Trial Title:
Randomized Study to Evaluate MACE in Patients With Prostate Cancer Treated With Relugolix or Leuprolide Acetate
NCT ID:
NCT05605964
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Leuprolide
Relugolix
Conditions: Keywords:
ORGOVYX
relugolix
prostate cancer
leuprolide acetate
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Relugolix
Description:
Relugolix tablet
Arm group label:
Relugolix
Other name:
ORGOVYX
Other name:
TAK-385
Other name:
MVT-601
Other name:
RVT-601
Other name:
T-1331285
Intervention type:
Drug
Intervention name:
Leuprolide Acetate
Description:
Leuprolide acetate injection
Arm group label:
Leuprolide Acetate
Other name:
Leuprolide
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.
Criteria for 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
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Urology Associates of Mobile
Address:
City:
Mobile
Zip:
36608
Country:
United States
Facility:
Name:
Arizona Urology Specialists, PLLC
Address:
City:
Tucson
Zip:
85704
Country:
United States
Facility:
Name:
Arkansas Urology
Address:
City:
Little Rock
Zip:
72211
Country:
United States
Facility:
Name:
Genesis Research, LLC Satellite
Address:
City:
Downey
Zip:
90241
Country:
United States
Facility:
Name:
Orange Coast Memorial Medical Center
Address:
City:
Fountain Valley
Zip:
92708
Country:
United States
Facility:
Name:
Genesis Research , LLC
Address:
City:
Los Alamitos
Zip:
90270
Country:
United States
Facility:
Name:
Tower Urology
Address:
City:
Los Angeles
Zip:
90048
Country:
United States
Facility:
Name:
Pacific Cancer Care
Address:
City:
Monterey
Zip:
93940
Country:
United States
Facility:
Name:
Tri Valley Urology Medical Group
Address:
City:
Murrieta
Zip:
92562
Country:
United States
Facility:
Name:
Tri Valley Urology Medical Group Satellite
Address:
City:
Murrieta
Zip:
92563
Country:
United States
Facility:
Name:
San Bernadino Urological Associates Medical Group
Address:
City:
San Bernardino
Zip:
92404
Country:
United States
Facility:
Name:
Genesis Research, LLC
Address:
City:
San Diego
Zip:
92123
Country:
United States
Facility:
Name:
Genesis Research, LLC Satellite
Address:
City:
Sherman Oaks
Zip:
91411
Country:
United States
Facility:
Name:
Tri Valley Urology Medical Group Satellite
Address:
City:
Temecula
Zip:
92592
Country:
United States
Facility:
Name:
Genesis Research, LLC Satellite
Address:
City:
Torrance
Zip:
90503
Country:
United States
Facility:
Name:
Genesis Research, LLC Satellite
Address:
City:
Torrance
Zip:
90505
Country:
United States
Facility:
Name:
Medstar Washington Hospital Center
Address:
City:
Washington
Zip:
20010
Country:
United States
Facility:
Name:
Urologic Surgeons of Washington
Address:
City:
Washington
Zip:
20036
Country:
United States
Facility:
Name:
Advanced Urology Institute
Address:
City:
Daytona Beach
Zip:
32114
Country:
United States
Facility:
Name:
East Coast Institute for Research, LLC Satellite
Address:
City:
Jacksonville
Zip:
32204
Country:
United States
Facility:
Name:
East Coast Institute for Research, LLC
Address:
City:
Jacksonville
Zip:
32216
Country:
United States
Facility:
Name:
East Coast Institute for Research, LLC Satellite
Address:
City:
Jacksonville
Zip:
32256
Country:
United States
Facility:
Name:
Lake City Cancer Center, LLC
Address:
City:
Lake City
Zip:
32024
Country:
United States
Facility:
Name:
SG Research LLC
Address:
City:
Miami
Zip:
33145
Country:
United States
Facility:
Name:
Florida Urology Partners, LLP Satellite
Address:
City:
Tampa
Zip:
33578
Country:
United States
Facility:
Name:
Florida Urology Partners, LLP
Address:
City:
Tampa
Zip:
33609
Country:
United States
Facility:
Name:
Florida Urology Partners, LLP Satellite
Address:
City:
Tampa
Zip:
33615
Country:
United States
Facility:
Name:
Augusta University
Address:
City:
Augusta
Zip:
30912
Country:
United States
Facility:
Name:
Georgia Cancer Center Satellite
Address:
City:
Augusta
Zip:
30912
Country:
United States
Facility:
Name:
St. Luke's Regional Medical Center Satellite
Address:
City:
Boise
Zip:
83712
Country:
United States
Facility:
Name:
St. Luke's Regional Medical Center
Address:
City:
Boise
Zip:
83712
Country:
United States
Facility:
Name:
St. Luke's Cancer Institute - Fruitland Satellite
Address:
City:
Fruitland
Zip:
