A Comparative Study of Degarelix Three-month Depot in Three Different Dosing Regimens in Patients With Prostate Cancer
An Open-label Multi-center, Randomized Parallel Group Comparison of Efficacy and Safety of Degarelix Three-Month Depot in Three Different Dosing Regimens in Patients With Prostate Cancer
1 other identifier
interventional
460
11 countries
56
Brief Summary
The rationale of the study was to evaluate different degarelix dosing regimens for a three-month interval that was to produce and maintain castration in prostate cancer patients through immediate and prolonged testosterone suppression, and to provide confirmatory evidence of the safety of degarelix.
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 Jan 2005
Shorter than P25 for phase_2 prostate-cancer
56 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
January 1, 2005
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
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedResults Posted
Study results publicly available
December 10, 2010
CompletedDecember 10, 2010
November 1, 2010
1.8 years
June 30, 2005
October 6, 2010
November 12, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Testosterone Level <=0.5 ng/mL From Day 28 Until the End of the Study
Figure in the table give the number of participants with all testosterone values \<=0.5 ng/mL from Day 28 to the end of the study.
From Day 28 to 12 or 13 months
Secondary Outcomes (4)
Number of Participants With Testosterone Level <=0.5 ng/mL After the Dose at Day 28 Until the End of the Study
From after Day 28 to 12 or 13 months
Number of Participants With Testosterone <=0.5 ng/mL at Day 28
28 Days
Liver Function Tests
12 or 13 months
Number of Participants With Markedly Abnormal Change in Vital Signs and Body Weight as Compared to Baseline
12 or 13 months
Study Arms (3)
Degarelix 240@40/240@40 (1,3,6,9)
ACTIVE COMPARATOR240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.
Degarelix 240@40/240@60(1,3,6,9)
ACTIVE COMPARATOR240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.
Degarelix 240@40/240@60(1,4,7,10)
ACTIVE COMPARATOR240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
Interventions
Drug: Degarelix subcutaneous 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9
Eligibility Criteria
You may qualify if:
- Has given written consent before 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.
- Has a histologically confirmed (Gleason graded) 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 undergone prostatectomy or radiotherapy with curative intention.
- Is a male patient aged 18 years or over.
- Has a baseline serum testosterone level above the lower limit of normal range, globally defined as \>2.2 ng/mL.
- Has an ECOG (Eastern Cooperative Oncology Group) score of 2.
- Has a PSA value of 2 ng/mL.
- Has a life expectancy of at least 13 months.
You may not qualify if:
- Has had previous or is currently under hormonal management of prostate cancer (surgical castration or other hormonal manipulation, e.g. GnRH agonists, GnRH antagonists, antiandrogens, oestrogens). However, patients having undergone prostatectomy or radiotherapy with curative intention, neoadjuvant hormonal therapy is accepted for a maximal duration of 6 months. This treatment should have been terminated at least 6 months prior to the Screening Visit.
- Is considered to be a candidate for curative therapy, i.e. radical prostatectomy or radiotherapy within 13 months from Screening Visit.
- Has a history of, or predisposition to, severe hypersensitivity reactions such as severe asthma (defined as a need for daily treatment with inhalation steroids to control the asthma), anaphylactic reactions, or chronic or recurrent urticaria and/or angioedema.
- Has hypersensitivity towards any component of the investigational medicinal product. 5. Has had a cancer disease within the last five years except for prostate cancer and surgically removed basal or squamous cell carcinoma of the skin.
- Has a known or suspected hepatic or symptomatic biliary disease.
- Has elevated serum ALT level above upper level of normal range or serum total bilirubin level above upper level of normal range as measured by the laboratory at the Screening Visit.
- Has other clinically significant laboratory abnormalities, which in the judgment of the investigator would interfere with the patient's participation 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 study 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 28 days preceding Screening Visit or longer if considered by the investigator to possibly influence the outcome of the current study.
