A serological PSA response is defined as a reduction from baseline PSA serum concentration of at least 50%, which is confirmed by a second PSA value 28 or more days later.
at least 18 yrs of age diagnosis of adenocarcinoma of the prostate no detectable metastatic disease as assessed by bone and CT scans has increasing serum PSA concentrations life expectancy of at least 3 months ECOG of 0 or 1 has been withdrawn from antiandrogen therapy for at least 6 weeks prior to entering screening period
Exclusion Criteria:
has asymptomatic disease has active GI ulceration or bleeding has been treated with non-hormonal systemic anticancer therapy or has received radiation within 4 weeks of baseline visit bilirubin >2x ULN or ALT or AST >2xULN or serum creatinine >1.5mg/dL hemoglobin <9g/dL or platelets below 100,000/uL or ANC below 1500/uL receiving treatment for HIV with protease inhibitors has had prior malignancy within past 5 yrs with exception of resected basal or squamous cell carcinomas of the skin has used investigational drug with previous one month
