Prostate Cancer
Conditions
Keywords
prostate cancer
Brief summary
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
Detailed description
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.
Interventions
BEHAVIORALGreen tea drink
Green tea drink
DIETARY_SUPPLEMENTgreen tea capsules
green tea capsules
OTHERGreen tea placebo capsules
Green tea placebo capsules
DIETARY_SUPPLEMENTLycopene capsules
Lycopene capsules
OTHERLycopene placebo capsules
Lycopene placebo capsules
OTHERTomato rich diet
Tomato rich diet
Sponsors
University of Bristol
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
50 Years to 69 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum lycopene and epigallocatechin-3-gallate (green tea) levels at 6 months following randomization | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Intervention tolerability (adverse event reporting during the six months of follow-up) | 6 months |
| Compliance (returned tablet counts and self-reported counts at 6 months) | 6 months |
| Trial retention (participants completing 6-month follow-up and questionnaires) | 6 months |
| PSA values at baseline and at 6 months | 6 months |
| Dietary compliance with recommendations (dietary questionnaire completed at 6 months and participant data reporting dietary change) | 6 months |
| Trial recruitment and randomization rates at each stage of the study | 6 months |
| Blood pressure at 1 and 6 months | 6 months |
| Attitudes and views of men and their spouses about dietary modification and participation in long-term study (qualitative interviews conducted throughout the study) | 6 months |
| Anxiety, depression, and psychological state as measured by the Hospital Anxiety and Depression Scale and the Profile of Moods States | 6 months |
| Urinary symptoms as measured by the ICSmaleSF questionnaire (including voiding and incontinence scores, nocturia, frequency, and urinary-specific quality-of-life care data sources) | 6 months |
| Weight and body mass index at 1 and 6 months | 6 months |
Countries
United Kingdom
Outcome results
None listed