Randomized, double-blind, placebo-controlled trial of polyphenon E in prostate cancer patients before prostatectomy: Evaluation of potential chemopreventive activities

Mike M. Nguyen, Frederick R Ahmann, Raymond B Nagle, Chiu-Hsieh Hsu, Joseph A. Tangrea, Howard L. Parnes, Mitchell H. Sokoloff, Matthew B Gretzer, Hsiao-Hui Chow

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Abstract

Compelling preclinical and pilot clinical data support the role of green tea polyphenols in prostate cancer prevention. We conducted a randomized, double-blind, placebo-controlled trial of polyphenon E (enriched green tea polyphenol extract) in men with prostate cancer scheduled to undergo radical prostatectomy. The study aimed to determine the bioavailability of green tea polyphenols in prostate tissue and to measure its effects on systemic and tissue biomarkers of prostate cancer carcinogenesis. Participants received either polyphenon E (containing 800 mg epigallocatechin gallate) or placebo daily for 3 to 6 weeks before surgery. Following the intervention, green tea polyphenol levels in the prostatectomy tissue were low to undetectable. Polyphenon E intervention resulted in favorable but not statistically significant changes in serum prostate-specific antigen, serum insulin-like growth factor axis, and oxidative DNA damage in blood leukocytes. Tissue biomarkers of cell proliferation, apoptosis, and angiogenesis in the prostatectomy tissue did not differ between the treatment arms. The proportion of subjects who had a decrease in Gleason score between biopsy and surgical specimens was greater in those on polyphenon E but was not statistically significant. The study's findings of low bioavailability and/or bioaccumulation of green tea polyphenols in prostate tissue and statistically insignificant changes in systemic and tissue biomarkers from 3 to 6 weeks of administration suggests that prostate cancer preventive activity of green tea polyphenols, if occurring, may be through indirect means and/or that the activity may need to be evaluated with longer intervention durations, repeated dosing, or in patients at earlier stages of the disease.

Original languageEnglish (US)
Pages (from-to)290-298
Number of pages9
JournalCancer Prevention Research
Volume5
Issue number2
DOIs
StatePublished - Feb 2012

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Prostatectomy
Polyphenols
Tea
Prostatic Neoplasms
Placebos
Biomarkers
Biological Availability
Prostate
Neoplasm Grading
Somatomedins
Prostate-Specific Antigen
polyphenon E
Serum
DNA Damage
Carcinogenesis
Leukocytes
Cell Proliferation
Apoptosis
Biopsy

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

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title = "Randomized, double-blind, placebo-controlled trial of polyphenon E in prostate cancer patients before prostatectomy: Evaluation of potential chemopreventive activities",
abstract = "Compelling preclinical and pilot clinical data support the role of green tea polyphenols in prostate cancer prevention. We conducted a randomized, double-blind, placebo-controlled trial of polyphenon E (enriched green tea polyphenol extract) in men with prostate cancer scheduled to undergo radical prostatectomy. The study aimed to determine the bioavailability of green tea polyphenols in prostate tissue and to measure its effects on systemic and tissue biomarkers of prostate cancer carcinogenesis. Participants received either polyphenon E (containing 800 mg epigallocatechin gallate) or placebo daily for 3 to 6 weeks before surgery. Following the intervention, green tea polyphenol levels in the prostatectomy tissue were low to undetectable. Polyphenon E intervention resulted in favorable but not statistically significant changes in serum prostate-specific antigen, serum insulin-like growth factor axis, and oxidative DNA damage in blood leukocytes. Tissue biomarkers of cell proliferation, apoptosis, and angiogenesis in the prostatectomy tissue did not differ between the treatment arms. The proportion of subjects who had a decrease in Gleason score between biopsy and surgical specimens was greater in those on polyphenon E but was not statistically significant. The study's findings of low bioavailability and/or bioaccumulation of green tea polyphenols in prostate tissue and statistically insignificant changes in systemic and tissue biomarkers from 3 to 6 weeks of administration suggests that prostate cancer preventive activity of green tea polyphenols, if occurring, may be through indirect means and/or that the activity may need to be evaluated with longer intervention durations, repeated dosing, or in patients at earlier stages of the disease.",
author = "Nguyen, {Mike M.} and Ahmann, {Frederick R} and Nagle, {Raymond B} and Chiu-Hsieh Hsu and Tangrea, {Joseph A.} and Parnes, {Howard L.} and Sokoloff, {Mitchell H.} and Gretzer, {Matthew B} and Hsiao-Hui Chow",
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T2 - Evaluation of potential chemopreventive activities

AU - Nguyen, Mike M.

AU - Ahmann, Frederick R

AU - Nagle, Raymond B

AU - Hsu, Chiu-Hsieh

AU - Tangrea, Joseph A.

AU - Parnes, Howard L.

AU - Sokoloff, Mitchell H.

AU - Gretzer, Matthew B

AU - Chow, Hsiao-Hui

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