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Randomized Study to Evaluate MACE in Patients With Prostate Cancer Treated With Relugolix or Leuprolide Acetate
Sponsor: Sumitomo Pharma America, Inc.
Summary
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.
Official title: Relugolix Versus Leuprolide in Patients With Prostate Cancer: A Randomized, Open-Label Study to Assess Major Adverse Cardiovascular Events (REPLACE-CV)
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
387
Start Date
2023-01-28
Completion Date
2024-12-31
Last Updated
2026-06-15
Healthy Volunteers
No
Conditions
Interventions
Relugolix
Relugolix tablet
Leuprolide Acetate
Leuprolide acetate injection
Locations (108)
Urology Associates of Mobile
Mobile, Alabama, United States
Arizona Urology Specialists, PLLC
Tucson, Arizona, United States
Arkansas Urology
Little Rock, Arkansas, United States
Genesis Research, LLC Satellite
Downey, California, United States
Orange Coast Memorial Medical Center
Fountain Valley, California, United States
Genesis Research , LLC
Los Alamitos, California, United States
Tower Urology
Los Angeles, California, United States
Pacific Cancer Care
Monterey, California, United States
Tri Valley Urology Medical Group
Murrieta, California, United States
Tri Valley Urology Medical Group Satellite
Murrieta, California, United States
San Bernadino Urological Associates Medical Group
San Bernardino, California, United States
Genesis Research, LLC
San Diego, California, United States
Genesis Research, LLC Satellite
Sherman Oaks, California, United States
Tri Valley Urology Medical Group Satellite
Temecula, California, United States
Genesis Research, LLC Satellite
Torrance, California, United States
Genesis Research, LLC Satellite
Torrance, California, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
Urologic Surgeons of Washington
Washington D.C., District of Columbia, United States
Advanced Urology Institute
Daytona Beach, Florida, United States
East Coast Institute for Research, LLC Satellite
Jacksonville, Florida, United States
East Coast Institute for Research, LLC
Jacksonville, Florida, United States
East Coast Institute for Research, LLC Satellite
Jacksonville, Florida, United States
Lake City Cancer Center, LLC
Lake City, Florida, United States
SG Research LLC
Miami, Florida, United States
Florida Urology Partners, LLP Satellite
Tampa, Florida, United States
Florida Urology Partners, LLP
Tampa, Florida, United States
Florida Urology Partners, LLP Satellite
Tampa, Florida, United States
Augusta University
Augusta, Georgia, United States
Georgia Cancer Center Satellite
Augusta, Georgia, United States
St. Luke's Regional Medical Center Satellite
Boise, Idaho, United States
St. Luke's Regional Medical Center
Boise, Idaho, United States
St. Luke's Cancer Institute - Fruitland Satellite
Fruitland, Idaho, United States
St. Luke's Cancer Institute - Meridian Satellite
Meridian, Idaho, United States
St. Luke's Meridian Medical Center Satellite
Meridian, Idaho, United States
St. Luke's Cancer Institute - Nampa Satellite
Nampa, Idaho, United States
St. Luke's Nampa Medical Center Satellite
Nampa, Idaho, United States
St. Luke's Cancer Institute Satellite
Twin Falls, Idaho, United States
St. Luke's Magic Valley Medical Center Satellite
Twin Falls, Idaho, United States
Illinois CancerCare - Bloomington Satellite
Bloomington, Illinois, United States
Northwestern University
Chicago, Illinois, United States
Swedish Hospital Satellite
Chicago, Illinois, United States
Associated Urological Specialists
Chicago Ridge, Illinois, United States
NorthShore University Health System - Evanston Hospital
Evanston, Illinois, United States
Illinois CancerCare - Galesburg Satellite
Galesburg, Illinois, United States
NorthShore University Health System - Glenbrook Hospital Ambulatory Care Center Satellite
Glenview, Illinois, United States
NorthShore University Health System - Highland Park Hospital Ambulatory Care Center Satellite
Highland Park, Illinois, United States
Comprehensive Urologic Care
Lake Barrington, Illinois, United States
Advanced Urology Associates
New Lenox, Illinois, United States
Illinois CancerCare - Ottawa Satellite
Ottawa, Illinois, United States
Illinois CancerCare - Pekin Satellite
Pekin, Illinois, United States
Illinois CancerCare, P.C.
Peoria, Illinois, United States
Illinois CancerCare - Peru Satellite
Peru, Illinois, United States
Illinois CancerCare - Washington Satellite
Washington, Illinois, United States
Urology of Indiana, LLC Satellite
Carmel, Indiana, United States
Urology of Indiana, LLC
Greenwood, Indiana, United States
IU Health Arnett Cancer Center
Lafayette, Indiana, United States
IU Health Ball Memorial Hospital Satellite
Muncie, Indiana, United States
Adult and Pediatric Urology P.C. Satellite
Council Bluffs, Iowa, United States
Greater Regional Medical Center
Creston, Iowa, United States
Wichita Urology Group Satellite
Wichita, Kansas, United States
Wichita Urology Group Satellite
Wichita, Kansas, United States
Wichita Urology Group
Wichita, Kansas, United States
Comprehensive Urology
Royal Oak, Michigan, United States
Michigan Institute of Urology
Troy, Michigan, United States
Lake Regional Health System
Osage Beach, Missouri, United States
Specialty Clinical Research of St. Louis
St Louis, Missouri, United States
Urology of St. Louis Satellite
St Louis, Missouri, United States
St. Vincent Healthcare Satellite
Billings, Montana, United States
St. Vincent - Frontier Cancer Center
Billings, Montana, United States
Adult and Pediatric Urology P.C.
Omaha, Nebraska, United States
Capital Health Medical Center - Hopewell
Pennington, New Jersey, United States
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, United States
Albany Medical College
Albany, New York, United States
Associated Medical Professionals of NY, PLLC
Syracuse, New York, United States
Oncology Specialists of Charlotte
Charlotte, North Carolina, United States
Associated Urologists of North Carolina
Raleigh, North Carolina, United States
Altru Cancer Center
Grand Forks, North Dakota, United States
Altru Health System Satellite
Grand Forks, North Dakota, United States
Altru Professional Center Satellite
Grand Forks, North Dakota, United States
University Hospitals Seidman Cancer Center at UH Avon Health Center Satellite
Avon, Ohio, United States
TriState Urologic Services PSC Inc.
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Central Ohio Urology Group Satellite
Gahanna, Ohio, United States
Central Ohio Urology Group
Gahanna, Ohio, United States
University Hospitals Seidman Cancer Center at UH Mentor Health Center Satellite
Mentor, Ohio, United States
Helios CR, LLC
Middleburg Heights, Ohio, United States
UH Minoff Health Center at Chagrin Highlands
Orange, Ohio, United States
MidLantic Urology
Bala-Cynwyd, Pennsylvania, United States
Keystone Urology Specialists
Lancaster, Pennsylvania, United States
Guthrie Medical Group, PC
Sayre, Pennsylvania, United States
Robert Packer Hospital Satellite
Sayre, Pennsylvania, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Lowcountry Urology Clinics
North Charleston, South Carolina, United States
Urology Associates, P.C.
Nashville, Tennessee, United States
Valley Cancer Associates
Harlingen, Texas, United States
Houston Metro Urology CRC, LLC
Houston, Texas, United States
Urology San Antonio Clinical Trials
San Antonio, Texas, United States
The Urology Place
San Antonio, Texas, United States
Logan Regional Hospital Satellite
Logan, Utah, United States
Intermountain Medical Center Satellite
Murray, Utah, United States