Trial document




This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004078

Trial Description

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Title

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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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.

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Organizational Data

  •   DRKS00004078
  •   2012/08/23
  •   2010/11/16
  •   no
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Secondary IDs

  •   2010-021434-55 
  •   NCT01242748  (ClinicalTrials.gov)
  •   FE200486 CS35A  (Ferring Pharmaceuticals)
  •   2010-021434-55 
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Health Condition or Problem studied

  •   Prostate Cancer
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Drug: Degarelix
  •   Drug: Goserelin acetate
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
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Primary Outcome

- 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; 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.

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Secondary Outcome

- Hazard Ratio of PFS Failure Rates During 3 Years Treatment Between Degarelix and Goserelin; time frame: From baseline to 3 years; 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; 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; 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; 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; 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; 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; 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.

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Countries of Recruitment

  •   United States
  •   Belgium
  •   Canada
  •   Czech Republic
  •   Finland
  •   Germany
  •   Hungary
  •   Mexico
  •   Netherlands
  •   Poland
  •   Romania
  •   Ukraine
  •   United Kingdom
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Locations of Recruitment

  •  
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Recruitment

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  •   2010/10/31
  •   288
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional 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.

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Exclusion Criteria

- Has been withdrawn from the CS35 trial.

- Has had end of trial visit in CS35 prior to approval of the CS35A protocol.

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Addresses

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    • Ferring Pharmaceuticals
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    • Ferring Pharmaceuticals
    • Clinical Development Support 
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    • Ferring Pharmaceuticals
    • Clinical Development Support 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting stopped after recruiting started
  •   2012/01/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   5
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.