A Trial of Degarelix in Patients With Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00946920
First received: July 3, 2009
Last updated: May 2, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: Degarelix
Drug: Goserelin acetate
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, 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

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) With Degarelix [ Time Frame: From Day 28 to Day 364 ] [ Designated as safety issue: No ]
    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.

  • Difference in Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) Between Degarelix and Goserelin [ Time Frame: Day 3 to Day 364 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Serum Levels of Testosterone Over Time [ Time Frame: Baseline and after 1, 2, 3, 6 and 13 months ] [ Designated as safety issue: No ]
    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.

  • Percent Change in Serum Levels of Prostate-specific Antigen (PSA) Over Time [ Time Frame: Baseline and after 1, 2, 3, 6 and 13 months ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 859
Study Start Date: June 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Zoladex

  Eligibility

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

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00946920

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Locations
United States, Alabama
Urology Centers Of Alabama
Homewood, Alabama, United States
United States, Arkansas
Arkansas Urology
Little Rock, Arkansas, United States
United States, California
Urology Associates of Central CA
Fresno, California, United States
Medresearch
La Mesa, California, United States
South Orange County Medical Research Center
Laguna Hills, California, United States
Atlantic Urology Medical Group
Long Beach, California, United States
United States, Colorado
Anschutz Cancer Pavillion
Aurora, Colorado, United States
The Urology Center of Colorado
Denver, Colorado, United States
United States, Connecticut
Urological Associates of Bridgeport, P.C.
Trumbull, Connecticut, United States
United States, Delaware
Urology Associates of Dover, PA
Dover, Delaware, United States
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States
United States, Florida
South Florida Medical Research
Aventura, Florida, United States
Florida Foundation for Healthcare Research
Ocala, Florida, United States
Georgis Patsias, MD, PA
Wellington, Florida, United States
Palm Beach Urology Associates, PA
Wellington, Florida, United States
United States, Indiana
Indiana University Department of Urology
Indianapolis, Indiana, United States
United States, Kansas
Kansas City Urology Care, PA
Overland Park, Kansas, United States
United States, New Jersey
Urological Associates of Englewood
Englewood, New Jersey, United States
Hamilton Urology PA
Hamilton, New Jersey, United States
Lawrenceville Urology
Lawrenceville, New Jersey, United States
United States, New Mexico
Urology Group of New Mexico, PC
Albuquerque, New Mexico, United States
United States, New York
Capital Region Urological Surgeons and Research Associates
Albany, New York, United States
Hudson Valley Urology P.C.
Poughkeepsie, New York, United States
United States, North Carolina
Metrolina Urology Clinic
Charlotte, North Carolina, United States
Northeast Urology Research
Concord, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Alliance Urology Specialists
Greensboro, North Carolina, United States
United States, Pennsylvania
Urologic Consultants of SEPA
Bala Cynwyd, Pennsylvania, United States
State College Urologic Association
State College, Pennsylvania, United States
United States, South Carolina
Grand Strand Urology
Myrtle Beach, South Carolina, United States
United States, Texas
Urology Clinics of North Texas, PA
Dallas, Texas, United States
Urology San Antonio Research
San Antonio, Texas, United States
United States, Virginia
Urology of Virginia
Norfolk, Virginia, United States
Virginia Urology Center
Richmond, Virginia, United States
Urology of Virginia
Virginia Beach, Virginia, United States
United States, Washington
Seattle Urology Research Center
Burien, Washington, United States
Belgium
Cliniques Universitaires Saint-Luc
Bruxelles, Belgium
UZ Antwerpen
Edegem, Belgium
UZ Gent
Gent, Belgium
AZ Groeninge - Campus Sint-Maarten
Kortrijk, Belgium
Canada, British Columbia
Southern Interior Medical Research Inc.
Kelowna, British Columbia, Canada
Dr. Cal Andreou Research
Surrey, British Columbia, Canada
Can-Med Clinical Research Inc.
Victoria, British Columbia, Canada
Dr Gary Steinhoff Clinical Research
Victoria, British Columbia, Canada
Canada, Ontario
Bramalea Medical Centre
Brampton, Ontario, Canada
Urology Associates / Urologic Medical Research
Kitchener, Ontario, Canada
Mor Urology, Inc.
Newmarket, Ontario, Canada
Ivestigational site
Scarborough, Ontario, Canada
Anthony Skehan Medicine Professionals Corporation
Thunder Bay, Ontario, Canada
The Health Institute for Men
Toronto, Ontario, Canada
Bloor West Professional Center
