NCT05605964CompletedPhase 3
Randomized Study to Evaluate MACE in Patients With Prostate Cancer Treated With Relugolix or Leuprolide Acetate
Relugolix Versus Leuprolide in Patients With Prostate Cancer: A Randomized, Open-Label Study to Assess Major Adverse Cardiovascular Events (REPLACE-CV)
Source: ClinicalTrials.gov · Last updated 15 Jun 2026
Brief summary (registry, in English)
This was a randomized study to evaluate the risk of major adverse cardiovascular events (MACE) for relugolix compared with leuprolide acetate. Enrollment in this study was discontinued by the Sponsor on 01 Dec 2023. In an effort to mitigate any treatment interruptions, actively enrolled patients will be allowed to remain on study drug up to a period of 12 months ending Dec 2024 if they choose to remain in the discontinuation phase of the study.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 387 (actual)
- First submitted
- 25 Oct 2022
- Start date
- 28 Jan 2023
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Diseases
- Prostate cancer
- NCT number
- NCT05605964
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 387
- From 28 Jan 2023 to the primary completion date, 31 Dec 2024
- 104 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- A patient will be eligible for inclusion in the discontinuation phase of the study if the following applies:
- Was previously enrolled under the original version and amendment 1 of this study
- Has voluntarily resigned and dated the informed consent form prior to transition to the discontinuation phase of this study
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (104)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Albany Medical College Coordinator of this site? Confirm its status | Albany | United States | Unknown status |
| University of New Mexico Comprehensive Cancer Center Coordinator of this site? Confirm its status | Albuquerque | United States | Unknown status |
| Potomac Urology Center, PC Coordinator of this site? Confirm its status | Alexandria | United States | Unknown status |
| Augusta University Coordinator of this site? Confirm its status | Augusta | United States | Unknown status |
| Georgia Cancer Center Satellite Coordinator of this site? Confirm its status | Augusta | United States | Unknown status |
| University Hospitals Seidman Cancer Center at UH Avon Health Center Satellite Coordinator of this site? Confirm its status | Avon | United States | Unknown status |
| MidLantic Urology Coordinator of this site? Confirm its status | Bala-Cynwyd | United States | Unknown status |
| St. Vincent Healthcare Satellite Coordinator of this site? Confirm its status | Billings | United States | Unknown status |
| St. Vincent Frontier Cancer Center Coordinator of this site? Confirm its status | Billings | United States | Unknown status |
| Illinois CancerCare - Bloomington Satellite Coordinator of this site? Confirm its status | Bloomington | United States | Unknown status |
| St. Luke's Regional Medical Center Satellite Coordinator of this site? Confirm its status | Boise | United States | Unknown status |
| St. Luke's Regional Medical Center Coordinator of this site? Confirm its status | Boise | United States | Unknown status |
| Urology of Indiana, LLC Satellite Coordinator of this site? Confirm its status | Carmel | United States | Unknown status |
| Oncology Specialists of Charlotte Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Swedish Hospital Satellite Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Associated Urological Specialists Coordinator of this site? Confirm its status | Chicago Ridge | United States | Unknown status |
| TriState Urologic Services PSC Inc. Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| University Hospitals Cleveland Medical Center* Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Adult and Pediatric Urology P.C. Satellite Coordinator of this site? Confirm its status | Council Bluffs | United States | Unknown status |
| Greater Regional Medical Center Coordinator of this site? Confirm its status | Creston | United States | Unknown status |
| Advanced Urology Institute Coordinator of this site? Confirm its status | Daytona Beach | United States | Unknown status |
| Genesis Research, LLC Satellite Coordinator of this site? Confirm its status | Downey | United States | Unknown status |
| NorthShore University Health System - Evanston Hospital Coordinator of this site? Confirm its status | Evanston | United States | Unknown status |
| Orange Coast Memorial Medical Center Coordinator of this site? Confirm its status | Fountain Valley | United States | Unknown status |
| St. Luke's Cancer Institute - Fruitland Satellite Coordinator of this site? Confirm its status | Fruitland | United States | Unknown status |
| Central Ohio Urology Group Satellite Coordinator of this site? Confirm its status | Gahanna | United States | Unknown status |
| Central Ohio Urology Group Coordinator of this site? Confirm its status | Gahanna | United States | Unknown status |
| Illinois CancerCare - Galesburg Satellite Coordinator of this site? Confirm its status | Galesburg | United States | Unknown status |
| NorthShore University Health System - Glenbrook Hospital Ambulatory Care Center Satellite Coordinator of this site? Confirm its status | Glenview | United States | Unknown status |
| Altru Cancer Center Coordinator of this site? Confirm its status | Grand Forks | United States | Unknown status |
| Altru Health System Satellite Coordinator of this site? Confirm its status | Grand Forks | United States | Unknown status |
| Altru Professional Center Satellite Coordinator of this site? Confirm its status | Grand Forks | United States | Unknown status |
| Urology of Indiana, LLC Coordinator of this site? Confirm its status | Greenwood | United States | Unknown status |
| Valley Cancer Associates Coordinator of this site? Confirm its status | Harlingen | United States | Unknown status |
| NorthShore University Health System - Highland Park Hospital Ambulatory Care Center Satellite Coordinator of this site? Confirm its status | Highland Park | United States | Unknown status |
| Houston Metro Urology CRC, LLC Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| East Coast Institute for Research, LLC Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| East Coast Institute for Research, LLC Satellite Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| IU Health Arnett Cancer Center Coordinator of this site? Confirm its status | Lafayette | United States | Unknown status |
| Comprehensive Urologic Care Coordinator of this site? Confirm its status | Lake Barrington | United States | Unknown status |
| Lake City Cancer Center, LLC Coordinator of this site? Confirm its status | Lake City | United States | Unknown status |
| Keystone Urology Specialists Coordinator of this site? Confirm its status | Lancaster | United States | Unknown status |
| Arkansas Urology Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| Logan Regional Hospital Satellite Coordinator of this site? Confirm its status | Logan | United States | Unknown status |
| Genesis Research , LLC Coordinator of this site? Confirm its status | Los Alamitos | United States | Unknown status |
| Tower Urology Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| University Hospitals Seidman Cancer Center at UH Mentor Health Center Satellite Coordinator of this site? Confirm its status | Mentor | United States | Unknown status |
| St. Luke's Meridian Medical Center Satellite Coordinator of this site? Confirm its status | Meridian | United States | Unknown status |
| St. Luke's Cancer Institute - Meridian Satellite Coordinator of this site? Confirm its status | Meridian | United States | Unknown status |
| SG Research LLC Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Helios CR, LLC Coordinator of this site? Confirm its status | Middleburg Heights | United States | Unknown status |
| Urology Associates of Mobile Coordinator of this site? Confirm its status | Mobile | United States | Unknown status |
| Pacific Cancer Care Coordinator of this site? Confirm its status | Monterey | United States | Unknown status |
| IU Health Ball Memorial Hospital Satellite Coordinator of this site? Confirm its status | Muncie | United States | Unknown status |
| Intermountain Medical Center Satellite Coordinator of this site? Confirm its status | Murray | United States | Unknown status |
| Tri Valley Urology Medical Group Satellite Coordinator of this site? Confirm its status | Murrieta | United States | Unknown status |
| Tri Valley Urology Medical Group Coordinator of this site? Confirm its status | Murrieta | United States | Unknown status |
| Carolina Urologic Research Center Coordinator of this site? Confirm its status | Myrtle Beach | United States | Unknown status |
| St. Luke's Nampa Medical Center Satellite Coordinator of this site? Confirm its status | Nampa | United States | Unknown status |
| St. Luke's Cancer Institute - Nampa Satellite Coordinator of this site? Confirm its status | Nampa | United States | Unknown status |
| Urology Associates, P.C. Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Advanced Urology Associates Coordinator of this site? Confirm its status | New Lenox | United States | Unknown status |
