Journal des essais cliniques
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Chimioprévention du cancer de la prostate ciblant les hommes atteints de néoplasie intraépithéliale prostatique de haut grade (HGPIN) et de prolifération acineuse atypique de petite taille (ASAP) : modèle de conception d'essai et mesures de résultats

Nagi Kumar, Theresa Crocker, Tiffany Smith, Shahnjayla Connors, Julio Pow-Sang, Philippe E. Spiess, Kathleen Egan, Gwen Quinn, Michael Schell, Said Sebti, Aslam Kazi, Tian Chuang, Raoul Salup, Mohamed Helal, Gregory Zagaja, Édouard Trabulsi, Jerry McLarty, Tajammul Fazili, Christopher R. Williams, Fred Schreiber et Kyle Anderson

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