- Has previously participated in any degarelix study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (56)
Urology Centers of Alabama
Homewood, Alabama, 35209, United States
Medical Affiliationed Research Center
Huntsville, Alabama, 35801, United States
Alaska Clinical Research Center, LLC
Anchorage, Alaska, 99508, United States
Advanced Urology Medical Center
Anaheim, California, 92801, United States
Center for Urological Research
La Mesa, California, 91942, United States
South Orange County Medical Research Center
Laguna Woods, California, 92653, United States
West Coast Clinical Research
Tarzana, California, 91356, United States
Western Clinical Research
Torrance, California, 90505, United States
Urology Research Option
Aurora, Colorado, 80012, United States
South Florida Medical Research
Aventura, Florida, 33180, United States
RT Services, Inc
Fort Myers, Florida, 33901, United States
SW Florida Urological Associates
Fort Myers, Florida, 33907, United States
Regional Urology
Shreveport, Louisiana, 71106, United States
Mississippi Urology Clinic
Jackson, Mississippi, 39202, United States
University of Missouri, Urology, Deptof Surgery
Columbia, Missouri, 65212, United States
Kansas City Urology Care
Kansas City, Missouri, 64131, United States
Northeast Urology Research
Concord, North Carolina, 28025, United States
The Urology Center
Greensboro, North Carolina, 27401, United States
State College Urologic Association
State College, Pennsylvania, 16801, United States
Grand Strand Urology
Myrtle Beach, South Carolina, 29572, United States
Urology Association of Northern Texas
Fort Worth, Texas, 76104, United States
Urology San Antonio Research
San Antonio, Texas, 78229, United States
Seatle Urology Research Centre
Seattle, Washington, 98166, United States
UZ Gasthuisberg Leuven
Leuven, Belgium
Southern Interior Medical Research Corp
Kelowna, British Columbia, Canada
Andreou Researce
Surrey, British Columbia, Canada
Can-Med Clinical Research Inc.
Victoria, British Columbia, Canada
The Male/Female Health Centres and Research
Barrie, Ontario, Canada
Brantford Urology Research
Brantford, Ontario, Canada
North Bay Hospital
North Bay, Ontario, Canada
The Male/Female Health Centres and Research
Oakville, Ontario, Canada
The Male Health Center
Toronto, Ontario, Canada
Helsinki University Hospital, Maria Hospital, Dept Urology
Helsinki, Finland
Central Hospital, North Karelian, Dept. of Urology
Joensuu, Finland
Oulu University Hospital, Department of Surgery Division of Urology
Oys, Finland
Tampere University Hospital, Dept. of Urology
Tampere, Finland
Centre Hospitalier Départemental des Oudairies, Chirurgie Urologie
La Roche-sur-Yon, France
Fédération d'Urologie et Néphrologie
Nice, France
Gemeinschaftspraxis Dres Effert und Benedic
Aachen, Germany
Klinik fuer Urologie, Vivantes Klinikum Am Urban
Berlin, Germany
Academic Medical Center, Urology
Amsterdam, Netherlands
St. Elisabeth Hospital
Tilburg, Netherlands
Centrul Medical Privat
Arad, Romania
Clinical Hospital "Prof. Dr. Theodor Burghele", Urology Department
Bucharest, Romania
University CF Hospital No.2, Urology Clinic
Bucharest, Romania
Andros Clinic
Saint Petersburg, Russia
City Hospital #15
Saint Petersburg, Russia
City Hospital #26
Saint Petersburg, Russia
Pavlov State Medical University, Outpatient Diagnostic Center affiliated with the Urology Department
Saint Petersburg, Russia
Pavlov State Medical University, Urology Department
Saint Petersburg, Russia
Clinical Center of Serbia Institute of Urology and Nephrology
Belgrade, Serbia and Montenegro
Clinical Center Novi Sad, Clinic of Urology Hajduk
Novi Sad, Serbia and Montenegro
Ward 10, NHS Forth Valley Acute Operating Division, Falkirk and District Royal Infirmary
Falkirk, United Kingdom
Mount Vernon Cancer Centre, Marie Curie Research Wing
Middlesex, United Kingdom
Castle Hill Hospital, Dept. Urology
North Humberside, United Kingdom
Level 7, Urology Research Unit, Derriford Hospital
Plymouth, United Kingdom
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
Study Record Dates
First Submitted
June 30, 2005
First Posted
July 1, 2005
Study Start
January 1, 2005
Primary Completion
November 1, 2006
Study Completion
November 1, 2006
Last Updated
December 10, 2010
Results First Posted
December 10, 2010
Record last verified: 2010-11