title: The prostate health index selectively identifies clinically significant prostate cancer.
abstract: OBJECTIVE
  The Prostate Health Index (phi) is a new test combining total, free and [-2]proPSA into a single score. It was recently approved by the FDA and is now commercially available in the U.S., Europe and Australia. We investigate whether phi improves specificity for detecting clinically significant prostate cancer and can help reduce prostate cancer over diagnosis.
  
  
  METHODS
  From a multicenter prospective trial we identified 658 men age 50 years or older with prostate specific antigen 4 to 10 ng/ml and normal digital rectal examination who underwent prostate biopsy. In this population we compared the performance of prostate specific antigen, % free prostate specific antigen, [-2]proPSA and phi to predict biopsy results and, specifically, the presence of clinically significant prostate cancer using multiple criteria.
  
  
  RESULTS
  The Prostate Health Index was significantly higher in men with Gleason 7 or greater and "Epstein significant" cancer. On receiver operating characteristic analysis phi had the highest AUC for overall prostate cancer (AUCs phi 0.708, percent free prostate specific antigen 0.648, [-2]proPSA 0.550 and prostate specific antigen 0.516), Gleason 7 or greater (AUCs phi 0.707, percent free prostate specific antigen 0.661, [-2]proPSA 0.558, prostate specific antigen 0.551) and significant prostate cancer (AUCs phi 0.698, percent free prostate specific antigen 0.654, [-2]proPSA 0.550, prostate specific antigen 0.549). At the 90% sensitivity cut point for phi (a score less than 28.6) 30.1% of patients could have been spared an unnecessary biopsy for benign disease or insignificant prostate cancer compared to 21.7% using percent free prostate specific antigen.
  
  
  CONCLUSIONS
  The new phi test outperforms its individual components of total, free and [-2]proPSA for the identification of clinically significant prostate cancer. Phi may be useful as part of a multivariable approach to reduce prostate biopsies and over diagnosis.
authors.affiliation: Department of Urology and Population Health, New York University, New York, New York. Electronic address: stacyloeb@gmail.com.
authors.forename: Stacy
authors.initials: S
authors.lastname: Loeb
authors.affiliation: Department of Urology, Emory University and Emory Healthcare, Atlanta, Georgia.
authors.forename: Martin G
authors.initials: MG
authors.lastname: Sanda
authors.affiliation: Beckman Coulter Incorporated, Carlsbad, California.
authors.forename: Dennis L
authors.initials: DL
authors.lastname: Broyles
authors.affiliation: Beckman Coulter Incorporated, Carlsbad, California.
authors.forename: Sanghyuk S
authors.initials: SS
authors.lastname: Shin
authors.affiliation: Department of Urology, Erasmus University Medical Center, Rotterdam, the Netherlands.
authors.forename: Chris H
authors.initials: CH
authors.lastname: Bangma
authors.affiliation: Department of Urology, University of Michigan School of Medicine, Ann Arbor, Michigan.
authors.forename: John T
authors.initials: JT
authors.lastname: Wei
authors.affiliation: Department of Urology, Johns Hopkins University School of Medicine, Baltimore, Maryland.
authors.forename: Alan W
authors.initials: AW
authors.lastname: Partin
authors.affiliation: Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota.
authors.forename: George G
authors.initials: GG
authors.lastname: Klee
authors.affiliation: Vanguard Urologic Institute and Texas Prostate Center, Houston, Texas.
authors.forename: Kevin M
authors.initials: KM
authors.lastname: Slawin
authors.affiliation: Department of Urology, University of California Los Angeles, Los Angeles, California.
authors.forename: Leonard S
authors.initials: LS
authors.lastname: Marks
authors.affiliation: Department of Clinical Chemistry, Erasmus University Medical Center, Rotterdam, the Netherlands.
authors.forename: Ron H N
authors.initials: RH
authors.lastname: van Schaik
authors.affiliation: Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland.
authors.forename: Daniel W
authors.initials: DW
authors.lastname: Chan
authors.affiliation: Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland.
authors.forename: Lori J
authors.initials: LJ
authors.lastname: Sokoll
authors.affiliation: Beckman Coulter Incorporated, Carlsbad, California.
authors.forename: Amabelle B
authors.initials: AB
authors.lastname: Cruz
authors.affiliation: Beckman Coulter Incorporated, Carlsbad, California.
authors.forename: Isaac A
authors.initials: IA
authors.lastname: Mizrahi
authors.affiliation: Department of Urology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
authors.forename: William J
authors.initials: WJ
authors.lastname: Catalona
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D006305:Health Status Indicators; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D017430:Prostate-Specific Antigen / Q000097:blood*; D011471:Prostatic Neoplasms / Q000097:blood* / Q000175:diagnosis*; D011498:Protein Precursors / Q000097:blood*
chemical_list: C583834:(-2)pro-prostate-specific antigen, human; D011498:Protein Precursors; D017430:Prostate-Specific Antigen
keywords: biological markers; early detection of cancer; prostatic neoplasms