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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Degarelix; Drug: Degarelix; Drug: Degarelix

• Study Type: Interventional
• Enrollment (Actual): 460
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium
    • UZ Gasthuisberg Leuven
• Canada
  • British Columbia
    • Kelowna, British Columbia, Canada
      • Southern Interior Medical Research Corp
    • Surrey, British Columbia, Canada
      • Andreou Researce
    • Victoria, British Columbia, Canada
      • Can-Med Clinical Research Inc.
  • Ontario
    • Barrie, Ontario, Canada
      • The Male/Female Health Centres and Research
    • Brantford, Ontario, Canada
      • Brantford Urology Research
    • North Bay, Ontario, Canada
      • North Bay Hospital
    • Oakville, Ontario, Canada
      • The Male/Female Health Centres and Research
    • Toronto, Ontario, Canada
      • The Male Health Center
• Finland
  • Helsinki, Finland
    • Helsinki University Hospital, Maria Hospital, Dept Urology
  • Joensuu, Finland
    • Central Hospital, North Karelian, Dept. of Urology
  • Oys, Finland
    • Oulu University Hospital, Department of Surgery Division of Urology
  • Tampere, Finland
    • Tampere University Hospital, Dept. of Urology
• Former Serbia and Montenegro
  • Belgrade, Former Serbia and Montenegro
    • Clinical Center of Serbia Institute of Urology and Nephrology
  • Novi Sad, Former Serbia and Montenegro
    • Clinical Center Novi Sad, Clinic of Urology Hajduk
• France
  • La Roche-sur-Yon, France
    • Centre Hospitalier Départemental des Oudairies, Chirurgie Urologie
  • Nice, France
    • Fédération d'Urologie et Néphrologie
• Germany
  • Aachen, Germany
    • Gemeinschaftspraxis Dres Effert und Benedic
  • Berlin, Germany
    • Klinik fuer Urologie, Vivantes Klinikum Am Urban
• Netherlands
  • Amsterdam, Netherlands
    • Academic Medical Center, Urology
  • Tilburg, Netherlands
    • St. Elisabeth Hospital
• Romania
  • Arad, Romania
    • Centrul Medical Privat
  • Bucharest, Romania
    • Clinical Hospital "Prof. Dr. Theodor Burghele", Urology Department
  • Bucharest, Romania
    • University CF Hospital No.2, Urology Clinic
• Russian Federation
  • Saint Petersburg, Russian Federation
    • City Hospital #15
  • Saint Petersburg, Russian Federation
    • City Hospital #26
  • Saint Petersburg, Russian Federation
    • Andros Clinic
  • Saint Petersburg, Russian Federation
    • Pavlov State Medical University, Outpatient Diagnostic Center affiliated with the Urology Department
  • Saint Petersburg, Russian Federation
    • Pavlov State Medical University, Urology Department
• United Kingdom
  • Falkirk, United Kingdom
    • Ward 10, NHS Forth Valley Acute Operating Division, Falkirk and District Royal Infirmary
  • Middlesex, United Kingdom
    • Mount Vernon Cancer Centre, Marie Curie Research Wing
  • North Humberside, United Kingdom
    • Castle Hill Hospital, Dept. Urology
  • Plymouth, United Kingdom
    • Level 7, Urology Research Unit, Derriford Hospital
• United States
  • Alabama
    • Homewood, Alabama, United States, 35209
      • Urology Centers Of Alabama
    • Huntsville, Alabama, United States, 35801
      • Medical Affiliationed Research Center
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Alaska Clinical Research Center, LLC
  • California
    • Anaheim, California, United States, 92801
      • Advanced Urology Medical Center
    • La Mesa, California, United States, 91942
      • Center for Urological Research
    • Laguna Woods,, California, United States, 92653
      • South Orange County Medical Research Center
    • Tarzana, California, United States, 91356
      • West Coast Clinical Research
    • Torrance, California, United States, 90505
      • Western Clinical Research
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Urology Research Option
  • Florida
    • Aventura, Florida, United States, 33180
      • South Florida Medical Research
    • Fort Myers, Florida, United States, 33907
      • SW Florida Urological Associates
    • Ft Myers, Florida, United States, 33901
      • RT Services, Inc
  • Louisiana
    • Shreveport, Louisiana, United States, 71106
      • Regional Urology
  • Mississippi
    • Jackson, Mississippi, United States, 39202
      • Mississippi Urology Clinic
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri, Urology, Deptof Surgery
    • Kansas City, Missouri, United States, 64131
      • Kansas City Urology Care
  • North Carolina
    • Concord, North Carolina, United States, 28025
      • Northeast Urology Research
    • Greensboro, North Carolina, United States, 27401
      • The Urology Center
  • Pennsylvania
    • State College, Pennsylvania, United States, 16801
      • State College Urologic Association
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Grand Strand Urology
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Urology Association of Northern Texas
    • San Antonio, Texas, United States, 78229
      • Urology San Antonio Research
  • Washington
    • Seattle, Washington, United States, 98166
      • Seatle Urology Research Centre

Participation Criteria

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:

• 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.

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: 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; Other Names: FE200486; Drug: 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; Other Names: FE200486; Drug: 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 Names: FE200486
Active Comparator: 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.	Drug: 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; Other Names: FE200486; Drug: 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; Other Names: FE200486; Drug: 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 Names: FE200486
Active Comparator: 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.	Drug: 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; Other Names: FE200486; Drug: 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; Other Names: FE200486; Drug: 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 Names: FE200486

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Testosterone Level <=0.5 ng/mL After the Dose at Day 28 Until the End of the Study	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.	From after Day 28 to 12 or 13 months
Number of Participants With Testosterone <=0.5 ng/mL at Day 28	Figures in the table give number of participants with testosterone <=0.5 ng/mL 28 days after the initial dose of trial medication.	28 Days
Liver Function Tests	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.	12 or 13 months
Number of Participants With Markedly Abnormal Change in Vital Signs and Body Weight as Compared to Baseline	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.	12 or 13 months

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (Actual): November 1, 2006
• Study Completion (Actual): November 1, 2006

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 10, 2010
• Last Update Submitted That Met QC Criteria: November 12, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: Prostate Cancer; Androgen ablation therapy
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: FE200486 CS15