The Efficacy and Safety of Degarelix One Month Dosing Regimens in Prostate Cancer

What Was Tested

The trial (phase 3) is built around Leuprolide and Degarelix.

The study was a three-arm, active-control, multi-centre, parallel group study.

It had three arms (groups): one (experimental), one (experimental) and one (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 620 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: Patients, aged 18 years or over, with histologically proven prostate cancer of all stages in whom endocrine treatment is indicated. Baseline testosterone \>1.5 ng/mL. Life expectancy of at least 12 months.

The full record lists 3 inclusion and 0 exclusion criteria.

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 Leuprolide and who got the comparison, which limits bias.

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

Nothing was hidden in this open-label Leuprolide study: the participants and staff both knew the treatment.

It started in 2006-02 with completion listed for 2007-10.

It ran at 35 sites in United States (23), Puerto Rico (2), Canada (1), Czechia (1), Germany (1) and Hungary (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage of Patients With Testosterone <=0.5ng/mL From Day 28 Through Day 364 (time frame: 12 months).

It also tracked 8 secondary outcomes, for example Percentage of Patients With Testosterone Surge During the First Two Weeks of Treatment, Percentage of Patients With Testosterone Level <=0.5 ng/mL at Day 3, Frequency and Size of Testosterone Changes at Day 255 and/or Day 259 Compared to the Testosterone Level at Day 252, Percentage Change in Prostate-specific Antigen From Baseline to Day 14 and Day 28, Participants Grouped by Time to Prostate-specific Antigen Failure and Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Leuprolide and Degarelix in 620 people.

With 620 participants it is a large trial for this field.

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.