Investigation of a New Trial Drug (FE200486) in Prostate Cancer Patients

What Was Tested

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

Patients participating were treated with FE200486 on one occasion.

It had eight arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and one (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 172 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 obtained before any trial related procedures. Male patient with proven prostate cancer in need for endocrine treatment, except for neoadjuvant hormonal therapy. 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 12 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.

Because people in this Degarelix study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2002-11 with completion listed for 2004-10.

It ran at 30 sites in Finland (6), Hungary (6), Russia (5), Sweden (5), Romania (4) and Denmark (3).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 7 secondary outcomes, for example Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 28 Days, Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 84 Days, Time to Testosterone Castration (Testosterone ≤0.5 ng/mL), Evaluation of Liver Function Tests and Participants With Markedly Abnormal Change in Vital Signs and Body Weight.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Degarelix in 172 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.