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Studies

Interventional Active not recruiting Phase 3

NCT06120491 on ClinicalTrials.gov

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

Official title: A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of Saruparib (AZD5305) in Combination With Physician's Choice New Hormonal Agents in Patients With HRRm and Non-HRRm Metastatic Castration-Sensitive Prostate Cancer (EvoPAR-Prostate01)

  • Sponsor: AstraZeneca (Sweden)
  • Enrollment: 1898 (Actual)
  • Study start: 2023-11-21 (Actual)
  • Primary completion: 2027-09-30 (Estimated)
  • Study completion: 2031-04-30 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: Within each cohort (HRRm and non-HRRm), participants are randomised in 1:1 ratio to one of two treatment arms
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • PrimaryPurpose: Treatment

Brief Summary

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.

Conditions

  • Metastatic Castration-Sensitive Prostate Cancer

Intervention / Treatment

  • Drug: Saruparib
  • Drug: Placebo
  • Drug: Abiraterone Acetate
  • Drug: Abiraterone Acetate
  • Drug: Darolutamide
  • Drug: Darolutamide
  • Drug: Enzalutamide
  • Drug: Enzalutamide

Primary Outcome Measures

  • Radiographic Progression-Free Survival (rPFS) (Up to approximately 50 months)
    rPFS is defined as the time from randomisation to radiographic progression, as assessed by the investigator per RECIST 1.1 (soft tissue) and/or PCWG3 criteria (bone), or, death due to any cause.

Countries

Australia, Austria, Belgium, Brazil, Canada, Chile, China, France, Germany, Hungary, India, Italy, Japan, Malaysia, Netherlands, Peru, Poland, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States

Locations and Investigators

  • Research Site, Chandler, United States
  • Research Site, Gilbert, United States
  • Research Site, Phoenix, United States
  • Research Site, Tucson, United States
  • Research Site, Little Rock, United States
  • Research Site, Springdale, United States
  • Research Site, Bakersfield, United States
  • Research Site, Fountain Valley, United States
  • Research Site, Fullerton, United States
  • Research Site, Los Angeles, United States
  • Research Site, Montebello, United States
  • Research Site, San Francisco, United States
  • Research Site, Santa Barbara, United States
  • Research Site, Santa Monica, United States
  • Research Site, Santa Rosa, United States
  • Research Site, Golden, United States
  • Research Site, Lakewood, United States
  • Research Site, New Haven, United States
  • Research Site, Atlanta, United States
  • Research Site, Glenview, United States
  • Research Site, Lake Barrington, United States
  • Research Site, Fort Wayne, United States
  • Research Site, Indianapolis, United States
  • Research Site, Westwood, United States
  • Research Site, Shreveport, United States
  • Research Site, Scarborough, United States
  • Research Site, Baltimore, United States
  • Research Site, Baltimore, United States
  • Research Site, Bethesda, United States
  • Research Site, Towson, United States
  • Research Site, Upper Marlboro, United States
  • Research Site, Grand Rapids, United States
  • Research Site, Troy, United States
  • Research Site, Rochester, United States
  • Research Site, Bozeman, United States
  • Research Site, Las Vegas, United States
  • Research Site, Las Vegas, United States
  • Research Site, Camden, United States
  • Research Site, Albuquerque, United States
  • Research Site, East Syracuse, United States
  • Research Site, New Hyde Park, United States
  • Research Site, New York, United States
  • Research Site, Syracuse, United States
  • Research Site, Durham, United States
  • Research Site, Cincinnati, United States
  • Research Site, Cincinnati, United States
  • Research Site, Cleveland, United States
  • Research Site, Cleveland, United States
  • Research Site, Columbus, United States
  • Research Site, Portland, United States

And 272 other sites.

Study Officials