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A Trial of Degarelix in Patients With Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00946920
First received: July 3, 2009
Last updated: March 9, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
 Drug: Degarelix
Drug: Zoladex
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Testosterone level [ Time Frame: Every month during one year of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 859
Study Start Date: June 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A: Degarelix Drug: Degarelix
Active Comparator: B: Zoladex Drug: Zoladex

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00946920

  Show 126 Study Locations
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00946920     History of Changes
Other Study ID Numbers: FE200486 CS35
Study First Received: July 3, 2009
Last Updated: March 9, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Mexico: Ministry of Health
Belgium: Directorate general for the protection of Public health: Medicines
Finland: Finnish Medicines Agency
Germany: Ministry of Health
Netherlands: Ministry of Health, Welfare and Sport
United Kingdom: National Health Service
Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Poland: Ministry of Health
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Ukraine: Ministry of Health

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
 Prostatic Diseases
Goserelin
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013