A Trial of Degarelix in Patients With Prostate Cancer

May 2, 2014 updated by: Ferring Pharmaceuticals

An Open-Label, Multi-Centre, Randomised, Parallel-Arm One-Year Trial, Comparing the Efficacy and Safety of Degarelix Three-Month Dosing Regimen With Goserelin Acetate in Patients With Prostate Cancer Requiring Androgen Deprivation Therapy

A phase 3, open-label, parallel group, one year trial comparing the efficacy and safety of degarelix 3-month depot with the established therapy goserelin acetate 3-month implant in patients with prostate cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

859

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

  • Belgium
      • Bruxelles, Belgium
        • Cliniques universitaires Saint-Luc
      • Edegem, Belgium
        • UZ Antwerpen
      • Gent, Belgium
        • UZ Gent
      • Kortrijk, Belgium
        • AZ Groeninge - Campus Sint-Maarten
  • Canada
      • Montreal, Canada
        • Notre Dame Hopital
    • British Columbia
      • Kelowna, British Columbia, Canada
        • Southern Interior Medical Research Inc.
      • Surrey, British Columbia, Canada
        • Dr. Cal Andreou Research
      • Victoria, British Columbia, Canada
        • Can-Med Clinical Research Inc.
      • Victoria, British Columbia, Canada
        • Dr Gary Steinhoff Clinical Research
    • Ontario
      • Brampton, Ontario, Canada
        • Bramalea Medical Centre
      • Kitchener, Ontario, Canada
        • Urology Associates / Urologic Medical Research
      • Newmarket, Ontario, Canada
        • Mor Urology, Inc.
      • Scarborough, Ontario, Canada
        • Ivestigational site
      • Thunder Bay, Ontario, Canada
        • Anthony Skehan Medicine Professionals Corporation
      • Toronto, Ontario, Canada
        • Bloor West Professional Center
      • Toronto, Ontario, Canada
        • The Health Institute for Men
    • Quebec
      • Laval, Quebec, Canada
        • Uro Laval
  • Czech Republic
      • Brno, Czech Republic
        • Urocentrum Brno
      • Jindrichuv Hradec, Czech Republic
        • Nemocnice Jindrichuv Hradec, a.s.
      • Kromeriz, Czech Republic
        • Kromerizska nemocnice a.s.
      • Opava, Czech Republic
        • Slezská nemocnice
      • Prague, Czech Republic
        • Fakultni nemocnice v Motole, Praha 5
      • Prague, Czech Republic
        • Fakultni Thomayerova nemocnice s poliklinikou, Praha 4
      • Prague, Czech Republic
        • Vseobecna fakultni nemocnice v Praze, Praha 2
      • Zlin, Czech Republic
        • Krajska nemocnice T. Bati a.s.
  • Finland
      • Joensuu, Finland
        • Pohjois-Karjalan keskussairaala
      • Oulu, Finland
        • ODL Terveys Oy
      • Pietarsaari, Finland
        • Pietarsaaren sairaala/ Malmin terveydenhuoltoalue
      • Tampere, Finland
        • Tampereen yliopistollinen sairaala
  • Germany
      • Aachen, Germany
        • Investigational site
      • Kirchheim, Germany
        • Investigational site
      • Mannheim, Germany
        • Klinikum Mannheim Universitätsklinikum GmbH
      • Nürtingen, Germany
        • Urologische Studienpraxis
  • Hungary
      • Budapest, Hungary
        • Semmelweis Egyetem
      • Budapest, Hungary
        • Fővárosi Önkormányzat Bajcsy-Zsilinszky Kórház
      • Budapest, Hungary
        • Fövárosi Önkormányzat uzsoki utcai Kórház
      • Dombovar, Hungary
        • Dombóvári Szent Lukács Egészségügyi Kht.
      • 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
        • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
      • Vác, Hungary
        • Javorszky Odon Korhaz
  • Mexico
      • Chihuahua, Mexico
        • Hospital Christus Muguerza del Parque
      • Durango, Mexico
        • Consultorio de Especialidad en Urologia Privado, Durango
      • Mexico City, Mexico
        • Centro Medico Dalinde
      • Mexico City, Mexico
        • Hospital Angeles Lindavista
      • Mexico City, Mexico
        • Operadora MSB, S.A. de C.V. (Medica Sur CIF-BIOTEC)
      • Zapopan, Jalisco, Mexico
        • Consultorio Médico
    • GTO
      • Leon, GTO, Mexico
        • Hospital Aranda de la Parra , S.A. de C.V.
    • Sinaloa
      • Culiacan, Sinaloa, Mexico
        • Hospital Angeles Culiacan
  • Netherlands
      • Amsterdam, Netherlands
        • AMC
      • Den Haag, Netherlands
        • MC Haaglanden
      • Eindhoven, Netherlands
        • Catharina-ziekenhuis
      • Heerlen, Netherlands
        • Atrium MC
  • Poland
      • Bialystok, Poland
        • SPZOZ Wojewodzki Szpital Zespolony im. J.Sniadeckiego
      • Bielsko-Biala, Poland
        • Centrum Medyczne Medur Sp. z o.o.
      • Krakow, Poland
        • Gabinet Lekarski
      • Slupsk, Poland
        • Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku
      • Wroclaw, Poland
        • Lexmedica
  • Romania
      • Arad, Romania
        • Private Medical Center
      • Brasov, Romania
        • Brasov Emergency Clinical County Hospital
      • Bucharest, Romania
        • "Fundeni" Clinical Institute
      • Bucharest, Romania
        • "Sfantul Ioan" Emergency Clinical Hospital
      • Bucharest, Romania
        • Dinu Uromedica
      • Bucharest, Romania
        • Prof. Dr. Th. Burghele Clinical Urology Hospital
      • Constanta, Romania
        • PROVITA 2000 Medical Center
      • Lasi, Romania
        • "Dr. C.I. Parhon" Clinical Hospital
      • Pitesti, Romania
        • Vita Care Flav Medical Center
