The Effects of Lycopene on High Risk Prostatic Tissue

Study Overview
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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.

Official Title
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R01 CA90759: The Effects of Lycopene on High Risk Prostatic Tissue

Conditions
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Intraepithelial Prostatic Neoplasia, Prostatic Neoplasms

Intervention / Treatment
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* Drug: Lycopene 30mg
* Drug: Placebo


Participation Criteria
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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 Exclusion Criteria: No repeat biopsy planned Not willing to change diet Have a diagnosis of prostate cancer

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lycopene<br>Lycopene 30 mg/day | Drug: Lycopene 30mg<br>* Lycopene 30 mg.<br>* Other names: Lyco-Mato;|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo<br>* Other names: Sugar Pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tissue Biomarkers | We will use conventional immunohistochemistry and computer-based image analysis to test the hypothesis that the lycopene supplements alter the expression of proteins marking the status of proliferation, differentiation, cell regulation and apoptosis in high-risk tissue. | baseline and 6 months | 
| Changes in Serum Biomarkers | Change in serum lycopene, umol/L | baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Nuclear Morphometry | We will use a computerized image analysis system designed for the chemoprevention setting to test the hypothesis that the antioxidants cause a favorable change in a nuclear morphometry index based on nuclear size, shape and chromatin texture. | baseline and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intraepithelial Prostatic Neoplasia, Prostatic neoplasms, Male urogenital disease, Prostate