Degarelix as Second-Line Hormonal Treatment After Prostate-specific Antigen (PSA)-Failure in GnRH Agonist Treated Patients With Prostate Cancer

What Was Tested

This registered phase 2 trial tested Degarelix.

This was an open-label, multi-centre, uncontrolled, exploratory trial with a duration of 12 months in two cohorts.

The trial aimed to investigate Degarelix as a second-line hormonal treatment in Prostate Cancer patients who experienced PSA-Failure following gonadotropin-releasing hormone (GnRH) agonist treatment.

The two cohorts differ in Testosterone levels at inclusion.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 37 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. Patient is 18 years or older. Histologically confirmed prostate cancer. Testosterone on castrate level (defined as ≤ 0.5 ng/mL) (cohort 1); Testosterone ≥0.2 ng/mL at inclusion (cohort 2). Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

The full record lists 8 inclusion and 12 exclusion criteria; among the exclusions: previous or current treatment with chemotherapy (e.g. estramustine) for prostate cancer; known hypersensitivity towards any component of the investigational medical product; history of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria and/or angioedema.

How the Study Was Run

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

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

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

It started in 2008-07 with completion listed for 2011-12.

It ran at 15 sites in Germany (15).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Participants' Response in Prostate-Specific Antigen (PSA) Level at Three Months As Compared to Baseline (time frame: Day 0 (baseline), 3 months).

It also tracked 11 secondary outcomes, for example Participants' Response in Prostate-Specific Antigen (PSA) Level at One Month As Compared to Baseline, Participants' Response in Prostate-Specific Antigen (PSA) Level at Two Months As Compared to Baseline, Participants at Testosterone Castrate Level Throughout the Study, Change From Baseline in Serum Levels of Testosterone at the Last Visit, Change From Baseline in Serum Levels of Prostate-Specific Antigen (PSA) at Last Visit and Percent Change From Baseline in Serum Levels of Luteinising Hormone (LH) at the Last Visit.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Degarelix in 37 people.

Its size is small, so on its own it can only give an early look.

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.