Introduction

Multi-parametric MRI targeted prostate biopsies can improve detection of clinically significant prostate cancer and decrease the diagnosis of clinically insignificant cancers. There is debate whether visual estimated targeting is sufficient or whether image-fusion software is required. We conducted an ethics committee approved, prospective, blinded, paired validating clinical trial of visual estimated targeted biopsies compared to non-rigid MR/US image-fusion using an academically developed fusion system (SmartTarget®)._x000D_

Methods

141 men requiring targeted transperineal biopsies for accurate risk stratification were enrolled following written informed consent (August2014-September2016). Entry required prior trans-rectal ultrasound biopsy, a discrete lesion on mpMRI (PIRADS 3-5) and no previous prostate cancer treatment. _x000D_ All men underwent a targeted transperineal biopsy of a single lesion using visual estimation (3 cores) and image-fusion (3 cores). Two different urologists independently conducted the targeting strategies with each urologist assigned a strategy and order by randomised. Only one urologist was permitted to be present for each biopsy strategy and did not communicate with the other about any aspect of the procedure (blinded). 14 urologists of varying levels of experience participated. All were competent in transperineal targeting. _x000D_ UCL definition 2 clinically significant prostate cancer was used as the target condition for the primary outcome (>/= G3+4 and or MCCL >/= 4mm). _x000D_

Results

129 men completed both biopsy strategies. Median age (IQR) was 65 years (58-70) and median PSA was 8.5ng/ml (5.6-12.1). 94 (72.8%) had clinically significant prostate cancer; 81/94 (86.2%) were identified on visual estimation targeting and 81/94 (86.2%) on image-fusion targeting. Fusion biopsy and visual estimation targeting each identified clinically significant cancers that the other missed, 13 and 13 respectively. We found no statistically significant difference between visual estimation and image-fusion (McNemar, p=1.00)._x000D_

Conclusions

Our prospective, paired blinded trial demonstrates that there is no overall difference in detection of clinically significant prostate cancer between visual estimation and image-fusion targeted biopsies. Our results suggest that both techniques should be used together for optimal cancer detection. _x000D_

Funding

This trial was funded by the Wellcome Trust and the Department of Health UK - Health Innovation Challenge Fund