Randomized Study to Evaluate MACE in Patients With Prostate NCT05605964

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number	NCT05605964
Other study ID #	MVT-601-056
Secondary ID
Status	Active, not recruiting
Phase	Phase 3
First received
Last updated
Start date	January 25, 2023
Est. completion date	December 31, 2024

Study information
Verified date	May 2024
Source	Sumitomo Pharma Switzerland GmbH
Contact	n/a
Is FDA regulated	No
Health authority
Study type	Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status	Active, not recruiting
Enrollment	2250
Est. completion date	December 31, 2024
Est. primary completion date	December 31, 2024
Accepts healthy volunteers	No
Gender	Male
Age group	18 Years and older
Eligibility	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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Relugolix
Relugolix tablet
• Leuprolide Acetate
Leuprolide acetate injection

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

Sponsors *(1)*
Lead Sponsor	Collaborator
Sumitomo Pharma Switzerland GmbH

Country where clinical trial is conducted

United States,

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Safety Outcomes	Incidence of selective safety data including all 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

See also
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Recruiting	`NCT05156424` - A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer	Phase 1/Phase 2
Completed	`NCT03177759` - Living With Prostate Cancer (LPC)
Completed	`NCT01331083` - A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer	Phase 2
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Completed	`NCT04400656` - PROState Pathway Embedded Comparative Trial
Completed	`NCT02282644` - Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry	N/A
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Recruiting	`NCT03101176` - Multiparametric Ultrasound Imaging in Prostate Cancer	N/A
Completed	`NCT03290417` - Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer	N/A
Completed	`NCT00341939` - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Completed	`NCT01497925` - Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer	Phase 1
Recruiting	`NCT03679819` - Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
Completed	`NCT03554317` - COMbination of Bipolar Androgen Therapy and Nivolumab	Phase 2
Completed	`NCT03271502` - Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy	N/A

Randomized Study to Evaluate MACE in Patients With Prostate Cancer Treated With Relugolix or Leuprolide Acetate

Clinical Trial Details — Status: Active, not recruiting

Administrative data

Study information

Clinical Trial Summary

Description:

Recruitment information / eligibility

Study Design

Related Conditions & MeSH terms

Intervention

Locations

Sponsors (1)

Country where clinical trial is conducted

Outcome