Investigating Efficacy and Safety of Two Degarelix Three-Month Dosing Regimens in Patients With Prostate Cancer Requiring Androgen Ablation Therapy

What Was Tested

This registered phase 2 trial tested Degarelix.

It had two arms (groups): A (experimental) and B (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 133 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.

The full record lists 0 inclusion and 4 exclusion criteria; among the exclusions: patients, aged 18 years or older, with histologically proven prostate cancer of all stages in whom endocrine treatment is indicated; screening testosterone level above the lower limit of normal range, globally defined as \>2.2 ng/ml; eastern cooperative oncology group (ecog) score of ≤2.

How the Study Was Run

The set-up was 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.

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

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 2007-05 with completion listed for 2008-08.

It ran at 29 sites in United States (11), Romania (7), Canada (4), Hungary (4) and Czechia (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Probability of Testosterone at Castration Level (≤0.5 ng/mL) From Day 28 Through Day 364 (time frame: 1 year).

It also tracked 8 secondary outcomes, for example Serum Levels of Testosterone Over Time, Probability of Testosterone at Castration Level (≤0.5 ng/mL) From Day 56 Through Day 364, Probability of no PSA Failure, Serum Levels of PSA Over Time, Serum Levels of Follicle Stimulating Hormone (FSH) Over Time and Serum Levels of Luteinizing Hormone (LH) Over Time.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Degarelix in 133 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.