A Parallel Group Comparison of the Efficacy and Safety of Degarelix at Two Different Dosing Regimens in Patients With Prostate Cancer

What Was Tested

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

It had two arms (groups): one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 127 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: Male patient aged 18 years or over. Has a baseline testosterone above the lower limit of normal range. Has an ECOG (Eastern Co-operative Oncology Group) score equal to or less than 2. Has a PSA value of greater than or equal to 2ng/mL.

The full record lists 6 inclusion and 13 exclusion criteria; among the exclusions: currently or recently (within the last 12 weeks preceding the screening visit) under treatment with any other drug modifying testosterone level or function; is considered to be a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 6 months from screening visit; has hypersensitivity towards any component of the investigational products (degarelix or mannitol).

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 Degarelix and who got the comparison, which limits bias.

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 2004-02 with completion listed for 2005-08.

It ran at 35 sites in United States (26) and Canada (9).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of Participants With Testosterone <=0.5 Nanogram/Milliliter From Day 28 to Day 364 (time frame: Day 28 to Day 364). Number of Participants With Testosterone Level <= 0.5 Nanogram/Milliliter From Day 28 to Day 364 for Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 28 (time frame: Day 28 - Day 364).

It also tracked 11 secondary outcomes, for example Number of Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 3, Days to Prostate-Specific Antigen Progression, Median Di-Hydrotestosterone Levels At Various Study Timepoints, Median Prostate-Specific Antigen Values at Various Study Timepoints, Median Luteinizing Hormone Levels at Various Study Timeframes and Median Testosterone Levels at Various Days During the Study.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Degarelix in 127 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.