Randomized Study Comparing MR-guided in Bore Versus MRI/US Fusion-guided Prostate Biopsy
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.
Inclusion Criteria:

 -  At least one prior negative prostate biopsy

 -  Prostate-specific antigen (PSA) > 4 ng/ml

 Exclusion Criteria:

 -  Known prostate cancer

 -  Contraindications against MRI

 -  Contraindications against prostate biopsy