- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00116779
A Parallel Group Comparison of the Efficacy and Safety of Degarelix at Two Different Dosing Regimens in Patients With Prostate Cancer
December 15, 2011 updated by: Ferring Pharmaceuticals
An Open-label, Randomized, Multi-center, Parallel Group Comparison of the Efficacy and Safety of Degarelix at Two Different Dosing Regimens in Patients With Prostate Cancer Dosed for Thirteen 28-day Cycles
The purpose of the study was to contribute, along with other such dose-finding studies, to the identification of the most effective treatment regimen for a one month depot injection of degarelix in the treatment of prostate cancer by a rapid and sustained suppression of testosterone.
Study Overview
Study Type
Interventional
Enrollment (Actual)
127
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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British Columbia
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Kelowna, British Columbia, Canada, V1Y2H4
- Southern Interior Medical Research Corporation
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Surrey, British Columbia, Canada, V3V1N1
- Dr. Cal Abdreau Research
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Victoria, British Columbia, Canada, V8T5G1
- Can-Med Clinical Research, Inc.
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Victoria, British Columbia, Canada, V8V3N1
- Dr. Gary Steinhoff Clinical Research
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Nova Scotia
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Kentville, Nova Scotia, Canada, B4N4K9
- Valley Professional Center
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Ontario
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Barrie, Ontario, Canada, L4M7G1
- The Male and Female Health and Research Centers
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Brantford, Ontario, Canada, N3R4N3
- Brantford Urology Research
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Burlington, Ontario, Canada, L7N3V2
- Burlington Professional Care
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Oakville, Ontario, Canada, L6H3P1
- The Female/Male Health Centres
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Alabama
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Homewood, Alabama, United States, 35209
- Urology Centers of Alabama
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Alaska
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Anchorage, Alaska, United States, 99508
- Alaska Clinical Research Center, LLC
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California
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Anaheim, California, United States, 92801
- Advanced Urology Medical Center
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Laguna Woods,, California, United States, 92653
- South Orange County Medical Research Cnter
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Santa Monica, California, United States, 90404
- Pacific Clinical Research
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Tarzana, California, United States, 91356
- West Coast Clinical Research
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Torrance, California, United States, 90505
- Western Clinical Research
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Colorado
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Denver, Colorado, United States, 80210
- Urology Associate PC
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Florida
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Aventura, Florida, United States, 33180
- South Florida Medical Research
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Fort Myers, Florida, United States, 33907
- SW Florida Urological Associates
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Ocala, Florida, United States, 34474
- Florida Foundation for Healthcare Research
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Illinois
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Melrose Park, Illinois, United States, 60160
- RMD Clinical Reseach Institution LLC
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Indiana
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Fort Wayne, Indiana, United States, 46825
- Northeast Indiana Research, LLC
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Louisiana
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Shreveport, Louisiana, United States, 71106
- Regional Urology
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Nevada
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Reno, Nevada, United States, 89511
- Nevada Urology Associates
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New Jersey
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Lawrenceville, New Jersey, United States, 08648
- Lawrenceville Urology
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New York
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Poughkeepsie, New York, United States, 12601
- Hudson Valley Urology PC
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North Carolina
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Greensboro, North Carolina, United States, 27401
- The Urology Center
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Pennsylvania
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State College, Pennsylvania, United States, 16801
- State College Urologic Association
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Rhode Island
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Providence, Rhode Island, United States, 02904
- Univeristy Urological Research Institute
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Texas
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San Antonio, Texas, United States, 78229
- Urology San Antonio Research
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Temple, Texas, United States, 76508
- Scott & White Memorial Hospital
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Vermont
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South Burlington, Vermont, United States, 05403
- University of Vermont, Dept of Surgery
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Virginia
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Richmond, Virginia, United States, 23235
- Virginia Urology Center
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Washington
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Seattle, Washington, United States, 98166
- Office of Jeffrey Frankel
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Wyoming
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Cheyenne, Wyoming, United States, 82001
- Wyoming Research Foundation
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
Each patient must meet the following inclusion criteria before entry into the study.
- Has given written consent prior to any study-related activity is performed (a study-related activity is defined as any procedure that would not have been performed during the normal management of the patient).
- 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:
Any patient meeting one or more of the following exclusion criteria will not be entered into the study.
- Previous or present hormonal management of prostate cancer (surgical castration or other hormonal manipulation, e.g. GnRH agonists, GnRH antagonists, antiandrogens, estrogens). However, patients having undergone neoadjuvant hormonal therapy in conjunction with prostatectomy or radiotherapy with curative intention may be included so long as the hormonal therapy did not exceed a total duration of 6 months and was terminated at least 6 months prior to the Screening Visit.
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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.
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Drug supplied as a powder to be dissolved in the solvent for solution for injection.
Maintenance dose given in twelve 28-day cycles.
