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
Start Date
8/6/2025
Completion Date
4/30/2036
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).
Detailed Description
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).
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Saruparib
Placebo
Abiraterone + Prednisolone/Prednisone
Androgen Deprivation Therapy (ADT)
Conditions
Locations
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Phoenix, Arizona 85054
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Tucson, Arizona 85741
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La Jolla, California 92037
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La Jolla, California 92093
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Los Angeles, California 90048
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San Diego, California 92123
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San Luis Obispo, California 93401
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Lakewood, Colorado 80215
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Hialeah, Florida 33016
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Jacksonville, Florida 32224
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Tallahassee, Florida 32308
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Tampa, Florida 33612
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Newnan, Georgia 30265
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Chicago, Illinois 60611
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Chicago Ridge, Illinois 60415
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Lake Barrington, Illinois 60010
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Greenwood, Indiana 46143
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Jeffersonville, Indiana 47130
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Bethesda, Maryland 20817
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Towson, Maryland 21204
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Plymouth, Massachusetts 02360
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Rochester, Minnesota 55905
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Hackensack, New Jersey 07601
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Voorhees Township, New Jersey 08043
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Albany, New York 12206
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New York, New York 10065
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Syracuse, New York 13210
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Columbus, Ohio 43230
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Springfield, Oregon 97477
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Hershey, Pennsylvania 17033
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Lancaster, Pennsylvania 17601
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Pittsburgh, Pennsylvania 15212
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Providence, Rhode Island 02903
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Myrtle Beach, South Carolina 29572
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Nashville, Tennessee 37209
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Austin, Texas 78705
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Austin, Texas 78745
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Houston, Texas 77074
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San Antonio, Texas 78229
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Spring, Texas 77380
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Salt Lake City, Utah 84112
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Norfolk, Virginia 23502
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Roanoke, Virginia 24014
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Virginia Beach, Virginia 23462
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Seattle, Washington 98109
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CABA, 1426
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CABA, C1113AAE
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Ciudad de Buenos Aires, 1181
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Ciudad de Buenos Aires, 1426
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Ciudad de Buenos Aires, C1419AHL
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Córdoba, 5000
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Córdoba, X5008HHW
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Cuidad Autónoma de Buenos Aire, C1426ANZ
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La Plata, 1900
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Pergamino, B2700CPM
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Cachoeiro de Itapemirim, 29308-014
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Curitiba, 80810-050
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Curitiba,
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Jaú, 17210-120
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Londrina, 86015-520
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Pelotas, 96020-080
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Porto Alegre, 90035-000
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Porto Alegre, 91350200
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Rio de Janeiro, 22.250-905
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Rio de Janeiro, 22775-001
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La Serena, 1720430
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Temuco, 4781156
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Beijing, 100020
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Beijing, 100021
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