A Comparative Study of Degarelix Three-month Depot in Three Different Dosing Regimens in Patients With Prostate Cancer
- Registration Number
- NCT00116753
- Lead Sponsor
- Ferring Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 460
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Degarelix 240@40/240@40 (1,3,6,9) Degarelix 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) Degarelix 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) Degarelix 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
- Primary Outcome Measures
Name Time Method Number of Participants With Testosterone Level <=0.5 ng/mL From Day 28 Until the End of the Study From Day 28 to 12 or 13 months 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.
- Secondary Outcome Measures
Name Time Method 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 Figures in the table give the number of participants with all testosterone values \<=0.5 ng/mL after the dose at Day 28 to end of study. Thus, the testosterone response after the initial dose is not included in this outcome measure.
Number of Participants With Testosterone <=0.5 ng/mL at Day 28 28 Days Figures in the table give number of participants with testosterone \<=0.5 ng/mL 28 days after the initial dose of trial medication.
Liver Function Tests 12 or 13 months The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases \>3x ULN and ALT increases \>3x ULN with concurrently increased bilirubin \>1.5 ULN.
Number of Participants With Markedly Abnormal Change in Vital Signs and Body Weight as Compared to Baseline 12 or 13 months This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.
Trial Locations
- Locations (55)
SW Florida Urological Associates
🇺🇸Fort Myers, Florida, United States
Regional Urology
🇺🇸Shreveport, Louisiana, United States
The Male Health Center
🇨🇦Toronto, Ontario, Canada
Seatle Urology Research Centre
🇺🇸Seattle, Washington, United States
Urology Centers of Alabama
🇺🇸Homewood, Alabama, United States
Medical Affiliationed Research Center
🇺🇸Huntsville, Alabama, United States
Advanced Urology Medical Center
🇺🇸Anaheim, California, United States
Alaska Clinical Research Center, LLC
🇺🇸Anchorage, Alaska, United States
Center for Urological Research
🇺🇸La Mesa, California, United States
West Coast Clinical Research
🇺🇸Tarzana, California, United States
Western Clinical Research
🇺🇸Torrance, California, United States
South Orange County Medical Research Center
🇺🇸Laguna Woods,, California, United States
RT Services, Inc
🇺🇸Ft Myers, Florida, United States
Urology Research Option
🇺🇸Aurora, Colorado, United States
South Florida Medical Research
🇺🇸Aventura, Florida, United States
University of Missouri, Urology, Deptof Surgery
🇺🇸Columbia, Missouri, United States
Mississippi Urology Clinic
🇺🇸Jackson, Mississippi, 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 San Antonio Research
🇺🇸San Antonio, Texas, United States
Urology Association of Northern Texas
🇺🇸Fort Worth, Texas, United States
Southern Interior Medical Research Corp
🇨🇦Kelowna, British Columbia, Canada
Andreou Researce
🇨🇦Surrey, British Columbia, Canada
UZ Gasthuisberg Leuven
🇧🇪Leuven, Belgium
The Male/Female Health Centres and Research
🇨🇦Oakville, Ontario, Canada
Can-Med Clinical Research Inc.
🇨🇦Victoria, British Columbia, Canada
Brantford Urology Research
🇨🇦Brantford, Ontario, Canada
Central Hospital, North Karelian, Dept. of Urology
🇫🇮Joensuu, Finland
North Bay Hospital
🇨🇦North Bay, Ontario, Canada
Helsinki University Hospital, Maria Hospital, Dept Urology
🇫🇮Helsinki, Finland
Oulu University Hospital, Department of Surgery Division of Urology
🇫🇮Oys, Finland
Clinical Center Novi Sad, Clinic of Urology Hajduk
Novi Sad, Former Serbia and Montenegro
Fédération d'Urologie et Néphrologie
🇫🇷Nice, France
Clinical Center of Serbia Institute of Urology and Nephrology
Belgrade, Former Serbia and Montenegro
Academic Medical Center, Urology
🇳🇱Amsterdam, Netherlands
Centre Hospitalier Départemental des Oudairies, Chirurgie Urologie
🇫🇷La Roche-sur-Yon, France
Gemeinschaftspraxis Dres Effert und Benedic
🇩🇪Aachen, Germany
Klinik fuer Urologie, Vivantes Klinikum Am Urban
🇩🇪Berlin, Germany
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, Russian Federation
Ward 10, NHS Forth Valley Acute Operating Division, Falkirk and District Royal Infirmary
🇬🇧Falkirk, United Kingdom
City Hospital #15
🇷🇺Saint Petersburg, Russian Federation
Pavlov State Medical University, Urology Department
🇷🇺Saint Petersburg, Russian Federation
City Hospital #26
🇷🇺Saint Petersburg, Russian Federation
Pavlov State Medical University, Outpatient Diagnostic Center affiliated with the Urology Department
🇷🇺Saint Petersburg, Russian Federation
Mount Vernon Cancer Centre, Marie Curie Research Wing
🇬🇧Middlesex, United Kingdom
Level 7, Urology Research Unit, Derriford Hospital
🇬🇧Plymouth, United Kingdom
Castle Hill Hospital, Dept. Urology
🇬🇧North Humberside, United Kingdom
Tampere University Hospital, Dept. of Urology
🇫🇮Tampere, Finland