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Randomized, Placebo-Controlled Trial Evaluating The Safety Of One-Year Administration Of Green Tea Catechins, Nagi B. Kumar, Julio Pow-Sang, Philippe E. Spiess, Jong Park, Raoul Salup, Christopher R. Williams, Howard Parnes, Michael J. Schell

Urology Faculty Publications

Purpose: Although preclinical, epidemiological and prior clinical trial data suggest that green tea catechins (GTCs) may reduce prostate cancer (PCa) risk, several preclinical studies and case reports have reported liver toxicities and acute gastrointestinal bleeding. Based on these observations, regulatory bodies have required stringent inclusion criteria with frequent, excessive toxicity monitoring and early stopping rules in clinical trials. These requirements have impeded recruitment and retention of subjects in chemoprevention trials and subsequent progress in agent development efforts.

Experimental Design: We conducted a placebo-controlled, randomized clinical trial of Polyphenon E® (PolyE®), a proprietary mixture of decaffeinated GTCs, containing 400 mg (−)-epigallocatechin-3-gallate …