Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents

Part of paid clinical trials in Chandler, Arizona.

Sponsor
AstraZeneca
Study ID
NCT06120491
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Metastatic Castration-Sensitive Prostate Cancer

Eligibility Criteria

Sex
MALE
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Saruparib — DRUG
    Oral
  • Placebo — DRUG
    Oral
  • Abiraterone Acetate — DRUG
    Oral
  • Darolutamide — DRUG
    Oral
  • Enzalutamide — DRUG
    Oral

Study Details

The intention of the study is to demonstrate superiority of Saruparib (AZD5305) + physician's choice NHA relative to placebo + physician's choice NHA by assessment of radiographic progression-free survival (rPFS) in participants with mCSPC.

Key Dates

Start date
Nov 21, 2023
Status verified
May 2026
Primary completion
Sep 30, 2027
Completion
Apr 30, 2031

Study Design

Enrollment
1,889 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Saruparib (AZD5305) + Physician's Choice NHA
    Saruparib (AZD5305) + physician's choice NHA (Abiraterone, Darolutamide, or Enzalutamide)
  • Placebo Comparator: Arm 2: Placebo + Physician's Choice NHA
    Placebo + physician's choice NHA (Abiraterone, Darolutamide, or Enzalutamide)

Primary Outcome Measure

Radiographic Progression-Free Survival (rPFS) [ Time Frame: Up to approximately 50 months ]

Locations (71)

FacilityCityStateZIPSite coordinators
Research SiteChandlerArizona85224-
Research SiteGilbertArizona85234-
Research SitePhoenixArizona85054-
Research SiteTucsonArizona85741-
Research SiteLittle RockArkansas72205-
Research SiteSpringdaleArkansas72762-
Research SiteBakersfieldCalifornia93301-
Research SiteFountain ValleyCalifornia92708-
Research SiteFullertonCalifornia92835-
Research SiteLos AngelesCalifornia90073-
Research SiteMontebelloCalifornia90640-
Research SiteSan FranciscoCalifornia94115-
Research SiteSanta BarbaraCalifornia93105-
Research SiteSanta MonicaCalifornia90404-
Research SiteSanta RosaCalifornia95403-
Research SiteGoldenColorado80401-
Research SiteLakewoodColorado80228-
Research SiteNew HavenConnecticut06510-
Research SiteAtlantaGeorgia30318-
Research SiteGlenviewIllinois60026-
Research SiteLake BarringtonIllinois60010-
Research SiteFort WayneIndiana46804-
Research SiteIndianapolisIndiana46202-
Research SiteWestwoodKansas66205-
Research SiteShreveportLouisiana71103-
Research SiteScarboroughMaine04074-
Research SiteBaltimoreMaryland21201-
Research SiteBaltimoreMaryland21287-
Research SiteBethesdaMaryland20817-
Research SiteTowsonMaryland21204-
Research SiteUpper MarlboroMaryland20774-
Research SiteGrand RapidsMichigan49503-
Research SiteTroyMichigan48084-
Research SiteRochesterMinnesota55905-
Research SiteBozemanMontana59715-
Research SiteLas VegasNevada89102-
Research SiteLas VegasNevada89148-
Research SiteCamdenNew Jersey08103-
Research SiteAlbuquerqueNew Mexico87109-
Research SiteEast SyracuseNew York13057-
Research SiteNew Hyde ParkNew York11042-
Research SiteNew YorkNew York10029-
Research SiteSyracuseNew York13210-
Research SiteDurhamNorth Carolina27710-
Research SiteCincinnatiOhio45212-
Research SiteCincinnatiOhio45219-
Research SiteClevelandOhio44111-
Research SiteClevelandOhio44124-
Research SiteColumbusOhio43210-
Research SitePortlandOregon97227-
Research SiteBala-CynwydPennsylvania19004-1017-
Research SitePhiladelphiaPennsylvania19104-
Research SitePittsburghPennsylvania15212-
Research SiteProvidenceRhode Island02903-
Research SiteMyrtle BeachSouth Carolina29572-
Research SiteNorth CharlestonSouth Carolina29406-
Research SiteSioux FallsSouth Dakota57105-
Research SiteGermantownTennessee38138-
Research SiteNashvilleTennessee37203-
Research SiteDallasTexas75231-
Research SiteHoustonTexas77025-
Research SiteSan AntonioTexas78229-
Research SiteSugar LandTexas77479-
Research SiteTylerTexas75702-
Research SiteWichita FallsTexas76310-
Research SiteSalt Lake CityUtah84106-
Research SiteSalt Lake CityUtah84132-
Research SiteSt. GeorgeUtah84790-
Research SiteFairfaxVirginia22031-
Research SiteSpokaneWashington99202-
Research SiteTacomaWashington98405-

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