Clinical trial NCT05605964: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: ORGOVYX
relugolix
prostate cancer
leuprolide acetate
Lead sponsor: Sumitomo Pharma Switzerland GmbH
Sponsor class: INDUSTRY
First posted: 2022-11-04
Enrollment: 387
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 criteria: 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

Primary outcomes:
measure: Incidence of Safety Outcomes
timeFrame: Screening; Day 1; 3, 6, 9, and 12 months; and every 3 months thereafter
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Urology Associates of Mobile
state: Alabama
city: Tucson
country: United States
facility: Arizona Urology Specialists, PLLC
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Urology
state: Arkansas
city: Downey
country: United States
facility: Genesis Research, LLC Satellite
state: California
city: Fountain Valley
country: United States
facility: Orange Coast Memorial Medical Center
state: California
city: Los Alamitos
country: United States
facility: Genesis Research , LLC
state: California
city: Los Angeles
country: United States
facility: Tower Urology
state: California
city: Monterrey
country: United States
facility: Pacific Cancer Care
state: California
city: Murrieta
country: United States
facility: Tri Valley Urology Medical Group
state: California
city: Murrieta
country: United States
facility: Tri Valley Urology Medical Group Satellite
state: California
city: San Bernardino
country: United States
facility: San Bernadino Urological Associates Medical Group
state: California
city: San Diego
country: United States
facility: Genesis Research, LLC
state: California
city: Sherman Oaks
country: United States
facility: Genesis Research, LLC Satellite
state: California
city: Temecula
country: United States
facility: Tri Valley Urology Medical Group Satellite
state: California
city: Torrance
country: United States
facility: Genesis Research, LLC Satellite
state: California
city: Torrance
country: United States
facility: Genesis Research, LLC Satellite
state: California
city: Washington DC
country: United States
facility: Urologic Surgeons of Washington
state: District of Columbia
city: Washington
country: United States
facility: Medstar Washington Hospital Center
state: District of Columbia
city: Daytona Beach
country: United States
facility: Advanced Urology Institute
state: Florida
city: Jacksonville
country: United States
facility: East Coast Institute for Research, LLC Satellite
state: Florida
city: Jacksonville
country: United States
facility: East Coast Institute for Research, LLC
state: Florida
city: Jacksonville
country: United States
facility: East Coast Institute for Research, LLC Satellite
state: Florida
city: Lake City
country: United States
facility: Lake City Cancer Center, LLC
state: Florida
city: Miami
country: United States
facility: SG Research LLC
state: Florida
city: Tampa
country: United States
facility: Florida Urology Partners, LLP Satellite
state: Florida
city: Tampa
country: United States
facility: Florida Urology Partners, LLP
state: Florida
city: Tampa
country: United States
facility: Florida Urology Partners, LLP Satellite
state: Florida
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Augusta
country: United States
facility: Georgia Cancer Center Satellite
state: Georgia
city: Boise
country: United States
facility: St. Luke's Regional Medical Center Satellite
state: Idaho
city: Boise
country: United States
facility: St. Luke's Regional Medical Center
state: Idaho
city: Fruitland
country: United States
facility: St. Luke's Cancer Institute - Fruitland Satellite
state: Idaho
city: Meridian
country: United States
facility: St. Luke's Cancer Institute - Meridian Satellite
state: Idaho
city: Meridian
country: United States
facility: St. Luke's Meridian Medical Center Satellite
state: Idaho
city: Nampa
country: United States
facility: St. Luke's Cancer Institute - Nampa Satellite
state: Idaho
city: Nampa
country: United States
facility: St. Luke's Nampa Medical Center Satellite
state: Idaho
city: Twin Falls
country: United States
facility: St. Luke's Cancer Institute Satellite
state: Idaho
city: Twin Falls
country: United States
facility: St. Luke's Magic Valley Medical Center Satellite
state: Idaho
city: Bloomington
country: United States
facility: Illinois CancerCare - Bloomington Satellite
state: Illinois
city: Chicago Ridge
country: United States
facility: Associated Urological Specialists
state: Illinois
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Swedish Hospital Satellite
state: Illinois
city: Evanston
country: United States
facility: NorthShore University Health System - Evanston Hospital
state: Illinois
city: Galesburg
country: United States
facility: Illinois CancerCare - Galesburg Satellite
state: Illinois
city: Glenview
country: United States
facility: NorthShore University Health System - Glenbrook Hospital Ambulatory Care Center Satellite
state: Illinois
city: Highland Park
country: United States
facility: NorthShore University Health System - Highland Park Hospital Ambulatory Care Center Satellite
state: Illinois
city: Lake Barrington
country: United States
facility: Comprehensive Urologic Care
state: Illinois
city: New Lenox
country: United States
facility: Advanced Urology Associates
state: Illinois
city: Ottawa
country: United States
facility: Illinois CancerCare - Ottawa Satellite
state: Illinois
city: Pekin
country: United States
facility: Illinois CancerCare - Pekin Satellite
state: Illinois
city: Peoria
country: United States
facility: Illinois CancerCare, P.C.
