Spots Global Cancer Trial Database for A Study of Degarelix in Patients With Prostate Cancer
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: A Study of Degarelix in Patients With Prostate Cancer
Official Title: A Randomized, Controlled, Open-Label Study Investigating the Safety and Efficacy of Degarelix Given Intermittently vs Continuous Androgen Deprivation Therapy With Lupron or Degarelix in Patients With Prostate Cancer With Prior Treatment Failure After Localized Treatment
Study ID: NCT00928434
Conditions
Study Description
Brief Summary: 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.
Detailed Description: This was an open-label, randomized, parallel-arm, multicenter study to determine if degarelix intermittent therapy was non-inferior to continuous androgen deprivation therapy (combination of treatment groups receiving continuous degarelix and leuprolide therapy, respectively) in maintaining PSA levels at ≤ 4.0 ng/mL at 14 months. The study consisted of two phases, Phase A and B. During Phase A, patients in the degarelix intermittent and degarelix continuous arms received 7 months of therapy with degarelix one-month depot formulation and patients in the leuprolide continuous arm received leuprolide one-month depot injection (7.5 mg) followed by two 3-month depot (22.5 mg) injections. After 7 months of treatment, patients with a PSA ≤2 ng/mL continued into Phase B. During Phase B, patients in the degarelix intermittent arm had a 7-month off-treatment period. Patients randomized to the degarelix continuous arm and the leuprolide continuous arm continued to receive degarelix or leuprolide depot as in Phase A for the remainder of the 14 months.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
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
Contact Details
Name: Clinical Development Support
Affiliation: Ferring Pharmaceuticals
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
