Anatomical approach in magnetic resonance imaging and ultrasonography fusion biopsy for prostate cancer detection: a cross-sectional study

doi:10.21203/rs.3.rs-4916079/v1

Download PDF

Research Article

Anatomical approach in magnetic resonance imaging and ultrasonography fusion biopsy for prostate cancer detection: a cross-sectional study

https://doi.org/10.21203/rs.3.rs-4916079/v1

This work is licensed under a CC BY 4.0 License

You are reading this latest preprint version

Background

Comparisons between the transperineal (TP) and the transrectal (TR) approach for prostate biopsies in detecting cancer have been reported; however, there are no reports comparing the cancer detection rates using an anatomical approach. In this study, magnetic resonance imaging and ultrasonography (MRI/US) fusion prostate biopsies were compared between the TP and the TR approaches for detecting cancer at the target sites.

Methods

The MRI/US fusion prostate biopsies were performed between November 2016 and October 2021. There were 251 and 200 patients in the TP and TR groups, respectively. Age, serum prostate specific antigen level, prostate volume, number of biopsies, target site (anterior, posterior, apex, base, middle), cancer detection rate, and the Gleason Grading Group classification were examined.

Results

Significantly higher cancer detection rates were noted for Prostate Imaging Reporting and Data System category 4–5 lesions than for category 3 lesions in both the TP and TR groups (p < 0.001). The cancer detection rates for category 4–5 lesions in the TP and TR groups were 94.4% and 73.3% (p = 0.036), 92.3% and 64.7% (p = 0.017), 69.4% and 93.3% (p = 0.055), and 66.7% and 89.3% (p = 0.010) at the anterior, apex, lateral, and posterior sites, respectively.

Conclusions

The cancer detection rate was significantly different between the TP and TR groups at the anterior, apex, and posterior sites. These differences may be due to the sampling deflection of the needle on the posterior site in the TP group and on the apex and anterior sites in the TR group. These results suggest that urologists should be mindful of the benefits for each patient by considering the advantages with each approach.

prostate cancer

MRI/US fusion biopsy

transperineal biopsy

transrectal biopsy

Prostate biopsy is extremely important and is frequently used in the diagnosis of prostate cancer and is performed using either a transperineal (TP) or a transrectal (TR) approach; however, it has been reported that there are no significant differences in the cancer detection rates between the two groups [1–4]. Recent data shows that magnetic resonance imaging and ultrasonography (MRI/US) fusion biopsy is beneficial in the diagnosis of prostate cancer owing to the higher detection rates [5, 6]. Although comparisons of cancer detection rates between the TP and TR approaches have been reported [7, 8], there are no reports comparing the detection rates at target sites through an anatomical regional approach. This study aimed to compare the TP and TR approaches in detecting prostate cancer at anatomical sites using MRI/US fusion prostate biopsy.

Study population

A total of 251 and 200 patients were examined using the TP and TR approaches, respectively, using MRI/US fusion at Kanazawa Medical University Hospital between November 2016 and October 2021. MRI/US fusion prostate biopsies were indicated with a serum prostate-specific antigen (PSA) value ≥ 4.0 ng/mL and < 50.0 ng/mL.

Multiparametric magnetic resonance imaging (mp-MRI)

mp-MRI using a MAGNETOM Trio a Tim System® (SIEMENS, Munich, Germany) and an enhanced MRI was performed. A radiologist analyzed the imaging using the Prostate Imaging Reporting and Data System (PI-RADS) version 2.0 [9].

Biopsy procedure

In the TP group, the MRI/US fusion software used was a BioJet® (D&K Technologies GmbH, Barum, Germany) [2, 10]. The HIVISION Preirus® device (HITACHI ALOKA, Tokyo, Japan) and the biplane probe EUP-U533® (HITACHI ALOKA, Tokyo, Japan) ultrasound were used. Lumbar anesthesia was performed and the perineum was disinfected with povidone-iodine. The procedure was performed by a radiologist and an experienced urologist. Biopsies at 2–4 cores per target was obtained using the MAX-CORE B® automatic biopsy device (C. R. Bard, Murray Hill, NJ).

