To prove the feasibility and evaluate the initial clinical results of targeted prostate biopsies using the Urostation novel platform using magnetic resonance imaging (MRI)/transrectal ultrasound (TRUS) registration to help steer the biopsy needle to suspicious areas.

We prospectively included 30 patients for suspicion of prostate cancer from November 2011 to August 2012. All patients were previously evaluated by a multiparametric MRI, interpreted by a single radiologist who attributed a Prostate Imaging-Reporting and Data System (PI-RADS) score to each lesion. A conventional 12-core randomized biopsy protocol was performed and 2 additional targeted biopsies were performed on suspicious area(s). The results of randomized and targeted biopsies were compared.

Among the 30 patients, suspicious area(s) were found on MRI in 20 cases (67%). Median procedure time was 23 minutes. Targeting success rate (biopsy visualized inside the target) was 83%, with at least 1 biopsy reaching the target in all cases. Prostate cancer was detected in 14 cases (47%), including 11 cases with an abnormal MRI. Targeted biopsies detected cancer in all 11 cases and all but 1 were clinically significant. Randomized biopsies detected 10 of these 11 cases, and 3 more cases that MRI considered normal. Sensitivity to detect a significant cancer was 91% in both modalities.

This initial clinical study showed encouraging results for targeted MRI-guided prostate biopsies using MRI-TRUS fusion. Although further studies are needed to determine the role of prostate MRI before biopsy and the relevance of targeted biopsies, the Urostation is an MRI-TRUS fusion device that has good accuracy for targeting suspicious areas on MRI.