Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients

What Was Tested

In this phase 2 trial, researchers set out to test Degarelix.

Participants responding well in Study FE200486 CS06 (NCT00117949) were given the opportunity to continue treatment with degarelix under a clinical study until FE200486 was available on the market or until the study was discontinued.

Study FE200486 CS06A was to provide knowledge of the long-term safety and tolerability of FE200486.

It had four arms (groups): one (experimental), one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

The data include participants from both the main study (FE200486 CS06; NCT00117949) and the extension study FE200486 CS06A.

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: Has had sufficient testosterone suppression (as defined in the withdrawal criteria of FE200486 CS06) for at least 28 days.

The full record lists 2 inclusion and 10 exclusion criteria; among the exclusions: requires hormonal therapy for neoadjuvant purposes; requires treatment with any other drug modifying the testosterone level or function; is considered to be a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy, within 6 months after visit 1.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Degarelix group and the comparison group should start out alike.

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

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

It started in 2002-10 with completion listed for 2005-11.

It ran at 12 sites in United States (12).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Liver Function Tests (time frame: 3 years). Participants With Markedly Abnormal Change in Vital Signs and Body Weight (time frame: 3 years).

What This Means in Plain Language

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

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

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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