A Randomized, Double-Blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of Dutasteride in Extending the Time to Progression of Low-Risk, Localized Prostate Cancer in Men Who Are Candidates for or Undergoing Expectant Management
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Number of Participants With Prostate Cancer (PCa) Progression [Restricted Crude Rate Analysis: Number of Participants With PCa Divided by Number of Participants in the Intent-to-Treat (ITT) Population Who Had >=1 Post-baseline Biopsy or Had a Progression
PC progression (prog.) was defined as the earliest occurrence of primary therapy, also referred to as therapeutic prog., for PC (prostatectomy/radiation/hormonal therapy); or pathological prog., defined as 1 of the following: >=4 cores involved; >=50% of any 1 core involved; or a Gleason pattern of >=4 as a result of any on-study/for-cause biopsy. Primary Gleason grade is assigned to the most common tumor pattern; a second grade to the next most common tumor pattern. The two grades are added together to get a score. Gleason grade= 1-5; Gleason score=2-10; 5 and 10 indicate worst prognosis.
Year 1.5 and Overall (Years 0-3)
No
GSK Clinical Trials
Study Director
GlaxoSmithKline
United States: Food and Drug Administration
AVO105948
NCT00363311
July 2006
March 2010
Name | Location |
---|---|
GSK Investigational Site | Little Rock, Arkansas 72205 |
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 | Albuquerque, New Mexico 87109 |
GSK Investigational Site | Raleigh, North Carolina 27609 |
GSK Investigational Site | Akron, Ohio 44304 |
GSK Investigational Site | Fort Worth, Texas 76104 |
GSK Investigational Site | Savannah, Georgia 31405 |
GSK Investigational Site | Park Ridge, Illinois 60068 |
GSK Investigational Site | Baltimore, Maryland 21201 |
GSK Investigational Site | Pittsburgh, Pennsylvania 15213 |
GSK Investigational Site | Germantown, Tennessee 38138 |
GSK Investigational Site | Salem, Virginia 24153 |
GSK Investigational Site | New York, New York 10021 |
GSK Investigational Site | Aurora, Colorado 80012 |
GSK Investigational Site | Hartford, Connecticut 06106 |
GSK Investigational Site | Washington, District of Columbia 20307-5001 |
GSK Investigational Site | Coeur d'Alene, Idaho 83814 |
GSK Investigational Site | Kansas City, Kansas 66160 |
GSK Investigational Site | Henderson, Nevada 89014 |
GSK Investigational Site | Oregon City, Oregon 97045 |
GSK Investigational Site | Salt Lake City, Utah 84107 |
GSK Investigational Site | Seattle, Washington 98133 |