A Randomized Double-Blind Parallel Group Study Comparing Casodex 50mg Plus Placebo to Casodex 50mg Plus Dutasteride 3.5mg Administered for 18 Months to Men With Prostate Cancer Who Have Failed First-Line Androgen Deprivation Therapy (Assessed by Rising PSA) Followed by a Two-Year Extension Phase
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Time to disease progression with up to 18 months of treatment PSA progression monitored by monthly PSAs
18 months, with 2 year safety extension phase
GSK Clinical Trials
Study Director
GlaxoSmithKline
United States: Food and Drug Administration
AVO108943
NCT00470834
May 2007
March 2013
Name | Location |
---|---|
GSK Investigational Site | Bakersfield, California 93309 |
GSK Investigational Site | Gainesville, Florida 32610 |
GSK Investigational Site | Indianapolis, Indiana 46260 |
GSK Investigational Site | New Orleans, Louisiana 70112 |
GSK Investigational Site | Springfield, Massachusetts 01107 |
GSK Investigational Site | Duluth, Minnesota 55805 |
GSK Investigational Site | St. Louis, Missouri 63141 |
GSK Investigational Site | Raleigh, North Carolina 27609 |
GSK Investigational Site | Akron, Ohio 44304 |
GSK Investigational Site | Fort Worth, Texas 76104 |
GSK Investigational Site | Green Bay, Wisconsin 54301 |
GSK Investigational Site | Park Ridge, Illinois 60068 |
GSK Investigational Site | Baltimore, Maryland 21201 |
GSK Investigational Site | Pittsburgh, Pennsylvania 15213 |
GSK Investigational Site | Columbia, South Carolina 29210 |
GSK Investigational Site | Germantown, Tennessee 38138 |
GSK Investigational Site | Salem, Virginia 24153 |
GSK Investigational Site | New York, New York 10021 |
GSK Investigational Site | Birmingham, Alabama 35209 |
GSK Investigational Site | Aurora, Colorado 80012 |
GSK Investigational Site | Washington, District of Columbia 20307-5001 |
GSK Investigational Site | Kansas City, Kansas 66160 |
GSK Investigational Site | Henderson, Nevada 89014 |
GSK Investigational Site | Seattle, Washington 98133 |