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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.
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

Full criteria on ClinicalTrials.gov

Sites (104)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Albany Medical College
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AlbanyUnited StatesUnknown status
University of New Mexico Comprehensive Cancer Center
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AlbuquerqueUnited StatesUnknown status
Potomac Urology Center, PC
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AlexandriaUnited StatesUnknown status
Augusta University
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AugustaUnited StatesUnknown status
Georgia Cancer Center Satellite
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AugustaUnited StatesUnknown status
University Hospitals Seidman Cancer Center at UH Avon Health Center Satellite
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AvonUnited StatesUnknown status
MidLantic Urology
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Bala-CynwydUnited StatesUnknown status
St. Vincent Healthcare Satellite
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BillingsUnited StatesUnknown status
St. Vincent Frontier Cancer Center
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BillingsUnited StatesUnknown status
Illinois CancerCare - Bloomington Satellite
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BloomingtonUnited StatesUnknown status
St. Luke's Regional Medical Center Satellite
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BoiseUnited StatesUnknown status
St. Luke's Regional Medical Center
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BoiseUnited StatesUnknown status
Urology of Indiana, LLC Satellite
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CarmelUnited StatesUnknown status
Oncology Specialists of Charlotte
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CharlotteUnited StatesUnknown status
Swedish Hospital Satellite
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ChicagoUnited StatesUnknown status
Northwestern University
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ChicagoUnited StatesUnknown status
Associated Urological Specialists
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Chicago RidgeUnited StatesUnknown status
TriState Urologic Services PSC Inc.
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CincinnatiUnited StatesUnknown status
University Hospitals Cleveland Medical Center*
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ClevelandUnited StatesUnknown status
Adult and Pediatric Urology P.C. Satellite
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Council BluffsUnited StatesUnknown status
Greater Regional Medical Center
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CrestonUnited StatesUnknown status
Advanced Urology Institute
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Daytona BeachUnited StatesUnknown status
Genesis Research, LLC Satellite
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DowneyUnited StatesUnknown status
NorthShore University Health System - Evanston Hospital
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EvanstonUnited StatesUnknown status
Orange Coast Memorial Medical Center
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Fountain ValleyUnited StatesUnknown status
St. Luke's Cancer Institute - Fruitland Satellite
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FruitlandUnited StatesUnknown status
Central Ohio Urology Group Satellite
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GahannaUnited StatesUnknown status
Central Ohio Urology Group
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GahannaUnited StatesUnknown status
Illinois CancerCare - Galesburg Satellite
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GalesburgUnited StatesUnknown status
NorthShore University Health System - Glenbrook Hospital Ambulatory Care Center Satellite
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GlenviewUnited StatesUnknown status
Altru Cancer Center
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Grand ForksUnited StatesUnknown status
Altru Health System Satellite
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Grand ForksUnited StatesUnknown status
Altru Professional Center Satellite
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Grand ForksUnited StatesUnknown status
Urology of Indiana, LLC
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GreenwoodUnited StatesUnknown status
Valley Cancer Associates
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HarlingenUnited StatesUnknown status
NorthShore University Health System - Highland Park Hospital Ambulatory Care Center Satellite
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Highland ParkUnited StatesUnknown status
Houston Metro Urology CRC, LLC
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HoustonUnited StatesUnknown status
East Coast Institute for Research, LLC
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JacksonvilleUnited StatesUnknown status
East Coast Institute for Research, LLC Satellite
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JacksonvilleUnited StatesUnknown status
IU Health Arnett Cancer Center
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LafayetteUnited StatesUnknown status
Comprehensive Urologic Care
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Lake BarringtonUnited StatesUnknown status
Lake City Cancer Center, LLC
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Lake CityUnited StatesUnknown status
Keystone Urology Specialists
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LancasterUnited StatesUnknown status
Arkansas Urology
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Little RockUnited StatesUnknown status
Logan Regional Hospital Satellite
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LoganUnited StatesUnknown status
Genesis Research , LLC
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Los AlamitosUnited StatesUnknown status
Tower Urology
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Los AngelesUnited StatesUnknown status
University Hospitals Seidman Cancer Center at UH Mentor Health Center Satellite
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MentorUnited StatesUnknown status
St. Luke's Meridian Medical Center Satellite
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MeridianUnited StatesUnknown status
St. Luke's Cancer Institute - Meridian Satellite
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MeridianUnited StatesUnknown status
SG Research LLC
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MiamiUnited StatesUnknown status
Helios CR, LLC
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Middleburg HeightsUnited StatesUnknown status
Urology Associates of Mobile
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MobileUnited StatesUnknown status
Pacific Cancer Care
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MontereyUnited StatesUnknown status
IU Health Ball Memorial Hospital Satellite
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MuncieUnited StatesUnknown status
Intermountain Medical Center Satellite
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MurrayUnited StatesUnknown status
Tri Valley Urology Medical Group Satellite
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MurrietaUnited StatesUnknown status
Tri Valley Urology Medical Group
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MurrietaUnited StatesUnknown status
Carolina Urologic Research Center
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Myrtle BeachUnited StatesUnknown status
St. Luke's Nampa Medical Center Satellite
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NampaUnited StatesUnknown status
St. Luke's Cancer Institute - Nampa Satellite
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NampaUnited StatesUnknown status
Urology Associates, P.C.
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NashvilleUnited StatesUnknown status
Advanced Urology Associates
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New LenoxUnited StatesUnknown status
Lowcountry Urology Clinics
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North CharlestonUnited StatesUnknown status
McKay-Dee Hospital Satellite
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OgdenUnited StatesUnknown status
Adult and Pediatric Urology P.C.
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OmahaUnited StatesUnknown status
UH Minoff Health Center at Chagrin Highlands
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OrangeUnited StatesUnknown status
Lake Regional Health System
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Osage BeachUnited StatesUnknown status
Illinois CancerCare - Ottawa Satellite
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OttawaUnited StatesUnknown status
Illinois CancerCare - Pekin Satellite
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PekinUnited StatesUnknown status
Capital Health Medical Center-Hopewell
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PenningtonUnited StatesUnknown status
Illinois CancerCare, P.C.
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PeoriaUnited StatesUnknown status
Illinois CancerCare - Peru Satellite
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PeruUnited StatesUnknown status
Utah Valley Hospital
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ProvoUnited StatesUnknown status
Associated Urologists of North Carolina
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RaleighUnited StatesUnknown status
Virginia Urology
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RichmondUnited StatesUnknown status
Comprehensive Urology
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Royal OakUnited StatesUnknown status
The Urology Place
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San AntonioUnited StatesUnknown status
Urology San Antonio Clinical Trials
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San AntonioUnited StatesUnknown status
San Bernadino Urological Associates Medical Group
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San BernardinoUnited StatesUnknown status
Genesis Research, LLC
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San DiegoUnited StatesUnknown status
Guthrie Medical Group, PC
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SayreUnited StatesUnknown status
Robert Packer Hospital Satellite
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SayreUnited StatesUnknown status
Genesis Research, LLC Satellite
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Sherman OaksUnited StatesUnknown status
Spokane Urology
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SpokaneUnited StatesUnknown status
St. George Regional Hospital Satellite
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St. GeorgeUnited StatesUnknown status
Urology of St. Louis Satellite
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St LouisUnited StatesUnknown status
Specialty Clinical Research of St. Louis
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St LouisUnited StatesUnknown status
Associated Medical Professionals of NY, PLLC
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SyracuseUnited StatesUnknown status
Florida Urology Partners, LLP
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TampaUnited StatesUnknown status
Florida Urology Partners, LLP Satellite
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TampaUnited StatesUnknown status
Tri Valley Urology Medical Group Satellite
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TemeculaUnited StatesUnknown status
Genesis Research, LLC Satellite
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TorranceUnited StatesUnknown status
Michigan Institute of Urology
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TroyUnited StatesUnknown status
Arizona Urology Specialists, PLLC
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TucsonUnited StatesUnknown status
St. Luke's Cancer Institute Satellite
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Twin FallsUnited StatesUnknown status
St. Luke's Magic Valley Medical Center Satellite
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Twin FallsUnited StatesUnknown status
Urology of Virginia
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Virginia BeachUnited StatesUnknown status
Illinois CancerCare - Washington Satellite
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WashingtonUnited StatesUnknown status
MedStar Washington Hospital Center
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Washington D.C.United StatesUnknown status
Urologic Surgeons of Washington
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Washington D.C.United StatesUnknown status
Wichita Urology Group
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WichitaUnited StatesUnknown status
Wichita Urology Group Satellite
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WichitaUnited StatesUnknown status
Potomac Urology Satellite
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WoodbridgeUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.