83619
Country:
United States
Facility:
Name:
St. Luke's Cancer Institute - Meridian Satellite
Address:
City:
Meridian
Zip:
83642
Country:
United States
Facility:
Name:
St. Luke's Meridian Medical Center Satellite
Address:
City:
Meridian
Zip:
83642
Country:
United States
Facility:
Name:
St. Luke's Cancer Institute - Nampa Satellite
Address:
City:
Nampa
Zip:
83687
Country:
United States
Facility:
Name:
St. Luke's Nampa Medical Center Satellite
Address:
City:
Nampa
Zip:
83687
Country:
United States
Facility:
Name:
St. Luke's Cancer Institute Satellite
Address:
City:
Twin Falls
Zip:
83301
Country:
United States
Facility:
Name:
St. Luke's Magic Valley Medical Center Satellite
Address:
City:
Twin Falls
Zip:
83301
Country:
United States
Facility:
Name:
Illinois CancerCare - Bloomington Satellite
Address:
City:
Bloomington
Zip:
61704
Country:
United States
Facility:
Name:
Associated Urological Specialists
Address:
City:
Chicago Ridge
Zip:
60415
Country:
United States
Facility:
Name:
Northwestern University
Address:
City:
Chicago
Zip:
60611
Country:
United States
Facility:
Name:
Swedish Hospital Satellite
Address:
City:
Chicago
Zip:
60625
Country:
United States
Facility:
Name:
NorthShore University Health System - Evanston Hospital
Address:
City:
Evanston
Zip:
60201
Country:
United States
Facility:
Name:
Illinois CancerCare - Galesburg Satellite
Address:
City:
Galesburg
Zip:
61401
Country:
United States
Facility:
Name:
NorthShore University Health System - Glenbrook Hospital Ambulatory Care Center Satellite
Address:
City:
Glenview
Zip:
60026
Country:
United States
Facility:
Name:
NorthShore University Health System - Highland Park Hospital Ambulatory Care Center Satellite
Address:
City:
Highland Park
Zip:
60035
Country:
United States
Facility:
Name:
Comprehensive Urologic Care
Address:
City:
Lake Barrington
Zip:
60010
Country:
United States
Facility:
Name:
Advanced Urology Associates
Address:
City:
New Lenox
Zip:
60451
Country:
United States
Facility:
Name:
Illinois CancerCare - Ottawa Satellite
Address:
City:
Ottawa
Zip:
61350
Country:
United States
Facility:
Name:
Illinois CancerCare - Pekin Satellite
Address:
City:
Pekin
Zip:
61554
Country:
United States
Facility:
Name:
Illinois CancerCare, P.C.
Address:
City:
Peoria
Zip:
61615
Country:
United States
Facility:
Name:
Illinois CancerCare - Peru Satellite
Address:
City:
Peru
Zip:
61354
Country:
United States
Facility:
Name:
Illinois CancerCare - Washington Satellite
Address:
City:
Washington
Zip:
61571
Country:
United States
Facility:
Name:
Urology of Indiana, LLC Satellite
Address:
City:
Carmel
Zip:
46032
Country:
United States
Facility:
Name:
Urology of Indiana, LLC
Address:
City:
Greenwood
Zip:
46143
Country:
United States
Facility:
Name:
IU Health Arnett Cancer Center
Address:
City:
Lafayette
Zip:
47904
Country:
United States
Facility:
Name:
IU Health Ball Memorial Hospital Satellite
Address:
City:
Muncie
Zip:
47303
Country:
United States
Facility:
Name:
Adult and Pediatric Urology P.C. Satellite
Address:
City:
Council Bluffs
Zip:
51501
Country:
United States
Facility:
Name:
Greater Regional Medical Center
Address:
City:
Creston
Zip:
50801
Country:
United States
Facility:
Name:
Wichita Urology Group Satellite
Address:
City:
Wichita
Zip:
67205
Country:
United States
Facility:
Name:
Wichita Urology Group Satellite
Address:
City:
Wichita
Zip:
67206
Country:
United States
Facility:
Name:
Wichita Urology Group
Address:
City:
Wichita
Zip:
67226
Country:
United States
Facility:
Name:
Comprehensive Urology
Address:
City:
Royal Oak
Zip:
48073
Country:
United States
Facility:
Name:
Michigan Institute of Urology
Address:
City:
Troy
Zip:
48084
Country:
United States
Facility:
Name:
Lake Regional Health System
Address:
City:
Osage Beach
Zip:
65065
Country:
United States
Facility:
Name:
Specialty Clinical Research of St. Louis
Address:
City:
Saint Louis
Zip:
63141
Country:
United States
Facility:
Name:
Urology of St. Louis Satellite
Address:
City:
Saint Louis
Zip:
63141
Country:
United States
Facility:
Name:
St. Vincent Healthcare Satellite
Address:
City:
Billings
Zip:
59101
Country:
United States
Facility:
Name:
St. Vincent - Frontier Cancer Center
Address:
City:
Billings
Zip:
59102
Country:
United States
Facility:
Name:
Adult and Pediatric Urology P.C.
