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).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
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
Where Is This Study? (16 UK sites)
Research Site
Aberdeen AB25 2ZN, United Kingdom
Research Site
Bristol BS2 8ED, United Kingdom
Research Site
Cambridge CB2 0QQ, United Kingdom
Research Site
Edinburgh EH4 2XU, United Kingdom
Research Site
Exeter EX2 5DW, United Kingdom
Research Site
Glasgow G12 0YN, United Kingdom
Research Site
Greater London SW3 6JJ, United Kingdom
Research Site
Guildford GU2 7XX, United Kingdom
Research Site
London EC1M6BQ, United Kingdom
Research Site
London NW3 2QG, United Kingdom
Research Site
London WC1N 3BG, United Kingdom
Research Site
Manchester M20 4BX, United Kingdom
Research Site
Newcastle NE7 7DN, United Kingdom
Research Site
Plymouth PL6 8DH, United Kingdom
Research Site
Preston PR2 9HT, United Kingdom
Research Site
Romford RM7 0AG, United Kingdom
How to Get in Touch
AstraZeneca Clinical Study Information Center
Sponsor contactCONTACT
