Randomized Study Comparing MR-guided in Bore Versus MRI/US Fusion-guided Prostate Biopsy

The hypothesis of the study is that targeted MRI/US fusion-guided prostate biopsy with additional systematic transrectal ultrasound (TRUS)-guided biopsy significantly detects more prostate cancers than targeted MR-guided in-bore prostate.

In men with previously negative prostate biopsy and persistent elevated prostate-specific antigen (PSA) value, it is unclear which strategy offers the highest detection rate for prostate cancer. The hypothesis of this study is that targeted MRI-guided biopsy combined with transrectal ultrasound (TRUS)-guided biopsy may potentially detect more cancers than MRI-guided prostate biopsies alone. Men with at least one previously negative TRUS-guided biopsy and persistently elevated PSA values will be submitted to a multiparametric MRI examination of the prostate. Subsequently, all participants will be randomized (1:1) into both study arms. In study arm A patients will be submitted to targeted prostate biopsy based on the multiparametric MRI findings. Targeted biopsies will be performed using MRI-guided in-bore prostate biopsy. In study arm B targeted biopsies will be performed using MRI/TRUS-fusion-guided prostate biopsy with software-registration (MRI/TRUS image fusion). Patients of study arm B undergo additional systematic 12-core TRUS-guided prostate biopsy.