Neoadjuvant Study Investigating Degarelix in Patients Suffering From Prostate Cancer

What Was Tested

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

In this trial, participants were randomly selected (like flipping a coin) to receive either degarelix given alone or a standard hormone therapy (combination of goserelin and bicalutamide.

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

The registry classes the interventions as drug.

Who Took Part

246 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: Patient has given written informed consent before any trial-related activity is performed. Has a confirmed prostate cancer in which this type of treatment is needed.

The full record lists 2 inclusion and 10 exclusion criteria; among the exclusions: previous treatment for prostate cancer; previous trans-urethral resection of the prostate; patients who are lymph node positive or have other metastatic disease.

How the Study Was Run

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

Because people in this Goserelin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

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

It started in 2009-04 with completion listed for 2011-09.

It ran at 66 sites in United States (19), France (19), United Kingdom (10), Netherlands (6), Germany (4) and Greece (4).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set) (time frame: After treatment of 12 weeks compared to Baseline). Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Per Protocol Analysis Set) (time frame: After treatment of 12 weeks compared to Baseline).

It also tracked 7 secondary outcomes, for example Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12, Change From Baseline in Serum Testosterone Levels During the Study, Change From Baseline in Serum Prostate-Specific Antigen (PSA) Levels During the Study, Change From Baseline in Serum Oestradiol Levels During the Study, Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit and Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Goserelin and Degarelix in 246 people.

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

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