MR-targeted vs. Random TRUS-guided Prostate Biopsy
MR-targeted vs. Random TRUS-guided Prostate Biopsy
To compare prostate cancer (PCa) detection rate of magnetic resonance (MR)-targeted biopsy
 and transrectal ultrasound (TRUS)-guided biopsy in patients with high PSA values and at least
 one previous negative prostate biopsy. Subjects will be submitted to a multiparametric MR
 scan of the prostate and subsequently patients with a suspicious MR for PCa presence will be
 randomized (1:1) into the two study arms.
In men with previously negative prostate biopsy and persistent elevated PSA value, it is
 unclear which biopsy strategy offers the highest detection rate for significant PCa. The
 hypothesis of this study is that MR-targeted biopsy improves the detection rates of
 significant prostate cancers compared with systematic TRUS-guided prostate biopsy.

 Men with at least one previously negative TRUS-guided biopsy and persistently elevated PSA
 values (> 4 ng/ml) will be submitted to a multiparametric MR imaging examination of the
 prostate. Subsequently, participants with suspected regions at MR imaging will be randomized
 (1:1) into the two study arms. In study arm A patients will be submitted to MR-targeted
 in-bore prostate biopsy based on the multiparametric MR imaging findings. In study arm B
 patients will be submitted to systematic TRUS-guided prostate biopsy with saturation scheme.
Inclusion Criteria:

 -  men aged 50-80

 -  at least one negative TRUS-guided prostate biopsy

 -  PSA > 4 ng/ml

 -  at least one suspected region detected at multiparametric MR imaging

 -  signed informed consent

 Exclusion Criteria:

 -  known prostate cancer diagnosis

 -  contraindication against MR imaging or uncooperative patients