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.
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.
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.
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.
Mottet N, Bellmunt J, Briers E, Bolla M, Cornford P, De Santis M et al. EAU Guidelines on Prostate Cancer - Update March 2016. European Association of Urology [Internet]. 2016 [cited 2017 March 21] Available from: http://uroweb.org/wp-content/uploads/EAU-Guidelines-Prostate-Cancer-2016-1.pdf. Accessed 21 Mar 2017.
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
Bjurlin MA, Meng X, Le Nobin J, Wysock JS, Lepor H, Rosenkrantz AB, et al. Optimization of prostate biopsy: The role of magnetic resonance imaging targeted biopsy in detection, localization and risk assessment. J Urol. 2014;192:648–58. Available from: http://dx.doi.org/10.1016/j.juro.2014.03.117. CrossRefPubMedPubMedCentral
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.
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.
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
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
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
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.
Smeenge M, De La Rosette JJMCH, Wijkstra H. Current status of transrectal ultrasound techniques in prostate cancer. Curr. Opin. Urol. [Internet]. 2012 [cited 2013 Mar 31];22:297–302. Available from: http://www.ncbi.nlm.nih.gov/pubmed/22595778
Russo G, Mischi M, Scheepens W, De la Rosette JJ, Wijkstra H. Angiogenesis in prostate cancer: onset, progression and imaging. BJU Int. [Internet]. 2012 [cited 2013 Apr 2];110:E794–808. Available from: http://www.ncbi.nlm.nih.gov/pubmed/22958524
Kuenen MPJ, Saidov TA, Wijkstra H, Mischi M. Contrast-ultrasound dispersion imaging for prostate cancer localization by improved spatiotemporal similarity analysis. Ultrasound Med. Biol. [Internet]. 2013 [cited 2014 Apr 29];39:1631–41. Available from: http://www.ncbi.nlm.nih.gov/pubmed/23791350
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
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.
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.
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
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
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
Halpern EJ, Ramey JR, Strup SE, Frauscher F, McCue P, Gomella LG. Detection of prostate carcinoma with contrast-enhanced sonography using intermittent harmonic imaging. Cancer [Internet]. 2005 [cited 2013 May 21];104:2373–83. Available from: http://www.ncbi.nlm.nih.gov/pubmed/16240450
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
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.
Becher H, Lofiego C, Mitchell A, Timperley J. Current indications for contrast echocardiography imaging. Eur J Echocardiogr. 2005;6:1–5. CrossRef
- 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
A. W. Postema
M. J. V. Scheltema
C. K. Mannaerts
R. J. G. Van Sloun
M. R. E. Engelbrecht
J. J. M. C. H. De la Rosette
- BioMed Central
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