ProDiet - Prostate and Diet Study
50 Years
69 Years
Male
Prostate Cancer
Trial Information
ProDiet - Prostate and Diet Study
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
RADCLIFFE-PROTECT and currently enrolled on CRUK-ProMPT treated with lycopene versus
green tea.
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: This is a multicenter study. Patients are stratified according to PSA test levels
obtained from RADCLIFFE-PROTECT study recruitment clinic (< 3.0 ng/mL vs 3.0-19.99 ng/mL).
Patients are randomized to 1 of 2 treatment arms.
- Arm I (lycopene): Patients receive 1 of the following treatment regimes.
- Regimen 1: Patients receive dietary advice regarding a daily portion of cooked
tomatoes rich in lycopene. Patients also receive oral placebo capsules once daily.
- Regimen 2: Patients also receive dietary advice recommending 5 daily portions of
fruit and vegetables. Patients also receive tomato-derived lycopene supplement
capsules once daily. .
- Regimen 3: Patients receive healthy dietary advice. Patients also receive oral
placebo capsules once daily.
- Arm II (green tea): Patients receive 1 of the following treatment regimes.
- Regimen 1: Patients receive oral green tea capsules once daily.
- Regimen 2: Patients receive oral placebo capsules once daily.
- Regimen 3: Patients receive dietary advice regarding drinking green tea. Patients
complete quality-of-life questionnaires on urinary symptoms (ICSmaleSF
questionnaire/FTQ1), general health status [Hospital Anxiety and Depression scale
(HAD) and Profile of Moods States], and current diet (Food Frequency
Questionnaire/FTQ1a) periodically.
Patients are followed at 1 and 6 months after randomization.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Previously enrolled on RADCLIFFE-PROTECT, meeting the following criteria:
- 50-69 years of age on the date of preparation of the list of potential
participants
- PSA level 2.0-2.95 ng/mL OR PSA level ≥ 3.0 ng/mL with a negative biopsy (10
core procedure)
- Currently enrolled on CRUK-ProMPT and willing to be contacted about further studies
- No PSA ≥ 20 ng/mL
PATIENT CHARACTERISTICS:
- 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
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No concurrent finasteride or dutasteride
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
Serum lycopene and epigallocatechin-3-gallate (green tea) levels at 6 months following randomization
Safety Issue:
No
Principal Investigator
Athene Lane, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Bristol
Authority:
Unspecified
Study ID:
CDR0000669884
NCT ID:
NCT01105338
Start Date:
August 2009
Completion Date:
Related Keywords:
- Prostate Cancer
- recurrent prostate cancer
- prostate cancer
- Prostatic Neoplasms
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