OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.