Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Bristol
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
Sex
MALE
Healthy volunteers
Accepted
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
