A Parallel Group Comparison of the Efficacy and Safety of Degarelix at Two Different Dosing Regimens in Patients With Prostate Cancer
NCT ID: NCT00116779
Last Updated: 2011-12-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
127 participants
INTERVENTIONAL
2004-02-29
2005-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Degarelix 60mg
Initial dose of 200 milligrams (40 milligrams per milliliter) of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams (20 milligrams per milliliter) of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
Degarelix
Drug supplied as a powder to be dissolved in the solvent for solution for injection. Maintenance dose given in twelve 28-day cycles.
Degarelix 80mg
Initial dose of 200 milligrams (40 milligrams per milliliter) of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams (20 milligrams per milliliter) of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
Degarelix
Drug supplied as a powder to be dissolved in the solvent for solution for injection. Maintenance dose given in twelve 28-day cycles.
Interventions
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Degarelix
Drug supplied as a powder to be dissolved in the solvent for solution for injection. Maintenance dose given in twelve 28-day cycles.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed adenocarcinoma of the prostate (all stages), in whom endocrine treatment (except for neoadjuvant hormonal therapy) is indicated. This includes patients with rising PSA after having received radical prostatectomy (removal of the entire prostate and seminal vesicles) or radiotherapy with curative intention.
* Male patient aged 18 years or over.
* Has a baseline testosterone above the lower limit of normal range.
* Has an ECOG (Eastern Co-operative Oncology Group) score equal to or less than 2.
* Has a PSA value of greater than or equal to 2ng/mL.
Exclusion Criteria
* Currently or recently (within the last 12 weeks preceding the Screening Visit) under treatment with any other drug modifying testosterone level or function.
* Is considered to be a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 6 months from Screening Visit.
* Has a history of severe asthma (defined as a need for daily treatment with oral or inhalation steroids to control the asthma), anaphylactic reactions, angioedema, angioneurotic edema or Quincke's Edema.
* Has hypersensitivity towards any component of the investigational products (degarelix or mannitol).
* Has history of other cancer within the last 5 years except for prostate cancer and surgically removed basal or squamous cell carcinoma of the skin.
* Has elevated serum ALT level more than three times above upper level of normal range or serum total bilirubin level above one and a half times above upper level of normal range as measured by the laboratory at the Screening Visit.
* Has known or suspect hepatic disease of any sort. Patients with liver disease are not to be enrolled in this study.
* Has other clinically significant laboratory abnormalities, which in the judgment of the investigator would interfere with the participation of the patient in this study or evaluation of study results.
* Has a clinically significant disorder (other than prostate cancer) or any other condition, including excessive alcohol or drug abuse, which may interfere with trial participation or which may affect the conclusion of the study as judged by the investigator.
* Has a mental incapacity or language barriers precluding adequate understanding or cooperation.
* Has received an investigational drug within the last 12 weeks preceding Screening Visit.
* Has previously participated in any degarelix study
18 Years
MALE
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Development Support
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
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Urology Centers of Alabama
Homewood, Alabama, United States
Alaska Clinical Research Center, LLC
Anchorage, Alaska, United States
Advanced Urology Medical Center
Anaheim, California, United States
South Orange County Medical Research Cnter
Laguna Woods, California, United States
Pacific Clinical Research
Santa Monica, California, United States
West Coast Clinical Research
Tarzana, California, United States
Western Clinical Research
Torrance, California, United States
Urology Associate PC
Denver, Colorado, United States
South Florida Medical Research
Aventura, Florida, United States
SW Florida Urological Associates
Fort Myers, Florida, United States
Florida Foundation for Healthcare Research
Ocala, Florida, United States
RMD Clinical Reseach Institution LLC
Melrose Park, Illinois, United States
Northeast Indiana Research, LLC
Fort Wayne, Indiana, United States
Regional Urology
Shreveport, Louisiana, United States
Nevada Urology Associates
Reno, Nevada, United States
Lawrenceville Urology
Lawrenceville, New Jersey, United States
Hudson Valley Urology PC
Poughkeepsie, New York, United States
The Urology Center
Greensboro, North Carolina, United States
State College Urologic Association
State College, Pennsylvania, United States
Univeristy Urological Research Institute
Providence, Rhode Island, United States
Urology San Antonio Research
San Antonio, Texas, United States
Scott & White Memorial Hospital
Temple, Texas, United States
University of Vermont, Dept of Surgery
South Burlington, Vermont, United States
Virginia Urology Center
Richmond, Virginia, United States
Office of Jeffrey Frankel
Seattle, Washington, United States
Wyoming Research Foundation
Cheyenne, Wyoming, United States
Southern Interior Medical Research Corporation
Kelowna, British Columbia, Canada
Dr. Cal Abdreau Research
Surrey, British Columbia, Canada
Can-Med Clinical Research, Inc.
Victoria, British Columbia, Canada
Dr. Gary Steinhoff Clinical Research
Victoria, British Columbia, Canada
Valley Professional Center
Kentville, Nova Scotia, Canada
The Male and Female Health and Research Centers
Barrie, Ontario, Canada
Brantford Urology Research
Brantford, Ontario, Canada
Burlington Professional Care
Burlington, Ontario, Canada
The Female/Male Health Centres
Oakville, Ontario, Canada
Countries
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References
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Gittelman M, Pommerville PJ, Persson BE, Jensen JK, Olesen TK; Degarelix Study Group. A 1-year, open label, randomized phase II dose finding study of degarelix for the treatment of prostate cancer in North America. J Urol. 2008 Nov;180(5):1986-92. doi: 10.1016/j.juro.2008.07.033. Epub 2008 Sep 17.
Other Identifiers
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FE200486 CS14
Identifier Type: -
Identifier Source: org_study_id