International,Multi-Center,Open Label,Randomized Study Assessing the Safety and Efficacy of a Monthly Dosing Regimen of Ozarelix Versus Goserelin Depot in Men With Prostate Cancer

What Was Tested

This registered phase 2 trial tested Goserelin.

This is an international, multi-center, randomized, open label 84 days study.

Men who are at least 18 years of age or older, with histologically proven prostate cancer of all stages, in whom endocrine treatment is indicated will be eligible for study entry.

It had two arms (groups): Ozarelix (experimental) and Goserelin (active comparator).

The registry classes the interventions as drug.

More on the Plan

Prospective study subjects will undergo screening procedures.

Approximately 214 eligible patients will enter the study.

Patients will be randomized in a 1:1 ratio to one of two treatment arms (Ozarelix or Goserelin).

Who Took Part

203 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: Patients, aged 18 years or older, with histologically proven prostate cancer of any stages, for whom endocrine treatment is indicated. Screening testosterone \> 1.5 ng/ml. Life expectancy of at least 12 months. ECOG score of ≤ 2. Patient has reviewed and signed Informed consent form.

The full record lists 6 inclusion and 12 exclusion criteria; among the exclusions: any hormone therapy prior to study entrance; any patient at risk of urinary tract obstruction or spinal cord compression due to potential testosterone surge; history of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria and/or angioedema.

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 Goserelin and who got the comparison, which limits bias.

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

Nothing was hidden in this open-label Goserelin study: the participants and staff both knew the treatment.

It started in 2010-11 with completion listed for 2014-09.

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

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: To assess the percentage of patients with testosterone <=0.5ng/mL (time frame: From Day 28 through Day 84, in men receiving Ozarelix versus Goserelin).

It also tracked 1 secondary outcome, for example Percentage change in Prostate-Specific Antigen level.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Goserelin in 203 people.

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

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