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

What Was Tested

This registered phase 3 trial tested Leuprolide.

This was a randomized study to evaluate the risk of major adverse cardiovascular events (MACE) for relugolix compared with leuprolide acetate.

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.

It had two arms (groups): Relugolix (experimental) and Leuprolide Acetate (active comparator).

The registry classes the interventions as drug.

More on the Plan

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.

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.

Who Took Part

The registry lists 387 actual participants took part.

It was open to men only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 2 inclusion and 0 exclusion criteria.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Leuprolide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Leuprolide study did not mask who received what.

It started in 2023-01-28 with completion listed for 2024-12-31.

It ran at 108 sites in United States (108).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): 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).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Leuprolide in 387 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Leuprolide compound page, all human trials.