title: Prostate Cancer Chemoprevention Targeting Men with High-Grade Prostatic Intraepithelial Neoplasia (HGPIN) and Atypical Small Acinar Proliferation (ASAP): Model for Trial Design and Outcome Measures.
abstract: In spite of the large number of nutrient-derived agents demonstrating promise as potential chemopreventive agents, most have failed to prove effectiveness in clinical trials. Critical requirements for moving nutrient-derived agents to recommendation for clinical use include adopting a systematic, molecular-mechanism based approach and utilizing the same ethical and rigorous methods such as are used to evaluate other pharmacological agents. Preliminary data on a mechanistic rationale for chemoprevention activity as observed from epidemiological,in vitroand preclinical studies, phase I data of safety in suitable cohorts, duration of intervention based on time to progression of preneoplastic disease to cancer and the use of a valid panel of biomarkers representing the hypothesized carcinogenesis pathway for measuring efficacy must inform the design of phase II clinical trials. The goal of this paper is to provide a model for evaluating a well characterized agent- Polyphenon E- in a phase II clinical trial of prostate cancer chemoprevention.
authors.affiliation: Departments of Epidemiology, Health Outcomes and Behavior, Biostatistics, H. Lee Moffitt Cancer Center & Research Institute, University of South Florida College of Medicine, Florida, USA ; Oncological Sciences, University of South Florida College of Medicine, Tampa Florida.
authors.forename: Nagi
authors.initials: N
authors.lastname: Kumar
authors.affiliation: Departments of Epidemiology, Health Outcomes and Behavior, Biostatistics, H. Lee Moffitt Cancer Center & Research Institute, University of South Florida College of Medicine, Florida, USA.
authors.forename: Theresa
authors.initials: T
authors.lastname: Crocker
authors.affiliation: Departments of Epidemiology, Health Outcomes and Behavior, Biostatistics, H. Lee Moffitt Cancer Center & Research Institute, University of South Florida College of Medicine, Florida, USA.
authors.forename: Tiffany
authors.initials: T
authors.lastname: Smith
authors.affiliation: Departments of Epidemiology, Health Outcomes and Behavior, Biostatistics, H. Lee Moffitt Cancer Center & Research Institute, University of South Florida College of Medicine, Florida, USA ; Oncological Sciences, University of South Florida College of Medicine, Tampa Florida.
authors.forename: Shahnjayla
authors.initials: S
authors.lastname: Connors
authors.affiliation: Departments of Epidemiology, Health Outcomes and Behavior, Biostatistics, H. Lee Moffitt Cancer Center & Research Institute, University of South Florida College of Medicine, Florida, USA ; Oncological Sciences, University of South Florida College of Medicine, Tampa Florida.
authors.forename: Julio
authors.initials: J
authors.lastname: Pow-Sang
authors.affiliation: Departments of Epidemiology, Health Outcomes and Behavior, Biostatistics, H. Lee Moffitt Cancer Center & Research Institute, University of South Florida College of Medicine, Florida, USA ; Oncological Sciences, University of South Florida College of Medicine, Tampa Florida.
authors.forename: Philippe E
authors.initials: PE
authors.lastname: Spiess
authors.affiliation: Departments of Epidemiology, Health Outcomes and Behavior, Biostatistics, H. Lee Moffitt Cancer Center & Research Institute, University of South Florida College of Medicine, Florida, USA ; Oncological Sciences, University of South Florida College of Medicine, Tampa Florida.
authors.forename: Kathleen
authors.initials: K
authors.lastname: Egan
authors.affiliation: Departments of Epidemiology, Health Outcomes and Behavior, Biostatistics, H. Lee Moffitt Cancer Center & Research Institute, University of South Florida College of Medicine, Florida, USA ; Oncological Sciences, University of South Florida College of Medicine, Tampa Florida.
authors.forename: Gwen
authors.initials: G
authors.lastname: Quinn
authors.affiliation: Departments of Epidemiology, Health Outcomes and Behavior, Biostatistics, H. Lee Moffitt Cancer Center & Research Institute, University of South Florida College of Medicine, Florida, USA ; Oncological Sciences, University of South Florida College of Medicine, Tampa Florida.
authors.forename: Michael
authors.initials: M
authors.lastname: Schell
authors.affiliation: Departments of Epidemiology, Health Outcomes and Behavior, Biostatistics, H. Lee Moffitt Cancer Center & Research Institute, University of South Florida College of Medicine, Florida, USA ; Oncological Sciences, University of South Florida College of Medicine, Tampa Florida.
authors.forename: Said
authors.initials: S
authors.lastname: Sebti
authors.affiliation: Departments of Epidemiology, Health Outcomes and Behavior, Biostatistics, H. Lee Moffitt Cancer Center & Research Institute, University of South Florida College of Medicine, Florida, USA ; Oncological Sciences, University of South Florida College of Medicine, Tampa Florida.
authors.forename: Aslam
authors.initials: A
authors.lastname: Kazi
authors.affiliation: Departments of Epidemiology, Health Outcomes and Behavior, Biostatistics, H. Lee Moffitt Cancer Center & Research Institute, University of South Florida College of Medicine, Florida, USA ; Oncological Sciences, University of South Florida College of Medicine, Tampa Florida.
authors.forename: Tian
authors.initials: T
authors.lastname: Chuang
authors.affiliation: Oncological Sciences, University of South Florida College of Medicine, Tampa Florida ; James A. Haley V.A. Hospital, Tampa, FL.
authors.forename: Raoul
authors.initials: R
authors.lastname: Salup
authors.affiliation: Oncological Sciences, University of South Florida College of Medicine, Tampa Florida.
authors.forename: Mohamed
authors.initials: M
authors.lastname: Helal
authors.affiliation: University of Chicago, Chicago, IL.
authors.forename: Gregory
authors.initials: G
authors.lastname: Zagaja
authors.affiliation: Jefferson Medical College, Philadelphia, PA.
authors.forename: Edouard
authors.initials: E
authors.lastname: Trabulsi
authors.affiliation: LSUHSC - Feist-Weiller Cancer Center, Shreveport, LA.
authors.forename: Jerry
authors.initials: J
authors.lastname: McLarty
authors.affiliation: Overton Brooks VA, Shreveport, LA.
authors.forename: Tajammul
authors.initials: T
authors.lastname: Fazili
authors.affiliation: University of Florida - Jacksonville.
authors.forename: Christopher R
authors.initials: CR
authors.lastname: Williams
authors.affiliation: Watson Clinic - Center for Cancer Care & Research, Lakeland, FL.
authors.forename: Fred
authors.initials: F
authors.lastname: Schreiber
authors.affiliation: Minneapolis VA Medical Center, Minneapolis, MN.
authors.forename: Kyle
authors.initials: K
authors.lastname: Anderson
keywords: ASAP; Chemoprevention; Green tea polyphenols; HGPIN; PSA; Proliferative and apoptotic markers; Prostate cancer; Proteasome inhibition; Steroid hormones