Firmagon (Degarelix) Intermittent Therapy

What Was Tested

In this phase 4 trial, researchers set out to test Degarelix.

It had two arms (groups): 10 month degarelix therapy (active comparator) and 4 month degarelix therapy arm (active comparator).

The registry classes the interventions as drug.

More on the Plan

This is an open-label, multi-centre, randomised trial with subjects receiving subcutaneous (s.c.) monthly injections of degarelix depot.

The trial will also assess the effect of degarelix therapy on PSA kinetics (specifically PSA doubling time), PSA nadir, and effect on quality of life as well as other measures.

Who Took Part

The registry lists 144 actual participants took part.

It was open to men only aged from 18 years up to 85 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Histologically confirmed adenocarcinoma of the prostate for which intermittent endocrine treatment therapy is indicated. PSA level meeting both of these criteria:. PSA level of ≥ 5 ng/mL. For patients with recurrence after radiotherapy or cryotherapy: Patients should have a serum PSA (two measurements) to be \>2 ng/mL higher than a previously confirmed PSA nadir. Screening serum testosterone level above the lower limit of normal range defined as \>2.2 ng/mL.

The full record lists 5 inclusion and 2 exclusion criteria; among the exclusions: has had previous or is currently under hormonal management of prostate cancer (surgical castration or other hormonal manipulation).

How the Study Was Run

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

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

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

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

It started in 2012-01 with completion listed for 2018-01.

It ran at 15 sites in Canada (15).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: serum PSA (time frame: approximately 15 months).

It also tracked 1 secondary outcome, for example serum PSA.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Degarelix in 144 people.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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