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BMC Urology
Published in: BMC Urology 1/2017

Open Access 01-12-2017 | Study protocol

The prostate cancer detection rates of CEUS-targeted versus MRI-targeted versus systematic TRUS-guided biopsies in biopsy-naïve men: a prospective, comparative clinical trial using the same patients

Authors: A. W. Postema, M. J. V. Scheltema, C. K. Mannaerts, R. J. G. Van Sloun, T. Idzenga, M. Mischi, M. R. E. Engelbrecht, J. J. M. C. H. De la Rosette, H. Wijkstra

Published in: BMC Urology | Issue 1/2017

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Abstract

Background

The current standard for Prostate Cancer (PCa) detection in biopsy-naïve men consists of 10–12 systematic biopsies under ultrasound guidance. This approach leads to underdiagnosis and undergrading of significant PCa while insignificant PCa may be overdiagnosed. The recent developments in MRI and Contrast Enhanced Ultrasound (CEUS) imaging have sparked an increasing interest in PCa imaging with the ultimate goal of replacing these “blind” systematic biopsies with reliable imaging-based targeted biopsies.

Methods/design

In this trial, we evaluate and compare the PCa detection rates of multiparametric (mp)MRI-targeted biopsies, CEUS-targeted biopsies and systematic biopsies under ultrasound guidance in the same patients. After informed consent, 299 biopsy-naïve men will undergo mpMRI scanning and CEUS imaging 1 week prior to the prostate biopsy procedure. During the biopsy procedure, a systematic transrectal 12-core biopsy will be performed by one operator blinded for the imaging results and targeted biopsy procedure. Subsequently a maximum of 4 CEUS-targeted biopsies and/or 4 mpMRI-targeted biopsies of predefined locations determined by an expert CEUS reader using quantification techniques and an expert radiologist, respectively, will be taken by a second operator using an MRI-US fusion device. The primary outcome is the detection rate of PCa (all grades) and clinically significant PCa (defined as Gleason score ≥7) compared between the three biopsy protocols.

Discussion

This trial compares the detection rate of (clinically significant) PCa, between both traditional systematic biopsies and targeted biopsies based on predefined regions of interest identified by two promising imaging technologies. It follows published recommendations on study design for the evaluation of imaging guided prostate biopsy techniques, minimizing bias and allowing data pooling. It is the first trial to combine mpMRI imaging and advanced CEUS imaging with quantification.

