The purpose of this trial is to study the effect - in terms of time to progression and overall survival - of 2 years of adjuvant bicalutamide 150mg monotherapy, versus placebo, in subjects with histologically or cytologically confirmed non-metastatic adenocarcinoma of the prostate gland.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
3,618
150mg daily
once daily
Time to clinical progression
Time frame: Throughout study period
Overall patient survival
Time frame: Throughout study period
Time to treatment failure
Time frame: Throughout study period
Serum prostate-specific antigen
Time frame: Initial study period up to 2006 amended protocol
Tolerability in terms of adverse events and laboratory parameters
Time frame: Throughout study period
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Research Site
Birmingham, Alabama, United States
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Mobile, Alabama, United States
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Scottsdale, Arizona, United States
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Tucson, Arizona, United States
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Berkeley, California, United States
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Laguna Woods, California, United States
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Newport Beach, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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Santa Monica, California, United States
...and 75 more locations