title: Reflex PCA3 messenger ribonucleic acid testing: validation of postbiopsy urine samples and correlation with prostate biopsy findings in ∼2000 patients.
abstract: OBJECTIVE
  To validate post-transrectal ultrasonography (TRUS) prostate biopsy (bx) urine samples for PCA3 messenger ribonucleic acid testing, including correlation of PCA3 score with concurrent bx findings.
  
  
  METHODS
  From July 2008 to July 2010, 2015 patients had urine collected immediately after a TRUS-guided prostate bx. Excluded were men with history of prostate carcinoma (CaP), <6 or ≥24 bx cores, and/or prostate-specific antigen (PSA) level ≥50 ng/mL, resulting in 1909 included men. PCA3 and PSA messenger ribonucleic acid were quantitated using transcription-mediated amplification. A PCA3 score of ≥35 was considered positive.
  
  
  RESULTS
  Mean and median ages were 66 years. Mean and median PSA levels were 6.7 and 5.1 ng/mL, respectively. Bxs were benign in 970 (50.8%), CaP in 726 (38%), high-grade prostatic intraepithelial neoplasia (HGPIN) in 124 (6.5%), and atypical in 89 (4.7%). PCA3 test was informative in 1887 (98.8%) patients. Means ± standard deviations (median) of PCA3 scores for benign, HGPIN, atypical, and CaP were 22.3 ± 27.9 (12.8), 37.6 ± 43.2 (24.1), 35.7 ± 36.2 (25.7), and 46.9 ± 48.1 (31.6; P <.05 benign vs CaP, benign vs HGPIN and atypical, HGPIN and atypical vs CaP). Sensitivity and specificity of PCA3 for CaP were 46.3% and 78.7%, respectively. CaP risk increased with progressively higher PCA3 score ranges from 14.8% for PCA3 <5 to 66.7% for PCA3 >100. Area under the curve (AUC) for the PCA3 receiver operating characteristics was not significantly different in men without prior bx (AUC = 0.716) compared with men with at least 1 prior nonpositive bx (AUC = 0.702).
  
  
  CONCLUSIONS
  Post-TRUS bx urine is a valid sample for PCA3 testing. Patients with a negative bx and a positive PCA3 test may have a higher likelihood of unsampled CaP.
authors.affiliation: Avero Diagnostics, Irving, TX. Electronic address: brown.jeffreyg@gmail.com.
authors.forename: Jeffrey G
authors.initials: JG
authors.lastname: Brown
authors.affiliation: Avero Diagnostics, Irving, TX.
authors.forename: John R
authors.initials: JR
authors.lastname: Fulmer
authors.affiliation: Avero Diagnostics, Irving, TX.
authors.forename: Javier
authors.initials: J
authors.lastname: Romano
authors.affiliation: Avero Diagnostics, Irving, TX.
authors.forename: John
authors.initials: J
authors.lastname: Pownell
authors.affiliation: Avero Diagnostics, Irving, TX.
authors.forename: Wayne
authors.initials: W
authors.lastname: Rigler
authors.affiliation: Urological Consultants of Florida, Miami, FL.
authors.forename: Amery
authors.initials: A
authors.lastname: Wirtshafter
authors.affiliation: Vision Biotechnology Consulting, Escondido, CA.
authors.forename: Mark
authors.initials: M
authors.lastname: Sarno
authors.affiliation: Avero Diagnostics, Irving, TX.
authors.forename: Scott B
authors.initials: SB
authors.lastname: Shappell
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000951:Antigens, Neoplasm / Q000235:genetics* / Q000652:urine*; D001706:Biopsy; D055088:Early Detection of Cancer; D006801:Humans; D008297:Male; D008875:Middle Aged; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000175:diagnosis / Q000000981:diagnostic imaging / Q000652:urine*; D012333:RNA, Messenger / Q000652:urine*; D012189:Retrospective Studies; D012307:Risk Factors; D012680:Sensitivity and Specificity; D014158:Transcription, Genetic; D014463:Ultrasonography
chemical_list: D000951:Antigens, Neoplasm; D012333:RNA, Messenger; C479341:prostate cancer antigen 3, human; D017430:Prostate-Specific Antigen