A Degarelix Trial in Patients With Prostate Cancer
Status and phase
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Details and patient eligibility
About
A phase III extension trial comparing the efficacy and safety of degarelix 3 month depot with the established therapy Zoladex 3 month implant in patients with prostate cancer.
Full description
CS35A was an open-label, multicentre, comparative non-inferiority extension trial to the Phase 3 CS35 trial (NCT00946920).
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. Patients entering the CS35A trial continued with the same 3-monthly treatment as they received in CS35 (i.e. degarelix 480 mg or goserelin 10.8 mg).
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. Maximum exposure of treatment was 111 weeks (in both treatment arms).
The baseline characteristics are based on the CS35A Full Analysis Set (FAS)defined as all participants who received at least one dose of degarelix or goserelin acetate during CS35A and had at least one efficacy assessment after dosing. All efficacy analyses were performed for the CS35/CS35A FAS defined as all participants who received at least one dose of degarelix or goserelin acetate during CS35 and had at least one efficacy assessment after dosing. All safety analyses were performed for the CS35/CS35A Safety analysis set, which included all patients who received at least one dose of degarelix or goserelin acetate during CS35.
Enrollment
Sex
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Volunteers
Inclusion criteria
- Has given written consent prior to any trial-related activity is performed. (A trial-related activity is defined as any procedure that would not have been performed during the normal management of the patient).
- Has completed the CS35 trial.
Exclusion criteria
- Has been withdrawn from the CS35 trial.
- Has had end of trial visit in CS35 prior to approval of the CS35A protocol.
Trial design
Primary purpose
Allocation
Interventional model
Masking
288 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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