Lycopene in Healthy Male Participants

OBJECTIVES: I. Compare the toxicity and safety of 2 different doses of oral lycopene in healthy male participants. II. Compare the pharmacokinetics of 2 different doses of this drug in these participants. III. Determine the toxicity and pharmacokinetics needed to proceed to a large phase II/III study in men at high risk for prostate cancer. OUTLINE: This is a randomized, crossover study. Participants are randomized to 1 of 2 treatment arms. Arm I: Participants receive high-dose oral lycopene once or twice a day for 14 days. After 2 weeks of a lycopene-free period, participants crossover and receive high-dose lycopene at the alternative daily schedule (once or twice a day) for 14 days. Arm II: Participants receive low-dose oral lycopene once or twice a day for 14 days. After 2 weeks of a lycopene-free period, participants crossover and receive low-dose lycopene at the alternative daily schedule (once or twice a day) for 14 days. Treatment continues in the absence of unacceptable toxicity. Participants adhere to dietary restrictions for 2 weeks at baseline, 2 weeks during study treatment, and 2 weeks during pharmacokinetic sampling. Blood samples are collected periodically at baseline and during study treatment for pharmacokinetic studies. PROJECTED ACCRUAL: A total of 20 participants will be accrued for this study.