Prospective comparison of transperineal magnetic resonance imaging/ultrasonography fusion biopsy and transrectal systematic biopsy in biopsy-naïve patients

Objectives To evaluate the value of multiparametric magnetic resonance imaging (mp MRI ) in the detection of significant prostate cancer ( PC a) and to compare transperineal MRI /ultrasonography fusion biopsy (fusPbx) with conventional transrectal systematic biopsy (sysPbx) in biopsy‐naïve patients. Patients and Methods This multicentre, prospective trial investigated biopsy‐naïve patients with suspicion of PC a undergoing transperineal fusPbx in combination with transrectal sysPbx (comPbx). The primary outcome was the detection of significant PC a, defined as Gleason pattern 4 or 5. We analysed the results after a study period of 2 years. Results The study included 214 patients. The median (range) number of targeted and systematic cores was 6 (2–15) and 12 (6–18), respectively. The overall PC a detection rate of comPbx was 52%. FusPbx detected more PC a than sysPbx (47% vs 43%; P = 0.15). The detection rate of significant PC a was 38% for fusPbx and 35% for sysPbx ( P = 0.296). The rate of missed significant PC a was 14% in fusPbx and 21% in sysPbx. ComPbx detected significantly more significant PC a than fusPbx and sysPbx alone (44% vs 38% vs 35%; P < 0.005). In patients presenting with Prostate Imaging Reporting and Data System ( PI ‐ RADS ) 4 and 5 lesions there was a higher detection rate of significant PC a than in patients presenting with PI ‐ RADS ≤3 lesions in comPbx (61% vs 14%; P < 0.005). Conclusions For biopsy‐naïve men with tumour‐suspicious lesions in mp MRI , the combined approach outperformed both fusPbx and sysPbx in the detection of overall PC a and significant PC a. Thus, biopsy‐naïve patients may benefit from sysPbx in combination with mp MRI targeted fusPbx.