Lycopene in Preventing Prostate Cancer in Healthy Participants

OBJECTIVES:

Primary

- 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.

DISEASE CHARACTERISTICS:

- Healthy participants

- No existing prostate disease

PATIENT CHARACTERISTICS:

- 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