Phase I Clinical Trial: Randomized Lycopene Supplementation in Tobago Men With High-Grade Prostatic-Intraepithelial Neoplasia
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Serum PSA at randomization, one month, four months
Clareann H Bunker, PhD
Principal Investigator
University of Pittsburgh
United States: Food and Drug Administration
R01CA084950-05S1
NCT00178113
July 2003
July 2004
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