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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00451958
First received: March 23, 2007
Last updated: March 20, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: Degarelix 80 mg / Degarelix 80 mg
Drug: Degarelix 160 mg / Degarelix 160 mg
Drug: Leuprolide 7.5 mg / Degarelix 80 mg
Drug: Leuprolide 7.5 mg / Degarelix 160 mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight [ Time Frame: Up to 4 years of treatment ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables [ Time Frame: Up to 4 years of treatment ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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).

  • 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 ] [ Designated as safety issue: No ]

    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.


  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 386
Study Start Date: March 2007
Study Completion Date: December 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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:
  • Firmagon
  • Lupron
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:
  • Firmagon
  • Lupron

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00451958

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

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00451958     History of Changes
Other Study ID Numbers: FE200486 CS21A, 2006-006913-34
Study First Received: March 23, 2007
Results First Received: October 10, 2012
Last Updated: March 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Ferring Pharmaceuticals:
Degarelix
prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Leuprolide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on July 20, 2014