Comparison of Multi-parametric and Bi-parametric Magnetic Resonance Imaging in Men With Suspicion of Prostate Cancer
Condition: Prostatic Neoplasm
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      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).
    

Detailed description: 
      The trial is a prospective, randomized, two-arms study with a 2:1 ratio. Subjects meeting the
      inclusion criteria will be randomized either into the bp-MRI group (arm A), or the mp-MRI one
      (arm B). All subjects will perform blood sampling in EDTA tubes before undergoing imaging
      session. Plasma will be isolated within 1 hour from sampling, with a double round
      centrifugation, aliquoted and stored at -80°C before undergoing miR analysis.

      MRI will be performed with a 1.5 T using axial T2w and diffusion-weighted imaging for
      subjects in arm A with no endorectal coil and no intravenous contrast agent. Men randomized
      in arm B will undergo MRI with T2w in the three acquisition planes, diffusion-weighted and
      dynamic contrast-enhanced imaging usign endorectal coil.

      Random biopsy will be performed in subjects with no suspicious regions for PCa found on MRI.
      Men with suspicious regions on MRI will be invited to a targeted or in-bore biopsy.
    

Intervention name(s): bi-parametric MRI; multi-parametric MRI
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Axial T2-weighted and diffusion-weighted imaging with no endorectal coil nor intravenous contrast agent administration; T2-weighted imaging in the three planes, diffusion-weighted and dynamic contrast-enhanced imaging using endorectal coil and intravenous contrast agent administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: magnetic resonance imaging; prostate biopsy; microRNA