A Trial of Degarelix in Patients With Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00946920
Recruitment Status : Completed
First Posted : July 27, 2009
Results First Posted : June 2, 2014
Last Update Posted : June 2, 2014
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Brief Summary:
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 or disease Intervention/treatment Phase
Prostate Cancer Drug: Degarelix Drug: Goserelin acetate Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 859 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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 Name: Zoladex

Primary Outcome Measures :
  1. 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.

  2. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00946920

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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
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
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Urological Associates of Bridgeport, P.C.
Trumbull, Connecticut, United States
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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
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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
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Indiana University Department of Urology
Indianapolis, Indiana, United States
United States, Kansas
Kansas City Urology Care, PA
Overland Park, Kansas, United States
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Urological Associates of Englewood
Englewood, New Jersey, United States
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Hamilton, New Jersey, United States
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Lawrenceville, New Jersey, United States
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Urology Group of New Mexico, PC
Albuquerque, New Mexico, United States
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Albany, New York, United States
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Poughkeepsie, New York, United States
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Charlotte, North Carolina, United States
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Concord, North Carolina, United States
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Durham, North Carolina, United States
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Greensboro, North Carolina, United States
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Bala Cynwyd, Pennsylvania, United States
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State College, Pennsylvania, United States
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Victoria, British Columbia, Canada
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Victoria, British Columbia, Canada
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Brampton, Ontario, Canada
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Kitchener, Ontario, Canada
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Thunder Bay, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Laval, Quebec, Canada
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Montreal, Canada
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Brno, Czech Republic
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Jindrichuv Hradec, Czech Republic
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Oulu, Finland
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Bialystok, Poland
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Bielsko-Biala, Poland
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Krakow, Poland
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Moscow, Russian Federation
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St. Petersburg, Russian Federation
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Vladimir, Russian Federation
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Donetsk, Ukraine
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Ivano-Frankivsk, Ukraine
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Kharkiv, Ukraine
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Cottingham, United Kingdom
Ipswich Hospital
Ipswich, United Kingdom
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Liverpool, United Kingdom
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Sutton, United Kingdom
Sponsors and Collaborators
Ferring Pharmaceuticals
Study Director: Clinical Development Support Ferring Pharmaceuticals

Responsible Party: Ferring Pharmaceuticals Identifier: NCT00946920     History of Changes
Other Study ID Numbers: FE200486 CS35
2008-005276-27 ( EudraCT Number )
First Posted: July 27, 2009    Key Record Dates
Results First Posted: June 2, 2014
Last Update Posted: June 2, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents