Abstract

ABSTRACT Background: The treatment landscape for men with later-stage prostate cancer has changed dramatically over the past several years due to an increase in the understanding of the natural history of the disease and the availability of multiple new therapies. The influx of new agents has made treatment decisions for clinicians increasingly complex and little is known about how patients are treated in daily clinical practice. We report the initiation of a new observational study designed to provide insight into global treatment trends and outcomes across the treatment continuum for later stage prostate cancer. The findings of this study may inform the design of new interventional studies and the development of global best practices. Trial design: This is a prospective, multinational, longitudinal, observational study. Men are included if they have been diagnosed with prostate adenocarcinoma, provided written informed consent, belong to one of three patient subsets: (1) biochemical failure and a rapid PSA doubling time following curative-intent treatment; (2) newly diagnosed with castration-resistant disease; or (3) metastatic disease at initial presentation, and will receive active treatment at study entry. Exclusion criteria include prior treatment with systemic chemotherapy, life expectancy of Disclosure: M. De Santis: Consultant or Advisory Role: Amgen, Astellas, Bayer, Dendreon, GSK, Janssen, Novartis, OncoGenex, Pierre Fabre, Roche, Sanofi, Shionogi Honoraria: Amgen, Bayer, Dendreon, GSK, Janssen, Novartis, Pierre Fabre, Roche, Sanofi Research Funding: Pierre Fabre; M.R. Cooperberg: Consultant: Astellas, Janssen, Dendreon, Abbott Labs, Genomic Health, GenomeDx, andnMyriad Genetics; T. Pickles: Advisory Board: Amgen, Astellas Honoraria: Abbvie, Diagnostic Solutions & Results Inc, Ferring, GlaxoSmithKline, Janssen Clinical Trials or Research Support: Sanofi Aventis, Oncura; R. Curiel: Employment: Astellas. All other authors have declared no conflicts of interest.

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