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Prostate CancerPhase 3NCT05605964

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

A Phase 3 study testing Relugolix and Leuprolide Acetate in people with Prostate Cancer, run by Sumitomo Pharma America, Inc. at 108 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Relugolix and Leuprolide Acetate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
387 participants
Where
108 sitesUnited States
Study dates
28 Jan 2023to 31 Dec 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

108 sites in 1 country.

108 sites in 1 country

United States108 sites

  • Albany Medical College

    Albany, New York, 12208

  • University of New Mexico Comprehensive Cancer Center

    Albuquerque, New Mexico, 87131

  • Potomac Urology Center, PC

    Alexandria, Virginia, 22311

  • Augusta University

    Augusta, Georgia, 30912

  • Georgia Cancer Center Satellite

    Augusta, Georgia, 30912

  • University Hospitals Seidman Cancer Center at UH Avon Health Center Satellite

    Avon, Ohio, 44011

  • MidLantic Urology

    Bala-Cynwyd, Pennsylvania, 19004

  • St. Vincent Healthcare Satellite

    Billings, Montana, 59101

  • St. Vincent - Frontier Cancer Center

    Billings, Montana, 59102

  • Illinois CancerCare - Bloomington Satellite

    Bloomington, Illinois, 61704

  • St. Luke's Regional Medical Center Satellite

    Boise, Idaho, 83712

  • St. Luke's Regional Medical Center

    Boise, Idaho, 83712

  • Urology of Indiana, LLC Satellite

    Carmel, Indiana, 46032

  • Oncology Specialists of Charlotte

    Charlotte, North Carolina, 28207

  • Northwestern University

    Chicago, Illinois, 60611

  • Swedish Hospital Satellite

    Chicago, Illinois, 60625

  • Associated Urological Specialists

    Chicago Ridge, Illinois, 60415

  • TriState Urologic Services PSC Inc.

    Cincinnati, Ohio, 45212

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Adult and Pediatric Urology P.C. Satellite

    Council Bluffs, Iowa, 51501

  • Greater Regional Medical Center

    Creston, Iowa, 50801

  • Advanced Urology Institute

    Daytona Beach, Florida, 32114

  • Genesis Research, LLC Satellite

    Downey, California, 90241

  • NorthShore University Health System - Evanston Hospital

    Evanston, Illinois, 60201

  • Orange Coast Memorial Medical Center

    Fountain Valley, California, 92708

  • St. Luke's Cancer Institute - Fruitland Satellite

    Fruitland, Idaho, 83619

  • Central Ohio Urology Group Satellite

    Gahanna, Ohio, 43230

  • Central Ohio Urology Group

    Gahanna, Ohio, 43230

  • Illinois CancerCare - Galesburg Satellite

    Galesburg, Illinois, 61401

  • NorthShore University Health System - Glenbrook Hospital Ambulatory Care Center Satellite

    Glenview, Illinois, 60026

  • Altru Cancer Center

    Grand Forks, North Dakota, 58201

  • Altru Health System Satellite

    Grand Forks, North Dakota, 58201

  • Altru Professional Center Satellite

    Grand Forks, North Dakota, 58201

  • Urology of Indiana, LLC

    Greenwood, Indiana, 46143

  • Valley Cancer Associates

    Harlingen, Texas, 78550

  • NorthShore University Health System - Highland Park Hospital Ambulatory Care Center Satellite

    Highland Park, Illinois, 60035

  • Houston Metro Urology CRC, LLC

    Houston, Texas, 77027

  • East Coast Institute for Research, LLC Satellite

    Jacksonville, Florida, 32204

  • East Coast Institute for Research, LLC

    Jacksonville, Florida, 32216

  • East Coast Institute for Research, LLC Satellite

    Jacksonville, Florida, 32256

  • IU Health Arnett Cancer Center

    Lafayette, Indiana, 47904

  • Comprehensive Urologic Care

    Lake Barrington, Illinois, 60010

  • Lake City Cancer Center, LLC

    Lake City, Florida, 32024

  • Keystone Urology Specialists

    Lancaster, Pennsylvania, 17604

  • Arkansas Urology

    Little Rock, Arkansas, 72211

  • Logan Regional Hospital Satellite

    Logan, Utah, 84341

  • Genesis Research , LLC

    Los Alamitos, California, 90270

  • Tower Urology

    Los Angeles, California, 90048

  • University Hospitals Seidman Cancer Center at UH Mentor Health Center Satellite

    Mentor, Ohio, 44060

  • St. Luke's Cancer Institute - Meridian Satellite

    Meridian, Idaho, 83642

  • St. Luke's Meridian Medical Center Satellite

    Meridian, Idaho, 83642

  • SG Research LLC

    Miami, Florida, 33145

  • Helios CR, LLC

    Middleburg Heights, Ohio, 44130

  • Urology Associates of Mobile

    Mobile, Alabama, 36608

  • Pacific Cancer Care

    Monterey, California, 93940

  • IU Health Ball Memorial Hospital Satellite

    Muncie, Indiana, 47303

  • Intermountain Medical Center Satellite

    Murray, Utah, 84107

  • Tri Valley Urology Medical Group

    Murrieta, California, 92562

  • Tri Valley Urology Medical Group Satellite

    Murrieta, California, 92563

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • St. Luke's Cancer Institute - Nampa Satellite

    Nampa, Idaho, 83687

  • St. Luke's Nampa Medical Center Satellite

    Nampa, Idaho, 83687

  • Urology Associates, P.C.

