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NCT05605964·Phase 3·INTERVENTIONAL

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

LeuprolideOtherCompleted

Status

Completed

Phase

Phase 3

Enrollment

387

Locations

108

Results

Posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

DRUG

Relugolix

Relugolix tablet

DRUG

Leuprolide Acetate

Leuprolide acetate injection

Timeline

From registration to results.

  1. First posted

    Nov 4, 2022

  2. Study start

    Jan 28, 2023

  3. Primary completion

    Dec 31, 2024

  4. Study completion

    Dec 31, 2024

  5. Results posted

    Jun 15, 2026

  6. Registry updated

    Jun 15, 2026

Outcomes

What the study measures.

Primary outcomes

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

Number of patients with adverse events and serious adverse events

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
MALE
Healthy volunteers
No

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 locations

108 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

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 D.C., District of Columbia, United States

Urologic Surgeons of Washington

Washington D.C., 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

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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More studies on Leuprolide.

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