The Effects of Lycopene on High Risk Prostatic Tissue
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The purpose of this research study is to compare the effects of a lycopene supplement made from tomatoes to a placebo (a capsule with no active ingredients) in men who have abnormal cells in the prostate, but have not yet had cancer detected. This study will allow us to see if taking lycopene for six months leads to favorable changes in abnormal prostate tissue and in chemicals measured in the blood that go along with a higher risk of developing cancer.
Tissue Biomarkers [ Time Frame: baseline and 6 months ]
We will use conventional immunohistochemistry and computer-based image analysis to test the hypothesis that the lycopene supplements alter the expression of proteins marking the status of proliferation, differentiation, cell regulation and apoptosis in high-risk tissue.
Changes in Serum Biomarkers [ Time Frame: baseline and 6 months ]
Change in serum lycopene, umol/L
Secondary Outcome Measures :
Changes in Nuclear Morphometry [ Time Frame: baseline and 6 months ]
We will use a computerized image analysis system designed for the chemoprevention setting to test the hypothesis that the antioxidants cause a favorable change in a nuclear morphometry index based on nuclear size, shape and chromatin texture.
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Ages Eligible for Study:
40 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Have a history of prostate biopsy indicating HGPIN without cancer within 2 years prior to registration. At least 4 weeks must have elapsed between the last biopsy and the biopsy used for baseline data.
Have an AUA symptom score <=25 at time of registration.
Refrain from taking lycopene, selenium, vitamin E, or other antioxidant supplements within 1 month of randomization. Participants must agree to refrain from taking non-study dietary supplements while on study
Refrain from taking exogenous hormones, drugs affecting hormone metabolism, or specified non-prescription substances (e.g. saw palmetto, PC-Spes) taken to affect the prostate within 1 month of registration. Patients must also agree to refrain from taking the non-prescription substances while on study
Be willing to limit intake of lycopene-containing foods while on study
Have no prior cancer (except basal cell or squamous cell skin cancer) or complete remission for at least 5 years
Be ambulatory, capable of self-care and able to carry out light or sedentary work
Have a dietary fat intake of 23-48% of calories
Participant's physician recommends repeat biopsy 4-6 months after randomization
Keywords provided by Peter Gann, University of Illinois at Chicago:
Intraepithelial Prostatic Neoplasia
Male urogenital disease
Additional relevant MeSH terms:
Prostatic Intraepithelial Neoplasia
Genital Neoplasms, Male
Neoplasms by Site
Genital Diseases, Male
Carcinoma in Situ
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs