Lycopene In Preventing of Prostate Cancer

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. The use of lycopene may be an effective way to prevent prostate cancer. PURPOSE: Phase I trial to study the effectiveness of lycopene in preventing prostate cancer.

OBJECTIVES: * Determine any dose limiting toxicities and the maximum tolerated dose of lycopene administered orally as a food based delivery system in healthy male subjects 18-45 years of age for the chemoprevention of prostate cancer. * Determine the pharmacokinetics of this regimen in this population. * Determine the dose range of this regimen to be used in the 3 month multiple dose study, based on the toxicity, pharmacokinetics and feasibility resulting from the present study in this population. OUTLINE: This is a dose-escalation study. Patients receive a single dose of oral lycopene in a mixture of tomato paste, water, and olive oil over 15 minutes on day 1. Patients are asked to maintain a diet that contains negligible carotinoid for 28 days. Cohorts of 5 patients receive escalating doses of lycopene until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 5 patients experience dose limiting toxicities. Patients are followed weekly for 4 weeks. PROJECTED ACCRUAL: A total of 5-25 patients will be accrued for this study.