Eligibility and outcomes reporting guidelines for clinical trials for patients in the state of a rising prostate-specific antigen: recommendations from the Prostate-Specific Antigen Working Group.

@article{Scher2004EligibilityAO,
  title={Eligibility and outcomes reporting guidelines for clinical trials for patients in the state of a rising prostate-specific antigen: recommendations from the Prostate-Specific Antigen Working Group.},
  author={Howard I. Scher and Mario J Eisenberger and Anthony V. D'Amico and Susan Halabi and Eric Jay Small and Michael J Morris and Michael W. Kattan and Mack Roach and Philip W. Kantoff and Kenneth J. Pienta and Michael Anthony Carducci and David Agus and Susan F. Slovin and Glenn Heller and William Kevin Kelly and Paul H. Lange and Daniel Peter Petrylak and William Berg and Celestra Higano and George Wilding and Judd W. Moul and Alan N Partin and Christopher Logothetis and Howard R. Soule},
  journal={Journal of clinical oncology : official journal of the American Society of Clinical Oncology},
  year={2004},
  volume={22 3},
  pages={537-56}
}
PURPOSE To define methodology to show clinical benefit for patients in the state of a rising prostate-specific antigen (PSA). RESULTS HYPOTHESIS A clinical states framework was used to address the hypothesis that definitive phase III trials could not be conducted in this patient population. PATIENT POPULATION The Group focused on men with systemic (nonlocalized) recurrence and a defined risk of developing clinically detectable metastases. Models to define systemic versus local recurrence… CONTINUE READING

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