A Pilot Study of Lycopene Supplementation in Prostatic Intraepithelial Neoplasia
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).
Prostatic Intraepithelial Neoplasia
Drug: - Lyc-O-Mato (dietary supplement, 30 mg lycopene/day)
Drug: - Certagen (multivitamins with minerals)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Phase I Clinical Trial: Randomized Lycopene Supplementation in Tobago Men With High-Grade Prostatic-Intraepithelial Neoplasia|
- Serum PSA at randomization, one month, four months
- Serum lycopene at randomization, one month, four months
|Study Start Date:||July 2003|
|Estimated Study Completion Date:||July 2004|
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.
|Trinidad and Tobago|
|Tobago Prostate Survey Office|
|Scarborough, Tobago, Trinidad and Tobago|
|Principal Investigator:||Clareann H Bunker, PhD||University of Pittsburgh|
|Study Director:||Lewis H Kuller, MD||University of Pittsburgh|