A Parallel Group Comparison of the Efficacy and Safety of Degarelix at Two Different Dosing Regimens in Patients With Prostate Cancer
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
1 other identifier
interventional
127
2 countries
35
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 prostate-cancer
Started Feb 2004
Shorter than P25 for phase_2 prostate-cancer
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 30, 2005
CompletedFirst Posted
Study publicly available on registry
July 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedResults Posted
Study results publicly available
March 20, 2009
CompletedDecember 19, 2011
December 1, 2011
1.5 years
June 30, 2005
January 22, 2009
December 15, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants With Testosterone <=0.5 Nanogram/Milliliter From Day 28 to Day 364
Number of participants with all testosterone values \<=0.5 nanogram/milliliter from Day 28 to Day 364
Day 28 to Day 364
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
Number of participants who maintained a testosterone level of \<=0.5 nanogram/milliliter from Day 28 to Day 364.
Day 28 - Day 364
Secondary Outcomes (11)
Number of Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 3.
Day 3
Days to 50 Percent and 90 Percent Reduction in Prostate-Specific Antigen
Day 0 (post dose) to Day 364
Days to Prostate-Specific Antigen Progression
Day 0 (post dose) to Day 364
Median Di-Hydrotestosterone Levels At Various Study Timepoints
Baseline, Days 1, 3, 7, 14
Median Prostate-Specific Antigen Values at Various Study Timepoints
Baseline, Days 3, 14, 28, 84, 364
- +6 more secondary outcomes
Study Arms (2)
Degarelix 60mg
EXPERIMENTALInitial 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 80mg
EXPERIMENTALInitial 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.
Interventions
Drug supplied as a powder to be dissolved in the solvent for solution for injection. Maintenance dose given in twelve 28-day cycles.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Urology Centers of Alabama
Homewood, Alabama, 35209, United States
Alaska Clinical Research Center, LLC
Anchorage, Alaska, 99508, United States
Advanced Urology Medical Center
Anaheim, California, 92801, United States
South Orange County Medical Research Cnter
Laguna Woods, California, 92653, United States
Pacific Clinical Research
Santa Monica, California, 90404, United States
West Coast Clinical Research
Tarzana, California, 91356, United States
Western Clinical Research
Torrance, California, 90505, United States
Urology Associate PC
Denver, Colorado, 80210, United States
South Florida Medical Research
Aventura, Florida, 33180, United States
SW Florida Urological Associates
Fort Myers, Florida, 33907, United States
Florida Foundation for Healthcare Research
Ocala, Florida, 34474, United States
RMD Clinical Reseach Institution LLC
Melrose Park, Illinois, 60160, United States
Northeast Indiana Research, LLC
Fort Wayne, Indiana, 46825, United States
Regional Urology
Shreveport, Louisiana, 71106, United States
Nevada Urology Associates
Reno, Nevada, 89511, United States
Lawrenceville Urology
Lawrenceville, New Jersey, 08648, United States
Hudson Valley Urology PC
Poughkeepsie, New York, 12601, United States
The Urology Center
Greensboro, North Carolina, 27401, United States
State College Urologic Association
State College, Pennsylvania, 16801, United States
Univeristy Urological Research Institute
Providence, Rhode Island, 02904, United States
Urology San Antonio Research
San Antonio, Texas, 78229, United States
Scott & White Memorial Hospital
Temple, Texas, 76508, United States
University of Vermont, Dept of Surgery
South Burlington, Vermont, 05403, United States
Virginia Urology Center
Richmond, Virginia, 23235, United States
Office of Jeffrey Frankel
Seattle, Washington, 98166, United States
Wyoming Research Foundation
Cheyenne, Wyoming, 82001, United States
Southern Interior Medical Research Corporation
Kelowna, British Columbia, V1Y2H4, Canada
Dr. Cal Abdreau Research
Surrey, British Columbia, V3V1N1, Canada
Can-Med Clinical Research, Inc.
Victoria, British Columbia, V8T5G1, Canada
Dr. Gary Steinhoff Clinical Research
Victoria, British Columbia, V8V3N1, Canada
Valley Professional Center
Kentville, Nova Scotia, B4N4K9, Canada
The Male and Female Health and Research Centers
Barrie, Ontario, L4M7G1, Canada
Brantford Urology Research
Brantford, Ontario, N3R4N3, Canada
Burlington Professional Care
Burlington, Ontario, L7N3V2, Canada
The Female/Male Health Centres
Oakville, Ontario, L6H3P1, Canada
Related Publications (1)
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.
PMID: 18801505RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ferring Pharmaceuticals
- Organization
- Clinical Development Support
Study Officials
- STUDY DIRECTOR
Clinical Development Support
Ferring Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2005
First Posted
July 1, 2005
Study Start
February 1, 2004
Primary Completion
August 1, 2005
Study Completion
August 1, 2005
Last Updated
December 19, 2011
Results First Posted
March 20, 2009
Record last verified: 2011-12