Randomized Study to Evaluate MACE in Patients With Prostate Cancer Treated With Relugolix or Leuprolide Acetate (REPLACE-CV)

June 11, 2026 updated by: Sumitomo Pharma America, Inc.

Relugolix Versus Leuprolide in Patients With Prostate Cancer: A Randomized, Open-Label Study to Assess Major Adverse Cardiovascular Events (REPLACE-CV)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Eligible patients were randomized (1:1) to receive either relugolix or leuprolide acetate for prostate cancer or as an adjunct to primary or salvage radiation therapy. The study was intended to collect clinical and cardiovascular risk factor data on patients ages 18 and older who were receiving relugolix or leuprolide acetate for their prostate cancer or as adjunct to radiation therapy with a treatment plan to be on at least 12 months of continuous ADT. Enrollment in this study was discontinued by the Sponsor on 04 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. During this discontinuation phase, all active investigative sites will be expected to formulate a transition plan for their study patients from this clinical study to SOC as soon as practicable.

The primary endpoint in this study was the time to first adjudicated MACE (nonfatal myocardial infarction, nonfatal stroke, and cardiovascular death). However, with the discontinuation of enrollment in the study on 04 DEC 2023 by the sponsor, the primary endpoint will be to describe the safety of relugolix in the study population while actively enrolled patients remain on study drug.

Study Type

Interventional

Enrollment (Actual)

