NCT00178113

A Pilot Study of Lycopene Supplementation in Prostatic Intraepithelial Neoplasia

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (planned)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: Male
• Age: 40 Years – 79 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Prostatic Intraepithelial Neoplasia

Interventions

Type	Name	Description
DRUG	- Lyc-O-Mato (dietary supplement, 30 mg lycopene/day)
DRUG	- Certagen (multivitamins with minerals)

Timeline

• Start date: 2003-07-01
• Completion: 2004-07-01
• First posted: 2005-09-15
• Last updated: 2015-05-27

Locations

1 site across 1 country: Trinidad and Tobago