state: Illinois
city: Peru
country: United States
facility: Illinois CancerCare - Peru Satellite
state: Illinois
city: Washington
country: United States
facility: Illinois CancerCare - Washington Satellite
state: Illinois
city: Carmel
country: United States
facility: Urology of Indiana, LLC Satellite
state: Indiana
city: Greenwood
country: United States
facility: Urology of Indiana, LLC
state: Indiana
city: Lafayette
country: United States
facility: IU Health Arnett Cancer Center
state: Indiana
city: Muncie
country: United States
facility: IU Health Ball Memorial Hospital Satellite
state: Indiana
city: Council Bluffs
country: United States
facility: Adult and Pediatric Urology P.C. Satellite
state: Iowa
city: Creston
country: United States
facility: Greater Regional Medical Center
state: Iowa
city: Wichita
country: United States
facility: Wichita Urology Group Satellite
state: Kansas
city: Wichita
country: United States
facility: Wichita Urology Group Satellite
state: Kansas
city: Wichita
country: United States
facility: Wichita Urology Group
state: Kansas
city: Royal Oak
country: United States
facility: Comprehensive Urology
state: Michigan
city: Troy
country: United States
facility: Michigan Institute of Urology
state: Michigan
city: Osage Beach
country: United States
facility: Lake Regional Health System
state: Missouri
city: Saint Louis
country: United States
facility: Specialty Clinical Research of St. Louis
state: Missouri
city: Saint Louis
country: United States
facility: Urology of St. Louis Satellite
state: Missouri
city: Billings
country: United States
facility: St. Vincent Healthcare Satellite
state: Montana
city: Billings
country: United States
facility: St. Vincent - Frontier Cancer Center
state: Montana
city: Omaha
country: United States
facility: Adult and Pediatric Urology P.C.
state: Nebraska
city: Pennington
country: United States
facility: Capital Health Medical Center - Hopewell
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico Comprehensive Cancer Center
state: New Mexico
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Syracuse
country: United States
facility: Associated Medical Professionals of NY, PLLC
state: New York
city: Charlotte
country: United States
facility: Oncology Specialists of Charlotte
state: North Carolina
city: Raleigh
country: United States
facility: Associated Urologists of North Carolina
state: North Carolina
city: Grand Forks
country: United States
facility: Altru Cancer Center
state: North Dakota
city: Grand Forks
country: United States
facility: Altru Health System Satellite
state: North Dakota
city: Grand Forks
country: United States
facility: Altru Professional Center Satellite
state: North Dakota
city: Avon
country: United States
facility: University Hospitals Seidman Cancer Center at UH Avon Health Center Satellite
state: Ohio
city: Cincinnati
country: United States
facility: TriState Urologic Services PSC Inc.
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Gahanna
country: United States
facility: Central Ohio Urology Group Satellite
state: Ohio
city: Gahanna
country: United States
facility: Central Ohio Urology Group
state: Ohio
city: Mentor
country: United States
facility: University Hospitals Seidman Cancer Center at UH Mentor Health Center Satellite
state: Ohio
city: Middleburg Heights
country: United States
facility: Helios CR, LLC
state: Ohio
city: Orange Village
country: United States
facility: UH Minoff Health Center at Chagrin Highlands
state: Ohio
city: Bala Cynwyd
country: United States
facility: MidLantic Urology
state: Pennsylvania
city: Lancaster
country: United States
facility: Keystone Urology Specialists
state: Pennsylvania
city: Sayre
country: United States
facility: Guthrie Medical Group, PC
state: Pennsylvania
city: Sayre
country: United States
facility: Robert Packer Hospital Satellite
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: North Charleston
country: United States
facility: Lowcountry Urology Clinics
state: South Carolina
city: Nashville
country: United States
facility: Urology Associates, P.C.
state: Tennessee
city: Harlingen
country: United States
facility: Valley Cancer Associates
state: Texas
city: Houston
country: United States
facility: Houston Metro Urology CRC, LLC
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio Clinical Trials
state: Texas
city: San Antonio
country: United States
facility: The Urology Place
state: Texas
city: Logan
country: United States
facility: Logan Regional Hospital Satellite
state: Utah
city: Murray
country: United States
facility: Intermountain Medical Center Satellite
state: Utah
city: Ogden
country: United States
facility: McKay-Dee Hospital Satellite
state: Utah
city: Provo
country: United States
facility: Utah Valley Hospital
state: Utah
city: Saint George
country: United States
facility: St. George Regional Hospital Satellite
state: Utah
city: Alexandria
country: United States
facility: Potomac Urology Center, PC
state: Virginia
city: Richmond
country: United States
facility: Virginia Urology
state: Virginia
city: Virginia Beach
country: United States
facility: Urology of Virginia
state: Virginia
city: Woodbridge
country: United States
facility: Potomac Urology Satellite
state: Virginia
city: Spokane
country: United States
facility: Spokane Urology
state: Washington
Study officials:
References: