Spots Global Cancer Trial Database for Randomized Study to Evaluate MACE in Patients With Prostate Cancer Treated With Relugolix or Leuprolide Acetate
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Trial Identification
Brief Title: Randomized Study to Evaluate MACE in Patients With Prostate Cancer Treated With Relugolix or Leuprolide Acetate
Official Title: Relugolix Versus Leuprolide in Patients With Prostate Cancer: A Randomized, Open-Label Study to Assess Major Adverse Cardiovascular Events (REPLACE-CV)
Study ID: NCT05605964
Conditions
Study Description
Brief 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.
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
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, District of Columbia, United States
Urologic Surgeons of Washington, Washington, 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
Associated Urological Specialists, Chicago Ridge, Illinois, United States
Northwestern University, Chicago, Illinois, United States
Swedish Hospital Satellite, Chicago, 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, Saint Louis, Missouri, United States
Urology of St. Louis Satellite, Saint 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 Village, 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
McKay-Dee Hospital Satellite, Ogden, Utah, United States
Utah Valley Hospital, Provo, Utah, United States
St. George Regional Hospital Satellite, Saint George, Utah, United States
Potomac Urology Center, PC, Alexandria, Virginia, United States
Virginia Urology, Richmond, Virginia, United States
Urology of Virginia, Virginia Beach, Virginia, United States
Potomac Urology Satellite, Woodbridge, Virginia, United States
Spokane Urology, Spokane, Washington, United States
Contact Details
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