title: Multicenter Evaluation of the Prostate Health Index to Detect Aggressive Prostate Cancer in Biopsy Naïve Men.
abstract: OBJECTIVE
  We evaluated the ability of PHI to discriminate aggressive prostate cancer from indolent or no cancer in a biopsy naïve population.
  
  
  METHODS
  Two independent prospective cohorts of 561 and 395 subjects, respectively, with no prior prostate biopsy who were enrolled at different clinical sites were used to validate the results. We compared the diagnostic specificity of PHI to prebiopsy total and percent free prostate specific antigen using prostate biopsy results. We also determined the optimal PHI threshold to discriminate aggressive prostate cancer (Gleason score 7 or greater) from indolent or no prostate cancer (Gleason score 6 or less).
  
  
  RESULTS
  In the primary cohort higher PHI values were significantly associated with Gleason score 7 or greater. The AUC to detect aggressive prostate cancer was 0.815. At 95% sensitivity PHI specificity was 36.0% vs 17.2% and 19.4% for total and percent free prostate specific antigen, respectively. At 95% sensitivity for detecting aggressive prostate cancer the optimal PHI cutoff was 24, which would help avoid 41% of unnecessary biopsies. A cutoff of 24 led to 36% biopsies avoided with few aggressive cancers missed. These results were confirmed in the validation cohort.
  
  
  CONCLUSIONS
  The PHI detected aggressive prostate cancer with better specificity than total and percent free prostate specific antigen in a biopsy naïve population. It could be a useful tool to decrease unnecessary prostate biopsies.
authors: Department of Urology, Emory University School of Medicine, Atlanta, Georgia.
authors: Claire
authors: C
authors: de la Calle
authors: Department of Urology, Emory University School of Medicine, Atlanta, Georgia.
authors: Dattatraya
authors: D
authors: Patil
authors: Department of Urology, University of Michigan Medical School, Ann Arbor, Michigan.
authors: John T
authors: JT
authors: Wei
authors: Department of Urology, Weill Cornell Medical College and New York Presbyterian Hospital, New York, New York.
authors: Douglas S
authors: DS
authors: Scherr
authors: Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland.
authors: Lori
authors: L
authors: Sokoll
authors: Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland.
authors: Daniel W
authors: DW
authors: Chan
authors: Department of Urology, University of Michigan Medical School, Ann Arbor, Michigan.
authors: Javed
authors: J
authors: Siddiqui
authors: Department of Pathology, Weill Cornell Medical College and New York Presbyterian Hospital, New York, New York; Institute for Precision Medicine, Weill Cornell Medical College and New York Presbyterian Hospital, New York, New York.
authors: Juan Miguel
authors: JM
authors: Mosquera
authors: Department of Urology, Weill Cornell Medical College and New York Presbyterian Hospital, New York, New York; Department of Pathology, Weill Cornell Medical College and New York Presbyterian Hospital, New York, New York; Institute for Precision Medicine, Weill Cornell Medical College and New York Presbyterian Hospital, New York, New York.
authors: Mark A
authors: MA
authors: Rubin
authors: Department of Urology, Emory University School of Medicine, Atlanta, Georgia. Electronic address: msanda@emory.edu.
authors: Martin G
authors: MG
authors: Sanda
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001706:Biopsy; D006305:Health Status Indicators; D006801:Humans; D008297:Male; D055641:Mathematical Concepts; D008875:Middle Aged; D011446:Prospective Studies; D011467:Prostate / Q000473:pathology; D017430:Prostate-Specific Antigen / Q000097:blood*; D011471:Prostatic Neoplasms / Q000097:blood* / Q000175:diagnosis* / Q000473:pathology
chemical_list: D017430:Prostate-Specific Antigen
keywords: biopsy; nomograms; prostate; prostate-specific antigen; prostatic neoplasms
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