A Comparative Study of Degarelix Three-month Depot in Three Different Dosing Regimens in Patients With Prostate Cancer
NCT ID: NCT00116753
Last Updated: 2010-12-10
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
460 participants
INTERVENTIONAL
2005-01-31
2006-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Degarelix 240@40/240@40 (1,3,6,9)
240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.
Degarelix
Drug: Degarelix subcutaneous 240 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)
240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.
Degarelix
Drug: Degarelix subcutaneous 240 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)
240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
Degarelix
Drug: Degarelix subcutaneous 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Degarelix
Drug: Degarelix subcutaneous 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9
Degarelix
Drug: Degarelix subcutaneous 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9
Degarelix
Drug: Degarelix subcutaneous 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ferring Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ferring Pharmaceuticals
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Development Support
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Urology Centers of Alabama
Homewood, Alabama, United States
Medical Affiliationed Research Center
Huntsville, Alabama, United States
Alaska Clinical Research Center, LLC
Anchorage, Alaska, United States
Advanced Urology Medical Center
Anaheim, California, United States
Center for Urological Research
La Mesa, California, United States
South Orange County Medical Research Center
Laguna Woods, California, United States
West Coast Clinical Research
Tarzana, California, United States
Western Clinical Research
Torrance, California, United States
Urology Research Option
Aurora, Colorado, United States
South Florida Medical Research
Aventura, Florida, United States
RT Services, Inc
Fort Myers, Florida, United States
SW Florida Urological Associates
Fort Myers, Florida, United States
Regional Urology
Shreveport, Louisiana, United States
Mississippi Urology Clinic
Jackson, Mississippi, United States
University of Missouri, Urology, Deptof Surgery
Columbia, Missouri, United States
Kansas City Urology Care
Kansas City, Missouri, United States
Northeast Urology Research
Concord, North Carolina, United States
The Urology Center
Greensboro, North Carolina, United States
State College Urologic Association
State College, Pennsylvania, United States
Grand Strand Urology
Myrtle Beach, South Carolina, United States
Urology Association of Northern Texas
Fort Worth, Texas, United States
Urology San Antonio Research
San Antonio, Texas, United States
Seatle Urology Research Centre
Seattle, Washington, 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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FE200486 CS15
Identifier Type: -
Identifier Source: org_study_id