In the TR group, the ultrasound device Pro Sound SSD 4000® (HITACHI ALOKA, Tokyo, Japan) and end-fire probe EUP-U531® (Hitachi ALOKA, Tokyo, Japan) were used. The MAXCORE B® biopsy needle was used. An enema was administered using 60 g of glycerin as a pretreatment. The rectum was disinfected with povidone-iodine and a 2% lidocaine jelly was injected into the rectum prior to the biopsy. This procedure was performed without any further anesthesia, however, in cases of a high degree of stenosis, further sacral anesthesia was administered. This procedure was performed by two urologists, and the images were acquired in advance. Based on mp-MRI images, biopsies were performed at 1–2 cores per target.

Patients were admitted for examination, and 200 mg of isepamycin sulfate was administered 30 min before the biopsy. Patients were followed up until the next day and discharged if there were no adverse events, such as hematuria or fever.

Data extraction

For all patients, age, serum PSA levels, estimated prostate volume, ratio of serum PSA value to the estimated prostate volume (PSA density: PSAD), number of biopsies, number of biopsy cores, target site (anterior, posterior, apex, base, middle) (Fig. 1), cancer detection rate, and the Gleason Grading Group (GGG) were examined.

Figure 1. Anatomical categorization of the prostate target sites into anterior, posterior, apex, and base

Statistical analysis

Statistical analysis was performed using the EZR software [11]. Fisher’s exact probability test and Student’s t-test were used. P < 0.05 was deemed as significant.

Ethics

This study was approved by the Ethics Committee of Kanazawa Medical University Hospital (approval number I 735).

Patient characteristics

The characteristics of the patients in the TP and TR groups are shown in Table 1. The median age was 71 (40–85) and 71 (48–87) years, median PSA levels were 7.18 ng/mL (1.15–42.61) and 6.39 ng/mL (1.20–40.29), median prostate volumes were 30.4 mL (10.0–201.0) and 29.1 mL (9.7–127.5), and the median PSAD was 0.247 ng/mL (0.030–2.086) and 0.248 ng/mL/mL (0.037–2.023) in the TP and TR groups, respectively. Regarding the GGG classification, 18 (7.2%) and 30 patients (15.0%) were classified as group 1, 18 (7.2%) and 50 (25.0%) as grade 2, 36 (14.3%) and 20 (10.0%) as grade 3, 7 (2.8%) and 22 patients (11.0%) as grade 4, and 6 (2.4%) and 12 (6.0%) as grade 5 in the TP and TR groups, respectively.

Although there was an average of 1.45 target sites in each patient in the TP group, there was only one target site in each patient in the TR group [1–5]. In the classification using PI-RADS, lesions in 134 (36.8%) and 66 sites (33.0%) were classified as category 2 (p = 0.408), those in 76 (20.9%) and 33 sites (16.5%) as category 3 (p = 0.222), those in 103 (28.3%) and 56 sites as category 4 (28.0%) (p = 0.185), and those in 51 (14.0%) and 45 sites (22.5%) as category 5 (p = 0.013) in the TP and TR groups, respectively.

GGG and cancer detection rate using the PI-RADS categories

GGG and cancer detection rates using PI-RADS categories in the TP and TR groups are shown in Fig. 2. The cancer detection rate using the TP and TR approaches for lesions with PI-RADS category 2–5 were 6.7% and 12.1%, 30.3% and 45.5%, 81.6% and 78.5%, and 92.2% and 91.1%, respectively. Significantly higher cancer detection rates were found for category 4–5 lesions than for category 3 lesions in the TP (85.1% vs 30.3%, P < 0.001) and TR (78.5% vs 45.5%, P < 0.001) groups. In addition, the detection rate of clinically significant cancer (GGG 2 or higher) was significantly higher in categories 4–5 than in category 3 in the TP (75.3% vs 25.0%, P < 0.001) and TR (72.3% vs 36.4%, P < 0.001) groups.

