Docetaxel Plus Lycopene in Castration Resistant, Chemotherapy-Naïve Prostate Cancer Patients

PRIMARY OBJECTIVES: I. To define the prostate-specific antigen (PSA) response rate according to the criteria of Bubley, et al. (\>50% reduction from baseline) in subjects treated with a combination of docetaxel and lycopene. SECONDARY OBJECTIVES: I.To determine the objective response rate (ORR) according to modified RECIST criteria in patients with measurable disease, following treatment with docetaxel and lycopene. II. To define the time to PSA progression, according to the response criteria of Scher, et al., in subjects treated with docetaxel and lycopene. III. To determine the safety and tolerability of lycopene in combination with docetaxel. IV. To determine the effects of docetaxel + lycopene therapy on the functioning of the IGFR-I, selected biomarkers, and docetaxel blood levels in plasma and peripheral blood mononuclear cells (correlative studies). OUTLINE: Patients receive 75 mg/m2 docetaxel intravenously (IV) over 1 hour q 21 days and lycopene 30 mg capsules orally (PO) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.