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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.
Age
50 - 69 years
Sex
MALE
Healthy Volunteers
Yes
Southmead Hospital
Bristol, England, United Kingdom
Start Date
August 1, 2009
Primary Completion Date
August 1, 2010
Completion Date
August 1, 2010
Last Updated
January 23, 2018
126
ACTUAL participants
Green tea drink
BEHAVIORAL
green tea capsules
DIETARY_SUPPLEMENT
Green tea placebo capsules
OTHER
Lycopene capsules
DIETARY_SUPPLEMENT
Lycopene placebo capsules
OTHER
Tomato rich diet
OTHER
Lead Sponsor
University of Bristol
NCT05691465
NCT04550494
Data Source & Attribution
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