RElugolix VErsus LeUprolide Cardiac Trial

What Was Tested

This registered phase 2 trial tested Leuprolide.

It had three arms (groups): Arm I (radiation therapy alone) (active comparator), Arm II (radiation therapy plus leuprolide) (experimental) and Arm III (radiation therapy plus relugolix) (experimental).

Patients undergo definitive radiation therapy alone (IMRT, SBRT, proton therapy, brachytherapy) in the absence of disease progression or unacceptable toxicity.

Patients undergo radiation therapy as in Arm I and receive leuprolide SC or IM every 3 or 6 months. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.

Patients undergo radiation therapy as in Arm I and receive relugolix PO QD. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.

The registry classes the interventions as drug and radiation.

More on the Plan

Determine the relationship between leuprolide versus relugolix with downstream immune effector response that is implicated in atherosclerosis.

Patients undergoing radiation therapy and ADT as part of their standard treatment are randomized to Arm II or Arm III.

ARM I: Patients undergo definitive radiation therapy in the absence of disease progression or unacceptable toxicity.

ARM II: Patients undergo radiation therapy as in Arm I and receive leuprolide subcutaneously (SC) or intramuscularly (IM) every 3 or 6 months.

Who Took Part

Enrollment: 94 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: Men \>= 18 years old. Plan to undergo curative-intent pelvic radiation therapy with or without ADT.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: prior exposure to androgen deprivation therapy; prior exposure to chemotherapy or immunotherapy; history of cardiac bypass surgery or percutaneous coronary intervention.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

The participants were allocated by chance, so the Leuprolide group and the comparison group should start out alike.

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

In this single-blind Leuprolide study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2022-06-06 with completion listed for 2025-01-30.

It ran at 4 sites in United States (4).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Total Coronary Plaque Volume in Major Coronary Arteries (i.e. Left Anterior Descending, Left Circumflex, Right Major Coronary Arteries) (time frame: From baseline to 12 months post-treatment initiation).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Leuprolide in 94 people.

Its status is active not recruiting; results are posted on the registry, and this page does not restate them.

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