Clinical Trial: A Pilot Study of Lycopene Supplementation in Prostatic Intraepithelial Neoplasia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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.

Sponsor: University of Pittsburgh

Current Primary Outcome: Serum PSA at randomization, one month, four months

Original Primary Outcome: Same as current

Current Secondary Outcome: Serum lycopene at randomization, one month, four months

Original Secondary Outcome: Same as current

Information By: University of Pittsburgh

Dates:
Date Received: September 13, 2005
Date Started: July 2003
Date Completion: July 2004
Last Updated: May 26, 2015
Last Verified: May 2015