Effect of green tea catechins in prostate cancer chemoprevention.

1572 Background: Preclinical, epidemiological and prior clinical trial data suggest that green tea catechins may reduce prostate cancer (PCa) risk. Methods: We, therefore, conducted a placebo-controlled, randomized clinical trial of one year of Polyphenon E (PolyE), a proprietary mixture of green tea catechins containing 400 mgs of epigallocatechin-3-gallate (EGCG) per day, in 97 men with high-grade prostatic intraepithelial neoplasia (HGPIN) or atypical small acinar proliferstion (ASAP) on prostate biopsy. The primary study endpoint was the total number of PCa diagnoses on the PolyE versus placebo arm at one year. Results: No differences in prostate cancer rates were observed in the two groups (4/49 PolyE vs 6/48 placebo, P = 0.25). A prespecified analysis comparing the combined rates of PCa + ASAP in the subgroup of men with HGPIN-only at baseline, showed a decrease in this composite endpoint (3/26 PolyE vs 10/25 placebo, P < 0.024). This was largely driven by a reduction in ASAP (0/26 PolyE vs 5/25 pla...