A Degarelix Trial in Patients With Prostate Cancer

This study has been terminated.
(Inadequate recruitment resulting in a too low patient number for collection of long term efficacy data.)
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01242748
First received: November 16, 2010
Last updated: May 13, 2015
Last verified: May 2015

November 16, 2010
May 13, 2015
October 2010
December 2011   (final data collection date for primary outcome measure)
Hazard Ratio of Prostate-specific Antigen (PSA) Progression-free Survival (PFS) Failure Rates During 3 Years' Treatment Between Degarelix and Goserelin [ Time Frame: From baseline to 3 years ] [ Designated as safety issue: No ]
PSA PFS failure is defined as either PSA failure (defined as increase in serum PSA of 50%, and at least 5 ng/mL, compared to nadir, measured on two consecutive occasions at least 2 weeks apart) or death, whichever is first. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PSA-PFS.
PSA level [ Time Frame: Every 3 months during 27 months of treatment ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01242748 on ClinicalTrials.gov Archive Site
  • Hazard Ratio of PFS Failure Rates During 3 Years Treatment Between Degarelix and Goserelin [ Time Frame: From baseline to 3 years ] [ Designated as safety issue: No ]
    PFS failure is defined as either PSA failure, introduction of additional therapy related to prostate cancer (radiation, anti-androgens or second-line treatment), or death, whichever is first. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PFS failure.
  • Hazard Ratio of PSA Failure Rates During 3 Years Treatment Between Degarelix and Goserelin [ Time Frame: From baseline to 3 years ] [ Designated as safety issue: No ]
    PSA failure is defined as increase in serum PSA of 50%, and at least 5 ng/mL, compared to nadir, measured on two consecutive occasions at least 2 weeks apart. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PSA failure.
  • Hazard Ratio of Testosterone Escape Rates During 3 Years' Treatment Between Degarelix and Goserelin [ Time Frame: From baseline to 3 years ] [ Designated as safety issue: No ]
    Testosterone escape is defined as serum levels >0.5 ng/mL. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no testosterone escape.
  • Hazard Ratio of the Rates of Introduction of Additional Therapy Related to Prostate Cancer During 3 Years' Treatment Between Degarelix and Goserelin [ Time Frame: From baseline to 3 years ] [ Designated as safety issue: No ]
    Additional therapy related to prostate cancer included radiation, anti-androgens and second-line treatment. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no additional therapy related to prostate cancer.
  • Hazard Ratio of Mortality Rates During 3 Years' Treatment Between Degarelix and Goserelin [ Time Frame: From baseline to 3 years ] [ Designated as safety issue: No ]
    The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of death.
  • Serum Levels of Testosterone During 3 Years' Treatment With Degarelix or Goserelin [ Time Frame: Baseline and after 1, 6, 12, 19, and 22 months ] [ Designated as safety issue: No ]
    Median testosterone levels are presented as absolute values in nanograms per milliliter (ng/mL) at baseline and after 1, 6, 12, 19, and 22 months. One month equals 28 days. After 22 months, only a limited number of samples were analysed.
  • Serum Levels of Prostate-specific Antigen (PSA) During 3 Years' Treatment With Degarelix or Goserelin [ Time Frame: Baseline and after 1, 6, 12, 19, and 22 months ] [ Designated as safety issue: No ]
    Median PSA levels are presented as absolute values in nanograms per milliliter (ng/mL) at baseline and after 1, 6, 12, 19, and 22 months. One month equals 28 days. After 22 months, only a limited number of samples were analysed.
  • Testosterone level [ Time Frame: Every three months during 27 months of treatment ] [ Designated as safety issue: No ]
  • Blood sample assessment [ Time Frame: Every 6 months during 27 months of treatment ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Degarelix Trial in Patients With Prostate Cancer
An Open-label, Multi-Centre, Extension Trial, Evaluating the Long-Term Progression-Free Survival of Degarelix or Goserelin Three-Month Dosing Regimens in Patients With Prostate Cancer Requiring Androgen Deprivation Therapy

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.

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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • Drug: Degarelix
    The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
    Other Names:
    • Firmagon
    • FE200486
  • Drug: Goserelin acetate
    The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
    Other Name: Zoladex
  • Experimental: Degarelix 240 mg/480 mg
    Intervention: Drug: Degarelix
  • Active Comparator: Goserelin acetate
    Intervention: Drug: Goserelin acetate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
288
January 2012
December 2011   (final data collection date for primary outcome measure)

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.
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Canada,   Czech Republic,   Finland,   Germany,   Hungary,   Mexico,   Netherlands,   Poland,   Romania,   Ukraine,   United Kingdom
Russian Federation
 
NCT01242748
FE200486 CS35A, 2010-021434-55
Yes
Ferring Pharmaceuticals
Ferring Pharmaceuticals
Not Provided
Study Director: Clinical Development Support Ferring Pharmaceuticals
Ferring Pharmaceuticals
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP