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Clinical Trial
. 2012 Feb;5(2):290-8.
doi: 10.1158/1940-6207.CAPR-11-0306. Epub 2011 Nov 1.

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

Mike M Nguyen  1 , Frederick R Ahmann, Raymond B Nagle, Chiu-Hsieh Hsu, Joseph A Tangrea, Howard L Parnes, Mitchell H Sokoloff, Matthew B Gretzer, H-H Sherry Chow
Affiliations
Clinical Trial

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

Mike M Nguyen et al. Cancer Prev Res (Phila). 2012 Feb.

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.

Trial registration: ClinicalTrials.gov NCT00459407.

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Figures

Figure 1
Figure 1
Consort flow diagram.
Figure 2
Figure 2
Post-intervention plasma green tea polyphenol concentrations following 3–6 weeks of Polyphenon E intervention. EGC: epigallocatechin; EC: epicatechin; ECG: epicatechin gallate; EGCG: epigallocatechin gallate; 4″-MeEGCG: 4″-O-methyl EGCG. Data are presented as means with standard errors (n = 24).
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References

    1. Thompson IM, Goodman PJ, Tangen CM, Lucia MS, Miller GJ, Ford LG, et al. The influence of finasteride on the development of prostate cancer. N Engl J Med. 2003;349:215–24. - PubMed
    1. Andriole GL, Bostwick DG, Brawley OW, Gomella LG, Marberger M, Montorsi F, et al. Effect of dutasteride on the risk of prostate cancer. N Engl J Med. 2010;362:1192–202. - PubMed
    1. Hamilton RJ, Kahwati LC, Kinsinger LS. Knowledge and use of finasteride for the prevention of prostate cancer. Cancer Epidemiol Biomarkers Prev. 2010;19:2164–71. - PubMed
    1. Gupta S, Hastak K, Ahmad N, Lewin JS, Mukhtar H. Inhibition of prostate carcinogenesis in TRAMP mice by oral infusion of green tea polyphenols. Proc Natl Acad Sci. 2001;98:10350–5. - PMC - PubMed
    1. Adhami VM, Siddiqui IA, Ahmad N, Gupta S, Mukhtar H. Oral consumption of green tea polyphenols inhibits insulin-like growth factor-I-induced signaling in an autochthonous mouse model of prostate cancer. Cancer Res. 2004;64:8715–22. - PubMed

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