387

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Urology Associates of Mobile
    • Arizona
      • Tucson, Arizona, United States, 85704
        • Arizona Urology Specialists, PLLC
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Arkansas Urology
    • California
      • Downey, California, United States, 90241
        • Genesis Research, LLC Satellite
      • Fountain Valley, California, United States, 92708
        • Orange Coast Memorial Medical Center
      • Los Alamitos, California, United States, 90270
        • Genesis Research , LLC
      • Los Angeles, California, United States, 90048
        • Tower Urology
      • Monterey, California, United States, 93940
        • Pacific Cancer Care
      • Murrieta, California, United States, 92562
        • Tri Valley Urology Medical Group
      • Murrieta, California, United States, 92563
        • Tri Valley Urology Medical Group Satellite
      • San Bernardino, California, United States, 92404
        • San Bernadino Urological Associates Medical Group
      • San Diego, California, United States, 92123
        • Genesis Research, LLC
      • Sherman Oaks, California, United States, 91411
        • Genesis Research, LLC Satellite
      • Temecula, California, United States, 92592
        • Tri Valley Urology Medical Group Satellite
      • Torrance, California, United States, 90503
        • Genesis Research, LLC Satellite
      • Torrance, California, United States, 90505
        • Genesis Research, LLC Satellite
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • MedStar Washington Hospital Center
      • Washington D.C., District of Columbia, United States, 20036
        • Urologic Surgeons of Washington
    • Florida
      • Daytona Beach, Florida, United States, 32114
        • Advanced Urology Institute
      • Jacksonville, Florida, United States, 32216
        • East Coast Institute for Research, LLC
      • Jacksonville, Florida, United States, 32204
        • East Coast Institute for Research, LLC Satellite
      • Jacksonville, Florida, United States, 32256
        • East Coast Institute for Research, LLC Satellite
      • Lake City, Florida, United States, 32024
        • Lake City Cancer Center, LLC
      • Miami, Florida, United States, 33145
        • SG Research LLC
      • Tampa, Florida, United States, 33609
        • Florida Urology Partners, LLP
      • Tampa, Florida, United States, 33578
        • Florida Urology Partners, LLP Satellite
      • Tampa, Florida, United States, 33615
        • Florida Urology Partners, LLP Satellite
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Augusta University
      • Augusta, Georgia, United States, 30912
        • Georgia Cancer Center Satellite
    • Idaho
      • Boise, Idaho, United States, 83712
        • St. Luke's Regional Medical Center
      • Boise, Idaho, United States, 83712
        • St. Luke's Regional Medical Center Satellite
      • Fruitland, Idaho, United States, 83619
        • St. Luke's Cancer Institute - Fruitland Satellite
      • Meridian, Idaho, United States, 83642
        • St. Luke's Cancer Institute - Meridian Satellite
      • Meridian, Idaho, United States, 83642
        • St. Luke's Meridian Medical Center Satellite
      • Nampa, Idaho, United States, 83687
        • St. Luke's Cancer Institute - Nampa Satellite
      • Nampa, Idaho, United States, 83687
        • St. Luke's Nampa Medical Center Satellite
      • Twin Falls, Idaho, United States, 83301
        • St. Luke's Cancer Institute Satellite
      • Twin Falls, Idaho, United States, 83301
        • St. Luke's Magic Valley Medical Center Satellite
    • Illinois
      • Bloomington, Illinois, United States, 61704
        • Illinois CancerCare - Bloomington Satellite
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60625
        • Swedish Hospital Satellite
      • Chicago Ridge, Illinois, United States, 60415
        • Associated Urological Specialists
      • Evanston, Illinois, United States, 60201
        • NorthShore University Health System - Evanston Hospital
      • Galesburg, Illinois, United States, 61401
        • Illinois CancerCare - Galesburg Satellite
      • Glenview, Illinois, United States, 60026
        • NorthShore University Health System - Glenbrook Hospital Ambulatory Care Center Satellite
      • Highland Park, Illinois, United States, 60035
        • NorthShore University Health System - Highland Park Hospital Ambulatory Care Center Satellite
      • Lake Barrington, Illinois, United States, 60010
        • Comprehensive Urologic Care
      • New Lenox, Illinois, United States, 60451
        • Advanced Urology Associates
      • Ottawa, Illinois, United States, 61350
        • Illinois CancerCare - Ottawa Satellite
      • Pekin, Illinois, United States, 61554
        • Illinois CancerCare - Pekin Satellite
      • Peoria, Illinois, United States, 61615
        • Illinois CancerCare, P.C.
      • Peru, Illinois, United States, 61354
        • Illinois CancerCare - Peru Satellite
      • Washington, Illinois, United States, 61571
        • Illinois CancerCare - Washington Satellite
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Urology of Indiana, LLC Satellite
      • Greenwood, Indiana, United States, 46143
        • Urology of Indiana, LLC
      • Lafayette, Indiana, United States, 47904
        • IU Health Arnett Cancer Center
      • Muncie, Indiana, United States, 47303
        • IU Health Ball Memorial Hospital Satellite
    • Iowa
      • Council Bluffs, Iowa, United States, 51501
        • Adult and Pediatric Urology P.C. Satellite
      • Creston, Iowa, United States, 50801
        • Greater Regional Medical Center
    • Kansas
      • Wichita, Kansas, United States, 67226
        • Wichita Urology Group
      • Wichita, Kansas, United States, 67205
        • Wichita Urology Group Satellite
      • Wichita, Kansas, United States, 67206
        • Wichita Urology Group Satellite
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • Comprehensive Urology
      • Troy, Michigan, United States, 48084
        • Michigan Institute of Urology
    • Missouri
      • Osage Beach, Missouri, United States, 65065
        • Lake Regional Health System
      • St Louis, Missouri, United States, 63141
        • Specialty Clinical Research of St. Louis
      • St Louis, Missouri, United States, 63141
        • Urology of St. Louis Satellite
    • Montana
      • Billings, Montana, United States, 59102
        • St. Vincent - Frontier Cancer Center
      • Billings, Montana, United States, 59101
        • St. Vincent Healthcare Satellite
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Adult and Pediatric Urology P.C.
    • New Jersey
      • Pennington, New Jersey, United States, 08534
        • Capital Health Medical Center - Hopewell
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico Comprehensive Cancer Center
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical College
      • Syracuse, New York, United States, 13210
        • Associated Medical Professionals of NY, PLLC
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Oncology Specialists of Charlotte
      • Raleigh, North Carolina, United States, 27612
        • Associated Urologists of North Carolina
    • North Dakota
      • Grand Forks, North Dakota, United States, 58201
        • Altru Cancer Center
      • Grand Forks, North Dakota, United States, 58201
        • Altru Health System Satellite
      • Grand Forks, North Dakota, United States, 58201
        • Altru Professional Center Satellite
    • Ohio
      • Avon, Ohio, United States, 44011
        • University Hospitals Seidman Cancer Center at UH Avon Health Center Satellite
      • Cincinnati, Ohio, United States, 45212
        • TriState Urologic Services PSC Inc.
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
      • Gahanna, Ohio, United States, 43230
        • Central Ohio Urology Group
      • Gahanna, Ohio, United States, 43230
        • Central Ohio Urology Group Satellite
      • Mentor, Ohio, United States, 44060
        • University Hospitals Seidman Cancer Center at UH Mentor Health Center Satellite
      • Middleburg Heights, Ohio, United States, 44130
        • Helios CR, LLC
      • Orange, Ohio, United States, 44122
        • UH Minoff Health Center at Chagrin Highlands
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, United States, 19004
        • MidLantic Urology
      • Lancaster, Pennsylvania, United States, 17604
        • Keystone Urology Specialists
      • Sayre, Pennsylvania, United States, 18840
        • Guthrie Medical Group, PC
      • Sayre, Pennsylvania, United States, 18840
        • Robert Packer Hospital Satellite
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Carolina Urologic Research Center
      • North Charleston, South Carolina, United States, 29406
        • Lowcountry Urology Clinics
    • Tennessee
      • Nashville, Tennessee, United States, 37209
        • Urology Associates, P.C.
    • Texas
      • Harlingen, Texas, United States, 78550
        • Valley Cancer Associates
      • Houston, Texas, United States, 77027
        • Houston Metro Urology CRC, LLC
      • San Antonio, Texas, United States, 78240
        • The Urology Place
      • San Antonio, Texas, United States, 78229
        • Urology San Antonio Clinical Trials
    • Utah
      • Logan, Utah, United States, 84341
        • Logan Regional Hospital Satellite
      • Murray, Utah, United States, 84107
        • Intermountain Medical Center Satellite
      • Ogden, Utah, United States, 84403
        • McKay-Dee Hospital Satellite
      • Provo, Utah, United States, 84604
        • Utah Valley Hospital
      • St. George, Utah, United States, 84790
        • St. George Regional Hospital Satellite
    • Virginia
      • Alexandria, Virginia, United States, 22311
        • Potomac Urology Center, PC
      • Richmond, Virginia, United States, 23235
        • Virginia Urology
      • Virginia Beach, Virginia, United States, 23462
        • Urology of Virginia
      • Woodbridge, Virginia, United States, 22191
        • Potomac Urology Satellite
    • Washington
      • Spokane, Washington, United States, 99202
        • Spokane Urology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

