ClinicalTrials.gov record
Randomized Study to Evaluate MACE in Patients With Prostate Cancer Treated With Relugolix or Leuprolide Acetate
ClinicalTrials.gov ID: NCT05605964
Public ClinicalTrials.gov record NCT05605964. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Relugolix Versus Leuprolide in Patients With Prostate Cancer: A Randomized, Open-Label Study to Assess Major Adverse Cardiovascular Events (REPLACE-CV)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05605964
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 387 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 28, 2023 (Actual)
- Primary completion
- Dec 31, 2024 (Actual)
- Completion
- Dec 31, 2024 (Actual)
- Last update posted
- Jun 15, 2026
2023 – 2024
United States locations
- U.S. sites
- 108
- U.S. states
- 29
- U.S. cities
- 86
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Urology Associates of Mobile | Mobile | Alabama | 36608 | — |
| Arizona Urology Specialists, PLLC | Tucson | Arizona | 85704 | — |
| Arkansas Urology | Little Rock | Arkansas | 72211 | — |
| Genesis Research, LLC Satellite | Downey | California | 90241 | — |
| Orange Coast Memorial Medical Center | Fountain Valley | California | 92708 | — |
| Genesis Research , LLC | Los Alamitos | California | 90270 | — |
| Tower Urology | Los Angeles | California | 90048 | — |
| Pacific Cancer Care | Monterey | California | 93940 | — |
| Tri Valley Urology Medical Group | Murrieta | California | 92562 | — |
| Tri Valley Urology Medical Group Satellite | Murrieta | California | 92563 | — |
| San Bernadino Urological Associates Medical Group | San Bernardino | California | 92404 | — |
| Genesis Research, LLC | San Diego | California | 92123 | — |
| Genesis Research, LLC Satellite | Sherman Oaks | California | 91411 | — |
| Tri Valley Urology Medical Group Satellite | Temecula | California | 92592 | — |
| Genesis Research, LLC Satellite | Torrance | California | 90503 | — |
| Genesis Research, LLC Satellite | Torrance | California | 90505 | — |
| Medstar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| Urologic Surgeons of Washington | Washington D.C. | District of Columbia | 20036 | — |
| Advanced Urology Institute | Daytona Beach | Florida | 32114 | — |
| East Coast Institute for Research, LLC Satellite | Jacksonville | Florida | 32204 | — |
| East Coast Institute for Research, LLC | Jacksonville | Florida | 32216 | — |
| East Coast Institute for Research, LLC Satellite | Jacksonville | Florida | 32256 | — |
| Lake City Cancer Center, LLC | Lake City | Florida | 32024 | — |
| SG Research LLC | Miami | Florida | 33145 | — |
| Florida Urology Partners, LLP Satellite | Tampa | Florida | 33578 | — |
| Florida Urology Partners, LLP | Tampa | Florida | 33609 | — |
| Florida Urology Partners, LLP Satellite | Tampa | Florida | 33615 | — |
| Augusta University | Augusta | Georgia | 30912 | — |
| Georgia Cancer Center Satellite | Augusta | Georgia | 30912 | — |
| St. Luke's Regional Medical Center Satellite | Boise | Idaho | 83712 | — |
| St. Luke's Regional Medical Center | Boise | Idaho | 83712 | — |
| St. Luke's Cancer Institute - Fruitland Satellite | Fruitland | Idaho | 83619 | — |
| St. Luke's Cancer Institute - Meridian Satellite | Meridian | Idaho | 83642 | — |
| St. Luke's Meridian Medical Center Satellite | Meridian | Idaho | 83642 | — |
| St. Luke's Cancer Institute - Nampa Satellite | Nampa | Idaho | 83687 | — |
| St. Luke's Nampa Medical Center Satellite | Nampa | Idaho | 83687 | — |
| St. Luke's Cancer Institute Satellite | Twin Falls | Idaho | 83301 | — |
| St. Luke's Magic Valley Medical Center Satellite | Twin Falls | Idaho | 83301 | — |
| Illinois CancerCare - Bloomington Satellite | Bloomington | Illinois | 61704 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Swedish Hospital Satellite | Chicago | Illinois | 60625 | — |
| Associated Urological Specialists | Chicago Ridge | Illinois | 60415 | — |
| NorthShore University Health System - Evanston Hospital | Evanston | Illinois | 60201 | — |
| Illinois CancerCare - Galesburg Satellite | Galesburg | Illinois | 61401 | — |
| NorthShore University Health System - Glenbrook Hospital Ambulatory Care Center Satellite | Glenview | Illinois | 60026 | — |
| NorthShore University Health System - Highland Park Hospital Ambulatory Care Center Satellite | Highland Park | Illinois | 60035 | — |
| Comprehensive Urologic Care | Lake Barrington | Illinois | 60010 | — |
