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ISSN: 1948-5956

Journal of Cancer Science & Therapy
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Research Article

Prostate Cancer Chemoprevention Targeting High Risk Populations: Model for Trial Design and Outcome Measures

Nagi Kumar1,2*, Theresa Crocker1, Tiffany Smith1, Julio Pow-Sang1,2, Philippe E. Spiess1,2, Shanjayla Connors1, Ganna Chornukur1, Shohreh Iravani Dickinson1,2, Wenlong Bai3*, Christopher R. Williams4, Raoul Salup5 and Wui Fu6

1Department of Epidemiology, H. Lee Moffitt Cancer Center & Research Institute, University of South Florida, College of Medicine, Tampa, Florida

2Department of Oncological Sciences, University of South Florida, College of Medicine, Tampa, Florida

3Department of Pathology and Cell Biology, H. Lee Moffitt Cancer Center & Research Institute, University of South Florida, College of Medicine, Tampa, Florida

4Department of Surgery, University of Florida, College of Medicine, Jacksonville, Florida

5Department of Urology, James A Haley Veterans Administration Hospital, University of South Florida, College of Medicine, Tampa, Florida

6Department of Cellular Biology, University of South Florida, College of Medicine, Tampa, Florida

*Corresponding Author:
Nagi B. Kumar, PhD, RD, FADA
Senior Member Population Sciences Division
Director, Cancer Chemoprevention
Moffitt Cancer Center, Professor, Oncologic Sciences
University of South Florida College of Medicine
12902 Magnolia Drive Tampa, FL 33612, USA
Tel: 8137456885
Fax: 8137457183
E-mail: [email protected]
Wenlong Bai, PhD
Professor, Department of Pathology and Cell Biology
USF College of Medicine, Member
Molecular Oncology Program
H. Lee Moffitt Cancer Center
12901 Bruce B. Downs Blvd., MDC 11
Tampa, FL 33612-4799, USA
Tel: 813-974-0563
Fax: 813-974-5536
E-mail: [email protected]

Received Date: December 09, 2011; Accepted Date: January 08, 2012; Published Date: January 10, 2012

Citation: Kumar N, Crocker T, Smith T, Pow-Sang J, Spiess PE, et al. (2012) Prostate Cancer Chemoprevention Targeting High Risk Populations: Model for Trial Design and Outcome Measures. J Cancer Sci Ther S3:007. doi:10.4172/1948-5956.S3-007

Copyright: © 2012 Kumar N, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Abstract

Inspite of the large number of promising 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 vitro and preclinical studies, phase I data of safety in high-risk cohorts are required to inform design of phase II clinical trials. Additionally, a valid panel of biomarkers representing the hypothesized carcinogenesis pathway for measuring efficacy must be utilized to evaluate effectiveness in these trials. The goal of this paper is to provide a model, using a systematic approach for evaluating the safety, effectiveness and mechanism of action of a well characterized nutrient-derived agent- isoflavones - in a phase II clinical trial for prostate cancer (CaP) chemoprevention, targeting a population of African American (AA) and Caucasian men. Based on our previous observations, we hypothesize that the effects of isoflavones on prostate carcinogenesis are mainly mediated through the down regulation of androgen receptor (AR) and AR activity in AA men is higher due to its shorter length of Glutamine repeats in its N-terminus. We thus believe that isoflavones will exert a stronger protective effect for CaP in AA men and cause a higher activation of FOXO factors and their target genes. The aim of the study is to evaluate the comparative effectiveness of the study agent and placebo, in addition to a comparison of the effectiveness and safety in African American men compared to Caucasian men treated with this agent.

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