RecoverPC: Relugolix vs GnRH Agonist in Quality of Life

What Was Tested

The trial (phase 2) is built around Leuprolide.

The names of the study drugs involved in this study are: * Leuprolide (type of ADT) * Relugolix (type of ADT).

It had two arms (groups): Arm A: Relugolix (experimental) and Arm B: Leuprolide (active comparator).

The registry classes the interventions as drug.

More on the Plan

Participants will be randomized into one of the study groups leuprolide versus relugolix.

Randomization means that a participant is put into a study group by chance.

The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits, ECGs, and blood tests.

Participation in this research study is expected to last 12 months.

Who Took Part

The registry lists 110 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: Participants cannot have received prior GnRH agonist or antagonist therapy. Patients must have testosterone level \> 200 ng/mL prior to initiation of ADT. Age ≥18 years. Life expectancy of greater than 12 months. Participants must have adequate organ and marrow function as defined below:.

The full record lists 22 inclusion and 7 exclusion criteria; among the exclusions: history of major adverse cardiac event, including myocardial infarction, new congestive heart failure (chf) or chf exacerbation, or stroke, within the past 6 months; participants who have prior or planned concurrent treatment with second generation ar targeted therapies (such as abiraterone, enzalutamide, darolutamide, apalutamide); participants who are receiving any other investigational agents.

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.

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

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

Those kept unaware of assignments: participant.

It started in 2024-02-12 with completion listed for 2027-07-01.

It ran at 3 sites in United States (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: 9-month Quality of Life (QOL) Score (time frame: At 9 months).

It also tracked 6 secondary outcomes, for example 12-month Quality of Life (QOL) Score, 9-month Hot flash related daily interference scale (HFRDIS), 9-month Insomnia Severity Index (ISI) Score, 9-month Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score, 9-month EPIC-26 Sexual Function Summary Score and 12-month Hot flash related daily interference scale (HFRDIS).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Leuprolide in 110 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.