Lycopene or Green Tea for Men at Risk of Prostate Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-08-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Green tea drink

Group Type ACTIVE_COMPARATOR

Green tea drink

Intervention Type BEHAVIORAL

Green tea drink

Green tea capsules

Group Type ACTIVE_COMPARATOR

green tea capsules

Intervention Type DIETARY_SUPPLEMENT

green tea capsules

Green tea placebo capsules

Group Type PLACEBO_COMPARATOR

Green tea placebo capsules

Intervention Type OTHER

Green tea placebo capsules

Lycopene capsules

Group Type ACTIVE_COMPARATOR

Lycopene capsules

Intervention Type DIETARY_SUPPLEMENT

Lycopene capsules

Lycopene placebo capsules

Group Type PLACEBO_COMPARATOR

Lycopene placebo capsules

Intervention Type OTHER

Lycopene placebo capsules

Tomato rich diet

Group Type ACTIVE_COMPARATOR

Tomato rich diet

Intervention Type OTHER

Tomato rich diet

Interventions

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Green tea drink

Intervention Type BEHAVIORAL

green tea capsules

Intervention Type DIETARY_SUPPLEMENT

Green tea placebo capsules

Intervention Type OTHER

Lycopene capsules

Intervention Type DIETARY_SUPPLEMENT

Lycopene placebo capsules

Intervention Type OTHER

Tomato rich diet

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Inclusion criteria: PSA level 2.0-2.95 ng/mL OR PSA level ≥ 3.

Exclusion Criteria

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

Minimum Eligible Age

50 Years

Maximum Eligible Age

69 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes