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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
66
Lycopene 30 mg.
Placebo
Northwestern Memorial Hospital
Chicago, Illinois, United States
Jesse Brown VA Medical Center
Chicago, Illinois, United States
Tissue Biomarkers
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.
Time frame: baseline and 6 months
Changes in Serum Biomarkers
Change in serum lycopene, umol/L
Time frame: baseline and 6 months
Changes in Nuclear Morphometry
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.
Time frame: baseline and 6 months
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