Microultrasonography a promising alternative to MRI for image-guided prostate biopsy

Microultrasonography-guided biopsy performs similarly as MRI/conventional ultrasonography fusion-guided biopsy in terms of detecting Gleason Grade Group 2 or higher prostate cancer in biopsy-naïve men, according to the results of the multicentre, international OPTIMUM study.

A total of 802 biopsy-naïve men with clinical suspicion of prostate cancer, defined as elevated prostate-specific antigen [PSA] and/or abnormal digital rectal examination findings, were recruited. They were randomly assigned to undergo microultrasonography-guided biopsy, microultrasonography/MRI fusion-guided biopsy (microultrasonography/MRI, in which microultrasonography biopsies were performed prior to unblinding the MRI), or MRI/conventional US fusion-guided biopsy (MRI/conventional ultrasonography). Synchronous systematic biopsy was performed in every participant.

Of the men, 678 (median age 65 years, 83 percent White, median PSA level 6.9 ng/mL) underwent biopsy and were included in the analysis (121 in the microultrasonography group, 226 in the microultrasonography/MRI group, and 331 in the MRI/conventional ultrasonography group).

The primary outcome of Gleason Grade Group 2 or higher cancer was detected in 47.1 percent of participants in the microultrasonography group, 42.6 percent in the MRI/conventional ultrasonography group, and 46.9 percent in the microultrasonography/MRI group. This result established the noninferiority of microultrasonography-guided biopsy to MRI fusion-guided biopsy (difference, 3.52 percent, 95 percent confidence interval [CI], −3.95 to 10.92; p<0.001 for noninferiority).

Combined biopsy with microultrasonography/MRI also showed noninferiority to MRI/conventional ultrasonography software-assisted MRI fusion biopsy using conventional ultrasonography devices (difference, 4.29 percent, 95 percent CI, −4.06 to 12.63; p<0.001 for noninferiority).

The rate of Gleason Grade Group 2 or higher cancer diagnosed by targeted biopsy only did not significantly differ across the three groups: 38.0 percent in the microultrasonography group, 34.1 percent in the MRI/conventional ultrasonography group, and 40.3 percent in the microultrasonography/MRI group.