title: Accuracy of the prostate health index versus the urinary prostate cancer antigen 3 score to predict overall and significant prostate cancer at initial biopsy.
abstract: BACKGROUND
  It remains unclear whether the Prostate Health Index (PHI) or the urinary Prostate-Cancer Antigen 3 (PCA-3) score is more accurate at screening for prostate cancer (PCa). The aim of this study was to prospectively compare the accuracy of PHI and PCA-3 scores to predict overall and significant PCa in men undergoing an initial prostate biopsy.
  
  
  METHODS
  Double-blind assessments of PHI and PCA-3 were conducted by referent physicians in 138 patients who subsequently underwent trans-rectal ultrasound-guided prostate biopsy according to a 12-core scheme. Predictive accuracies of PHI and PCA-3 were assessed using AUC and compared according to the DeLong method. Diagnostic performances with usual cut-off values for positivity (i.e., PHI >40 and PCA-3 >35) were calculated, and odds ratios associated with predicting PCa overall and significant PCa as defined by pathological updated Epstein criteria (i.e., Gleason score ≥7, more than three positive cores, or >50% cancer involvement in any core) were estimated using logistic regression.
  
  
  RESULTS
  Prevalences of overall and significant PCa were 44.9% and 28.3%, respectively. PCA-3 (AUC = 0.71) was the most accurate predictor of PCa overall, and significantly outperformed PHI (AUC = 0.65; P = 0.03). However, PHI (AUC = 0.80) remained the most accurate predictor when screening exclusively for significant PCa and significantly outperformed PCA-3 (AUC = 0.55; P = 0.03). Furthermore, PCA-3 >35 had the best accuracy, and positive or negative predictive values when screening for PCa overall whereas these diagnostic performances were greater for PHI >40 when exclusively screening for significant PCa. PHI > 40 combined with PCA-3 > 35 was more specific in both cases. In multivariate analyses, PCA-3 >35 (OR = 5.68; 95%CI = [2.21-14.59]; P < 0.001) was significantly correlated with the presence of PCa overall, but PHI >40 (OR = 9.60; 95%CI = [1.72-91.32]; P = 0.001) was the only independent predictor for detecting significant PCa.
  
  
  CONCLUSIONS
  Although PCA-3 score is the best predictor for PCa overall at initial biopsy, our findings strongly indicate that PHI should be used for population-based screening to avoid over-diagnosis of indolent tumors that are unlikely to cause death.
authors.affiliation: Academic Department of Urology, Pitié-Salpétrière Hospital, AP-HP, Paris, France; UPMC Univ Paris 06, GRC5, ONCOTYPE-URO, Institut Universitaire de Cancérologie, Paris, France.
authors.forename: Thomas
authors.initials: T
authors.lastname: Seisen
authors.forename: Morgan
authors.initials: M
authors.lastname: Rouprêt
authors.forename: Didier
authors.initials: D
authors.lastname: Brault
authors.forename: Priscilla
authors.initials: P
authors.lastname: Léon
authors.forename: Géraldine
authors.initials: G
authors.lastname: Cancel-Tassin
authors.forename: Eva
authors.initials: E
authors.lastname: Compérat
authors.forename: Raphaële
authors.initials: R
authors.lastname: Renard-Penna
authors.forename: Pierre
authors.initials: P
authors.lastname: Mozer
authors.forename: Jérome
authors.initials: J
authors.lastname: Guechot
authors.forename: Olivier
authors.initials: O
authors.lastname: Cussenot
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000951:Antigens, Neoplasm / Q000652:urine*; D019540:Area Under Curve; D015415:Biomarkers / Q000652:urine*; D001706:Biopsy; D015331:Cohort Studies; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011467:Prostate / Q000473:pathology*; D011471:Prostatic Neoplasms / Q000175:diagnosis*
chemical_list: D000951:Antigens, Neoplasm; D015415:Biomarkers; C479341:prostate cancer antigen 3, human
keywords: antigens; biological markers; biopsy; early detection of cancer; prostate-specific antigen; prostatic neoplasm