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)

Study acronym: EvoPAR-PR05
StatusRecruiting
PhasePhase 3
Started

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Record History

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  1. Notable Recruitment opened Show 6 more changesShow less
    • Trial sites expanded: 2 → 210 locations
    • Primary completion date: Jun 17, 2031 to May 30, 2031
    • Study completion date: Jun 14, 2033 to May 27, 2033
    • Start date changed from estimate of Oct 1, 2026 to Sep 15, 2026
    • Eligibility criteria expanded, about 32 words
    • Secondary endpoints: details revised at 4 of 12 entries
  2. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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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 Number NCT07711002
Lead Sponsor AstraZeneca
Conditions
(from sponsor)
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Related terms Prostatic Neoplasms
Enrollment 1,330 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov