title: A prospective study investigating the impact of multiparametric MRI in biopsy-naïve patients with clinically suspected prostate cancer: The PROKOMB study.
abstract: In patients with suspected prostate cancer (PCa) according to current guidelines systematic transrectal ultrasound (TRUS)-guided biopsy of the prostate is performed to verify or rule out PCa. However, TRUS-guided biopsy can result in underdetection of clinically significant cancers as well as diagnosis of clinically insignificant cancers. Multiparametric MRI (mpMRI) might improve the diagnostic pathway and help to avoid unnecessary biopsies.
  
  
  
  The PROKOMB (Prostata - Kooperatives MRT-Projekt Berlin) study is a prospective two-arm multicentre study designed to evaluate the potential role of mpMRI as a triage test before biopsy. Up to 600 biopsy-naïve men with suspicion for PCa undergo mpMRI at two dedicated imaging centers. Only patients with equivocal or suspicious lesions on mpMRI undergo prostate biopsy including systematic as well as MRI-guided targeted biopsies at several different community-based urologists or hospitals. The PROKOMB study is designed to evaluate how many biopsies can be avoided, how many clinically insignificant cancers are diagnosed on prostate biopsy in patients with positive findings on mpMRI, and how many clinically significant cancers are missed using this alternative diagnostic pathway. For the purpose of this study clinically significant PCa is defined as Gleason ≥3+4 cancer. In addition, the detection rates of different techniques for MRI-guided biopsy are evaluated as well as psychological distress before mpMRI and after the diagnosis of PCa.
  
  
  
  The PROKOMB study might help in defining the role of mpMRI in biopsy-naïve patients with suspected PCa in an ambulatory care setting.
authors.affiliation: Charité - Universitätsmedizin Berlin, Campus Charité Mitte, Klinik für Radiologie, Charitéplatz 1, 10117 Berlin, Germany. Electronic address: alexander.baur@charite.de.
authors.forename: Alexander D J
authors.initials: ADJ
authors.lastname: Baur
authors.affiliation: Praxis für Urologie, Britzer Damm 63, 12347 Berlin, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Henkel
authors.affiliation: Praxis für Urologie, Carl-Schurz-Straße 31, 13597 Berlin, Germany.
authors.forename: Manfred
authors.initials: M
authors.lastname: Johannsen
authors.affiliation: Praxis für Urologie, Treskowallee 103, 10318 Berlin, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Speck
authors.affiliation: Männergesundheitszentrum an der Meoclinic, Friedrichstraße 71, 10117 Berlin, Germany.
authors.forename: Lothar
authors.initials: L
authors.lastname: Weißbach
authors.affiliation: Charité - Universitätsmedizin Berlin, Campus Charité Mitte, Klinik für Radiologie, Charitéplatz 1, 10117 Berlin, Germany.
authors.forename: Bernd
authors.initials: B
authors.lastname: Hamm
authors.affiliation: ATURO, Mecklenburgische Straße 27, 14197 Berlin, Germany.
authors.forename: Frank
authors.initials: F
authors.lastname: König
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001706:Biopsy / Q000379:methods; D038524:Diffusion Magnetic Resonance Imaging; D005188:False Negative Reactions; D066235:Fluorine-19 Magnetic Resonance Imaging; D006801:Humans; D008279:Magnetic Resonance Imaging / Q000379:methods*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D017430:Prostate-Specific Antigen; D011471:Prostatic Neoplasms / Q000175:diagnosis* / Q000000981:diagnostic imaging / Q000523:psychology; D012107:Research Design; D013315:Stress, Psychological / Q000453:epidemiology; D055815:Young Adult
chemical_list: D017430:Prostate-Specific Antigen