    Nashville, Tennessee, 37209

  • Advanced Urology Associates

    New Lenox, Illinois, 60451

  • Lowcountry Urology Clinics

    North Charleston, South Carolina, 29406

  • McKay-Dee Hospital Satellite

    Ogden, Utah, 84403

  • Adult and Pediatric Urology P.C.

    Omaha, Nebraska, 68114

  • UH Minoff Health Center at Chagrin Highlands

    Orange, Ohio, 44122

  • Lake Regional Health System

    Osage Beach, Missouri, 65065

  • Illinois CancerCare - Ottawa Satellite

    Ottawa, Illinois, 61350

  • Illinois CancerCare - Pekin Satellite

    Pekin, Illinois, 61554

  • Capital Health Medical Center - Hopewell

    Pennington, New Jersey, 08534

  • Illinois CancerCare, P.C.

    Peoria, Illinois, 61615

  • Illinois CancerCare - Peru Satellite

    Peru, Illinois, 61354

  • Utah Valley Hospital

    Provo, Utah, 84604

  • Associated Urologists of North Carolina

    Raleigh, North Carolina, 27612

  • Virginia Urology

    Richmond, Virginia, 23235

  • Comprehensive Urology

    Royal Oak, Michigan, 48073

  • Urology San Antonio Clinical Trials

    San Antonio, Texas, 78229

  • The Urology Place

    San Antonio, Texas, 78240

  • San Bernadino Urological Associates Medical Group

    San Bernardino, California, 92404

  • Genesis Research, LLC

    San Diego, California, 92123

  • Guthrie Medical Group, PC

    Sayre, Pennsylvania, 18840

  • Robert Packer Hospital Satellite

    Sayre, Pennsylvania, 18840

  • Genesis Research, LLC Satellite

    Sherman Oaks, California, 91411

  • Spokane Urology

    Spokane, Washington, 99202

  • Specialty Clinical Research of St. Louis

    St Louis, Missouri, 63141

  • Urology of St. Louis Satellite

    St Louis, Missouri, 63141

  • St. George Regional Hospital Satellite

    St. George, Utah, 84790

  • Associated Medical Professionals of NY, PLLC

    Syracuse, New York, 13210

  • Florida Urology Partners, LLP Satellite

    Tampa, Florida, 33578

  • Florida Urology Partners, LLP

    Tampa, Florida, 33609

  • Florida Urology Partners, LLP Satellite

    Tampa, Florida, 33615

  • Tri Valley Urology Medical Group Satellite

    Temecula, California, 92592

  • Genesis Research, LLC Satellite

    Torrance, California, 90503

  • Genesis Research, LLC Satellite

    Torrance, California, 90505

  • Michigan Institute of Urology

    Troy, Michigan, 48084

  • Arizona Urology Specialists, PLLC

    Tucson, Arizona, 85704

  • St. Luke's Cancer Institute Satellite

    Twin Falls, Idaho, 83301

  • St. Luke's Magic Valley Medical Center Satellite

    Twin Falls, Idaho, 83301

  • Urology of Virginia

    Virginia Beach, Virginia, 23462

  • Illinois CancerCare - Washington Satellite

    Washington, Illinois, 61571

  • Medstar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Urologic Surgeons of Washington

    Washington D.C., District of Columbia, 20036

  • Wichita Urology Group Satellite

    Wichita, Kansas, 67205

  • Wichita Urology Group Satellite

    Wichita, Kansas, 67206

  • Wichita Urology Group

    Wichita, Kansas, 67226

  • Potomac Urology Satellite

    Woodbridge, Virginia, 22191

Other trials in United States

About this study

Official title: Relugolix Versus Leuprolide in Patients With Prostate Cancer: A Randomized, Open-Label Study to Assess Major Adverse Cardiovascular Events (REPLACE-CV)

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.

Read the 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.

Conditions
Prostate Cancer
Being tested
Relugolix, Leuprolide Acetate
Keywords
ORGOVYX, relugolix, prostate cancer, leuprolide acetate
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RelugolixDrug

    Also called ORGOVYX, TAK-385, MVT-601, RVT-601

    Relugolix tablet

  • Leuprolide AcetateDrug

    Also called Leuprolide

    Leuprolide acetate injection

Study groups in NCT05605964
Study groupRoleWhat they receive
RelugolixExperimentalOral relugolix 120 mg once daily with a loading dose of 360 mg on Day 1
Receives: Drug: Relugolix
Leuprolide AcetateActive comparatorSubcutaneous or intramuscular leuprolide acetate 22.5 mg 3-M depot or 45 mg 6-M injection or Leuprolide acetate injectable emulsion (42 mg injectable emulsion is not allowed)
Receives: Drug: Leuprolide Acetate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Patients With Adverse Events and Serious Adverse Events

    Number of patients with adverse events and serious adverse events

    Measured: Screening; Day 1; 3, 6, 9, and 12 months; and every 3 months thereafter, up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2022
  2. Study start28 Jan 2023
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
387 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05605964
Sponsor's protocol ID
MVT-601-056
Status last verified
Jun 2026
First submitted
25 Oct 2022
Last updated
15 Jun 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Relugolix and Leuprolide Acetate in people with Prostate Cancer, run by Sumitomo Pharma America, Inc. at 108 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 108 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With Adverse Events and Serious Adverse Events (time frame: Screening; Day 1; 3, 6, 9, and 12 months; and every 3 months thereafter, up to 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05605964.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.

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Clinical Trial NCT05605964 | AzTrials