Trial registration

The Dutch Central Committee on Research Involving Human Subjects registration number NL52851.018.15, registered on 3 Nov 2015. Clinicaltrials.gov database registration number NCT02831920, retrospectively registered on 5 July 2016.
Literature
1.
2.
Ferlay J, Steliarova-Foucher E, Lortet-Tieulent J, Rosso S, Coebergh JW, Comber H, et al. Cancer incidence and mortality patterns in Europe: estimates for 40 countries in 2012. Eur J Cancer. 2013;49:1374–403.CrossRefPubMed
3.
4.
Bjurlin MA, Carter HB, Schellhammer P, Cookson MS, Gomella LG, Troyer D, et al. Optimization of Initial Prostate Biopsy in Clinical Practice : Sampling, Labeling and Specimen Processing. JURO [Internet]. American Urological Association Education and Research, Inc.; 2013;189:2039–46. Available from: http://​dx.​doi.​org/​10.​1016/​j.​juro.​2013.​02.​072
5.
6.
Vargas HA, Hötker AM, Goldman DA, Moskowitz CS, Gondo T, Matsumoto K, et al. Updated prostate imaging reporting and data system (PIRADS v2) recommendations for the detection of clinically significant prostate cancer using multiparametric MRI: critical evaluation using whole-mount pathology as standard of reference. Eur Radiol. 2016;26(6):1606-12.
7.
Fütterer JJ, Briganti A, De Visschere P, Emberton M, Giannarini G, Kirkham A, et al. Can Clinically Significant Prostate Cancer Be Detected with Multiparametric Magnetic Resonance Imaging? A Systematic Review of the Literature. Eur Urol. 2015;68(6):1045-53.
8.
Schoots IG, Roobol MJ, Nieboer D, Bangma CH, Steyerberg EW, Hunink MGM. Magnetic Resonance Imaging-targeted Biopsy May Enhance the Diagnostic Accuracy of Significant Prostate Cancer Detection Compared to Standard Transrectal Ultrasound-guided Biopsy: A Systematic Review and Meta-analysis. Eur. Urol. [Internet]. European Association of Urology; 2015;68:438–50. Available from: http://​dx.​doi.​org/​10.​1016/​j.​eururo.​2014.​11.​037
9.
van Hove A, Savoie P-H, Maurin C, Brunelle S, Gravis G, Salem N, et al. Comparison of image-guided targeted biopsies versus systematic randomized biopsies in the detection of prostate cancer: a systematic literature review of well-designed studies. World J. Urol. [Internet]. 2014 [cited 2014 Sep 15];32:847–58. Available from: http://​www.​ncbi.​nlm.​nih.​gov/​pubmed/​24919965
10.
Bjurlin MA, Mendhiratta N, Wysock JS, Taneja SS. Multiparametric MRI and targeted prostate biopsy: Improvements in cancer detection, localization, and risk assessment. Cent Eur J Urol. 2016;69:9–18.CrossRef
11.
Gayet M, Van Der Aa A, Beerlage HP, Schrier BP, Mulders PFA, Wijkstra H. The value of magnetic resonance imaging and ultrasonography (MRI/US)-fusion biopsy platforms in prostate cancer detection: A systematic review. BJU Int. 2016;117:392–400.CrossRefPubMed
12.
Postema A, Mischi M, de la Rosette J, Wijkstra H. Multiparametric ultrasound in the detection of prostate cancer: a systematic review. World J Urol. 2015;33(11):1651-9.
13.
14.
Smeenge M, Barentsz J, Cosgrove D, De La Rosette J, De Reijke T, Eggener S, et al. Role of transrectal ultrasonography (TRUS) in focal therapy of prostate cancer: Report from a Consensus Panel. BJU Int. 2012;110:942–8.CrossRefPubMed
15.
16.
Postema A, Idzenga T, Mischi M, Frinking P, de la Rosette J, Wijkstra H. Ultrasound modalities and quantification: developments of multiparametric ultrasonography, a new modality to detect, localize and target prostatic tumors. Curr Opin Urol. 2015;25:191–7.CrossRefPubMed
17.
18.
Kuenen MPJ, Saidov T a, Wijkstra H, de la Rosette JJMCH, Mischi M. Spatiotemporal correlation of ultrasound contrast agent dilution curves for angiogenesis localization by dispersion imaging. IEEE Trans. Ultrason. Ferroelectr. Freq. Control [Internet]. 2013;60:2665–9. Available from: http://​www.​ncbi.​nlm.​nih.​gov/​pubmed/​24297031
19.
