Prostate Cancer Clinical Trial
Lycopene in Preventing Prostate Cancer in Healthy Participants
Summary
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.
Full Description
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.
Eligibility Criteria
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
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