RATIONALE: Chemoprevention is the use of certain drugs or substances to keep cancer from forming, growing, or coming back. The use of lycopene, a substance found in tomatoes, may keep prostate cancer from forming.
PURPOSE: This randomized clinical trial is studying how well lycopene works in preventing prostate cancer in healthy participants.
Determine whether lycopene supplementation affects percent free and bound prostate-specific antigen (PSA) in healthy participants.
Secondary
Determine whether lycopene reduces oxidative stress in these participants, as indicated by lipid peroxidation assay. Determine whether a 21-day washout period is sufficient to return lycopene, PSA, and lipid peroxidation products to baseline.
OUTLINE: This is a randomized, placebo-controlled study. Participants are randomized to 1 of 3 treatment arms.
Arm I: Participants receive an oral tomato dietary supplement containing lycopene twice daily for 3 weeks. Arm II: Participants receive an oral tomato dietary supplement containing lycopene at a higher dose twice daily for 3 weeks. Arm III: Participants receive oral placebo twice daily for 3 weeks. Urine and blood samples are collected on days 0, 21, and 42.
PROJECTED ACCRUAL: A total of 150 participants will be accrued for this study.
Able to supply blood and urine samples Able to answer demographic and dietary recall questionnaires No hospital inpatients Not allergic to tomatoes or tomato products Not abusing alcohol or non-prescribed drugs No existing gastrointestinal disease or cancer
PRIOR CONCURRENT THERAPY:
At least 2 weeks since prior lycopene (in supplement form) No concurrent participation in another clinical trial
