title: PCA3 molecular urine test as a predictor of repeat prostate biopsy outcome in men with previous negative biopsies: a prospective multicenter clinical study.
abstract: OBJECTIVE
  We evaluated the clinical usefulness of the PROGENSA® PCA3 Assay for predicting repeat prostate biopsy outcome.
  
  
  METHODS
  Men with at least 1 prior negative prostate biopsy who were scheduled for repeat prostate biopsy based on best clinical judgment were enrolled at 14 centers. Whole blood and post-digital rectal examination urine samples were collected before extended template transrectal biopsy with 12 or more cores. Urinary PCA3 scores and biopsy outcomes were assessed by logistic regression analysis, which also included age, race, serum prostate specific antigen, clinical stage, family history of prostate cancer and the number of previous negative biopsy sessions.
  
  
  RESULTS
  A total of 466 men were included in study and prostate cancer was identified in 21.9%. A PCA3 score cutoff of 25 yielded 77.5% sensitivity, 57.1% specificity, and negative and positive predictive values of 90% and 33.6%, respectively. On multivariable logistic regression men with a PCA3 score of less than 25 were 4.56 times as likely to have a negative repeat biopsy as men with a score of 25 or greater. PCA3 score significantly increased the predictive accuracy of the logistic regression model. At 90% sensitivity adding the PCA3 score to the model increased specificity, and positive and negative predictive values by 22.6%, 6.4% and 7.1%, respectively, relative to the model without the PCA3 score.
  
  
  CONCLUSIONS
  The PCA3 score supplements serum prostate specific antigen and other clinical information to provide more accurate prediction of repeat biopsy outcome. Thus, it provides clinicians and patients with independent, clinically useful information to make more informed repeat biopsy decisions.
authors: South Florida Medical Research, Aventura, Florida 33180, USA.
authors: Marc C
authors: MC
authors: Gittelman
authors: Bernard
authors: B
authors: Hertzman
authors: James
authors: J
authors: Bailen
authors: Thomas
authors: T
authors: Williams
authors: Isaac
authors: I
authors: Koziol
authors: Ralph Jonathan
authors: RJ
authors: Henderson
authors: Mitchell
authors: M
authors: Efros
authors: Mohamed
authors: M
authors: Bidair
authors: John F
authors: JF
authors: Ward
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000951:Antigens, Neoplasm / Q000235:genetics / Q000378:metabolism / Q000652:urine*; D014408:Biomarkers, Tumor / Q000652:urine*; D001707:Biopsy, Needle / Q000706:statistics & numerical data*; D016001:Confidence Intervals; D051517:Digital Rectal Examination; D018450:Disease Progression; D015972:Gene Expression Regulation, Neoplastic; D006801:Humans; D061705:Image-Guided Biopsy / Q000379:methods; D007150:Immunohistochemistry; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D016017:Odds Ratio; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000235:genetics / Q000473:pathology* / Q000652:urine*; D018570:Risk Assessment; D012680:Sensitivity and Specificity
chemical_list: D000951:Antigens, Neoplasm; D014408:Biomarkers, Tumor; C479341:prostate cancer antigen 3, human