Study to Evaluate the Safety and Efficacy of Switching From Zoladex® Monthly or Quarterly, to Eligard® Semiannual.

What Was Tested

In this phase 4 trial, researchers set out to test Leuprolide.

It had 1 arm (groups): one (experimental).

The registry classes the interventions as drug.

More on the Plan

When systemic treatment is indicated, androgen deprivation therapy is the standard treatment for patients with prostate cancer.

Who Took Part

The registry lists 48 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: Patient able to understand the process of the informed consent form (ICF);. Male aged ≥18 years old;. Having a histologically confirmed diagnosis of prostate adenocarcinoma;. Having an indication of androgen deprivation treatment:. Being on treatment with monthly or quarterly goserelin acetate depot formulation for at least 3 months and for a maximum of 18 months OR;.

The full record lists 11 inclusion and 10 exclusion criteria; among the exclusions: patients who did not have or do not have an indication for treatment with goserelin acetate;; patients with goserelin treatment for over 18 months;; patients who have received previous chemotherapy;.

How the Study Was Run

Design: single-group and open-label.

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.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2017-11-14 with completion listed for 2018-06-15.

It ran at 6 sites in Brazil (6).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Baseline testosterone levels (≤50 ng/dL) (time frame: One year of treatment).

It also tracked 6 secondary outcomes, for example Adverse events frequency (%), Number of Participants With Abnormal Laboratory Values (Number of participants), Number of Participants With Abnormal Vital Signs (Number of participants), Number of Participants With Abnormal Parameters for Quality of Life according to EORTC QLQ-C30 (Number of Participants) and Number of Participants With Abnormal Parameters for Quality of Life according to EORTC QLQ-PR25 (Number of participants).

What This Means in Plain Language

Put simply, this is a phase 4 trial of Leuprolide in 48 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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