Investigation of the Effect of Degarelix in Terms of Prostate Volume Reduction in Prostate Cancer Patients

What Was Tested

In this phase 3 trial, researchers set out to test Goserelin and Degarelix.

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 182 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. Patient is 18 years or older. Patient has histologically confirmed prostate cancer. Patient has a serum prostate-specific antigen (PSA) level at screening \>2 ng/mL. The prostate size is \>30 cubic centimetres (cc), measured by TRUS.

The full record lists 8 inclusion and 16 exclusion criteria; among the exclusions: any previous treatments for prostate cancer; previous trans-urethral resection of the prostate (turp); is not considered a candidate for medical castration.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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

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

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

It started in 2009-08 with completion listed for 2011-03.

It ran at 46 sites in Italy (13), Denmark (6), Sweden (6), Turkey (Türkiye) (5), Belgium (4) and Finland (4).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: 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 8 secondary outcomes, for example Change From Baseline in Prostate Size Based on TRUS at Week 4 and 8, Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12, Change in Serum Testosterone Levels During the Study, Change in Serum Prostate-Specific Antigen (PSA) Levels During the Study, Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit and Change From Baseline in Burden of Urinary Symptoms Based on the Benign Prostatic Hyperplasia Impact Index (BPHII).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Goserelin and Degarelix in 182 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.