title: Prebiopsy Multiparametric Magnetic Resonance Imaging for Prostate Cancer Diagnosis in Biopsy-naive Men with Suspected Prostate Cancer Based on Elevated Prostate-specific Antigen Values: Results from a Randomized Prospective Blinded Controlled Trial.
abstract: BACKGROUND
  Multiparametric magnetic resonance imaging (MP-MRI) may improve the detection of clinically significant prostate cancer (PCa).
  
  
  OBJECTIVE
  To compare MP-MRI transrectal ultrasound (TRUS)-fusion targeted biopsy with routine TRUS-guided random biopsy for overall and clinically significant PCa detection among patients with suspected PCa based on prostate-specific antigen (PSA) values.
  
  
  METHODS
  This institutional review board-approved, single-center, prospective, randomized controlled trial (April 2011 to December 2014) included 130 biopsy-naive patients referred for prostate biopsy based on PSA values (PSA <20 ng/ml or free-to-total PSA ratio ≤0.15 and PSA <10 ng/ml). Patients were randomized 1:1 to the MP-MRI or control group. Patients in the MP-MRI group underwent prebiopsy MP-MRI followed by 10- to 12-core TRUS-guided random biopsy and cognitive MRI/TRUS fusion targeted biopsy. The control group underwent TRUS-guided random biopsy alone.
  
  
  METHODS
  MP-MRI 3-T phased-array surface coil.
  
  
  METHODS
  The primary outcome was the number of patients with biopsy-proven PCa in the MP-MRI and control groups. Secondary outcome measures included the number of positive prostate biopsies and the proportion of clinically significant PCa in the MP-MRI and control groups. Between-group analyses were performed.
  
  
  CONCLUSIONS
  Overall, 53 and 60 patients were evaluable in the MP-MRI and control groups, respectively. The overall PCa detection rate and the clinically significant cancer detection rate were similar between the MP-MRI and control groups, respectively (64% [34 of 53] vs 57% [34 of 60]; 7.5% difference [95% confidence interval (CI), -10 to 25], p=0.5, and 55% [29 of 53] vs 45% [27 of 60]; 9.7% difference [95% CI, -8.5 to 27], p=0.8). The PCa detection rate was higher than assumed during the planning of this single-center trial.
  
  
  CONCLUSIONS
  MP-MRI/TRUS-fusion targeted biopsy did not improve PCa detection rate compared with TRUS-guided biopsy alone in patients with suspected PCa based on PSA values.
  
  
  RESULTS
  In this randomized clinical trial, additional prostate magnetic resonance imaging (MRI) before prostate biopsy appeared to offer similar diagnostic accuracy compared with routine transrectal ultrasound-guided random biopsy in the diagnosis of prostate cancer. Similar numbers of cancers were detected with and without MRI.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT01357512.
authors.affiliation: Medical Research Center Oulu, Oulu University Hospital and University of Oulu, Oulu, Finland.
authors.forename: Panu P
authors.initials: PP
authors.lastname: Tonttila
authors.affiliation: Medical Research Center Oulu, Oulu University Hospital and University of Oulu, Oulu, Finland.
authors.forename: Juha
authors.initials: J
authors.lastname: Lantto
authors.affiliation: Medical Research Center Oulu, Oulu University Hospital and University of Oulu, Oulu, Finland.
authors.forename: Eija
authors.initials: E
authors.lastname: Pääkkö
authors.affiliation: Medical Research Center Oulu, Oulu University Hospital and University of Oulu, Oulu, Finland.
authors.forename: Ulla
authors.initials: U
authors.lastname: Piippo
authors.affiliation: Medical Research Center Oulu, Oulu University Hospital and University of Oulu, Oulu, Finland.
authors.forename: Saila
authors.initials: S
authors.lastname: Kauppila
authors.affiliation: Medical Research Center Oulu, Oulu University Hospital and University of Oulu, Oulu, Finland.
authors.forename: Eveliina
authors.initials: E
authors.lastname: Lammentausta
authors.affiliation: Medical Research Center Oulu, Oulu University Hospital and University of Oulu, Oulu, Finland.
authors.forename: Pasi
authors.initials: P
authors.lastname: Ohtonen
authors.affiliation: Medical Research Center Oulu, Oulu University Hospital and University of Oulu, Oulu, Finland. Electronic address: markku.vaarala@oulu.fi.
authors.forename: Markku H
authors.initials: MH
authors.lastname: Vaarala
mesh_terms: D000328:Adult; D000368:Aged; D001706:Biopsy; D005387:Finland; D006801:Humans; D061705:Image-Guided Biopsy / Q000379:methods*; D007610:Kallikreins / Q000097:blood*; D008279:Magnetic Resonance Imaging; D053783:Magnetic Resonance Imaging, Interventional; D008297:Male; D008875:Middle Aged; D060787:Neoplasm Grading; D011237:Predictive Value of Tests; D011446:Prospective Studies; D017430:Prostate-Specific Antigen / Q000097:blood*; D011471:Prostatic Neoplasms / Q000097:blood* / Q000473:pathology*; D015203:Reproducibility of Results; D018084:Ultrasonography, Interventional; D015854:Up-Regulation
chemical_list: C549870:KLK3 protein, human; D007610:Kallikreins; D017430:Prostate-Specific Antigen
keywords: Biopsy; Diagnosis; Multiparametric magnetic resonance imaging; Prostate cancer; Prostate-specific antigen