Adult patients with hitologically confirmed adenocarcinoma of the prostate metastatic to the bone on bone scan or other imaging modelity, with castrate levels of serum testosterone less than 50ng/dL, Karnofsy's score>70%, evidence of progressive disease, and able to swallow and retain oral medication.
The following patients are excluded: Those with prior cytotoxic chemotherapy for the treatment of prostate cancer within 2 years prior to the study treatment. Previous therapy with antiandrogens within 4 weeks prior to the study treatment. Ongoing treatment with CYP1A2 or CYP3A4 substrate with narrow therapeutic range at the start of the study. myocardial infarction, class III/IV heart failure, ACS, CVA, TIA within 6 months prior to start of study treatment. history of pancreatitis, known brain or epidural metastasis, known positive serology for HIV, active TB, or chronic hepatits with advanced decompensated hepatic disease or cirrhosis of the liver.