title: Multiparametric magnetic resonance imaging vs. standard care in men being evaluated for prostate cancer: a randomized study.
abstract: OBJECTIVE
  To assess whether the proportion of men with clinically significant prostate cancer (PCa) is higher among men randomized to multiparametric magnetic resonance imaging (mp-MRI)/biopsy vs. those randomized to transrectal ultrasound (TRUS)-guided biopsy.
  
  
  METHODS
  In total, 1,140 patients with symptoms highly suggestive of PCa were enrolled and divided in 2 groups of 570 patients to follow 2 different diagnostic algorithms. Group A underwent a TRUS-guided random biopsy. Group B underwent an mp-MRI and a TRUS-guided targeted+random biopsy. The accuracy of mp-MRI in the diagnosis of PCa was calculated using prostatectomy as the standard of reference.
  
  
  RESULTS
  In group A, PCa was detected in 215 patients. The remaining 355 patients underwent an mp-MRI: the findings were positive in 208 and unremarkable in 147 patients. After the second random+targeted biopsy, PCa was detected in 186 of the 208 patients. In group B, 440 patients had positive findings on mp-MRI, and PCa was detected in 417 at first biopsy; 130 group B patients had unremarkable findings on both mp-MRI and biopsy. In the 130 group B patients with unremarkable findings on mp-MRI and biopsy, a PCa Gleason score of 6 or precancerous lesions were detected after saturation biopsy. mp-MRI showed an accuracy of 97% for the diagnosis of PCa.
  
  
  CONCLUSIONS
  The proportion of men with clinically significant PCa is higher among those randomized to mp-MRI/biopsy vs. those randomized to TRUS-guided biopsy; moreover, mp-MRI is a very reliable tool to identify patients to schedule in active surveillance.
authors.affiliation: Department of Radiological Sciences, Oncology and Pathology, Sapienza University of Rome, Rome, Italy. Electronic address: valeria.panebianco@gmail.com.
authors.forename: Valeria
authors.initials: V
authors.lastname: Panebianco
authors.affiliation: Department of Radiological Sciences, Oncology and Pathology, Sapienza University of Rome, Rome, Italy.
authors.forename: Flavio
authors.initials: F
authors.lastname: Barchetti
authors.affiliation: Department of Urology, Sapienza University of Rome, Rome, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Sciarra
authors.affiliation: Department of Radiological Sciences, Oncology and Pathology, Sapienza University of Rome, Rome, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Ciardi
authors.affiliation: Department of Radiological Sciences, Oncology and Pathology, Sapienza University of Rome, Rome, Italy.
authors.forename: Elena Lucia
authors.initials: EL
authors.lastname: Indino
authors.affiliation: Department of Urology, Regina Elena National Cancer Institute, Rome, Italy.
authors.forename: Rocco
authors.initials: R
authors.lastname: Papalia
authors.affiliation: Department of Urology, Regina Elena National Cancer Institute, Rome, Italy.
authors.forename: Michele
authors.initials: M
authors.lastname: Gallucci
authors.affiliation: Department of Radiological Sciences, Oncology and Pathology, Sapienza University of Rome, Rome, Italy.
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Tombolini
authors.affiliation: Department of Urology, Sapienza University of Rome, Rome, Italy.
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Gentile
authors.affiliation: Department of Radiological Sciences, Oncology and Pathology, Sapienza University of Rome, Rome, Italy.
authors.forename: Carlo
authors.initials: C
authors.lastname: Catalano
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D061765:Endoscopic Ultrasound-Guided Fine Needle Aspiration; D006801:Humans; D061705:Image-Guided Biopsy / Q000379:methods*; D007610:Kallikreins / Q000097:blood; D053783:Magnetic Resonance Imaging, Interventional / Q000379:methods; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000097:blood / Q000175:diagnosis* / Q000000981:diagnostic imaging; D011859:Radiography
chemical_list: C549870:KLK3 protein, human; D007610:Kallikreins; D017430:Prostate-Specific Antigen
keywords: Biopsy; Magnetic resonance imaging; Prostate cancer; Prostate-specific antigen; Ultrasonography