Comparison of Multi-parametric and Bi-parametric Magnetic Resonance Imaging in Men With Suspicion of Prostate Cancer

• Dimension of lesions identified at bp-MRI/mp-MRI;[ Time Frame: 2 weeks ]
  Mean lesion dimension will be assessed in each study arm
• The proportion of clinically significant PCa identified at bp-MRI;[ Time Frame: 2 weeks ]
  The number of clinically significant PCa over the total number of PCa detected at bp-MRI will be measured
• Positive predictive value of miR test alone and in combination with PSA blood test in identifying histologically confirmed PCa patients[ Time Frame: 3 months ]

To compare the detection rate of biparametric (bp) magnetic resonance imaging (MRI) for clinically significant prostate cancer (PCa) with that of multiparametric (mp)-MRI, in biopsy-naïve patients. Today, bp-MRI is not the standard diagnostic procedure, however preliminary studies showed its non-inferiority with respect to mp-MRI. Its implementation on a wide scale could significantly reduce examination costs (no iv contrast agent and no endorectal coil), and study time. Secondary objectives will be: - to assess specificity of a blood test based on microRNA (miR) score in biopsy-naïve patients, using pathological assessment after MR-guided biopsy as reference standard. If specificity of the miR score is higher than that of PSA, then fewer patients will undergo unnecessary MRI, thus increasing the efficiency of the diagnostic pipeline for PCa; - to develop a clinical decision support system (CDSS) based on MRI and circulating miR evaluation, to stratify patients according to their risk of PCa progression, using pathological assessment after prostatectomy as reference standard. Patients will be stratified into two classes of risk: i) low-risk PCa, in which patients may benefit from a conservative approach (i.e. active surveillance), and ii) medium/high-risk PCa in which patients should undergo radical treatment (i.e. surgery or radiation therapy).

• Diagnostic Test: bi-parametric MRI
  Axial T2-weighted and diffusion-weighted imaging with no endorectal coil nor intravenous contrast agent administration
• Diagnostic Test: multi-parametric MRI
  T2-weighted imaging in the three planes, diffusion-weighted and dynamic contrast-enhanced imaging using endorectal coil and intravenous contrast agent administration

• Experimental: bi-parametric MRI
  Patients will undergo axial T2-weighted and diffusion-weighted imaging (no contrast agent injection)
• Active Comparator: multi-parametric MRI
  Patients will undergo multiparametric MRI including morphological study (T2- and T1-weighted imaging) and functional acquisitions (diffusion-weighted and dynamic contrast-enhanced imaging)