Effects of Relugolix vs Leuprolide on Cardiac Function in Patients With Prostate Cancer

What Was Tested

The trial (phase 2) is built around Leuprolide.

The term androgen deprivation therapy means lowering a man's testosterone.

It had two arms (groups): Arm 1 (leuprolide) (experimental) and Arm 2 (relugolix) (experimental).

The registry classes the interventions as drug, other and procedure.

More on the Plan

To quantify the impact of 6-month relugolix vs. leuprolide on composite functional tests of strength and balance using three tests: 1) Timed Up-and-Go, 2) 10-meter walk time, and 3) grip strength.

To analyze body composition changes in response to 6-month relugolix vs. leuprolide by using abdominal computed tomography (CT) or magnetic resonance imaging (MRI) to quantitate abdominal/visceral fat and lean muscle mass with utilization of SliceOmatic software.

To compare the time course of recovery for hormonal and cardiometabolic markers after completion of 6-month relugolix vs. 6-month leuprolide with definitive RT for UIR PCa.

OUTLINE: Patients are randomized to 1 of 2 arms.

Who Took Part

70 planned participants were the target.

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: Has at least one intermediate risk factor (IRF):. Gleason Score 7 (Gleason 3+4 or 4+3 \[International Society of Urological Pathology \[ISUP\] grade group 2-3\]). Has one or more of the following "unfavorable" intermediate-risk designators:. \> 1 IRF. Gleason 4+3=7 (ISUP grade group 3).

The full record lists 32 inclusion and 22 exclusion criteria; among the exclusions: definitive clinical or radiologic evidence of metastatic disease (m1); previous bilateral orchiectomy; prior testosterone replacement therapy is allowed; however, any replacement therapy must be stopped for at least 1 year prior to registration.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Leuprolide and who got the comparison, which limits bias.

The Leuprolide group and the comparison group ran side by side rather than switching.

Everyone knew when Leuprolide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2024-08-12 with completion listed for 2027-12-31.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Physiologic alterations in cardiopulmonary function - Myocardial perfusion (time frame: Up to 6 months). Physiologic alterations in cardiopulmonary function - Maximal rate of oxygen consumption (time frame: Up to 6 months).

It also tracked 8 secondary outcomes, for example Quality of life using EPIC-26, Quality of life using EORTC QLQ-C30, Quality of life using European (Euro) Qol-5-Dimension 5-level (EQ-5D-5L), Quality of life using PROMIS, Functional tests of strength and balance using Timed Up-and-Go and Functional tests of strength and balance using 10-meter walk time.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Leuprolide in 70 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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