Safety and Efficacy Study of AT-101 in Combination With Docetaxel and Prednisone in Men With HRPC

Inclusion Criteria

• •1. Rising prostate specific antigen (PSA) despite castrate levels of testosterone due to orchiectomy or luteinizing hormone-releasing hormone (LHRH) agonist therapy.
• •2. Patients must have metastatic disease by bone scan, computed tomography (CT) scan, or magnetic resonance imaging (MRI).
• •3. ECOG performance status 0 or 1
• •4. Adequate hematologic function
• •5. Adequate liver and renal function
• •6. Able to swallow and retain oral medication.
• •7. Patients enrolled into Cohort B must have documented progression of disease during treatment with a docetaxel-containing regimen by meeting one or more of the following criteria- rising PSA, progression of disease per RECIST, or \>2 new lesions on bone scan.
• •8. Patients enrolled into Cohort B must have received at least two cycles of docetaxel. Minimum doses of prior docetaxel permitted are 60 mg/m2 on a q 3 week schedule or 20 mg/m2 on a weekly schedule.
• •9. At least 4 weeks since prior flutamide, megestrol, ketoconazole, and radiotherapy, and at least 6 weeks since prior bicalutamide or nilutamide.