A Comparative Study of Degarelix Three-month Depot in Three Different Dosing Regimens in Patients With Prostate Cancer

What Was Tested

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

It had three arms (groups): Degarelix 240@40/240@40 (1,3,6,9) (active comparator), Degarelix 240@40/240@60(1,3,6,9) (active comparator) and Degarelix 240@40/240@60(1,4,7,10) (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 460 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: Is a male patient aged 18 years or over. Has a baseline serum testosterone level above the lower limit of normal range, globally defined as \>2.2 ng/mL. Has an ECOG (Eastern Cooperative Oncology Group) score of 2. Has a PSA value of 2 ng/mL. Has a life expectancy of at least 13 months.

The full record lists 7 inclusion and 11 exclusion criteria; among the exclusions: is considered to be a candidate for curative therapy, i.e. radical prostatectomy or radiotherapy within 13 months from screening visit; has a known or suspected hepatic or symptomatic biliary disease; has a mental incapacity or language barriers precluding adequate understanding or cooperation.

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 2005-01 with completion listed for 2006-11.

It ran at 56 sites in United States (23), Canada (8), Russia (5), Finland (4), United Kingdom (4) and Romania (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of Participants With Testosterone Level <=0.5 ng/mL From Day 28 Until the End of the Study (time frame: From Day 28 to 12 or 13 months).

It also tracked 4 secondary outcomes, for example Number of Participants With Testosterone <=0.5 ng/mL at Day 28, Liver Function Tests and Number of Participants With Markedly Abnormal Change in Vital Signs and Body Weight as Compared to Baseline.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Degarelix in 460 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.