater London SW3 6JJ, United Kingdom

Recruiting

Research Site

Guildford GU2 7XX, United Kingdom

Recruiting

Research Site

London EC1M6BQ, United Kingdom

WITHDRAWN

Research Site

London NW3 2QG, United Kingdom

Recruiting

Research Site

London WC1N 3BG, United Kingdom

Recruiting

Research Site

Manchester M20 4BX, United Kingdom

Recruiting

Research Site

Newcastle NE7 7DN, United Kingdom

WITHDRAWN

Research Site

Plymouth PL6 8DH, United Kingdom

Recruiting

Research Site

Preston PR2 9HT, United Kingdom

WITHDRAWN

Research Site

Romford RM7 0AG, United Kingdom

Recruiting

How to Get in Touch

AstraZeneca Clinical Study Information Center

Sponsor contact

CONTACT

1-877-240-9479 information.center@astrazeneca.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09