Toronto, Ontario, Canada
Canada, Quebec
Uro Laval
Laval, Quebec, Canada
Canada
Notre Dame Hopital
Montreal, Canada
Czech Republic
Urocentrum Brno
Brno, Czech Republic
Nemocnice Jindrichuv Hradec, a.s.
Jindrichuv Hradec, Czech Republic
Kromerizska nemocnice a.s.
Kromeriz, Czech Republic
Slezska nemocnice
Opava, Czech Republic
Vseobecna fakultni nemocnice v Praze, Praha 2
Prague, Czech Republic
Fakultni nemocnice v Motole, Praha 5
Prague, Czech Republic
Fakultni Thomayerova nemocnice s poliklinikou, Praha 4
Prague, Czech Republic
Krajska nemocnice T. Bati a.s.
Zlin, Czech Republic
Finland
Pohjois-Karjalan keskussairaala
Joensuu, Finland
ODL Terveys Oy
Oulu, Finland
Pietarsaaren sairaala/ Malmin terveydenhuoltoalue
Pietarsaari, Finland
Tampereen yliopistollinen sairaala
Tampere, Finland
Germany
Investigational site
Aachen, Germany
Investigational site
Kirchheim, Germany
Klinikum Mannheim Universitätsklinikum GmbH
Mannheim, Germany
Urologische Studienpraxis
Nürtingen, Germany
Hungary
Fövárosi Önkormányzat uzsoki utcai Kórház
Budapest, Hungary
Fövárosi Önkormányzat Bajcsy-Zsilinszky Kórház
Budapest, Hungary
Semmelweis Egyetem
Budapest, Hungary
Dombóvári Szent Lukács Egészségügyi Kht.
Dombovar, Hungary
Miskolci Semmelweis Ignác Egészségügyi Központ és Egyetemi Oktató Kórház Nonprofit Kft
Miskolc, Hungary
Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház
Miskolc, Hungary
Pécsi Tudományegyetem
Pécs, Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged, Hungary
Jávorszky Ödön Kórház
Vác, Hungary
Mexico
Hospital Aranda de la Parra , S.A. de C.V.
Leon, GTO, Mexico
Hospital Angeles Culiacan
Culiacan, Sinaloa, Mexico
Hospital Christus Muguerza del Parque
Chihuahua, Mexico
Consultorio de Especialidad en Urologia Privado, Durango
Durango, Mexico
Operadora MSB, S.A. de C.V. (Medica Sur CIF-BIOTEC)
Mexico City, Mexico
Hospital Angeles Lindavista
Mexico City, Mexico
Centro Medico Dalinde
Mexico City, Mexico
Consultorio Medico
Zapopan, Jalisco, Mexico
Netherlands
AMC
Amsterdam, Netherlands
MC Haaglanden
Den Haag, Netherlands
Catharina-ziekenhuis
Eindhoven, Netherlands
Atrium MC
Heerlen, Netherlands
Poland
SPZOZ Wojewodzki Szpital Zespolony im. J.Sniadeckiego
Bialystok, Poland
Centrum Medyczne Medur Sp. z o.o.
Bielsko-Biala, Poland
Gabinet Lekarski
Krakow, Poland
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku
Slupsk, Poland
LexMedica
Wroclaw, Poland
Romania
Private Medical Center
Arad, Romania
Brasov Emergency Clinical County Hospital
Brasov, Romania
"Sfantul Ioan" Emergency Clinical Hospital
Bucharest, Romania
"Fundeni" Clinical Institute
Bucharest, Romania
Dinu Uromedica
Bucharest, Romania
Prof. Dr. Th. Burghele Clinical Urology Hospital
Bucharest, Romania
PROVITA 2000 Medical Center
Constanta, Romania
"Dr. C.I. Parhon" Clinical Hospital
Lasi, Romania
Vita Care Flav Medical Center
Pitesti, Romania
Emergency County Clinical Hospital Sibiu
Sibiu, Romania
Russian Federation
Moscow State University of Medicine and Dentistry
Moscow, Russian Federation
City Clinical Hospital #60
Moscow, Russian Federation
"Clinic Andros" LLC
St. Petersburg, Russian Federation
City Hospital # 26
St. Petersburg, Russian Federation
St. Petersburg State Medical University n.a. I.P. Pavlov
St. Petersburg, Russian Federation
City Hospital #15
St. Petersburg, Russian Federation
"Orkli" LLC
St. Petersburg, Russian Federation
St.Petersburg Multi-Field City Hospital #2
St. Petersburg, Russian Federation
Regional Clinical Oncology Center
Vladimir, Russian Federation
Ukraine
Municipal Institution "Cherkasy Regional Oncology Dispensary"
Cherkassy, Ukraine
Dnipropetrovsk State Medical Academy
Dnipropetrovsk, Ukraine
Donetsk Regional Clinical Territorial Medical Association
Donetsk, Ukraine
Ivano-Frankivsk Regional Oncology Dispensary
Ivano-Frankivsk, Ukraine
Regional Clinical Center of Urology and Nephrology n.a. V.I.Shapoval
Kharkiv, Ukraine
Kyiv City Clinical Hospital #3
Kyiv, Ukraine
Odesa Regional Clinical Hospital
Odesa, Ukraine
Municipal Institution "Zaporizhzhia Regional Clinical Hospital"
Zaporizhzhya, Ukraine
United Kingdom
Castle Hill Hospital
Cottingham, United Kingdom
Ipswich Hospital
Ipswich, United Kingdom
Royal Liverpool University Hospital
Liverpool, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, 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: NCT00946920     History of Changes
Other Study ID Numbers: FE200486 CS35, 2008-005276-27
Study First Received: July 3, 2009
Results First Received: February 14, 2014
Last Updated: May 2, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Mexico: Ministry of Health
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Finland: Finnish Medicines Agency
Germany: Ministry of Health
Netherlands: Ministry of Health, Welfare and Sport
United Kingdom: National Health Service
Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Poland: Ministry of Health
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Ukraine: Ministry of Health

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Goserelin
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014