Randomized, Placebo-Controlled Trial of Green Tea Catechins for Prostate Cancer Prevention

Cancer Prev Res (Phila). 2015 Oct;8(10):879-87. doi: 10.1158/1940-6207.CAPR-14-0324. Epub 2015 Apr 14.


Preclinical, epidemiologic, and prior clinical trial data suggest that green tea catechins (GTC) may reduce prostate cancer 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 prostate cancer rates on the two study arms. No differences in the number of prostate cancer cases were observed: 5 of 49 (PolyE) versus 9 of 48 (placebo), P = 0.25. A secondary endpoint comparing the cumulative rate of prostate cancer plus ASAP among men with HGPIN without ASAP at baseline, revealed a decrease in this composite endpoint: 3 of 26 (PolyE) versus 10 of 25 (placebo), P < 0.024. This finding was driven by a decrease in ASAP diagnoses on the Poly E (0/26) compared with the placebo arm (5/25). A decrease in serum prostate-specific antigen (PSA) was observed on the PolyE arm [-0.87 ng/mL; 95% confidence intervals (CI), -1.66 to -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 prostate cancer in men with baseline HGPIN or ASAP.

Trial registration: ClinicalTrials.gov NCT00596011.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Agents / therapeutic use*
  • Catechin / analogs & derivatives*
  • Catechin / therapeutic use
  • Disease Progression
  • Double-Blind Method
  • Humans
  • Male
  • Middle Aged
  • Prostatic Intraepithelial Neoplasia / pathology*
  • Prostatic Neoplasms / prevention & control*
  • Tea


  • Antineoplastic Agents
  • Tea
  • Catechin
  • polyphenon E

Associated data

  • ClinicalTrials.gov/NCT00596011