title: A panel of TMPRSS2:ERG fusion transcript markers for urine-based prostate cancer detection with high specificity and sensitivity.
abstract: BACKGROUND
  The TMPRSS2:ERG fusion is both prevalent and unique to prostate cancer (PCa) and has great potential for noninvasive diagnosis of PCa in bodily fluids.
  
  
  OBJECTIVE
  To evaluate the specificity and sensitivity of the TMPRSS2:ERG fusion in urine from diverse clinical contexts and to explore potential clinical applications.
  
  
  METHODS
  A total of 101 subjects were enrolled in 2008 from urologic oncology clinics to form three study groups: 44 PCa free, 46 confirmed PCa, and 11 negative prostate biopsies. The PCa-free group included females, healthy young men, and post-radical prostatectomy (RP) patients. The confirmed PCa group was composed of patients under active surveillance, scheduled for treatment, or with metastatic disease.
  
  
  METHODS
  Urine was collected after attentive digital rectal exam (DRE) and coded to blind group allocation for laboratory test. RNA from urine sediments was analyzed using a panel of four TMPRSS2:ERG fusion markers with quantitative polymerase chain reaction (qPCR).
  
  
  CONCLUSIONS
  Our fusion markers demonstrated very high technical specificity and sensitivity for detecting a single fusion-positive cancer cell (VCaP) in the presence of at least 3000 cells in urine sediments. In clinical analysis, there were no fusion-positive samples in the PCa-free group (0 of 44 samples), while there were 16 of 46 (34.8%) fusion-positive samples in the confirmed PCa group. The fusion incidence varied significantly among the three PCa subgroups. The clinical sensitivity increased to 45.4% in cancer patients prior to treatments. The fusion markers were detected in 2 of 11 (18.2%) biopsy-negative patients, suggesting potentially false negative biopsies. This study is not prospective and is limited in sample sizes.
  
  
  CONCLUSIONS
  Our novel panel of TMPRSS2:ERG fusion markers provided a very specific and sensitive tool for urine-based detection of PCa. Theses markers can potentially be used to diagnose patients with PCa who have negative biopsies.
authors.affiliation: Department of Surgery/Division of Urology, McGill University Health Center, Montreal, Quebec, H3G 1A4 Canada.
authors.forename: Phuong-Nam
authors.initials: PN
authors.lastname: Nguyen
authors.forename: Philippe
authors.initials: P
authors.lastname: Violette
authors.forename: Sam
authors.initials: S
authors.lastname: Chan
authors.forename: Simon
authors.initials: S
authors.lastname: Tanguay
authors.forename: Wassim
authors.initials: W
authors.lastname: Kassouf
authors.forename: Armen
authors.initials: A
authors.lastname: Aprikian
authors.forename: Junjian Z
authors.initials: JZ
authors.lastname: Chen
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D014408:Biomarkers, Tumor / Q000652:urine*; D001706:Biopsy; D045744:Cell Line, Tumor; D015331:Cohort Studies; D005260:Female; D020869:Gene Expression Profiling; D005820:Genetic Testing / Q000379:methods* / Q000592:standards; D006801:Humans; D008297:Male; D008875:Middle Aged; D015514:Oncogene Proteins, Fusion / Q000235:genetics / Q000652:urine*; D011471:Prostatic Neoplasms / Q000235:genetics / Q000556:secondary / Q000652:urine; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D014408:Biomarkers, Tumor; D015514:Oncogene Proteins, Fusion; C515553:TMPRSS2-ERG fusion protein, human