Saruparib in Combination With Physician's Choice of ARPI in Patients With mHSPC Previously Treated With Docetaxel or 177Lu-PSMA Therapy Without Disease Progression and PSA ≥ 0.2 ng/mL (EvoPAR-PR05)

The primary objective of this study is to measure efficacy of saruparib + physician's choice of ARPI compared with placebo + ARPI in men with metastatic hormone-sensitive prostate cancer (mHSPC) who have previously received docetaxel chemotherapy or a prostate-specific membrane antigen (PSMA)-directed lutetium-177 radioligand therapy with no evidence of disease progression and PSA ≥ 0.2 ng/mL.

Trial Details

NCT ID
NCT07711002
Phase
PHASE3
Sponsor
AstraZeneca
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • Saruparib
  • Placebo
  • Enzalutamide
  • Darolutamide
  • Abiraterone
Locations (sample)
  • Hot Springs, Arkansas, United States|34.5037,-93.05518
  • Springdale, Arkansas, United States|36.18674,-94.12881
  • Beverly Hills, California, United States|34.07362,-118.40036
  • Los Alamitos, California, United States|33.80307,-118.07256
  • Los Angeles, California, United States|34.05223,-118.24368

Key Eligibility Criteria

  • Participant must be ≥ 18 at the time of signing the informed consent.
  • Histologically documented diagnosis of prostate adenocarcinoma that is de novo or recurrent and hormone-sensitive.
  • Metastatic disease confirmed prior to initiation of previous treatment with docetaxel or Lu-PSMA-containing regimens for mHSPC.
  • Previous treatment with docetaxel (IV, Q3w)- or Lu-PSMA (IV, Q6w) with last dose within past 6 months.

For full eligibility, visit ClinicalTrials.gov.

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