A Long-term Extension Study Evaluating a One-Month Dosing Regimen of Degarelix in Prostate Cancer Requiring Androgen Ablation Therapy

March 20, 2013 updated by: Ferring Pharmaceuticals

An Open-Label, Multi-Centre, Extension Study, Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Patients With Prostate Cancer Requiring Androgen Ablation Therapy

Participants who completed the FE200486 CS21 study (NCT00295750) could enter the FE200486 CS21A study. The study continued until all non-discontinued participants had received treatment for at least 5 years.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

386

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Victoria, Canada
        • Can-Med Clinical Research Inc
    • Nova Scotia
      • Kentville, Nova Scotia, Canada
        • Investigational Site
    • Ontario
      • Barrie, Ontario, Canada
        • The Female/Male Health Centres
      • Brantford, Ontario, Canada
        • Brantford Urology Research
      • Burlington, Ontario, Canada
        • Burlington Professional Centre
      • Burlington, Ontario, Canada
        • The Urology Research Centre
      • Newmarket, Ontario, Canada
        • Investigational Site
      • Oakville, Ontario, Canada
        • The Female/Male Health Centres
    • Quebec
      • Greenfields, Quebec, Canada
        • Urology South Shore Research
  • Czech Republic
      • Brno, Czech Republic
        • Urocentrum Brno
      • Brno, Czech Republic
        • UROHELP - Bozetechova
      • Jindrichuv Hradec, Czech Republic
        • Nemocnice Jindrichuv Hradec, a.s.
      • Olomouc, Czech Republic
        • Fakultni Nemocnice Olomouc
      • Opava, Czech Republic
        • Slezská nemocnice
      • Prague, Czech Republic
        • Fakultni nemocnice v Motole, Prague5
      • Prague, Czech Republic
        • Vseobecna fakultni nemocnice v Praze, Prague2
  • Germany
      • Mannheim, Germany
        • Klinikum Mannheim Universitätsklinikum GmbH
      • Regensburg, Germany
        • Klinikum der Universität Regensburg
  • Hungary
      • Budapest, Hungary
        • Fövárosi Önkormányzat uzsoki utcai Kórház
      • Dombóvár, Hungary
        • Dombóvári Szent Lukács Egészségügyi Kht.
      • Györ, Hungary
        • Petz Aladár Megyei Oktató Kórház
      • Miskolc, Hungary
        • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
      • Miskolc, Hungary
        • Miskolci Semmelweis Ignác Egészségügyi Központ és Egyetemi Oktató Kórház Nonprofit Kft
      • Pécs, Hungary
        • Pecsi Tudomanyegyetem
      • Szeged, Hungary
        • Investigational Site
  • Mexico
      • Acapulco, Mexico
        • Investigational Site
      • Chihuahua, Chih., Mexico
        • Hospital Christus Muguerza del Parque
      • Durango, Mexico
        • Investigational Sit
      • Leon, GTO, Mexico
        • Hospital Aranda de la Parra , S.A. de C.V.
      • Mexico, DF, Mexico
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Mexico, DF Mexico
      • Mexico, DF, Mexico
        • Investigational Site
      • Zapopan, Jalisco, Mexico
        • Consultorio Médico
      • Zapopan, Jalisco, Mexico
        • Investigational Site
  • Netherlands
      • Ede, Netherlands
        • Investigational Site
      • Eindhoven, Netherlands
        • Investigational Site
      • Heerlen, Netherlands
        • Atrium MC
  • Puerto Rico
      • Ponce, Puerto Rico
        • Hospital Andres Grillasca
  • Romania
      • Arad, Romania
        • Investigational Site
      • Bucharest, Romania
        • Fundeni Uronephrology and Renal Transplant Clinical Institute
      • Bucharest, Romania
        • Investigational Site
      • Bucharest, Romania
        • Sfantul Ioan" Emergency Clinical Hospital
      • Constanta, Romania
        • PROVITA 2000 Medical Center
      • Iasi, Romania
        • Investigational Site
      • Sibiu, Romania
        • Sibiu Emergency Clinical County Hospital
  • Russian Federation
      • Moscow, Russian Federation
        • City Clinical Hospital #60
      • Moscow, Russian Federation
        • Moscow State University of Medicine and Dentistry
      • Moscow, Russian Federation
        • City Clinical Hospital #1 n.a. N.I.Pirogov
      • St. Petersburg, Russian Federation
        • City Pokrovskaya Hospital
      • St. Petersburg, Russian Federation
        • Investigational Site
      • St. Petersburg, Russian Federation
        • St.Petersburg State Medical Academy n. a. I.I.Mechnikov
  • Ukraine
      • Dnipropetrovsk, Ukraine
        • Dnipropetrovsk State Medical Academy
      • Kharkiv, Ukraine
        • Regional Clinical Center of Urology and Nephrology n.a. V.I.Shapoval
      • Kyiv, Ukraine
        • Kyiv City Clinical Hospital #3
      • Odesa, Ukraine
        • Odesa State Medical University
  • United Kingdom
      • Bebington, Wirral, United Kingdom
        • Clatterbridge Centre for Oncology
  • United States
    • Alabama
      • Homewood, Alabama, United States
        • Urology Centers of Alabama
    • California
      • Laguna Hills, California, United States
        • South Orange County Medical Research Center
      • Torrance, California, United States
        • Western Clinical Research
    • Colorado
      • Englewood, Colorado, United States
        • Urology Associates Research
    • Florida
      • Aventura, Florida, United States
        • South Florida Medical Research
      • Ocala, Florida, United States
        • Investigational Site
    • Louisiana
      • Shreveport, Louisiana, United States
        • Regional Urology
    • New Jersey
      • Lawrenceville, New Jersey, United States
        • Lawrenceville Urology
    • New York
      • Carmel, New York, United States
        • Investigational Site
    • North Carolina
      • Concord, North Carolina, United States
        • North Urology Research
      • Greensboro, North Carolina, United States
        • Investigational Site
    • Pennsylvania
      • State College, Pennsylvania, United States
        • State College Urologic Association
    • Texas
      • San Antonio, Texas, United States
        • Urology San Antonio Research
    • Washington
      • Burien, Washington, United States
        • Seattle Urology Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion/Exclusion Criteria:

