OBJECTIVES:
* Assess the ability of prostatic tissue to accumulate doses of lycopene in patients with prostate cancer or benign prostate hyperplasia.
* Determine whether the steady state level of DNA oxidation in blood and prostate tissue is responsive to lycopene dosing.
* Investigate the effect of lycopene dosing on the lipid peroxidation marker malondialdehyde in serum.
* Assess the importance of measuring multiple DNA oxidation products as biomarkers of oxidative stress and its chemoprevention.
* Determine the significance of DNA oxidation products in blood as an indicator of oxidative stress in the prostate.
* Measure prostate and blood uptake of the chemoprevention agent lycopene.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive oral lycopene once daily for 3 weeks.
* Arm II: Patients receive oral placebo once daily for 3 weeks. In both arms, patients undergo biopsy to confirm diagnosis of prostate cancer or benign prostatic hyperplasia after 3 weeks of study therapy.
Blood samples are collected at baseline and before surgery for biomarker/laboratory studies.
PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.
