Lycopene or Green Tea for Men at Risk of Prostate Cancer

Lycopene or Green Tea a Feasibility Study in Men at Risk of Prostate Cancer

RATIONALE: Lycopene and green tea may stop or delay the development of recurrent prostate cancer in patients has been treated for prostate cancer. It is not yet known whether lycopene or green tea may be more effective in preventing prostate cancer.

PURPOSE: This randomized phase II trial is studying lycopene to see how well it works compared with green tea in preventing prostate cancer in patients previously enrolled in the ProtecT trial

OBJECTIVES:

Primary

• To assess serum lycopene and epigallocatechin-3-gallate (green tea) levels at 6 months following randomization in patients with prostate cancer previously enrolled on ProtecT

Secondary

• To evaluate trial recruitment and randomization rates of patients treated with this regimen.
• To evaluate intervention tolerability in patients treated with this regimen.
• To evaluate compliance of patients treated with this regimen.
• To evaluate trial retention of patients treated with this regimen.
• To assess PSA values in patients treated with this regimen.
• To evaluate dietary compliance with recommendations of patients treated with this regimen.
• To assess weight and body mass index of patients treated with this regimen.
• To evaluate attitudes and views of men and their spouses about dietary modification and participation in long-term study.

OUTLINE: Patients are stratified according to PSA test levels obtained from ProtecT study recruitment clinic (< 3.0 ng/mL vs 3.0-19.99 ng/mL). Patients are randomized to 1 of 2 treatment arms.

Inclusion criteria: PSA level 2.0-2.95 ng/mL OR PSA level ≥ 3.0 ng/mL with a negative biopsy No major comorbidities No other cancers or prior prostate malignancy No history of allergic reactions to green tea or lycopene-containing products, including guava or watermelon Exclusion criteria: No concurrent finasteride or dutasteride