A Long-term Extension Study Evaluating a One-Month Dosing Regimen of Degarelix in Prostate Cancer Requiring Androgen Ablation Therapy

What Was Tested

This registered phase 3 trial tested Leuprolide and Degarelix.

Participants who completed the FE200486 CS21 study (NCT00295750) could enter the FE200486 CS21A study.

The study continued until all non-discontinued participants had received treatment for at least 5 years.

It had four arms (groups): one (experimental), one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 386 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 3 exclusion criteria; among the exclusions: patients with histologically proven prostate cancer of all stages in whom endocrine treatment is indicated; signed informed consent; the patients must have completed the fe 200486 cs21 study.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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

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

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

It started in 2007-03 with completion listed for 2011-10.

It ran at 69 sites in United States (14), Canada (9), Mexico (8), Czechia (7), Hungary (7) and Romania (7).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight (time frame: Up to 4 years of treatment). Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables (time frame: Up to 4 years of treatment).

It also tracked 6 secondary outcomes, for example Percentage of Participants With no Prostate-specific Antigen (PSA) Progression, Percentage of Participants With Testosterone Level Maintained at <=0.5 ng/mL From Day 28 in CS21 and Onwards, Serum Levels of Testosterone From the Time of Switch From Leuprolide to Degarelix up to Day 56, Serum Levels of PSA From the Time of Switch From Leuprolide to Degarelix to Day 56, Serum Levels of Luteinizing Hormone (LH) From the Time of Switch From Leuprolide to Degarelix to Day 56 and Serum Levels of Follicle Stimulating Hormone (FSH) From the Time of Switch From Leuprolide to Degarelix to Day 56.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Leuprolide and Degarelix in 386 people.

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

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