Randomized, Placebo-Controlled Trial of Green Tea Catechins for Prostate Cancer Prevention.
Randomized, Placebo-Controlled Trial of Green Tea Catechins for Prostate Cancer Prevention.
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DOI：
10.1158/1940-6207.capr-14-0324
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发表时间：
2015-10
期刊：
影响因子：
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通讯作者：
Schell MJ
中科院分区：
文献类型：
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作者：
Kumar NB;Pow-Sang J;Egan KM;Spiess PE;Dickinson S;Salup R;Helal M;McLarty J;Williams CR;Schreiber F;Parnes HL;Sebti S;Kazi A;Kang L;Quinn G;Smith T;Yue B;Diaz K;Chornokur G;Crocker T;Schell MJ
Preclinical, epidemiological and prior clinical trial data suggest that green tea catechins (GTCs) may reduce prostate cancer (PCa) risk. We conducted a placebo-controlled, randomized clinical trial of Polyphenon E® (PolyE), a proprietary mixture of GTCs, containing 400 mg (–)-epigallocatechin-3-gallate (EGCG) per day, in 97 men with high-grade prostatic intraepithelial neoplasia (HGPIN) and/or atypical small acinar proliferation (ASAP). The primary study endpoint was a comparison of the cumulative one-year PCa rates on the two study arms. No differences in the number of PCa cases were observed: 5/49 (PolyE) versus 9/48 (placebo), P=0.25. A secondary endpoint comparing the cumulative rate of PCa plus ASAP among men with HGPIN without ASAP at baseline, revealed a decrease in this composite endpoint: 3/26 (PolyE) versus 10/25 (placebo), P<0.024. This finding was driven by a decrease in ASAP diagnoses on the Poly E (0/26) compared to the placebo arm (5/25). A decrease in serum prostate specific antigen (PSA) was observed on the PolyE arm [−0.87 ng/ml (95%CI: −1.66, −0.09)]. Adverse events related to the study agent did not significantly differ between the two study groups. Daily intake of a standardized, decaffeinated catechin mixture containing 400 mg EGCG per day for 1 year accumulated in plasma and was well tolerated but did not reduce the likelihood of PCa in men with baseline HGPIN or ASAP.
