The Effects of Lycopene on High Risk Prostatic Tissue

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2009-04-30

Brief Summary

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The purpose of this research study is to compare the effects of a lycopene supplement made from tomatoes to a placebo (a capsule with no active ingredients) in men who have abnormal cells in the prostate, but have not yet had cancer detected. This study will allow us to see if taking lycopene for six months leads to favorable changes in abnormal prostate tissue and in chemicals measured in the blood that go along with a higher risk of developing cancer.

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Detailed Description

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Conditions

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Intraepithelial Prostatic Neoplasia Prostatic Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Lycopene

Lycopene 30 mg/day

Group Type EXPERIMENTAL

Lycopene 30mg

Intervention Type DRUG

Lycopene 30 mg.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Lycopene 30mg

Lycopene 30 mg.

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Lyco-Mato Sugar Pill

Eligibility Criteria

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Inclusion Criteria

* Male
* Have a history of prostate biopsy indicating HGPIN without cancer within 2 years prior to registration. At least 4 weeks must have elapsed between the last biopsy and the biopsy used for baseline data.
* Have an AUA symptom score \<=25 at time of registration.
* Refrain from taking lycopene, selenium, vitamin E, or other antioxidant supplements within 1 month of randomization. Participants must agree to refrain from taking non-study dietary supplements while on study
* Refrain from taking exogenous hormones, drugs affecting hormone metabolism, or specified non-prescription substances (e.g. saw palmetto, PC-Spes) taken to affect the prostate within 1 month of registration. Patients must also agree to refrain from taking the non-prescription substances while on study
* Be willing to limit intake of lycopene-containing foods while on study
* Have no prior cancer (except basal cell or squamous cell skin cancer) or complete remission for at least 5 years
* Be ambulatory, capable of self-care and able to carry out light or sedentary work
* Have a dietary fat intake of 23-48% of calories
* Participant's physician recommends repeat biopsy 4-6 months after randomization