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MRI-Guided PROSTATE Biopsy: Which Direction?

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MRI-Guided PROSTATE Biopsy: Which Direction? MRI-GUIDED PROSTATE BIOPSY: WHICH DIRECTION? Martijn G. Schouten Wat mij ontzettend heeft aangesproken tijdens het tot stand komen van dit proefschrift is het betrokken zijn bij de nieuwste technische ontwikkelingen en de implementatie hiervan in de klinische praktijk. Martijn G. Schouten MRI-GUIDED PROSTATE BIOPSY: WHICH DIRECTION? MRI-guided prostate biopsy: which direction? Proefschrift ter verkrijging van de graad van doctor aan de Radboud Universiteit Nijmegen op gezag van de rector magnificus prof. dr. J.H.J.M. van Krieken, volgens besluit van het college van decanen in het openbaar te verdedigen op maandag 19 juni 2017 om 12.30 uur precies door Martijn Gerjan Schouten geboren op 22 mei 1985 te Groningen Colofon © Martijn G. Schouten, Nijmegen, The Netherlands, Mei 2017 ISBN 9789462956469 Ontwerp Geert van Holland (www.geertvanholland.nl) Print Proefschriftmaken, Nijmegen The research in this thesis was funded by the Dutch Cancer Society (KWF Kankerbestrijding). The studies were performed at the Department of Radiology, Radboudumc, Nijmegen, the Netherlands. Publication of this thesis was financially supported by Radboudumc, Health Valley Netherlands, Guerbet Nederland B.V. and Soteria Medical. MRI-GUIDED PROSTATE BIOPSY: WHICH DIRECTION? Promotoren TABLE OF Chapter 5.0 prof. dr. J.O. Barentsz Differentiation of prostatitis and prof. dr. J.J. Fütterer (Universiteit Twente) CONTENTS prostate cancer by using diffusion- weighted MR imaging and MR-guided Copromotoren biopsy at 3T dr. ir. T.W.J. Scheenen Chapter 1.0 p 64 dr. S. Misra (Universiteit Twente) Introduction p 8 Manuscriptcommissie Chapter 6.0 prof. dr. J.A. Witjes The accuracy and safety aspects prof. dr. W.R. Gerritsen Chapter 2.0 of a novel robotic needle guide dr. M. Moche (Universitätsklinikum Leipzig, Duitsland) Three-tesla magnetic resonance manipulator to perform transrectal (MR)-guided prostate biopsy in prostate biopsies men with increased prostate p 82 specific antigen and repeated, negative, random, systematic, Paranimfen transrectal ultrasound biopsies: Chapter 7.0 dr. R.J. Klijn detection of clinically significant Evaluation of a robotic technique for drs. J. Doorduin prostate cancers transrectal MR-guided prostate biopsies p 16 p 98 Chapter 3.0 Chapter 8.0 Location of prostate cancers Automated real-time needle- determined by multi-parametric guide tracking for fast 3T MR- and MR-guided biopsy in patients guided transrectal prostate with elevated prostate specific biopsy: a feasibility study antigen level and at least one p 112 negative transrectal ultrasound- guided biopsy p 32 Chapter 9.0 Summary and discussion p 126 Chapter 4.0 Samenvatting en conclusies Why and where do we miss p 138 significant prostate cancer with multi-parametric MRI followed by MR- guided and TRUS-guided Dankwoord biopsy in biopsy naïve men? p 144 p 48 Curriculum Vitae p 147 Publications p 148 MRI-GUIDED PROSTATE BIOPSY: WHICH DIRECTION? Prostate cancer is the most commonly diagnosed form of cancer among CHAPTER 1.0 male in Europe and the United States (1, 2). In the Netherlands prostate 1.0 INTRODUCTION cancer was found in 21% of the total number of new cancer cases (Fig. 1) (3). Prostate cancer is not only frequently diagnosed it is also an important cause of death. In the Netherlands, prostate cancer is with 2535 men the second leading cause of death among men who die from cancer (11% of the total number of cancer deaths). In comparison, in the same year 3161 woman died from breast cancer (4). Males Females prostate 10897 20.5% 14402 295% prostate skin 7873 14.8% 7137 14.6% skin lung 7537 14.2% 5859 12.1% lung colon & rectum 7475 14.1% 5123 10.5% colon & rectum urinary tract 3973 7.5% 668 1.4% urinary tract total 53095 100% 48753 100% total Figure 1: Incidence of most frequently diagnosed cancer locations in the Netherlands in 2013. With 10,897 new cases prostate cancer is the most frequently diagnosed cancer among men. Current diagnosis of prostate cancer In patients with an elevated prostate specific antigen (PSA) and/or abnormal digital rectal examination (DRE), random systematic transrectal ultrasound (TRUS)-guided biopsy is the standard of practice for prostate cancer diagnosis. However, this diagnostic pathway has limitations, because the PSA-test is highly sensitive but an unspecific marker and DRE and TRUS-guided biopsy are rather insensitive examinations for prostate cancer detection (5, 6). With TRUS-guided biopsy an ultrasound probe is inserted in the rectum of the patient for biopsy guidance and 10 to 12 samples are obtained from the prostate according to a standardized scheme from the posterior peripheral zone. Due to sampling error more than 20% of the cancers are not detected in the first TRUS- guided biopsy session (7). With repeat TRUS-guided biopsies, prostate cancer detection rates decrease from 22% to 4% in four subsequent TRUS-guided biopsy sessions (7). Cancer detection rates of extensive saturation biopsy in men with 1, 2, and ≥3 prior negative TRUS biopsies were 56%, 42%, and 34%, respectively (8). Thus, a large number of patients with a persistently elevated or increasing PSA and one or more negative TRUS-guided biopsy sessions are subject to diagnostic insufficiency and uncertainty. p 8 ‹ BACK TO TABLE OF CONTENTS MRI-GUIDED PROSTATE BIOPSY: WHICH DIRECTION? p 9 Besides the fact that, clinically significant tumours are missed with the current diffusion coefficient (ADC)-values derived from DWI are related to prostate cancer TRUS-guided biopsy protocol, clinically insignificant tumours are identified by aggressiveness (20). Functional MRI increases prostate cancer localization accuracy 1.0 chance. These tumours often remain dormant and clinically unimportant for when added to anatomic T2-weighted MRI in a multi-parametric MRI exam (21, 22). decades. Consequently, early detection of prostate cancer, with the intent to Using the localization ability of multi-parametric MRI, it has recently become possible diagnose this disease in a curable state, currently leads to over-diagnosis which to target biopsies from cancer suspicious lesions with MR-guided biopsy rather than in turn can result in over-treatment (9). systematically sampling of the prostate with TRUS-guided biopsy. Besides the fact Furthermore, there is undergrading of tumour aggressiveness (represented by the that less sampling cores are needed for diagnosis, this technique predominantly (44- Gleason score) when the less aggressive part of a tumour is sampled or the clinically 87%) detects clinically significant prostate cancers in biopsy-naïve males and men significant lesion is missed. With the current clinical evaluation of PSA, DRE, and with prior negative biopsies (18). Furthermore, the high negative predictive value (63 TRUS-guided biopsy it is not possible to accurately determine tumour characteristics - 98%) of multi-parametric MRI can be used to rule out significant disease (18). These and location since understaging (36%) and undergrading of the Gleason score properties are promising regarding the current diagnostic dilemma since diagnosing (34-38%) is commonly seen (10-13). Understanding these limitations (Fig. 2) is of insignificant tumours may cause unnecessary treatment of men who probably will clinical importance because with these parameters, together with preference of not have clinical symptoms during their life (9). In this context it is important to keep the patient and physician, a decision is made for tailored treatment. in mind that most men will die with prostate cancer rather than die from it (23). Furthermore, multi-parametric MRI will play an important role in minimal invasive focal therapy regarding patient selection, treatment planning and monitoring and follow-up (14, 16, 24). The question “which direction?” seems to be answered with MR-guided biopsy since it becomes possible to obtain biopsies from the most aggressive part of cancer suspicious lesions within the prostate seen on multi-parametric MRI. However, we are not there yet. Currently the only commercially available transrectal MR-guided prostate biopsy device is a manually adjustable device Figure 2: With the current TRUS-guided biopsy protocol clinically significant tumours are for needle guide positioning (25). After inserting a needle guide into the rectum missed (A), furthermore clinically insignificant tumours are identified by chance (B), and there (Fig. 3), MR images are acquired. Based on these MR images, the needle guide is is undergrading of tumour aggressiveness (represented by the Gleason score ) when the less manually positioned in the direction of the cancer suspicious lesion (Fig. 3). aggressive part of a tumour is sampled (C) or the significant lesion is missed (D). Furthermore, minimally invasive therapies are increasingly being investigated in localized prostate cancer (14-16). An important aspect is patient selection which relies on accurate tumour localization and risk stratification (17). Therefore, with the introduction of focal therapy the need for an adequate diagnostic tool has become even more important. MR-guided prostate biopsy With multi-parametric magnetic resonance imaging (MRI) techniques it is possible to obtain anatomical and functional information from prostatic tissue to identify cancerous lesions (18). Anatomical information can be obtained from T2-weighted MR imaging. However, T2-weighted imaging alone is sensitive but not specific for prostate cancer and should therefore be combined with functional imaging Figure 3: The patient is positioned in prone position
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