| Advanced Urology Associates | New Lenox | Illinois | 60451 | — |
| Illinois CancerCare - Ottawa Satellite | Ottawa | Illinois | 61350 | — |
| Illinois CancerCare - Pekin Satellite | Pekin | Illinois | 61554 | — |
| Illinois CancerCare, P.C. | Peoria | Illinois | 61615 | — |
| Illinois CancerCare - Peru Satellite | Peru | Illinois | 61354 | — |
| Illinois CancerCare - Washington Satellite | Washington | Illinois | 61571 | — |
| Urology of Indiana, LLC Satellite | Carmel | Indiana | 46032 | — |
| Urology of Indiana, LLC | Greenwood | Indiana | 46143 | — |
| IU Health Arnett Cancer Center | Lafayette | Indiana | 47904 | — |
| IU Health Ball Memorial Hospital Satellite | Muncie | Indiana | 47303 | — |
| Adult and Pediatric Urology P.C. Satellite | Council Bluffs | Iowa | 51501 | — |
| Greater Regional Medical Center | Creston | Iowa | 50801 | — |
| Wichita Urology Group Satellite | Wichita | Kansas | 67205 | — |
| Wichita Urology Group Satellite | Wichita | Kansas | 67206 | — |
| Wichita Urology Group | Wichita | Kansas | 67226 | — |
| Comprehensive Urology | Royal Oak | Michigan | 48073 | — |
| Michigan Institute of Urology | Troy | Michigan | 48084 | — |
| Lake Regional Health System | Osage Beach | Missouri | 65065 | — |
| Specialty Clinical Research of St. Louis | St Louis | Missouri | 63141 | — |
| Urology of St. Louis Satellite | St Louis | Missouri | 63141 | — |
| St. Vincent Healthcare Satellite | Billings | Montana | 59101 | — |
| St. Vincent - Frontier Cancer Center | Billings | Montana | 59102 | — |
| Adult and Pediatric Urology P.C. | Omaha | Nebraska | 68114 | — |
| Capital Health Medical Center - Hopewell | Pennington | New Jersey | 08534 | — |
| University of New Mexico Comprehensive Cancer Center | Albuquerque | New Mexico | 87131 | — |
| Albany Medical College | Albany | New York | 12208 | — |
| Associated Medical Professionals of NY, PLLC | Syracuse | New York | 13210 | — |
| Oncology Specialists of Charlotte | Charlotte | North Carolina | 28207 | — |
| Associated Urologists of North Carolina | Raleigh | North Carolina | 27612 | — |
| Altru Cancer Center | Grand Forks | North Dakota | 58201 | — |
| Altru Health System Satellite | Grand Forks | North Dakota | 58201 | — |
| Altru Professional Center Satellite | Grand Forks | North Dakota | 58201 | — |
| University Hospitals Seidman Cancer Center at UH Avon Health Center Satellite | Avon | Ohio | 44011 | — |
| TriState Urologic Services PSC Inc. | Cincinnati | Ohio | 45212 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| Central Ohio Urology Group Satellite | Gahanna | Ohio | 43230 | — |
| Central Ohio Urology Group | Gahanna | Ohio | 43230 | — |
| University Hospitals Seidman Cancer Center at UH Mentor Health Center Satellite | Mentor | Ohio | 44060 | — |
| Helios CR, LLC | Middleburg Heights | Ohio | 44130 | — |
| UH Minoff Health Center at Chagrin Highlands | Orange | Ohio | 44122 | — |
| MidLantic Urology | Bala-Cynwyd | Pennsylvania | 19004 | — |
| Keystone Urology Specialists | Lancaster | Pennsylvania | 17604 | — |
| Guthrie Medical Group, PC | Sayre | Pennsylvania | 18840 | — |
| Robert Packer Hospital Satellite | Sayre | Pennsylvania | 18840 | — |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | — |
| Lowcountry Urology Clinics | North Charleston | South Carolina | 29406 | — |
| Urology Associates, P.C. | Nashville | Tennessee | 37209 | — |
| Valley Cancer Associates | Harlingen | Texas | 78550 | — |
| Houston Metro Urology CRC, LLC | Houston | Texas | 77027 | — |
| Urology San Antonio Clinical Trials | San Antonio | Texas | 78229 | — |
| The Urology Place | San Antonio | Texas | 78240 | — |
| Logan Regional Hospital Satellite | Logan | Utah | 84341 | — |
| Intermountain Medical Center Satellite | Murray | Utah | 84107 | — |
| McKay-Dee Hospital Satellite | Ogden | Utah | 84403 | — |
| Utah Valley Hospital | Provo | Utah | 84604 | — |
| St. George Regional Hospital Satellite | St. George | Utah | 84790 | — |
| Potomac Urology Center, PC | Alexandria | Virginia | 22311 | — |
| Virginia Urology | Richmond | Virginia | 23235 | — |
| Urology of Virginia | Virginia Beach | Virginia | 23462 | — |
| Potomac Urology Satellite | Woodbridge | Virginia | 22191 | — |
| Spokane Urology | Spokane | Washington | 99202 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05605964, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 15, 2026 · Synced Oct 23, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05605964 live on ClinicalTrials.gov.