Other Names:
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Experimental: 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.
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Drug supplied as a powder to be dissolved in the solvent for solution for injection.
Maintenance dose given in twelve 28-day cycles.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Testosterone <=0.5 Nanogram/Milliliter From Day 28 to Day 364
Time Frame: Day 28 to Day 364
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Number of participants with all testosterone values <=0.5 nanogram/milliliter from Day 28 to Day 364
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Day 28 to Day 364
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Number of Participants With Testosterone Level <= 0.5 Nanogram/Milliliter From Day 28 to Day 364 for Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 28
Time Frame: Day 28 - Day 364
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Number of participants who maintained a testosterone level of <=0.5 nanogram/milliliter from Day 28 to Day 364.
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Day 28 - Day 364
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 3.
Time Frame: Day 3
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Testosterone levels checked at Day 3 to determine if the reduction in testosterone level occurs rapidly after dosing.
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Day 3
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Days to 50 Percent and 90 Percent Reduction in Prostate-Specific Antigen
Time Frame: Day 0 (post dose) to Day 364
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Median number of days after the first dose of Degarelix when the Prostate-Specific Antigen levels fell to 50 percent and 90 percent of the baseline value.
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Day 0 (post dose) to Day 364
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Days to Prostate-Specific Antigen Progression
Time Frame: Day 0 (post dose) to Day 364
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Median days to prostate-specific antigen increase of >= 50 percent and >= 5 nanograms/milliliter compared to nadir on two consecutive visits at least 2 weeks apart.
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Day 0 (post dose) to Day 364
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Median Di-Hydrotestosterone Levels At Various Study Timepoints
Time Frame: Baseline, Days 1, 3, 7, 14
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Di-hydrotestosterone levels at baseline and days 1, 3, 7, 14
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Baseline, Days 1, 3, 7, 14
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Median Prostate-Specific Antigen Values at Various Study Timepoints
Time Frame: Baseline, Days 3, 14, 28, 84, 364
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Prostate-specific antigen levels at baseline and days 3, 14, 28, 84, and 364.
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Baseline, Days 3, 14, 28, 84, 364
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Median Luteinizing Hormone Levels at Various Study Timeframes
Time Frame: Baseline, Days 1, 3, 7, 14
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Luteinizing hormone levels at baseline, and days 1, 3, 7, and 14.
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Baseline, Days 1, 3, 7, 14
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Median Testosterone Levels at Various Days During the Study
Time Frame: Baseline, Days 1,3,7,14,364
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Testosterone levels at baseline and days 1, 3, 7, 14 and 364
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Baseline, Days 1,3,7,14,364
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Number of Participants With Abnormal Alanine Aminotransferase Values
Time Frame: Day 1 through day 364
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Participants whose alanine aminotransferase values were at levels above the normal range.
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Day 1 through day 364
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Number of Participants With Abnormal Aspartate Aminotransferase Values
Time Frame: Day 1 - 364
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Participants with aspartate aminotransferase values that were above the normal range.
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Day 1 - 364
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Number of Participants With Abnormal Total Bilirubin Values
Time Frame: Day 1 - 364
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Participants with abnormal total bilirubin values
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Day 1 - 364
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Participants With Markedly Abnormal Changes in Vital Signs or Body Weight
Time Frame: Day 364
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Vital sign and body weight values at the end of the trial are compared to baseline values.
The table represents the number of participants in each group with normal baseline values and markedly abnormal end-of-study values.
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Day 364
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2004
Primary Completion (Actual)
August 1, 2005
Study Completion (Actual)
August 1, 2005
Study Registration Dates
First Submitted
June 30, 2005
First Submitted That Met QC Criteria
June 30, 2005
First Posted (Estimate)
July 1, 2005
Study Record Updates
Last Update Posted (Estimate)
December 19, 2011
Last Update Submitted That Met QC Criteria
December 15, 2011
Last Verified
December 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FE200486 CS14
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Degarelix
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Ferring PharmaceuticalsCompleted
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Ferring PharmaceuticalsCompletedProstate CancerNetherlands, Belgium, Germany, Russian Federation, South Africa, Hungary, Romania, Poland
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Astellas Pharma IncCompleted
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Astellas Pharma IncCompleted
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Ferring PharmaceuticalsCompletedProstate CancerUnited States, Canada
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Ferring PharmaceuticalsCompletedLower Urinary Tract Symptoms (LUTS)United States, Canada, Belgium, Czech Republic, Italy, Poland
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Ferring PharmaceuticalsCompletedProstate CancerBelgium, Germany, Hungary, Netherlands, Romania, Russian Federation, South Africa
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Ferring PharmaceuticalsCompletedProstate CancerDenmark, Sweden, Finland, Hungary, Norway, Romania, Russian Federation
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VA Office of Research and DevelopmentCompleted