      • Sibiu, Romania
        • Emergency County Clinical Hospital Sibiu
  • Russian Federation
      • Moscow, Russian Federation
        • City Clinical Hospital #60
      • Moscow, Russian Federation
        • Moscow State University of Medicine and Dentistry
      • St. Petersburg, Russian Federation
        • "Clinic Andros" LLC
      • St. Petersburg, Russian Federation
        • "Orkli" LLC
      • St. Petersburg, Russian Federation
        • City Hospital # 26
      • St. Petersburg, Russian Federation
        • City Hospital #15
      • St. Petersburg, Russian Federation
        • St. Petersburg State Medical University n.a. I.P. Pavlov
      • St. Petersburg, Russian Federation
        • St.Petersburg Multi-Field City Hospital #2
      • Vladimir, Russian Federation
        • Regional Clinical Oncology Center
  • Ukraine
      • Cherkassy, Ukraine
        • Municipal Institution "Cherkasy Regional Oncology Dispensary"
      • Dnipropetrovsk, Ukraine
        • Dnipropetrovsk State Medical Academy
      • Donetsk, Ukraine
        • Donetsk Regional Clinical Territorial Medical Association
      • Ivano-Frankivsk, Ukraine
        • Ivano-Frankivsk Regional Oncology Dispensary
      • Kharkiv, Ukraine
        • Regional Clinical Center of Urology and Nephrology n.a. V.I.Shapoval
      • Kyiv, Ukraine
        • Kyiv City Clinical Hospital #3
      • Odesa, Ukraine
        • Odesa Regional Clinical Hospital
      • Zaporizhzhya, Ukraine
        • Municipal Institution "Zaporizhzhia Regional Clinical Hospital"
  • United Kingdom
      • Cottingham, United Kingdom
        • Castle Hill Hospital
      • Ipswich, United Kingdom
        • Ipswich Hospital
      • Liverpool, United Kingdom
        • Royal Liverpool University Hospital
      • Sutton, United Kingdom
        • The Royal Marsden Nhs Foundation Trust
  • United States
    • Alabama
      • Homewood, Alabama, United States
        • Urology Centers of Alabama
    • Arkansas
      • Little Rock, Arkansas, United States
        • Arkansas Urology
    • California
      • Fresno, California, United States
        • Urology Associates of Central CA
      • La Mesa, California, United States
        • Medresearch
      • Laguna Hills, California, United States
        • South Orange County Medical Research Center
      • Long Beach, California, United States
        • Atlantic Urology Medical Group
    • Colorado
      • Aurora, Colorado, United States
        • Anschutz Cancer Pavillion
      • Denver, Colorado, United States
        • The Urology Center of Colorado
    • Connecticut
      • Trumbull, Connecticut, United States
        • Urological Associates of Bridgeport, P.C.
    • Delaware
      • Dover, Delaware, United States
        • Urology Associates of Dover, PA
    • District of Columbia
      • Washington, District of Columbia, United States
        • Walter Reed Army Medical Center
    • Florida
      • Aventura, Florida, United States
        • South Florida Medical Research
      • Ocala, Florida, United States
        • Florida Foundation for Healthcare Research
      • Wellington, Florida, United States
        • Georgis Patsias, MD, PA
      • Wellington, Florida, United States
        • Palm Beach Urology Associates, PA
    • Indiana
      • Indianapolis, Indiana, United States
        • Indiana University Department of Urology
    • Kansas
      • Overland Park, Kansas, United States
        • Kansas City Urology Care, PA
    • New Jersey
      • Englewood, New Jersey, United States
        • Urological Associates of Englewood
      • Hamilton, New Jersey, United States
        • Hamilton Urology PA
      • Lawrenceville, New Jersey, United States
        • Lawrenceville Urology
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Urology Group of New Mexico, PC
    • New York
      • Albany, New York, United States
        • Capital Region Urological Surgeons and Research Associates
      • Poughkeepsie, New York, United States
        • Hudson Valley Urology P.C.
    • North Carolina
      • Charlotte, North Carolina, United States
        • Metrolina Urology Clinic
      • Concord, North Carolina, United States
        • Northeast Urology Research
      • Durham, North Carolina, United States
        • Duke University Medical Center
      • Greensboro, North Carolina, United States
        • Alliance Urology Specialists
    • Pennsylvania
      • Bala Cynwyd, Pennsylvania, United States
        • Urologic Consultants of SEPA
      • State College, Pennsylvania, United States
        • State College Urologic Association
    • South Carolina
      • Myrtle Beach, South Carolina, United States
        • Grand Strand Urology
    • Texas
      • Dallas, Texas, United States
        • Urology Clinics Of North Texas, Pa
      • San Antonio, Texas, United States
        • Urology San Antonio Research
    • Virginia
      • Norfolk, Virginia, United States
        • Urology of Virginia
      • Richmond, Virginia, United States
        • Virginia Urology Center
      • Virginia Beach, Virginia, United States
        • Urology of Virginia
    • 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 18 years or older.
  • Has a histological confirmed prostate cancer Gleason graded).
  • Has a screening testosterone above 2.2 ng/mL.
  • Rising prostate-specific antigen (PSA).
  • Has Eastern Cooperative Oncology Group (ECOG) score of ≤ 2.
  • Has a life expectancy of at least one year.

