Multiparametric magnetic resonance imaging vs standard care in men being evaluated for prostate cancer: A randomized study.

OBJECTIVES: To assess whether the proportion of men with clinically significant prostate cancer (PCa) is higher among men randomized to multiparametric magnetic resonance imaging (mp-MRI)/biopsy vs. those randomized to transrectal ultrasound (TRUS)-guided biopsy. METHODS: In total, 1,140 patients with symptoms highly suggestive of PCa were enrolled and divided in 2 groups of 570 patients to follow 2 different diagnostic algorithms. Group A underwent a TRUS-guided random biopsy. Group B underwent an mp-MRI and a TRUS-guided targeted+random biopsy. The accuracy of mp-MRI in the diagnosis of PCa was calculated using prostatectomy as the standard of reference. RESULTS: In group A, PCa was detected in 215 patients. The remaining 355 patients underwent an mp-MRI: the findings were positive in 208 and unremarkable in 147 patients. After the second random+targeted biopsy, PCa was detected in 186 of the 208 patients. In group B, 440 patients had positive findings on mp-MRI, and PCa was detected in 417 at first biopsy; 130 group B patients had unremarkable findings on both mp-MRI and biopsy. In the 130 group B patients with unremarkable findings on mp-MRI and biopsy, a PCa Gleason score of 6 or precancerous lesions were detected after saturation biopsy. mp-MRI showed an accuracy of 97% for the diagnosis of PCa. CONCLUSIONS: The proportion of men with clinically significant PCa is higher among those randomized to mp-MRI/biopsy vs. those randomized to TRUS-guided biopsy; moreover, mp-MRI is a very reliable tool to identify patients to schedule in active surveillance.