A Pilot Study of Lycopene Supplementation in Prostatic Intraepithelial Neoplasia

Study Overview
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Brief Summary
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The purpose of this study is to determine whether dietary lycopene supplementation lowers serum prostate specific antigen(PSA) in men with high grade intraepithelial neoplasia (HGPIN).

Detailed Description
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Observational studies suggest higher lycopene intake or higher lycopene blood levels are associated with a lower risk for prostate cancer. Two recent trials of lycopene supplementation conducted in men with prostate cancer, during the three weeks prior to radical prostatectomy, found a reduction in serum PSA suggesting a regression of prostate cancer. High grade intraepithelial neoplasia (HGPIN)is thought to be a precancerous lesion, and men with HGPIN have an elevated risk of prostate cancer diagnosis on subsequent biopsy. The objective of this study is to determine whether dietary lycopene supplementation lowers serum prostate specific antigen(PSA)over four months of supplementation. Serum PSA is compared in men randomized to 30 mg/day lycopene plus a standard multivitamin versus standard multivitamin alone.

Official Title
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Phase I Clinical Trial: Randomized Lycopene Supplementation in Tobago Men With High-Grade Prostatic-Intraepithelial Neoplasia

Conditions
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Prostatic Intraepithelial Neoplasia

Intervention / Treatment
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* Drug: - Lyc-O-Mato (dietary supplement, 30 mg lycopene/day)
* Drug: - Certagen (multivitamins with minerals)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: biopsy reported high grade prostatic intraepithelial neoplasia and/or biopsy reported atypia and/or persistently elevated serum prostate specific antigen with normal biopsy Exclusion Criteria: biopsy diagnosed prostate cancer serum prostate specific antigen > 40 ng/ml hospitalization in past six months history of allergy to tomatoes history of allergic dermatitis serious concurrent illness inability to provide informed consent

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: - Lyc-O-Mato (dietary supplement, 30 mg lycopene/day)|nan|
|Drug: - Certagen (multivitamins with minerals)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum PSA at randomization, one month, four months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum lycopene at randomization, one month, four months |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostatic Intraepithelial Neoplasia, Prostate-Specific Antigen, lycopene