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
| Autor: | Aslam Kazi, Said M. Sebti, Gwen Quinn, Julio M. Pow-Sang, Kyle Anderson, Fred Schreiber, Michael J. Schell, Jerry McLarty, Mohamed Helal, Tian Chuang, Philippe E. Spiess, Tiffany Smith, Shahnjayla Connors, Nagi B. Kumar, Tajammul Fazili, Kathleen Egan, Christopher R. Williams, Raoul Salup, Edouard J. Trabulsi, Theresa Crocker, Gregory P. Zagaja |
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| Rok vydání: | 2012 |
| Předmět: |
Oncology
Pathology medicine.medical_specialty 030232 urology & nephrology Phases of clinical research Proliferative and apoptotic markers Disease Chemoprevention Article law.invention PSA 03 medical and health sciences Prostate cancer 0302 clinical medicine Randomized controlled trial law Internal medicine medicine ASAP High-grade prostatic intraepithelial neoplasia Steroid hormones Green tea polyphenols Atypical small acinar proliferation Proteasome inhibition medicine.diagnostic_test business.industry Cancer HGPIN medicine.disease 3. Good health Clinical trial 030220 oncology & carcinogenesis business |
| Zdroj: | Journal of clinical trials |
| ISSN: | 2167-0870 |
| DOI: | 10.4172/jctr.1000105 |
| Popis: | 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 vitro and 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 chemopreventio |
| Databáze: | OpenAIRE |
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