Exclusion Criteria:

  • Current or previous hormone therapy.
  • Has received therapy with finasteride and dutasteride within 12 weeks and 25 weeks, respectively, prior to screening.
  • Has a history of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
  • Has a heart insufficiency.
  • Has a previous history or presence of another malignancy, other than prostate cancer or treated squamous/basal cell carcinoma of the skin, within the last five years.
  • Has a clinically significant medical condition (other than prostate cancer) including, but not limited to, renal, haematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease and alcohol or drug abuse or any other condition which may affect the patient's health or the outcome of the trial as judged by the Investigator.
  • Has received an investigational drug within the last 28 days before the Screening Visit or longer if considered to possibly influencing the outcome of the current trial.
  • Is candidate for curative therapy, i.e. radical prostatectomy or radiotherapy.

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 240 mg/480 mg
Drug: Degarelix
The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
Other Names:
  • Firmagon
  • FE200486
Active Comparator: Goserelin acetate
Drug: Goserelin acetate
The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).
Other Names:
  • Zoladex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) With Degarelix
Time Frame: From Day 28 to Day 364
This co-primary outcome measure was used to demonstrate that degarelix is effective with respect to achieving and maintaining testosterone suppression to castrate levels, evaluated as the proportion of patients with testosterone suppression ≤0.5 ng/mL from Day 28 to Day 364.
From Day 28 to Day 364
Difference in Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) Between Degarelix and Goserelin
Time Frame: Day 3 to Day 364
This co-primary outcome measure was used to establish non-inferiority of degarelix as compared to goserelin with regard to achieving and maintaining testosterone suppression at castrate levels (≤0.5 ng/mL) from Day 3 to Day 364, using a non-inferiority margin of 5 percentage points.
Day 3 to Day 364

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Levels of Testosterone Over Time
Time Frame: Baseline and after 1, 2, 3, 6 and 13 months
Median testosterone levels are presented as absolute values at Baseline (in Baseline measures) and after 1, 2, 3, 6 and 13 months (below). One treatment month equals 28 days.
Baseline and after 1, 2, 3, 6 and 13 months
Percent Change in Serum Levels of Prostate-specific Antigen (PSA) Over Time
Time Frame: Baseline and after 1, 2, 3, 6 and 13 months
Serum PSA levels are presented as mean percent change from Baseline (in Baseline measures) after 1, 2, 3, 6 and 13 months. One treatment month equals 28 days.
Baseline and after 1, 2, 3, 6 and 13 months
Change in Health-related Quality of Life (HRQoL), as Measured by Short Form-36 (SF-36) Score at Month 10 and Month 13 Compared to Baseline
Time Frame: At baseline, 10 months and 13 months
The SF-36 is a multi-purpose, short-form health survey with only 36 questions and with a minimum score of 0 and a maximum score of 100. The higher score the better health. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The SF-36 has proven useful in surveys of general and specific populations, comparing the relative burden of diseases, and in differentiating the health benefits produced by a wide range of different treatments.
At baseline, 10 months and 13 months
Change in International Prostate Symptom Score (IPSS) Score at Months 1, 4, 7, and 13 Compared to Baseline
Time Frame: At baseline, 1 month, 4 months, 7 months and 13 months
IPSS is used to assess severity of lower urinary tract symptoms and to monitor the progress of symptoms once treatment has been initiated. It contains 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5 (i.e. the minimum total score is 0 and the maximum is 35). A score of "0" corresponds to a response of "not at all" for the first six symptoms and "none" for nocturia, and a score of 5 corresponds to a response of "almost always" for the first six symptoms and "5 times or more" for nocturia.
At baseline, 1 month, 4 months, 7 months and 13 months

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

June 1, 2009

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

July 3, 2009

First Submitted That Met QC Criteria

July 24, 2009

First Posted (Estimate)

July 27, 2009

Study Record Updates

Last Update Posted (Estimate)

June 2, 2014

Last Update Submitted That Met QC Criteria

May 2, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FE200486 CS35
  • 2008-005276-27 (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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