Randomized Study to Evaluate MACE in Patients With Prostate Cancer Treated With Relugolix or Leup… (NCT05605964) | Clinical Trial Compass
CompletedPhase 3
Randomized Study to Evaluate MACE in Patients With Prostate Cancer Treated With Relugolix or Leuprolide Acetate
United States387 participantsStarted 2023-01-28
Plain-language 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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Was previously enrolled under the original version and amendment 1 of this study
. Has voluntarily resigned and dated the informed consent form prior to transition to the discontinuation phase of this study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This was a Phase 3 trial comparing relugolix to leuprolide acetate specifically looking at major adverse cardiovascular events — given my own heart health history, is one of these hormone therapies considered safer for my cardiovascular risk profile?
2Since this trial has already completed, has the data been published or presented, and what did it show about the rates of serious adverse events between the two drugs?
3Both relugolix and leuprolide acetate are hormone therapies that lower testosterone — how do their different delivery methods, a daily oral pill versus an injection, affect which one might realistically fit into my daily routine?
4Leuprolide acetate has been used for prostate cancer for decades, while relugolix is newer — based on what this completed trial found, does my doctor feel there is now enough evidence to confidently choose one over the other for my situation?
5If I were to discuss either of these treatments with you outside of a trial, are there standard-of-care guidelines that already reflect the findings from studies like this one, and would that change the treatment path you'd recommend for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Patients With Adverse Events and Serious Adverse Events
Timeframe: Screening; Day 1; 3, 6, 9, and 12 months; and every 3 months thereafter, up to 1 year