Efficacy and Safety of Degarelix One Month Dosing Regimen in Korean Patients With Prostate Cancer

What Was Tested

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

It had 1 arm (groups): one (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 157 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: Has given written informed consent before any trial-related activity is performed. Has a histologically confirmed (Gleason graded) adenocarcinoma of the prostate (all stages) (except for neoadjuvant hormonal therapy/ includes patients with rising PSA after prostatectomy or radiotherapy). Is a male patient aged 18 years or older. Has a screening serum testosterone level \>1.5 ng/mL. Has an ECOG (Eastern Cooperative Oncology Group) score of ≤ 2.

The full record lists 7 inclusion and 15 exclusion criteria; among the exclusions: is considered to be candidate for curative therapy, i.e. radical prostatectomy or radiotherapy; has a history of severe untreated asthma, anaphylactic reactions or severe urticaria and/or angioedema; has hypersensitivity towards any component of the investigational medicinal product.

How the Study Was Run

It was run as a single-group and open-label study.

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2010-03 with completion listed for 2011-11.

It ran at 11 sites in South Korea (11).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) From Day 28 to Day 196 (time frame: Day 28 to Day 196).

It also tracked 6 secondary outcomes, for example Proportion of Patients With Testosterone Level ≤0.5 ng/mL at Day 3, Percentage Change in Prostate-specific Antigen (PSA) From Baseline to Day 28, Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL)From Day 56 to Day 196, Cumulative Probability of no PSA Failure From Day 28 to Day 196, Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables 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 trial of Degarelix in 157 people.

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

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