| Lowcountry Urology Clinics Coordinator of this site? Confirm its status | North Charleston | United States | Unknown status |
| McKay-Dee Hospital Satellite Coordinator of this site? Confirm its status | Ogden | United States | Unknown status |
| Adult and Pediatric Urology P.C. Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| UH Minoff Health Center at Chagrin Highlands Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| Lake Regional Health System Coordinator of this site? Confirm its status | Osage Beach | United States | Unknown status |
| Illinois CancerCare - Ottawa Satellite Coordinator of this site? Confirm its status | Ottawa | United States | Unknown status |
| Illinois CancerCare - Pekin Satellite Coordinator of this site? Confirm its status | Pekin | United States | Unknown status |
| Capital Health Medical Center-Hopewell Coordinator of this site? Confirm its status | Pennington | United States | Unknown status |
| Illinois CancerCare, P.C. Coordinator of this site? Confirm its status | Peoria | United States | Unknown status |
| Illinois CancerCare - Peru Satellite Coordinator of this site? Confirm its status | Peru | United States | Unknown status |
| Utah Valley Hospital Coordinator of this site? Confirm its status | Provo | United States | Unknown status |
| Associated Urologists of North Carolina Coordinator of this site? Confirm its status | Raleigh | United States | Unknown status |
| Virginia Urology Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| Comprehensive Urology Coordinator of this site? Confirm its status | Royal Oak | United States | Unknown status |
| The Urology Place Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Urology San Antonio Clinical Trials Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| San Bernadino Urological Associates Medical Group Coordinator of this site? Confirm its status | San Bernardino | United States | Unknown status |
| Genesis Research, LLC Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| Guthrie Medical Group, PC Coordinator of this site? Confirm its status | Sayre | United States | Unknown status |
| Robert Packer Hospital Satellite Coordinator of this site? Confirm its status | Sayre | United States | Unknown status |
| Genesis Research, LLC Satellite Coordinator of this site? Confirm its status | Sherman Oaks | United States | Unknown status |
| Spokane Urology Coordinator of this site? Confirm its status | Spokane | United States | Unknown status |
| St. George Regional Hospital Satellite Coordinator of this site? Confirm its status | St. George | United States | Unknown status |
| Urology of St. Louis Satellite Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Specialty Clinical Research of St. Louis Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Associated Medical Professionals of NY, PLLC Coordinator of this site? Confirm its status | Syracuse | United States | Unknown status |
| Florida Urology Partners, LLP Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Florida Urology Partners, LLP Satellite Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Tri Valley Urology Medical Group Satellite Coordinator of this site? Confirm its status | Temecula | United States | Unknown status |
| Genesis Research, LLC Satellite Coordinator of this site? Confirm its status | Torrance | United States | Unknown status |
| Michigan Institute of Urology Coordinator of this site? Confirm its status | Troy | United States | Unknown status |
| Arizona Urology Specialists, PLLC Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| St. Luke's Cancer Institute Satellite Coordinator of this site? Confirm its status | Twin Falls | United States | Unknown status |
| St. Luke's Magic Valley Medical Center Satellite Coordinator of this site? Confirm its status | Twin Falls | United States | Unknown status |
| Urology of Virginia Coordinator of this site? Confirm its status | Virginia Beach | United States | Unknown status |
| Illinois CancerCare - Washington Satellite Coordinator of this site? Confirm its status | Washington | United States | Unknown status |
| MedStar Washington Hospital Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
| Urologic Surgeons of Washington Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
| Wichita Urology Group Coordinator of this site? Confirm its status | Wichita | United States | Unknown status |
| Wichita Urology Group Satellite Coordinator of this site? Confirm its status | Wichita | United States | Unknown status |
| Potomac Urology Satellite Coordinator of this site? Confirm its status | Woodbridge | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.