The SmartTarget Biopsy Trial: A Prospective, Within-person Randomised, Blinded Trial Comparing the Accuracy of Visual-registration and Magnetic Resonance Imaging/Ultrasound Image-fusion Targeted Biopsies for Prostate Cancer Risk Stratification

Sami Hamid, Ian A Donaldson, Yipeng Hu, Rachael Rodell, Barbara Villarini, Ester Bonmati, Pamela Tranter, Shonit Punwani, Harbir S Sidhu, Sarah Willis, Jan van der Meulen, David Hawkes, Neil McCartan, Ingrid Potyka, Norman R Williams, Chris Brew-Graves, Alex Freeman, Caroline M Moore, Dean Barratt, Mark Emberton, Hashim U Ahmed, Sami Hamid, Ian A Donaldson, Yipeng Hu, Rachael Rodell, Barbara Villarini, Ester Bonmati, Pamela Tranter, Shonit Punwani, Harbir S Sidhu, Sarah Willis, Jan van der Meulen, David Hawkes, Neil McCartan, Ingrid Potyka, Norman R Williams, Chris Brew-Graves, Alex Freeman, Caroline M Moore, Dean Barratt, Mark Emberton, Hashim U Ahmed

Abstract

Background: Multiparametric magnetic resonance imaging (mpMRI)-targeted prostate biopsies can improve detection of clinically significant prostate cancer and decrease the overdetection of insignificant cancers. It is unknown whether visual-registration targeting is sufficient or augmentation with image-fusion software is needed.

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 3-5) 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 ≥4mm; secondary outcome: Gleason pattern ≥4+3=7, maximum cancer core length ≥6mm) 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 detected 80/93 (86%) of these cancers; each strategy identified 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 wk) was observed. The key limitations were lack of parallel-group randomisation and a limit on the 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. A combination of the two strategies found the most clinically important cancers and should be used together whenever targeted biopsy is being performed.

Keywords: Biopsy; Diagnostic imaging; Prostatic neoplasms.

Copyright © 2018 The Authors. Published by Elsevier B.V. All rights reserved.

Figures

Fig. 1
Fig. 1
Disposition of patients.

References

    1. Ahmed H.U., El-Shater Bosaily A., Brown L.C. Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study. Lancet. 2017;389:815–822.
    1. Fütterer J.J., Briganti A., De Visschere P. Can clinically significant prostate cancer be detected with multiparametric magnetic resonance imaging?. A systematic review of the literature. Eur Urol. 2015;68:1045–1053.
    1. Wegelin O., van Melick H.H., Hooft L. Comparing three different techniques for magnetic resonance imaging-targeted prostate biopsies: a systematic review of in-bore versus magnetic resonance imaging-transrectal ultrasound fusion versus cognitive registration. Is there a preferred technique? Eur Urol. 2017;71:517–553.
    1. Valerio M., Donaldson I., Emberton M. Detection of clinically significant prostate cancer using magnetic resonance imaging-ultrasound fusion targeted biopsy: a systematic review. Eur Urol. 2015;68:8–19.
    1. Bonmati E., Hu Y., Villarini B. Technical note: Error metrics for estimating the accuracy of needle/instrument placement during transperineal magnetic resonance/ultrasound-guided prostate interventions. Med Phys. 2018;45:1408–1414.
    1. Ergina P.L., Barkun J.S., McCulloch P., Cook J.A., Altman D.G., IDEAL Group IDEAL framework for surgical innovation 2: observational studies in the exploration and assessment stages. BMJ. 2013;346:f3011.
    1. Muller B.G., Fütterer J.J., Gupta R.T. The role of magnetic resonance imaging (MRI) in focal therapy for prostate cancer: recommendations from a consensus panel. BJU Int. 2014;113:218–227.
    1. Kirkham A.P., Haslam P., Keanie J.Y. Prostate MRI: Who, when, and how? Report from a UK consensus meeting. Clin Radiol. 2013;68:1016–1023.
    1. Barentsz J.O., Richenberg J., Clements R. ESUR prostate MR guidelines 2012. Eur Radiol. 2012;22:746–757.
    1. Rosenkrantz A.B., Lim R.P., Haghighi M., Somberg M.B., Babb J.S., Taneja S.S. Comparison of interreader reproducibility of the prostate imaging reporting and data system and Likert scales for evaluation of multiparametric prostate MRI. AJR Am J Roentgenol. 2013;201:W612–W618.
    1. Rastinehad A.R., Waingankar N., Turkbey B. Comparison of multiparametric MRI scoring systems and the impact on cancer detection in patients undergoing MR US fusion guided prostate biopsies. PLoS One. 2015;10:e0143404.
    1. Bass E.J., Donaldson I.A., Freeman A. Magnetic resonance imaging targeted transperineal prostate biopsy: a local anaesthetic approach. Prostate Cancer Prostatic Dis. 2017;20:311–317.
    1. Barry M.J., Fowler F.J., Jr., O’Leary M.P. The American Urological Association symptom index for benign prostatic hyperplasia. J Urol. 1992;148:1549–1557.
    1. Rosen R.C., Riley A., Wagner G., Osterloh I.H., Kirkpatrick J., Mishra A. The International Index of Erectile Function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology. 1997;49:822–830.
    1. Ahmed H.U., Hu Y., Carter T. Characterizing clinically significant prostate cancer using template prostate mapping biopsy. J Urol. 2011;186:458–464.
    1. Huang H., Wang W., Lin T. Comparison of the complications of traditional 12 cores transrectal prostate biopsy with image fusion guided transperineal prostate biopsy. BMC Urol. 2016;16:68.
    1. Siddiqui M.M., Rais-Bahrami S., Turkbey B. Comparison of MR/ultrasound fusion-guided biopsy with ultrasound-guided biopsy for the diagnosis of prostate cancer. JAMA. 2015;313:390–397.
    1. Porpiglia F., Manfredi M., Mele F. Diagnostic pathway with multiparametric magnetic resonance imaging versus standard pathway: results from a randomized prospective study in biopsy-naïve patients with suspected prostate cancer. Eur Urol. 2017;72:282–288.
    1. Kasivisvanathan V., Rannikko A.S., Borghi M. MRI-targeted or standard biopsy for prostate-cancer diagnosis. N Engl J Med. 2018;378:1767–1777.
    1. Puech P., Rouvière O., Renard-Penna R. Prostate cancer diagnosis: multiparametric MR-targeted biopsy with cognitive and transrectal US-MR fusion guidance versus systematic biopsy—prospective multicenter study. Radiology. 2013;268:461–469.
    1. Wysock J.S., Rosenkrantz A.B., Huang W.C. A prospective, blinded comparison of magnetic resonance (MR) imaging-ultrasound fusion and visual estimation in the performance of MR-targeted prostate biopsy: the PROFUS trial. Eur Urol. 2014;66:343–351.
    1. Lee D.J., Recabal P., Sjoberg D.D. Comparative effectiveness of targeted prostate biopsy using magnetic resonance imaging ultrasound fusion software and visual targeting: a prospective study. J Urol. 2016;196:697–702.

Source: PubMed

Sponsors and Collaborators

Medical Conditions

Drug Interventions

3
Subscribe