Lycopene Supplementation in the Complementary Management of PSA Failure: A Randomized Placebo-Controlled Trial for Prostate Cancer Survivors
Final rept. 1 Jul 2005-30 Dec 2006
MEHARRY MEDICAL COLL NASHVILLE TN
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This is a hypothesis driven, double-blind, randomized, controlled Phase II clinical trial to compare the effect of daily 12-month supplementation of 30mgs lycopene as a single nutrient Lycopene or whole-food supplement Lyc-O-MatoRegistered in control of biochemical PSA failure in 78 African-American prostate cancer survivors treated initially by radical prostatectomy or radiation. Fasting blood samples to measure free and total PSA, lycopene, isoprostane and essential fatty acids will be collected at baseline, 3- 6- and 12-months. Demographic and medical history, clinical and quality of life QOL assessment, dietary assessment, body fat measures and adverse event information will be collected at baseline and all follow-up time-points. Clinical endpoints are 50 PSA reduction from baseline maintained for 2 successive readings 3 months apart, 25 improvement in QOL scores, and control of distant metastasis. Biomarker endpoints are changes in plasma lycopene, and 8-isoprostane-PGF2alpha, a measure of oxidative stress. The effect of the interventions will be analyzed based on evaluable patients as well as by intent-to-treat.
- Medicine and Medical Research