A Trial of Degarelix in Patients With Prostate Cancer

Completed · Phase 3

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00946920

Run by

Ferring Pharmaceuticals

People needed

859

Starts

2009-06-01

Expected to finish

2011-03-01

Last updated by the study team

2014-06-02

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Arkansas Urology — Little Rock, Arkansas, United States
• 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
• Anschutz Cancer Pavillion — Aurora, Colorado, United States
• The Urology Center of Colorado — Denver, Colorado, United States
• Urological Associates of Bridgeport, P.C. — Trumbull, Connecticut, United States
• Urology Associates of Dover, PA — Dover, Delaware, United States
• Walter Reed Army Medical Center — Washington D.C., District of Columbia, United States
• 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
• Indiana University Department of Urology — Indianapolis, Indiana, United States
• Kansas City Urology Care, PA — Overland Park, Kansas, United States
• Urological Associates of Englewood — Englewood, New Jersey, United States
• Hamilton Urology PA — Hamilton, New Jersey, United States
• Lawrenceville Urology — Lawrenceville, New Jersey, United States
• Urology Group of New Mexico, PC — Albuquerque, New Mexico, United States
• Capital Region Urological Surgeons and Research Associates — Albany, New York, United States
• Hudson Valley Urology P.C. — Poughkeepsie, New York, United States
• Metrolina Urology Clinic — Charlotte, North Carolina, United States
• Northeast Urology Research — Concord, North Carolina, United States
• Urology Centers Of Alabama — Homewood, Alabama, United States

Full record on ClinicalTrials.gov

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