title: Prostate cancer, comorbidity, and participation in randomized controlled trials of therapy.
abstract: BACKGROUND
  Randomized controlled trials (RCTs) evaluate the potential benefits of chemotherapy regimens and guide clinical care for patients with cancer. Inclusion criteria for RCTs are usually stringent and may exclude many patients seen in clinical practice. Our objective was to determine the proportion of men with castrate-resistant prostate cancer (CRPC) in a clinical setting that would have been excluded from major phase 3 RCTs.
  
  
  METHODS
  We reviewed eligibility criteria from 24 phase 3 clinical trials evaluating chemotherapy for CRPC active from January, 2004, through April, 2008. We created a common list of criteria used in at least 3 studies and separately considered the criteria from a prominent RCT (TAX 327). We applied these criteria to a population of patients with CRPC treated during 2004 to 2006 at the Veterans Affairs Connecticut Healthcare System.
  
  
  RESULTS
  Among 106 patients with CRPC, 99 (93%) had complete medical records, and 45 (45%) of the 99 would have been excluded from RCTs. Common reasons for exclusion were abnormal laboratory values, other malignancies, and other serious medical conditions including cardiac disease.
  
  
  CONCLUSIONS
  Almost half of the CRPC patients examined in a clinical setting would have been ineligible for phase 3 RCTs, highlighting that such trials may not be applicable to general oncology practice.
authors.affiliation: VA Clinical Epidemiology Research Center, VA Connecticut Healthcare System, West Haven, CT 06516, USA. herta.chao@yale.edu
authors.forename: Herta H
authors.initials: HH
authors.lastname: Chao
authors.forename: Tina
authors.initials: T
authors.lastname: Mayer
authors.forename: John
authors.initials: J
authors.lastname: Concato
authors.forename: Michal G
authors.initials: MG
authors.lastname: Rose
authors.forename: Edward
authors.initials: E
authors.lastname: Uchio
authors.forename: Wm Kevin
authors.initials: WK
authors.lastname: Kelly
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D015897:Comorbidity; D006801:Humans; D008297:Male; D008875:Middle Aged; D010358:Patient Participation; D018579:Patient Selection; D011471:Prostatic Neoplasms / Q000453:epidemiology* / Q000628:therapy*; D016032:Randomized Controlled Trials as Topic