title: Combined Biparametric Prostate Magnetic Resonance Imaging and Prostate-specific Antigen in the Detection of Prostate Cancer: A Validation Study in a Biopsy-naive Patient Population.
abstract: OBJECTIVE
  To validate the use of biparametric (T2- and diffusion-weighted) magnetic resonance imaging (B-MRI) and prostate-specific antigen (PSA) or PSA density (PSAD) in a biopsy-naive cohort at risk for prostate cancer (PCa).
  
  
  METHODS
  All patients (n = 59) underwent PSA screening and digital rectal exam prior to a B-MRI followed by MRI or transrectal ultrasound fusion-guided targeted biopsy. Previously reported composite formulas incorporating screen positive lesions (SPL) on B-MRI and PSA or PSAD were developed to maximize PCa detection. For PSA, a patient was considered screen positive if PSA level + 6 × (the number of SPL) >14. For PSAD, screening was positive if PSAD × 14 + (the number of SPL) >4.25. These schemes were employed in this new test set to validate the initial formulas. Performance assessment of these formulas was determined for all cancer detection and for tumors with Gleason ≥3 + 4.
  
  
  RESULTS
  Screen positive lesions on B-MRI had the highest sensitivity (95.5%) and negative predictive value of 71.4% compared with PSA and PSAD. B-MRI significantly improved sensitivity (43.2-72.7%, P = .0002) when combined with PSAD. The negative predictive value of PSA increased with B-MRI, achieving 91.7% for B-MRI and PSA for Gleason ≥3 + 4. Overall accuracies of the composite equations were 81.4% (B-MRI and PSA) and 78.0% (B-MRI and PSAD).
  
  
  CONCLUSIONS
  Validation with a biopsy-naive cohort demonstrates the parameter SPL performed better than PSA or PSAD alone in accurately detecting PCa. The combined use of B-MRI, PSA, and PSAD resulted in improved accuracy for detecting clinically significant PCa.
authors.affiliation: Urologic Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD.
authors.forename: Michele
authors.initials: M
authors.lastname: Fascelli
authors.affiliation: Urologic Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD; Departments of Urology and Radiology, University of Alabama at Birmingham, Birmingham, AL.
authors.forename: Soroush
authors.initials: S
authors.lastname: Rais-Bahrami
authors.affiliation: Molecular Imaging Program, National Cancer Institute, National Institutes of Health, Bethesda, MD.
authors.forename: Sandeep
authors.initials: S
authors.lastname: Sankineni
authors.affiliation: Molecular Imaging Program, National Cancer Institute, National Institutes of Health, Bethesda, MD.
authors.forename: Anna M
authors.initials: AM
authors.lastname: Brown
authors.affiliation: Urologic Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD.
authors.forename: Arvin K
authors.initials: AK
authors.lastname: George
authors.affiliation: Urologic Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD.
authors.forename: Richard
authors.initials: R
authors.lastname: Ho
authors.affiliation: Urologic Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD.
authors.forename: Thomas
authors.initials: T
authors.lastname: Frye
authors.affiliation: Urologic Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD.
authors.forename: Amichai
authors.initials: A
authors.lastname: Kilchevsky
authors.affiliation: Urologic Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD.
authors.forename: Raju
authors.initials: R
authors.lastname: Chelluri
authors.affiliation: Urologic Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD.
authors.forename: Steven
authors.initials: S
authors.lastname: Abboud
authors.affiliation: Urologic Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD; Department of Surgery, Division of Urology, University of Maryland, Baltimore, MD.
authors.forename: M Minhaj
authors.initials: MM
authors.lastname: Siddiqui
authors.affiliation: Laboratory of Pathology, National Cancer Institute, National Institutes of Health, Bethesda, MD.
authors.forename: Maria J
authors.initials: MJ
authors.lastname: Merino
authors.affiliation: Center for Interventional Oncology, Department of Radiology and Imaging Services, NIH Clinical Center and National Cancer Institute, National Institutes of Health, Bethesda, MD.
authors.forename: Bradford J
authors.initials: BJ
authors.lastname: Wood
authors.affiliation: Molecular Imaging Program, National Cancer Institute, National Institutes of Health, Bethesda, MD.
authors.forename: Peter L
authors.initials: PL
authors.lastname: Choyke
authors.affiliation: Center for Interventional Oncology, Department of Radiology and Imaging Services, NIH Clinical Center and National Cancer Institute, National Institutes of Health, Bethesda, MD; Urologic Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD.
authors.forename: Peter A
authors.initials: PA
authors.lastname: Pinto
authors.affiliation: Molecular Imaging Program, National Cancer Institute, National Institutes of Health, Bethesda, MD. Electronic address: ismail.turkbey@nih.gov.
authors.forename: Baris
authors.initials: B
authors.lastname: Turkbey
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001706:Biopsy; D006801:Humans; D008279:Magnetic Resonance Imaging / Q000379:methods*; D008297:Male; D008875:Middle Aged; D017430:Prostate-Specific Antigen / Q000097:blood*; D011471:Prostatic Neoplasms / Q000097:blood* / Q000175:diagnosis*; D012189:Retrospective Studies
chemical_list: D017430:Prostate-Specific Antigen