Valerio M, Donaldson I, Emberton M, Ehdaie B, Hadaschik BA, Marks LS, et al. Detection of clinically significant prostate cancer using magnetic resonance imaging-ultrasound fusion targeted biopsy: A systematic review. Eur Urol. 2015 Jul;68(1):8-19.
20.
Postema AW, Frinking PJA, Smeenge M, De Reijke TM, De la Rosette JJMCH, Tranquart F, et al. Dynamic contrast-enhanced ultrasound parametric imaging for the detection of prostate cancer. BJU Int. 2016 Apr;117(4):598-603.
21.
Kuru TH, Roethke MC, Rieker P, Roth W, Fenchel M, Hohenfellner M, et al. Histology core-specific evaluation of the European Society of Urogenital Radiology (ESUR) standardised scoring system of multiparametric magnetic resonance imaging (mpMRI) of the prostate. BJU Int. 2013;112:1080–7.CrossRefPubMed
22.
Nam JM. Establishing equivalence of two treatments and sample size requirements in matched-pairs design. Biometrics. 1997;53:1422–30.CrossRefPubMed
23.
Liu JP, Hsueh HM, Hsieh E, Chen JJ. Tests for equivalence or non-inferiority for paired binary data. Stat Med. 2002;21:231–45.CrossRefPubMed
24.
Presti JC, O’Dowd GJ, Miller MC, Mattu R, Veltri RW. Extended peripheral zone biopsy schemes increase cancer detection rates and minimize variance in prostate specific antigen and age related cancer rates: results of a community multi-practice study. J Urol. 2003;169:125–9.CrossRefPubMed
25.
Frauscher F, Klauser A, Volgger H, Halpern EJ, Pallwein L, Steiner H, et al. Comparison of contrast enhanced color Doppler targeted biopsy with conventional systematic biopsy: impact on prostate cancer detection. J. Urol. [Internet]. United States; 2002;167:1648–52. Available from: http://​www.​ncbi.​nlm.​nih.​gov/​pubmed/​11912381
26.
Pelzer A, Bektic J, Berger AP, Pallwein L, Halpern EJ, Horninger W, et al. Prostate cancer detection in men with prostate specific antigen 4 to 10 ng/ml using a combined approach of contrast enhanced color Doppler targeted and systematic biopsy. J. Urol. [Internet]. 2005 [cited 2013 Dec 16];173:1926–9. Available from: http://​www.​ncbi.​nlm.​nih.​gov/​pubmed/​15879783
27.
28.
Bokor D, Chambers JB, Rees PJ, Mant TG, Luzzani F, Spinazzi A. Clinical safety of SonoVue, a new contrast agent for ultrasound imaging, in healthy volunteers and in patients with chronic obstructive pulmonary disease. Invest Radiol. 2001;36:104–9.CrossRefPubMed
29.
Cohen JL, Cheirif J, Segar DS, Gillam LD, Gottdiener JS, Hausnerova E, et al. Improved left ventricular endocardial border delineation and opacification with OPTISON (FS069), a new echocardiographic contrast agent: Results of a phase III multicenter trial. J Am Coll Cardiol. 1998;32:746–52.CrossRefPubMed
30.
Correas JM, Bridal L, Lesavre A, Méjean A, Claudon M, Hélénon O. Ultrasound contrast agents: Properties, principles of action, tolerance, and artifacts. Eur. Radiol. 2001;11:1316–28.
31.
Jakobsen JA, Oyen R, Thomsen HS, Morcos SK. Safety of ultrasound contrast agents. Eur Radiol. 2005;15:941–5.CrossRefPubMed
32.
Becher H, Lofiego C, Mitchell A, Timperley J. Current indications for contrast echocardiography imaging. Eur J Echocardiogr. 2005;6:1–5.CrossRef
33.
Moore CM, Kasivisvanathan V, Eggener S, Emberton M, Futterer JJ, Gill IS, et al. Standards of reporting for MRI-targeted biopsy studies (START) of the prostate: Recommendations from an international working group. Eur Urol. 2013;64:544–52.CrossRefPubMed
Metadata
Title
The prostate cancer detection rates of CEUS-targeted versus MRI-targeted versus systematic TRUS-guided biopsies in biopsy-naïve men: a prospective, comparative clinical trial using the same patients
Authors
A. W. Postema
M. J. V. Scheltema
C. K. Mannaerts
R. J. G. Van Sloun
T. Idzenga
M. Mischi
M. R. E. Engelbrecht
J. J. M. C. H. De la Rosette
H. Wijkstra
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Urology / Issue 1/2017
Electronic ISSN: 1471-2490
DOI
https://doi.org/10.1186/s12894-017-0213-7

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