The purpose is to see if giving Degarelix every month for 7 months then stop treatment for 7
months (intermittent therapy) will show a reduction of negative effects of androgen
deprivation therapy by increasing the quality of life while keeping prostate specific
antigen (PSA) levels suppressed.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Inclusion Criteria:
- 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 with-in normal range ≥1. 5 ng/mL.
- Has ECOG score of ≤2.
- CT scan, MRI or bone scan report documenting no evidence of metastasis to the bone or
internal organs.
- Life expectancy of at least 15 months.
Exclusion Criteria:
- Taken hormone therapy in the last 6 months prior to entering this study.
- Has a history of sever uncontrolled asthma, anaphylactic reactions, or sever
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/basel cell carcinoma of the skin within the last five years.
- 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 previously participated in any Degarelix trial.
- Is part of an ongoing trial.
Alabama Clinical Research, Inc, Alexander City, Alabama, United States
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, 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
Midwest Urology/RMD Clinical Research Institute, Melrose Park, Illinois, United States
Deaconess Clinic Inc, Evansville, Indiana, United States
Northeast Indiana Research, Fort Wayne, Indiana, United States
Metropolitan Urology, PSC, Jeffersonville, Indiana, United States
Regional Urology, Lic, Shreveport, Louisiana, United States
Chesapeake Urology Associates, Baltimore, Maryland, United States
Chesapeake Urology Research Associates, Baltimore, Maryland, United States
Chesapeake Urology Research Associates, Glen Burnie, Maryland, United States
Myron Murdock M.D. LLC, Greenbelt, Maryland, United States
Chesapeake Urology Associates, PA, Towson, Maryland, United States
Urology Associates of Englewood, Englewood, New Jersey, United States
Hamilton Urology PA, Hamilton, New Jersey, United States
Lawrenceville Urology, Lawrenceville, New Jersey, United States
Nationsmed Clinical Research, Perth Amboy, New Jersey, United States
Center for Urologic Care, Voorhees, New Jersey, United States
Delaware Valley Urology LLC, Westampton, New Jersey, United States
The Urological Institute of NE NY, CCP, Albany, New York, United States
Medical & Clinical Research Associates, Bay Shore, New York, United States
Brooklyn Heights Urology Associates, P.C., Brooklyn, New York, United States
University Urology Associates, New York, New York, United States
Hudson Valley Urology P.C., Poughkeepsie, New York, United States
Northeast Urology Research, Concord, North Carolina, United States
Alliance Urology Specialists, Greensboro, North Carolina, United States
Urological Association of Lancaster, Lancaster, Pennsylvania, United States
State College Urologic Association, State College, Pennsylvania, United States
Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States
Lexington Urological Associates, PA, West Columbia, South Carolina, United States
Urology Associates, Nashville, Tennessee, United States
Lackland Air Force base, San Antonio, Texas, United States
Urology of Virginia, Norfolk, Virginia, United States
Virginal Urology, Richmond, Virginia, United States
Virginia Urology Center, Richmond, Virginia, United States
Seattle Urology Research Center, Seattle, Washington, United States
Roger D. Fincher, PS, Spokane, Washington, United States