title: A preliminary study of JM-27: a serum marker that can specifically identify men with symptomatic benign prostatic hyperplasia.
abstract: OBJECTIVE
  Benign prostatic hyperplasia is a common disease in men that until recently was considered a single disease with varying symptoms. Our recent analysis has revealed that a molecular marker, JM-27, is able to distinguish at the tissue level between highly symptomatic individuals and those with histological disease. The goal of these studies was to determine if a serum based assay to detect JM-27 could distinguish men with different forms of benign prostatic hyperplasia.
  
  
  METHODS
  A serum based enzyme-linked immunosorbent assay was developed using a novel anti-JM-27 monoclonal antibody. The assay was sensitive, detecting JM-27 at the low ng/ml level within the serum. A quantitative measurement of serum JM-27 levels was performed in 68 patients. The patients consisted of 3 groups of 29 patients with asymptomatic benign prostatic hyperplasia (American Urological Association symptom score of 15 or less), 39 with symptomatic benign prostatic hyperplasia (American Urological Association symptom score 16 to 32) and 17 with confirmed prostate cancer. The assay cutoff was determined after a pilot run of samples and applied prospectively.
  
  
  RESULTS
  Using the determined cutoff, serum levels of JM-27 can distinguish between symptomatic and asymptomatic patient sets. The sensitivity and specificity of the assay are 90% and 77%, respectively. The presence of prostate cancer in these men does not appear to alter the marker levels.
  
  
  CONCLUSIONS
  The present study is believed to represent the first characterization of a serum based marker for severe benign prostatic hyperplasia.
authors.affiliation: James Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland 21287, USA.
authors.forename: Grant W
authors.initials: GW
authors.lastname: Cannon
authors.forename: Chris
authors.initials: C
authors.lastname: Mullins
authors.forename: M Scott
authors.initials: MS
authors.lastname: Lucia
authors.forename: Simon W
authors.initials: SW
authors.lastname: Hayward
authors.forename: Victor
authors.initials: V
authors.lastname: Lin
authors.forename: Brian C-S
authors.initials: BC
authors.lastname: Liu
authors.forename: Kevin
authors.initials: K
authors.lastname: Slawin
authors.forename: Mark A
authors.initials: MA
authors.lastname: Rubin
authors.forename: Robert H
authors.initials: RH
authors.lastname: Getzenberg
mesh_terms: D000951:Antigens, Neoplasm / Q000097:blood*; D015415:Biomarkers / Q000097:blood; D006801:Humans; D008297:Male; D011470:Prostatic Hyperplasia / Q000097:blood* / Q000175:diagnosis*; D011471:Prostatic Neoplasms / Q000097:blood / Q000175:diagnosis; D012680:Sensitivity and Specificity
chemical_list: D000951:Antigens, Neoplasm; D015415:Biomarkers; C474505:PAGE4 protein, human