A Study of Degarelix in Patients With Prostate Cancer

Completed · Phase 3

Conditions studied: Prostate Cancer

In brief

The purpose of this study was to see if giving Degarelix every month for 7 months then stop treatment for 7 months (intermittent therapy) would show a reduction of negative effects of androgen deprivation therapy by increasing the quality of life while keeping prostate specific antigen (PSA) levels suppressed.

Key facts

Study ID

NCT00928434

Run by

Ferring Pharmaceuticals

People needed

409

Starts

2009-05-01

Expected to finish

2012-08-01

Last updated by the study team

2016-12-13

Who can join

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

You may qualify if…

• 18 years or older.
• Raising PSA after prior treatment failure of localized prostate cancer.
• Has a histological confirmed non-metastatic cancer of the prostate (Gleason graded) based on the most current biopsy.
• Has a screening testosterone within normal range (≥1.5 ng/mL).
• Has Eastern Cooperative Oncology Group score of ≤2.
• Bone scan or CT scan report documenting no evidence of metastasis to the bone or internal organs.
• Life expectancy of at least 15 months.

You may not qualify if…

• Taken hormone therapy in the last 6 months prior to entering this study.
• Being treated with 5-alpha reductase inhibitor at time of enrolment and remained on a stable dose throughout the trial.
• Has a history of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
• Has hypersensitivity towards any component of the study drug.
• 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 abnormal laboratory results which in the judgement of the Investigator would affect the patient's health or the outcome of the trial.
• 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 an intellectual incapacity or language barriers precluding adequate understanding or co-operation.
• Has received an investigational drug within the last 28 days before the Screening visit or longer if considered to possibly influence the outcome of the current trial.
• Has received ketoconazole or diflucan in the last 28 days preceding the Screening Visit.
• Has previously participated in any Degarelix trial.
• Is part of an ongoing trial.

Where it is running

• Urology Center of Alabama, PC — Homewood, Alabama, United States
• Advanced Urology Medical Center — Anaheim, California, United States
• Peninsula Urology Medical Center — Atherton, California, United States
• Urology Associates of Central California — Fresno, California, United States
• South Orange County Medical Research Center — Laguna Hills, California, United States
• Atlantic Urology Medical Group — Long Beach, California, United States
• San Bernardino Urological Associates — San Bernardino, California, United States
• San Diego Uro-Research — San Diego, California, United States
• Santa Barbara Clinical Research — Santa Barbara, California, United States
• University of Colorado Health Sciences Center — Aurora, Colorado, United States
• The Urology Center of Colorado — Denver, Colorado, United States
• Urology Associates Research — Englewood, Colorado, United States
• Connecticut Clinical Research Center — Middlebury, Connecticut, United States
• Grove Hill Medical Center — New Britain, Connecticut, United States
• Walter Reed Army Hospital Medical Center — Washington D.C., District of Columbia, United States
• South Florida Medical Research — Aventura, Florida, United States
• Urology Health Solutions, Inc — Celebration, Florida, United States
• Florida Urology Physicians — Fort Myers, Florida, United States
• University of Florida — Gainesville, Florida, United States
• Winter Park Urology Associates — Orlando, Florida, United States
• Southeastern Urology Center, PA — Tallahassee, Florida, United States
• Tampa Bay Urology — Tampa, Florida, United States
• Advanced Research Institute, Inc — Trinity, Florida, United States
• Urology Enterprises — Marietta, Georgia, United States
• Alabama Clinical Research, Inc — Alexander City, Alabama, United States

Full record on ClinicalTrials.gov

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