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Research Article

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

Nagi B. Kumar, Julio Pow-Sang, Kathleen M. Egan, Philippe E. Spiess, Shohreh Dickinson, Raoul Salup, Mohamed Helal, Jerry McLarty, Christopher R. Williams, Fred Schreiber, Howard L. Parnes, Said Sebti, Aslam Kazi, Loveleen Kang, Gwen Quinn, Tiffany Smith, Binglin Yue, Karen Diaz, Ganna Chornokur, Theresa Crocker and Michael J. Schell
Nagi B. Kumar
H. Lee Moffitt Cancer Center and Research Institute Cancer Epidemiology, Tampa, Florida.
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  • For correspondence: nagi.kumar@moffitt.org
Julio Pow-Sang
Department of Urology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.
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Kathleen M. Egan
H. Lee Moffitt Cancer Center and Research Institute Cancer Epidemiology, Tampa, Florida.
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Philippe E. Spiess
H. Lee Moffitt Cancer Center and Research Institute Cancer Epidemiology, Tampa, Florida.
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Shohreh Dickinson
Department of Pathology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.
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Raoul Salup
Department of Surgery, University of South Florida College of Medicine, Tampa, Florida.
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Mohamed Helal
Department of Urology, Tampa Urology, Tampa, Florida.
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Jerry McLarty
Department of MedicineLSU Health Sciences Center, Medicine, Tampa, Florida.
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Christopher R. Williams
University of Florida–Jacksonville, Tampa, Florida.
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Fred Schreiber
Watson Clinic–Center for Cancer Care and Research, Lakeland, Florida.
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Howard L. Parnes
National Cancer Institute, Rockville, MD.
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Said Sebti
Department of Drug Discovery, H. Lee Moffitt Cancer Center and Research Institute, Inc., Tampa, Florida.
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Aslam Kazi
Department of Drug Discovery, H. Lee Moffitt Cancer Center and Research Institute, Inc., Tampa, Florida.
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Loveleen Kang
James A. Haley VA Medical Center, Department of Pathology and Laboratory Medicine, Tampa, Florida.
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Gwen Quinn
Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, Florida.
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Tiffany Smith
H. Lee Moffitt Cancer Center and Research Institute Cancer Epidemiology, Tampa, Florida.
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Binglin Yue
Department of Biostatistics Core, H. Lee Moffitt Cancer Center and Research Institute, Inc., Tampa, Florida.
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Karen Diaz
H. Lee Moffitt Cancer Center and Research Institute Cancer Epidemiology, Tampa, Florida.
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Ganna Chornokur
H. Lee Moffitt Cancer Center and Research Institute Cancer Epidemiology, Tampa, Florida.
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Theresa Crocker
Center for Innovation in Disability and Rehabilitation Research, James A. Haley Veterans Administration Hospital, Tampa, Florida.
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Michael J. Schell
Department of Biostatistics, Moffitt Cancer Center, Tampa, Florida.
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DOI: 10.1158/1940-6207.CAPR-14-0324
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Abstract

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. Cancer Prev Res; 8(10); 1–9. ©2015 AACR.

Footnotes

  • Prior presentation:

  • Poster presentations at the AACR Seventh Annual Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved Conference, November 9–12, 2014, in San Antonio, TX.

  • Proffered abstract presentation at the AACR Thirteenth Annual International Conference on Frontiers in Cancer Prevention Research, New Orleans, LA on September 28 - October 1, 2014.

  • Received September 24, 2014.
  • Revision received March 23, 2015.
  • Accepted April 2, 2015.
  • ©2015 American Association for Cancer Research.
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Published OnlineFirst September 21, 2015
doi: 10.1158/1940-6207.CAPR-14-0324

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Randomized, Placebo-Controlled Trial of Green Tea Catechins for Prostate Cancer Prevention
Nagi B. Kumar, Julio Pow-Sang, Kathleen M. Egan, Philippe E. Spiess, Shohreh Dickinson, Raoul Salup, Mohamed Helal, Jerry McLarty, Christopher R. Williams, Fred Schreiber, Howard L. Parnes, Said Sebti, Aslam Kazi, Loveleen Kang, Gwen Quinn, Tiffany Smith, Binglin Yue, Karen Diaz, Ganna Chornokur, Theresa Crocker and Michael J. Schell
Cancer Prev Res September 21 2015 DOI: 10.1158/1940-6207.CAPR-14-0324

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Randomized, Placebo-Controlled Trial of Green Tea Catechins for Prostate Cancer Prevention
Nagi B. Kumar, Julio Pow-Sang, Kathleen M. Egan, Philippe E. Spiess, Shohreh Dickinson, Raoul Salup, Mohamed Helal, Jerry McLarty, Christopher R. Williams, Fred Schreiber, Howard L. Parnes, Said Sebti, Aslam Kazi, Loveleen Kang, Gwen Quinn, Tiffany Smith, Binglin Yue, Karen Diaz, Ganna Chornokur, Theresa Crocker and Michael J. Schell
Cancer Prev Res September 21 2015 DOI: 10.1158/1940-6207.CAPR-14-0324
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