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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
AstraZeneca
Study ID
NCT06952803
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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).

Key Dates

Start date
Aug 6, 2025
Status verified
May 2026
Primary completion
Mar 31, 2033
Completion
Apr 30, 2036

Study Design

Enrollment
700 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A: Saruparib (AZD5305) + Physician's Choice ADT
    Participants will receive saruparib along with ADT.
  • Placebo Comparator: Cohort A: Placebo + Physician's Choice ADT
    Participants will receive matching placebo to saruparib along with ADT.
  • Experimental: Cohort B: Saruparib (AZD5305) + Physician's Choice ADT + Abiraterone (and prednisone/prednisolone)
    Participants will receive saruparib, abiraterone and prednisolone/prednisone along with ADT.
  • Placebo Comparator: 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.

Primary Outcome Measure

Metastasis-free survival (MFS) [ Time Frame: Up to approximately 93 months ]

Central Contacts

Locations (42)

FacilityCityStateZIPSite coordinators
Research SitePhoenixArizona85054-
Research SiteTucsonArizona85741-
Research SiteLa JollaCalifornia92037-
Research SiteLa JollaCalifornia92093-
Research SiteLos AngelesCalifornia90048-
Research SiteSan DiegoCalifornia92123-
Research SiteSan Luis ObispoCalifornia93401-
Research SiteLakewoodColorado80215-
Research SiteHialeahFlorida33016-
Research SiteJacksonvilleFlorida32224-
Research SiteTampaFlorida33612-
Research SiteNewnanGeorgia30265-
Research SiteChicagoIllinois60611-
Research SiteChicago RidgeIllinois60415-
Research SiteGreenwoodIndiana46143-
Research SiteJeffersonvilleIndiana47130-
Research SiteBethesdaMaryland20817-
Research SiteTowsonMaryland21204-
Research SitePlymouthMassachusetts02360-
Research SiteRochesterMinnesota55905-
Research SiteHackensackNew Jersey07601-
Research SiteVoorhees TownshipNew Jersey08043-
Research SiteNew YorkNew York10065-
Research SiteSyracuseNew York13210-
Research SiteColumbusOhio43230-
Research SiteSpringfieldOregon97477-
Research SiteHersheyPennsylvania17033-
Research SiteLancasterPennsylvania17601-
Research SitePittsburghPennsylvania15212-
Research SiteProvidenceRhode Island02903-
Research SiteMyrtle BeachSouth Carolina29572-
Research SiteNashvilleTennessee37209-
Research SiteAustinTexas78705-
Research SiteAustinTexas78745-
Research SiteHoustonTexas77074-
Research SiteSan AntonioTexas78229-
Research SiteSpringTexas77380-
Research SiteSalt Lake CityUtah84112-
Research SiteNorfolkVirginia23502-
Research SiteRoanokeVirginia24014-
Research SiteVirginia BeachVirginia23462-
Research SiteSeattleWashington98109-

Find similar trials in Phoenix, AZ

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Research Site· Phoenix, AZResearch Site· Tucson, AZResearch Site· La Jolla, CAResearch Site· Los Angeles, CAResearch Site· San Diego, CAResearch Site· San Luis Obispo, CA

Related Studies