  • Patients with histologically proven prostate cancer of all stages in whom endocrine treatment is indicated.
  • Signed informed consent
  • The patients must have completed the FE 200486 CS21 Study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Degarelix 80 mg / Degarelix 80 mg
The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.
Drug: Degarelix 80 mg / Degarelix 80 mg
Other Names:
  • Firmagon
Experimental: Degarelix 160 mg / Degarelix 160 mg

The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days.

Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
Drug: Degarelix 160 mg / Degarelix 160 mg
Other Names:
  • Firmagon
Experimental: Leuprolide 7.5 mg / Degarelix 80 mg

During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.

Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.

Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
Drug: Leuprolide 7.5 mg / Degarelix 80 mg
Other Names:
  • Lupron
  • Firmagon
Experimental: Leuprolide 7.5 mg / Degarelix 160 mg

During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.

Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.

Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
Drug: Leuprolide 7.5 mg / Degarelix 160 mg
Other Names:
  • Lupron
  • Firmagon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
Time Frame: Up to 4 years of treatment
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 (from main CS21 study, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A.
Up to 4 years of treatment
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
Time Frame: Up to 4 years of treatment
This outcome measure included incidence of markedly abnormal changes in safety laboratory values. The table presents the number of participants with normal baseline (from main CS21 trial, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A. Only the laboratory variables that had at least five percentages of participants in either group with abnormal value are presented, more variables were included in the study. ULN=Upper limit of normal.
Up to 4 years of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With no Prostate-specific Antigen (PSA) Progression
Time Frame: Until all participants have received at least 5 years of treatment and at a frequency of every 3 months
PSA progression was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir (obtained in either CS21, NCT00295750, or CS21A). The figures below present the percentage of participants with no PSA progression at each of the selected time points (there were more time points in the study) along with corresponding 95% confidence intervals (CI).
Until all participants have received at least 5 years of treatment and at a frequency of every 3 months
Percentage of Participants With Testosterone Level Maintained at <=0.5 ng/mL From Day 28 in CS21 and Onwards
Time Frame: Until all participants have received at least 5 years of treatment and at a frequency of every 6 months

The results below present the percentage of participants of having testosterone <=0.5 ng/mL at each of the selected time points (there were more time points in the study) from Day 28 in CS21 (NCT00295750) until the end of the CS21A study.

In all treatment groups approximately 3% per year of the participants had at least one testosterone >0.5 ng/mL during the study.
Until all participants have received at least 5 years of treatment and at a frequency of every 6 months
Serum Levels of Testosterone From the Time of Switch From Leuprolide to Degarelix up to Day 56
Time Frame: From time of switch to Day 56
From time of switch to Day 56
Serum Levels of PSA From the Time of Switch From Leuprolide to Degarelix to Day 56
Time Frame: From time of switch to Day 56
From time of switch to Day 56
Serum Levels of Luteinizing Hormone (LH) From the Time of Switch From Leuprolide to Degarelix to Day 56
Time Frame: From time of switch to Day 56
From time of switch to Day 56
Serum Levels of Follicle Stimulating Hormone (FSH) From the Time of Switch From Leuprolide to Degarelix to Day 56
Time Frame: From time of switch to Day 56
From time of switch to Day 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ferring Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

March 23, 2007

First Submitted That Met QC Criteria

March 23, 2007

First Posted (Estimate)

March 26, 2007

Study Record Updates

Last Update Posted (Estimate)

March 21, 2013

Last Update Submitted That Met QC Criteria

March 20, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FE200486 CS21A
  • 2006-006913-34 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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