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
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
700 participants
INTERVENTIONAL
2025-08-06
2036-04-30
Brief Summary
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Detailed Description
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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).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cohort B: Placebo + Physician's Choice ADT + Abiraterone (and prednisone/prednisolone)
Participants will receive matching placebo to saruparib, abiraterone and prednisolone/prednisone along with ADT.
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.
Cohort A: Saruparib (AZD5305) + Physician's Choice ADT
Participants will receive saruparib along with ADT.
Saruparib
Saruparib will be administered orally.
Androgen Deprivation Therapy (ADT)
Standard of care ADT will be administered.
Cohort A: Placebo + Physician's Choice ADT
Participants will receive matching placebo to saruparib along with ADT.
Placebo
Matching placebo to saruparib will be administered orally.
Androgen Deprivation Therapy (ADT)
Standard of care ADT will be administered.
Cohort B: Saruparib (AZD5305) + Physician's Choice ADT + Abiraterone (and prednisone/prednisolone)
Participants will receive saruparib, abiraterone and prednisolone/prednisone along with ADT.
Saruparib
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
MALE
No
Sponsors
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Parexel
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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La Jolla, California, United States
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Lakewood, Colorado, United States
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Hialeah, Florida, United States
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Newnan, Georgia, United States
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Jeffersonville, Indiana, United States
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Bethesda, Maryland, United States
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Hackensack, New Jersey, United States
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Voorhees Township, New Jersey, United States
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Springfield, Oregon, United States
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Providence, Rhode Island, United States
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Norfolk, Virginia, United States
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Roanoke, Virginia, United States
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Virginia Beach, Virginia, United States
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Seattle, Washington, United States
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CABA, , Argentina
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Ciudad de Buenos Aires, , Argentina
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Orange, , Australia
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Graz, , Austria
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Calgary, Alberta, Canada
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London, Ontario, Canada
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Chicoutimi, Quebec, Canada
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Concepción, , Chile
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Oulu, , Finland
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Le Mans, , France
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Augsburg, , Germany
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Debrecen, , Hungary
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Győr, , Hungary
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Gyula, , Hungary
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Zalaegerszeg, , Hungary
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Ansārinagar, , India
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Babgalore, , India
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Delhi, , India
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Kannur, , India
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Mumbai, , India
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Nagpur, , India
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Arezzo, , Italy
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Batu Caves, , Malaysia
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Hilversum, , Netherlands
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Maastricht, , Netherlands
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Nijmegen, , Netherlands
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Roosendaal, , Netherlands
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Lima, , Peru
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Gdynia, , Poland
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Krakow, , Poland
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Warsaw, , Poland
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Busan, , South Korea
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Gothenburg, , Sweden
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Stockholm, , Sweden
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Stockholm, , Sweden
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Taichung, , Taiwan
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Taichung, , Taiwan
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Tainan, , Taiwan
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Taoyuan District, , Taiwan
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Bangkok, , Thailand
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Bangkok, , Thailand
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Khon Kaen, , Thailand
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Muang, , Thailand
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Pathum Thani, , Thailand
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Songkhla, , Thailand
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Karşıyaka, , Turkey (Türkiye)
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Şahinbey, , Turkey (Türkiye)
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Aberdeen, , United Kingdom
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Barnet, , United Kingdom
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Bristol, , United Kingdom
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Cambridge, , United Kingdom
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Guildford, , United Kingdom
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Manchester, , United Kingdom
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Newcastle, , United Kingdom
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Plymouth, , United Kingdom
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Preston, , United Kingdom
Countries
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Central Contacts
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AstraZeneca Clinical Study Information Center
Role: CONTACT
Phone: 1-877-240-9479
Email: [email protected]
Other Identifiers
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2024-513586-39
Identifier Type: OTHER
Identifier Source: secondary_id
D9727C00001
Identifier Type: -
Identifier Source: org_study_id