Assessment of Prostate MRI Before Prostate Biopsies
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      Background: Prostate cancer is difficult to detect using ultrasound. As a result, in case of
      suspicion of prostate cancer based on digital rectal examination (DRE) or Prostate Specific
      Antigen (PSA) level, it is currently recommended to perform "blinded" systematically
      distributed biopsies with 10-18 samples obtained from predefined locations in the gland.

      These so-called systematic biopsies (SB) may lead to improper patient management by (i)
      missing clinically significant cancer, especially in the anterior half of the gland that
      tends to be undersampled, (ii) inducing chance detection of clinically insignificant cancer
      foci that may result in overtreatments, (iii) undersampling the tumor foci and thus
      underestimating their volume and aggressiveness.

      Multiparametric Magnetic Resonance Imaging (mp-MRI) has yielded promising results in
      detecting aggressive (Gleason ≥7) prostate cancers. Several monocenter studies showed that
      targeted biopsies (TB) based on mp-MRI findings could detect significantly more aggressive
      cancers, reduce the diagnosis of clinically insignificant cancers, and better evaluate the
      aggressiveness of detected cancers than SB. However, these monocenter studies only provide
      low-level evidence and three recent independent reviews of literature concluded that there
      was a need for a robust multicenter trial evaluating the diagnostic yield of TB as compared
      to SB. This is particularly important since many academic and private centers in France
      already perform mp-MRI before prostate biopsy in daily routine. Therefore the risk is that
      this approach becomes the norm without being properly evaluated and it is crucial and urgent
      to perform a controlled multicentric study to provide high-level evidence as to whether
      mp-MRI should or should not be obtained before prostate biopsy.

      One controlled multicentric study has been published recently in which SB and TB had been
      obtained by two different operators in 95 patients. TB yielded a significantly higher
      detection rate for all prostate cancers (69% vs 59%, p=0.033) and for clinically significant
      cancers (67% vs 52%, p=0.0011). However, this study was limited by the fact that patients
      with negative mp-MRI were not included.

      Research hypotheses: There is currently no robust multicenter trial comparing prostate TB
      based on mp-MRI findings versus the current standard of care (SB). We propose a multicentre
      prospective trial comparing the results of SB and TB performed in the same patients by two
      independent operators. Our hypothesis is that TB detects aggressive (Gleason ≥7) cancers in a
      significantly higher percentage of patients than SB.

      Main objective: To compare the percentage of patients with "clinically significant cancer"
      (using definition A, i.e. cancer with Gleason score ≥7) detected by SB versus TB.
    


Intervention name(s): Prostate biopsy
Intervention type(s): Procedure
Intervention description(s): Systematic biopsies (SB) and targeted biopsies (TB) are performed in the same patients by two independent operators. In patients without abnormalities on mp-MRI, no targeted biopsies will be carried out and the detection of "clinically significant cancer" will be considered as negative for the TB strategy.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Prostate cancer; Multiparametric MRI; Prostate biopsy; Targeted biopsy; Comparative study