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)

Sponsor
AstraZeneca
Study ID
NCT07711002
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Eligibility Criteria

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

Interventions

  • Saruparib — DRUG
    Arm 1: Saruparib (AZD5305) + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone)
  • Placebo — OTHER
    Arm 2: Placebo + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone)
  • Enzalutamide — DRUG
    Arm 1: Saruparib (AZD5305) + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone) Arm 2: Placebo + Physician's Choice ARPI
  • Darolutamide — DRUG
    Arm 1: Saruparib (AZD5305) + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone) Arm 2: Placebo + Physician's Choice ARPI
  • Abiraterone — DRUG
    Arm 1: Saruparib (AZD5305) + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone) Arm 2: Placebo + Physician's Choice ARPI

Study Details

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.

Key Dates

First listed
Jul 17, 2026
Start date
Oct 1, 2026
Status verified
Jul 2026
Primary completion
Jun 17, 2031
Completion
Jun 14, 2033

Study Design

Enrollment
1,330 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Saruparib (AZD5305) + Physician's Choice ARPI - enzalutamide, darolutamide, or abiraterone
    Saruparib 60 mg + ARPI (enzalutamide, darolutamide, or abiraterone) : Participants will receive saruparib 60 mg orally once daily in combination with physician's choice of ARPI in cycles of 28 days
  • Placebo Comparator: Placebo + Physician's Choice ARPI - enzalutamide, darolutamide, or abiraterone
    Placebo + ARPI (enzalutamide, darolutamide, or abiraterone): Participants will receive placebo orally once daily in combination with physician's choice of ARPI in cycles of 28 days

Primary Outcome Measure

Radiographic progression-free survival (rPFS) [ Time Frame: Up to approximately 56 months ]

Central Contacts

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