A Degarelix Trial in Patients With Prostate Cancer

Plain-language guide to NCT01242748: phase 3 non-randomized trial of Goserelin and Degarelix, 288 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT01242748
Phase: phase 3
Status: terminated early
Start: 2010-10
Completion (planned or actual): 2011-12
Participants: 288 (actual)
Design: non-randomized, open label (everyone knows who gets what), treatment
Conditions studied: Prostate Cancer
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

This registered phase 3 trial tested Goserelin and Degarelix.

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

The registry classes the interventions as drug.

More on the Plan

In the main CS35 trial, participants were randomised 2:1 to treatment with degarelix or goserelin, respectively.

All participants who completed the main CS35 trial after initiation of the CS35A trial were eligible to enrol into this extension trial, provided that their treatment could continue uninterrupted.

It was intended that patients enrolled in the CS35A trial would receive treatment with degarelix or goserelin at 3-month intervals for a period of 40 months (including 13 months' treatment in CS35).

It was, however, decided to prematurely terminate the CS35A trial due to an insufficient number of patients being enrolled.

Who Took Part

Enrollment: 288 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 completed the CS35 trial.

The full record lists 2 inclusion and 2 exclusion criteria; among the exclusions: has been withdrawn from the cs35 trial; has had end of trial visit in cs35 prior to approval of the cs35a protocol.

How the Study Was Run

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

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

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

It started in 2010-10 with completion listed for 2011-12.

It ran at 63 sites in Romania (10), Hungary (9), United States (8), Czechia (6), Mexico (6) and Ukraine (6).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 7 secondary outcomes, for example Serum Levels of Testosterone During 3 Years' Treatment With Degarelix or Goserelin and Serum Levels of Prostate-specific Antigen (PSA) During 3 Years' Treatment With Degarelix or Goserelin.

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of Goserelin and Degarelix in 288 people.

It ended early (terminated); 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.

Our Notes on the Compounds

Goserelin: A GnRH analog implant (Zoladex) used to lower sex-hormone levels in prostate and breast cancer and gynecologic conditions.

Degarelix: A GnRH antagonist injection (Firmagon) for advanced prostate cancer that lowers testosterone within days without the initial surge seen with agonists.

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.