Dose Finding Trial With a New Treatment (Degarelix) for Prostate Cancer

What Was Tested

In this phase 2 trial, researchers set out to test Degarelix.

The patients participating in the trial were treated with degarelix every month for a year.

During the treatment the patients had to visit the clinic for investigations.

It had six arms (groups): Degarelix 200/80 (experimental), Degarelix 200/120 (experimental), Degarelix 200/160 (experimental), Degarelix 240/80 (experimental) and Degarelix 240/120 (experimental).

The registry classes the interventions as drug.

More on the Plan

Degarelix was not FDA regulated at the time of the trial.

After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention.

Who Took Part

The registry lists 189 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: Written informed consent prior to any study related procedures. Proven prostate cancer in need for endocrine treatment, except for neoadjuvant hormonal therapy, but including patients with a rising PSA further to prostatectomy or radiotherapy. ECOG score to be equal to or above 2. Testosterone level within age-specific normal range. PSA value equal to or above 2 ng/ml.

The full record lists 6 inclusion and 13 exclusion criteria; among the exclusions: previous or current hormonal treatment of prostate cancer; recent or current treatment with any drugs modifying the testosterone level; candidate for curative treatment such as prostatectomy or radiotherapy.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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

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

Being open-label, the Degarelix study did not mask who received what.

It started in 2004-02 with completion listed for 2005-06.

It ran at 39 sites in Russia (13), Hungary (6), South Africa (5), Germany (4), Romania (4) and Belgium (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of Patients With Testosterone <=0.5 Nanograms/Milliliter From Day 28 to Day 364 (time frame: 12 months).

It also tracked 13 secondary outcomes, for example Number of Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28, Number of Patients With Testoterone <=0.5 Nanogram/Milliliter at Day 3, Days to Prostate-Specific Antigen Progression, Median Serum Testosterone Levels, Median Prostate-specific Antigen Levels and Median Values of Di-Hydrotestosterone.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Degarelix in 189 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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