A Trial of Degarelix in Patients With Prostate Cancer


Tracking Information

Start Date  ICMJEJune 2009
Estimated Primary Completion DateJanuary 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2009)		Testosterone level [ Time Frame: Every month during one year of treatment ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00946920 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: July 24, 2009)
  • Testosterone level [ Time Frame: Every month during one year of treatment ] [ Designated as safety issue: No ]
  • PSA level [ Time Frame: Every month during one year of treatment ] [ Designated as safety issue: Yes ]
  • Reported Quality of Life - SF36 [ Time Frame: At baseline, 10 months and 13 months ] [ Designated as safety issue: No ]
  • Reported Quality of Life - IPPS [ Time Frame: At baseline, 1 month, 4 months, 7 months and 13 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJEA Trial of Degarelix in Patients With Prostate Cancer
Official Title  ICMJEAn Open-Label, Multi-Centre, Randomised, Parallel-Arm One-Year Trial, Comparing the Efficacy and Safety of Degarelix Three-Month Dosing Regimen With Goserelin Acetate in Patients With Prostate Cancer Requiring Androgen Deprivation Therapy
Brief Summary

A phase III one year trial comparing the efficacy and safety of degarelix 3 month depot with the established therapy Zoladex 3 month implant in patients with Prostate Cancer.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEProstate Cancer
Intervention  ICMJE
  • Drug: Degarelix
  • Drug: Zoladex
Study Arms / Comparison Groups
  • A: Degarelix: Experimental
    Intervention: Drug: Degarelix
  • B: Zoladex: Active Comparator
    Intervention: Drug: Zoladex

Recruitment Information

Estimated Enrollment  ICMJE825
Estimated Completion DateMarch 2011
Estimated Primary Completion DateJanuary 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 years or older.
  • Has a histological confirmed prostate cancer Gleason graded).
  • Has a screening testosterone above 2.2 ng/mL.
  • Rising PSA.
  • Has Eastern Cooperative Oncology Group (ECOG) score of ≤ 2.
  • Has a life expectancy of at least one year.

Exclusion Criteria:

  • Current or previous hormone therapy.
  • Has received therapy with finasteride and dutasteride within 12 weeks and 25 weeks, respectively, prior to screening.
  • Has a history of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
  • Has a heart insufficiency.
  • Has a previous history or presence of another malignancy, other than prostate cancer or treated squamous/basal cell carcinoma of the skin, within the last five years.
  • Has a clinically significant medical condition (other than prostate cancer) including, but not limited to, renal, haematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease and alcohol or drug abuse or any other condition which may affect the patient's health or the outcome of the trial as judged by the Investigator.
  • Has received an investigational drug within the last 28 days before the Screening Visit or longer if considered to possibly influencing the outcome of the current trial.
  • Is candidate for curative therapy, i.e. radical prostatectomy or radiotherapy.
GenderMale
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Clinical Development SupportDK0-Disclosure@ferring.com
Location Countries  ICMJEUnited States,   Belgium,   Canada,   Czech Republic,   Finland,   Germany,   Hungary,   Mexico,   Netherlands,   Poland,   Romania,   Russian Federation,   Ukraine,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00946920
Responsible PartyClinical Development Support, Ferring Pharmaceuticals
Study ID Numbers  ICMJEFE200486 CS35
Study Sponsor  ICMJEFerring Pharmaceuticals
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Clinical Development SupportFerring Pharmaceuticals
Information Provided ByFerring Pharmaceuticals