You have accessJournal of UrologyProstate Cancer: Detection & Screening III1 Apr 2017MP33-20 THE SMARTTARGET BIOPSY TRIAL: A PROSPECTIVE PAIRED BLINDED TRIAL WITH RANDOMISATION TO COMPARE VISUAL-ESTIMATION AND IMAGE-FUSION TARGETED PROSTATE BIOPSIES Ian Donaldson, Sami Hamid, Dean Barratt, Yipeng Hu, Rachel Rodell, Barbara Villarini, Ester Bonmati, Paul Martin, David Hawkes, Neil McCartan, Ingrid Potyka, Norman Williams, Chris Brew-Graves, Caroline Moore, Mark Emberton, and Hashim Ahmed Ian DonaldsonIan Donaldson More articles by this author , Sami HamidSami Hamid More articles by this author , Dean BarrattDean Barratt More articles by this author , Yipeng HuYipeng Hu More articles by this author , Rachel RodellRachel Rodell More articles by this author , Barbara VillariniBarbara Villarini More articles by this author , Ester BonmatiEster Bonmati More articles by this author , Paul MartinPaul Martin More articles by this author , David HawkesDavid Hawkes More articles by this author , Neil McCartanNeil McCartan More articles by this author , Ingrid PotykaIngrid Potyka More articles by this author , Norman WilliamsNorman Williams More articles by this author , Chris Brew-GravesChris Brew-Graves More articles by this author , Caroline MooreCaroline Moore More articles by this author , Mark EmbertonMark Emberton More articles by this author , and Hashim AhmedHashim Ahmed More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2017.02.1016AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES 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®). 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. 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. UCL definition 2 clinically significant prostate cancer was used as the target condition for the primary outcome (>/= G3+4 and or MCCL >/= 4mm). 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). 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. © 2017FiguresReferencesRelatedDetails Volume 197Issue 4SApril 2017Page: e425 Advertisement Copyright & Permissions© 2017MetricsAuthor Information Ian Donaldson More articles by this author Sami Hamid More articles by this author Dean Barratt More articles by this author Yipeng Hu More articles by this author Rachel Rodell More articles by this author Barbara Villarini More articles by this author Ester Bonmati More articles by this author Paul Martin More articles by this author David Hawkes More articles by this author Neil McCartan More articles by this author Ingrid Potyka More articles by this author Norman Williams More articles by this author Chris Brew-Graves More articles by this author Caroline Moore More articles by this author Mark Emberton More articles by this author Hashim Ahmed More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...