The Effects of Lycopene on High Risk Prostatic Tissue

R01 CA90759: The Effects of Lycopene on High Risk Prostatic Tissue

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.

Inclusion Criteria:

• Male
• 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

Exclusion Criteria:

• No repeat biopsy planned
• Not willing to change diet
• Have a diagnosis of prostate cancer