A patient will be eligible for inclusion in the discontinuation phase of the study if the following applies:

  1. Was previously enrolled under the original version and amendment 1 of this study
  2. Has voluntarily resigned and dated the informed consent form prior to transition to the discontinuation phase of this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Relugolix
Oral relugolix 120 mg once daily with a loading dose of 360 mg on Day 1
Drug: Relugolix
Relugolix tablet
Other Names:
  • TAK-385
  • MVT-601
  • RVT-601
  • T-1331285
  • ORGOVYX
Active Comparator: Leuprolide Acetate
Subcutaneous or intramuscular leuprolide acetate 22.5 mg 3-M depot or 45 mg 6-M injection or Leuprolide acetate injectable emulsion (42 mg injectable emulsion is not allowed)
Drug: Leuprolide Acetate
Leuprolide acetate injection
Other Names:
  • Leuprolide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients With Adverse Events and Serious Adverse Events
Time Frame: Screening; Day 1; 3, 6, 9, and 12 months; and every 3 months thereafter, up to 1 year
Number of patients with adverse events and serious adverse events
Screening; Day 1; 3, 6, 9, and 12 months; and every 3 months thereafter, up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time Course of Events Related to MACE
Time Frame: From date of enrollment until date of first confirmed MACE, assessed up to 5 years
Time to first adjudicated MACE or death due to all cause, time to first adjudicated nonfatal or fatal myocardial infarction, time to first adjudicated nonfatal or fatal stroke, time to adjudicated cardiovascular death, time to recurrent adjudicated MACE, and time to start of ADT in combination with enzalutamide/abiraterone/apalutamide/darolutamide for disease progression
From date of enrollment until date of first confirmed MACE, assessed up to 5 years
Incidence of Safety Outcomes
Time Frame: Screening; Day 1; 3, 6, 9, and 12 months; and every 3 months thereafter
Incidence of selective safety data including all treatment-emergent serious adverse events, nonserious adverse events leading to discontinuation of relugolix or leuprolide acetate, and clinical laboratory tests as obtained per standard of care
Screening; Day 1; 3, 6, 9, and 12 months; and every 3 months thereafter

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sumitomo Pharma America, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2023

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

October 25, 2022

First Submitted That Met QC Criteria

October 31, 2022

First Posted (Actual)

November 4, 2022

Study Record Updates

Last Update Posted (Actual)

June 15, 2026

Last Update Submitted That Met QC Criteria

June 11, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MVT-601-056

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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