A Study of Degarelix in Patients With Prostate Cancer

What Was Tested

This registered phase 3 trial tested Leuprolide and Degarelix.

It had three arms (groups): DI (Degarelix Intermittent) (experimental), DC (Degarelix Continuous) (experimental) and LC (Leuprolide Continuous) (active comparator).

The registry classes the interventions as drug.

More on the Plan

The study consisted of two phases, Phase A and B.

After 7 months of treatment, patients with a PSA ≤2 ng/mL continued into Phase B.

During Phase B, patients in the degarelix intermittent arm had a 7-month off-treatment period.

Patients randomized to the degarelix continuous arm and the leuprolide continuous arm continued to receive degarelix or leuprolide depot as in Phase A for the remainder of the 14 months.

Who Took Part

409 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: 18 years or older. Raising PSA after prior treatment failure of localized prostate cancer. Has a histological confirmed non-metastatic cancer of the prostate (Gleason graded) based on the most current biopsy. Has a screening testosterone within normal range (≥1.5 ng/mL). Has Eastern Cooperative Oncology Group score of ≤2.

The full record lists 7 inclusion and 12 exclusion criteria; among the exclusions: taken hormone therapy in the last 6 months prior to entering this study; has a history of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria and/or angioedema; has hypersensitivity towards any component of the study drug.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Leuprolide and who got the comparison, which limits bias.

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

Being open-label, the Leuprolide study did not mask who received what.

It started in 2009-05 with completion listed for 2012-08.

It ran at 59 sites in United States (59).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage of Patients With Serum PSA Levels ≤4.0 ng/mL (time frame: At 14 month).

It also tracked 19 secondary outcomes, for example Absolute Change From Baseline in Serum PSA Levels, Percent Change From Baseline in Serum PSA Levels, Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being, Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being, Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being and Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Leuprolide and Degarelix in 409 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.