Lycopene or Green Tea for Men at Risk of Prostate Cancer

University of Bristol126 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

126

Conditions

Prostate Cancer

Interventions

Green tea drinkBEHAVIORAL

Green tea drink

green tea capsulesDIETARY_SUPPLEMENT

green tea capsules

Green tea placebo capsulesOTHER

Green tea placebo capsules

Eligibility

Sex: MALEMin age: 50 YearsMax age: 69 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Southmead Hospital

Bristol, England, United Kingdom

Outcomes

Primary Outcomes

Serum lycopene and epigallocatechin-3-gallate (green tea) levels at 6 months following randomization

Time frame: 6 months

Secondary Outcomes

Trial recruitment and randomization rates at each stage of the study

Time frame: 6 months

Intervention tolerability (adverse event reporting during the six months of follow-up)

Time frame: 6 months

Compliance (returned tablet counts and self-reported counts at 6 months)

Time frame: 6 months

Trial retention (participants completing 6-month follow-up and questionnaires)

Time frame: 6 months

PSA values at baseline and at 6 months

Time frame: 6 months

Dietary compliance with recommendations (dietary questionnaire completed at 6 months and participant data reporting dietary change)

Time frame: 6 months

Weight and body mass index at 1 and 6 months

Time frame: 6 months

Blood pressure at 1 and 6 months

Time frame: 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)

Time frame: 6 months

Anxiety, depression, and psychological state as measured by the Hospital Anxiety and Depression Scale and the Profile of Moods States

Data from ClinicalTrials.gov

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