Background: Multiparametric magnetic resonance imaging (mpMRI)-targeted prostate biopsies can improve detection of clinically significant prostate cancer and decrease the overdetection of insignificant cancers. Whether visual-registration targeting is sufficient or if augmentation with image-fusion software is needed is unknown.
Objective: To assess concordance between the two methods.
Design, Setting, and Participants: We conducted a blinded, within-person randomised, paired validating clinical trial. From 2014 to 2016, 141 men who had undergone a prior (positive or negative) transrectal ultrasound biopsy and had a discrete lesion on mpMRI (score 3 to 5) requiring targeted transperineal biopsy were enrolled at a UK academic hospital; 129 underwent both biopsy strategies and completed the study.
Intervention: The order of performing biopsies using visual-registration and a computer-assisted MRI/ultrasound image-fusion system (SmartTarget) on each patient was randomised. The equipment was reset between biopsy strategies to mitigate incorporation bias.
Outcome Measurements and Statistical Analysis: The proportion of clinically significant prostate cancer (primary outcome: Gleason pattern ≥3+4=7, maximum cancer core length ≥4 mm; secondary outcome: Gleason pattern ≥4+3=7, maximum cancer core length ≥6 mm) detected by each method was compared using McNemar's test of paired proportions.
Results and Limitations: The two strategies combined detected 93 clinically significant prostate cancers (72% of the cohort). Each strategy individually detected 80/93 (86%) of these cancers; each strategy detected 13 cases missed by the other. Three patients experienced adverse events related to biopsy (urinary retention, urinary tract infection, nausea and vomiting). No difference in urinary symptoms, erectile function, or quality of life between baseline and follow-up (median 10.5 weeks) was observed. The key limitation was lack of parallel-group randomisation and limit on number of targeted cores.
Conclusions: Visual-registration and image-fusion targeting strategies combined had the highest detection rate for clinically significant cancers. Targeted prostate biopsy should be performed using both strategies together.
Patient Summary: We compared two prostate cancer biopsy strategies: visual-registration and image-fusion. The combination of the two strategies found the most clinically important cancers and should be used together whenever targeted biopsy is being performed.