Address:
City:
Omaha
Zip:
68114
Country:
United States
Facility:
Name:
Capital Health Medical Center - Hopewell
Address:
City:
Pennington
Zip:
08534
Country:
United States
Facility:
Name:
University of New Mexico Comprehensive Cancer Center
Address:
City:
Albuquerque
Zip:
87131
Country:
United States
Facility:
Name:
Albany Medical College
Address:
City:
Albany
Zip:
12208
Country:
United States
Facility:
Name:
Associated Medical Professionals of NY, PLLC
Address:
City:
Syracuse
Zip:
13210
Country:
United States
Facility:
Name:
Oncology Specialists of Charlotte
Address:
City:
Charlotte
Zip:
28207
Country:
United States
Facility:
Name:
Associated Urologists of North Carolina
Address:
City:
Raleigh
Zip:
27612
Country:
United States
Facility:
Name:
Altru Cancer Center
Address:
City:
Grand Forks
Zip:
58201
Country:
United States
Facility:
Name:
Altru Health System Satellite
Address:
City:
Grand Forks
Zip:
58201
Country:
United States
Facility:
Name:
Altru Professional Center Satellite
Address:
City:
Grand Forks
Zip:
58201
Country:
United States
Facility:
Name:
University Hospitals Seidman Cancer Center at UH Avon Health Center Satellite
Address:
City:
Avon
Zip:
44011
Country:
United States
Facility:
Name:
TriState Urologic Services PSC Inc.
Address:
City:
Cincinnati
Zip:
45212
Country:
United States
Facility:
Name:
University Hospitals Cleveland Medical Center
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Facility:
Name:
Central Ohio Urology Group Satellite
Address:
City:
Gahanna
Zip:
43230
Country:
United States
Facility:
Name:
Central Ohio Urology Group
Address:
City:
Gahanna
Zip:
43230
Country:
United States
Facility:
Name:
University Hospitals Seidman Cancer Center at UH Mentor Health Center Satellite
Address:
City:
Mentor
Zip:
44060
Country:
United States
Facility:
Name:
Helios CR, LLC
Address:
City:
Middleburg Heights
Zip:
44130
Country:
United States
Facility:
Name:
UH Minoff Health Center at Chagrin Highlands
Address:
City:
Orange Village
Zip:
44122
Country:
United States
Facility:
Name:
MidLantic Urology
Address:
City:
Bala-Cynwyd
Zip:
19004
Country:
United States
Facility:
Name:
Keystone Urology Specialists
Address:
City:
Lancaster
Zip:
17604
Country:
United States
Facility:
Name:
Guthrie Medical Group, PC
Address:
City:
Sayre
Zip:
18840
Country:
United States
Facility:
Name:
Robert Packer Hospital Satellite
Address:
City:
Sayre
Zip:
18840
Country:
United States
Facility:
Name:
Carolina Urologic Research Center
Address:
City:
Myrtle Beach
Zip:
29572
Country:
United States
Facility:
Name:
Lowcountry Urology Clinics
Address:
City:
North Charleston
Zip:
29406
Country:
United States
Facility:
Name:
Urology Associates, P.C.
Address:
City:
Nashville
Zip:
37209
Country:
United States
Facility:
Name:
Valley Cancer Associates
Address:
City:
Harlingen
Zip:
78550
Country:
United States
Facility:
Name:
Houston Metro Urology CRC, LLC
Address:
City:
Houston
Zip:
77027
Country:
United States
Facility:
Name:
Urology San Antonio Clinical Trials
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Facility:
Name:
The Urology Place
Address:
City:
San Antonio
Zip:
78240
Country:
United States
Facility:
Name:
Logan Regional Hospital Satellite
Address:
City:
Logan
Zip:
84341
Country:
United States
Facility:
Name:
Intermountain Medical Center Satellite
Address:
City:
Murray
Zip:
84107
Country:
United States
Facility:
Name:
McKay-Dee Hospital Satellite
Address:
City:
Ogden
Zip:
84403
Country:
United States
Facility:
Name:
Utah Valley Hospital
Address:
City:
Provo
Zip:
84604
Country:
United States
Facility:
Name:
St. George Regional Hospital Satellite
Address:
City:
Saint George
Zip:
84790
Country:
United States
Facility:
Name:
Potomac Urology Center, PC
Address:
City:
Alexandria
Zip:
22311
Country:
United States
Facility:
Name:
Virginia Urology
Address:
City:
Richmond
Zip:
23235
Country:
United States
Facility:
Name:
Urology of Virginia
Address:
City:
Virginia Beach
Zip:
23462
Country:
United States
Facility:
Name:
Potomac Urology Satellite
Address:
City:
Woodbridge
Zip:
22191
Country:
United States
Facility:
Name:
Spokane Urology
Address:
City:
Spokane
Zip:
99202
Country:
United States
Start date:
January 25, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Sumitomo Pharma Switzerland GmbH
Agency class:
Industry
Source:
Sumitomo Pharma Switzerland GmbH
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05605964
