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)
Condition(s) studied
Investigational drug(s) / intervention(s)
Saruparib: Arm 1: Saruparib (AZD5305) + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone)
Placebo: Arm 2: Placebo + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone)
Enzalutamide: Arm 1: Saruparib (AZD5305) + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone) Arm 2: Placebo + Physician's Choice ARPI
Darolutamide: Arm 1: Saruparib (AZD5305) + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone) Arm 2: Placebo + Physician's Choice ARPI
Abiraterone: Arm 1: Saruparib (AZD5305) + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone) Arm 2: Placebo + Physician's Choice ARPI
Study summary
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.
Eligibility
Primary outcome measure(s)
- Radiographic progression-free survival (rPFS) — Up to approximately 56 months
Radiographic PFS (rPFS) is the primary endpoint of this study, defined as the time from randomization 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.
Trial sites (210)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Hot Springs | Arkansas | Not Yet Recruiting |
| Research Site | Springdale | Arkansas | Recruiting |
| Research Site | Beverly Hills | California | Not Yet Recruiting |
| Research Site | Los Alamitos | California | Not Yet Recruiting |
| Research Site | Los Angeles | California | Not Yet Recruiting |
| Research Site | San Diego | California | Withdrawn |
| Research Site | Margate | Florida | Recruiting |
| Research Site | Miami | Florida | Recruiting |
| Research Site | Orlando | Florida | Not Yet Recruiting |
| Research Site | Honolulu | Hawaii | Not Yet Recruiting |
| Research Site | Chicago | Illinois | Not Yet Recruiting |
| Research Site | Chicago | Illinois | Not Yet Recruiting |
| Research Site | Elk Grove Village | Illinois | Not Yet Recruiting |
| Research Site | Hinsdale | Illinois | Not Yet Recruiting |
| Research Site | Ames | Iowa | Not Yet Recruiting |
| Research Site | Baltimore | Maryland | Not Yet Recruiting |
| Research Site | Baltimore | Maryland | Not Yet Recruiting |
| Research Site | Towson | Maryland | Not Yet Recruiting |
| Research Site | Detroit | Michigan | Not Yet Recruiting |
| Research Site | Grand Rapids | Michigan | Not Yet Recruiting |
| Research Site | Marshall | Minnesota | Not Yet Recruiting |
| Research Site | Camden | New Jersey | Not Yet Recruiting |
| Research Site | Albuquerque | New Mexico | Not Yet Recruiting |
| Research Site | Shirley | New York | Not Yet Recruiting |
| Research Site | Canton | Ohio | Not Yet Recruiting |
| Research Site | Cincinnati | Ohio | Not Yet Recruiting |
| Research Site | Portland | Oregon | Not Yet Recruiting |
| Research Site | Portland | Oregon | Not Yet Recruiting |
| Research Site | Greenville | South Carolina | Not Yet Recruiting |
| Research Site | Aberdeen | South Dakota | Not Yet Recruiting |
| Research Site | Mitchell | South Dakota | Not Yet Recruiting |
| Research Site | Pierre | South Dakota | Not Yet Recruiting |
| Research Site | Sioux Falls | South Dakota | Not Yet Recruiting |
| Research Site | Yankton | South Dakota | Not Yet Recruiting |
| Research Site | Nashville | Tennessee | Not Yet Recruiting |
| Research Site | Austin | Texas | Not Yet Recruiting |
| Research Site | Dallas | Texas | Not Yet Recruiting |
| Research Site | Fort Worth | Texas | Not Yet Recruiting |
| Research Site | Longview | Texas | Not Yet Recruiting |
| Research Site | Wichita Falls | Texas | Not Yet Recruiting |
+ 170 more sites — see the full list on the official registry below.
More AstraZeneca trials in the UK
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07711002 on ClinicalTrials.gov ↗ ← All trials in the UK