807TiP - A prospective, multinational observational study of men with later-stage prostate cancer, a new global study to examine patterns of care and outcomes

Date 27 September 2014
Event ESMO 2014
Session Poster Display session
Topics Prostate Cancer
Cancer Aetiology, Epidemiology, Prevention
Presenter Maria De Santis
Citation Annals of Oncology (2014) 25 (suppl_4): iv255-iv279. 10.1093/annonc/mdu336
Authors M. De Santis1, M.R. Cooperberg2, Y. Chang3, N.W. Clarke4, A.J. Costello5, T. Pickles6, R. Curiel7, A.C. Pompeo8
  • 13. Medizinische Abteilung Zentrum Für Onkologie Und Hämatologie, LBI-ACR and KFJ-Hospital, A­1100 - Vienna/AT
  • 2Urology, UCSF, San Francisco/US
  • 3Department Of Surgery, Taipei Veterans General Hospital, Taipei/TW
  • 4Department Of Urology, The Christie Hospital, Manchester/GB
  • 5Department Of Urology, The Royal Melbourne Hospital, Melbourne/AU
  • 6Department Of Surgery, University of British Columbia, Vancouver/CA
  • 7Global Medical Affairs, Astellas, Northbrook/US
  • 8Department Of Urology, Faculdade de Medicina do ABC (FM-ABC), São Paulo/BR

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 <1 year due to comorbidities, or participation in a clinical trial of investigational therapy at study entry. The primary objective of the study is to describe patterns in disease management and clinical outcomes. The secondary objectives are to identify factors influencing treatment decisions and to document healthcare resource utilization. Patients will be followed for a minimum of 4 years and up to 6 years. Data entry is electronic. Physician and patient confidentiality are strictly maintained. Study Status: Approximately 2,900 patients will be enrolled from 31 countries in the Americas (Latin America, Canada), Europe, Asia Pacific, and Middle East and North Africa. The study was recently opened for recruitment (NCT02066961) and the first few patients have been enrolled. Updated enrollment figures will be provided at the time of presentation.

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.