This study is being carried out to see if ZD1839 is effective in treating prostate cancer after being diagnosed with an early rising PSA (prostate specific antigen) following surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
250 mg tablet oral daily dose
Research Site
Vancouver, British Columbia, Canada
Research Site
London, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Montreal, Canada
The primary objective of the trial is to evaluate the activity of oral ZD1839 (250 mg once daily administered continuously) in subjects with early biochemical failure post prostatectomy by estimating the PSA response rate
To estimate the duration of PSA response
To estimate the partial PSA response rate
To estimate the change in the ratio of free PSA : total PSA at 6 and 12 months compared with baseline
To investigate the change in PSA levels after discontinuation of ZD1839
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