Prostate Cancer Clinical Trial
Official title:
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.
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