title: Randomized, Placebo-Controlled Trial of Green Tea Catechins for Prostate Cancer Prevention.
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.
authors: H. Lee Moffitt Cancer Center and Research Institute Cancer Epidemiology, Tampa, Florida. nagi.kumar@moffitt.org.
authors: Nagi B
authors: NB
authors: Kumar
authors: Department of Urology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.
authors: Julio
authors: J
authors: Pow-Sang
authors: H. Lee Moffitt Cancer Center and Research Institute Cancer Epidemiology, Tampa, Florida.
authors: Kathleen M
authors: KM
authors: Egan
authors: H. Lee Moffitt Cancer Center and Research Institute Cancer Epidemiology, Tampa, Florida.
authors: Philippe E
authors: PE
authors: Spiess
authors: Department of Pathology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.
authors: Shohreh
authors: S
authors: Dickinson
authors: Department of Surgery, University of South Florida College of Medicine, Tampa, Florida.
authors: Raoul
authors: R
authors: Salup
authors: Department of Urology, Tampa Urology, Tampa, Florida.
authors: Mohamed
authors: M
authors: Helal
authors: Department of MedicineLSU Health Sciences Center, Medicine, Tampa, Florida.
authors: Jerry
authors: J
authors: McLarty
authors: University of Florida-Jacksonville, Tampa, Florida.
authors: Christopher R
authors: CR
authors: Williams
authors: Watson Clinic-Center for Cancer Care and Research, Lakeland, Florida.
authors: Fred
authors: F
authors: Schreiber
authors: National Cancer Institute, Rockville, MD.
authors: Howard L
authors: HL
authors: Parnes
authors: Department of Drug Discovery, H. Lee Moffitt Cancer Center and Research Institute, Inc., Tampa, Florida.
authors: Said
authors: S
authors: Sebti
authors: Department of Drug Discovery, H. Lee Moffitt Cancer Center and Research Institute, Inc., Tampa, Florida.
authors: Aslam
authors: A
authors: Kazi
authors: James A. Haley VA Medical Center, Department of Pathology and Laboratory Medicine, Tampa, Florida.
authors: Loveleen
authors: L
authors: Kang
authors: Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, Florida.
authors: Gwen
authors: G
authors: Quinn
authors: H. Lee Moffitt Cancer Center and Research Institute Cancer Epidemiology, Tampa, Florida.
authors: Tiffany
authors: T
authors: Smith
authors: Department of Biostatistics Core, H. Lee Moffitt Cancer Center and Research Institute, Inc., Tampa, Florida.
authors: Binglin
authors: B
authors: Yue
authors: H. Lee Moffitt Cancer Center and Research Institute Cancer Epidemiology, Tampa, Florida.
authors: Karen
authors: K
authors: Diaz
authors: H. Lee Moffitt Cancer Center and Research Institute Cancer Epidemiology, Tampa, Florida.
authors: Ganna
authors: G
authors: Chornokur
authors: Center for Innovation in Disability and Rehabilitation Research, James A. Haley Veterans Administration Hospital, Tampa, Florida.
authors: Theresa
authors: T
authors: Crocker
authors: Department of Biostatistics, Moffitt Cancer Center, Tampa, Florida.
authors: Michael J
authors: MJ
authors: Schell
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002392:Catechin / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018450:Disease Progression; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D008875:Middle Aged; D019048:Prostatic Intraepithelial Neoplasia / Q000473:pathology*; D011471:Prostatic Neoplasms / Q000517:prevention & control*; D013662:Tea
chemical_list: D000970:Antineoplastic Agents; D013662:Tea; D002392:Catechin; C472086:polyphenon E