Figure 2. Gleason grading group and cancer detection rate according to the Prostate Imaging Reporting and Data System category for transperineal and transrectal groups. The cancer detection rate was significantly higher for category 4–5 lesions than for category 3 lesions in both groups.

Target lesion and cancer detection rates in PI-RADS category 4–5

The site-specific cancer detection rates of target lesions of category 4–5 are shown in Table 2. The overall cancer detection rates in the TP and TR groups were 85.1% and 84.2%, respectively. In the left lobe, the cancer detection rates were 82.1% and 84.5% (p = 0.795) in the TP and TR groups, respectively. Meanwhile, in the right lobe, the corresponding rates were 84.7% and 82.9% (p = 0.803), respectively. Lesions that were completely centrally located or those that included the left and the right lobes and were difficult to judge and were classified as “others.” Anatomical sites were defined as peripheral zone (PZ) and transitional zone (TZ). The cancer detection rates in the TP and TR groups were not significantly different for the anatomical sites (83.1% and 87.3% for PZ, p = 0.625; and 84.3% and 72.7% for TZ, p = 0.333, respectively). Lesions located on the border between PZ and TZ were classified as “others.”

Anatomical locations were defined as anterior, apex, lateral, and posterior. The middle location was difficult to classify and the number of patients with lesions at this location was small; these cases were therefore classified as “others.” The cancer detection rates in the TP and TR groups were 94.4% and 73.3% (p = 0.036), 92.3% and 64.7% (p = 0.017), 69.4% and 93.3% (p = 0.055), and 66.7% and 89.3% (p = 0.010) at the anterior, apex, lateral, and posterior sites, respectively.

This study showed that cancer detection rates were significantly higher in the TP group than in the TR group at the anterior and apex sites; however, it was significantly lower at the posterior site using the MRI/US fusion. The accurate number of biopsies for detecting prostate cancer has been suggested. Hodge et al. hypothesized that six systematic biopsies are necessary [12]. In an analysis of six patients with negative biopsies in 2001, Stewart et al. suggested that an average of 23 (14–45) biopsies increase the detection rates of prostate cancer [13]. They referred to this as saturation needle biopsy. In 2006, Eichler et al. proposed 12 biopsies consisting of six systematic biopsies plus far lateral PZ. In 2013 [14], Nelson et al. advocated MRI target biopsy for target sites suspected of cancer based on mp-MRI imaging for repeated biopsies and observed an increase in the cancer detection rate [15]. Since 2016, our hospital has also observed an increase in the cancer detection rate. We have performed cognitive fusion transrectal biopsies (or free-hand-targeted biopsy) [16, 17] and have a positive cancer detection rate of more than 60%. We have introduced the MRI/US fusion TP prostate needle biopsy using the BioJet® system, and a further increase in the cancer detection rate has been observed.

It is widely known that there are two approaches to prostate biopsy: TP and TR. From a health and adverse event perspective, the use of the TR approach has long been reported to be associated with adverse effects, such as infections and a higher risk of septic shock [18]. However, Udeh et al. found no significant differences in the incidence of fever, urethral bleeding, hemosemenity, prostate abscess, and urinary retention. However, TR was associated with rectal bleeding [19]. As per the National Cancer Common Terminology Criteria for Adverse Events version 5.0 [20], rectal bleeding, fever, and significant hematuria of more than grade 3 were not observed in both the TP and TR groups.

The cancer detection rates using the TP and TR approaches have been reported to be not significantly different [1–4]. Furthermore, no significant differences in the detection rate of clinically significant cancer in MRI/US fusion prostate target biopsies have been reported [7, 8]. This study shows that overall cancer detection rates were not significantly different between the TP and TR groups for lesions of PI-RADS category 4–5 and that the cancer detection rates were also not significantly different between the two groups.

The anatomical localization of the prostate may affect the cancer detection rates in the TP and TR biopsies. We hypothesized that the apex site would more likely to have a blind spot in the TR approach, and that the anterior site would have the disadvantage of the target lesion being the furthest away from the puncture site. TP biopsies are performed through a stabilized template, allowing for the direct puncture of the apex site sampling and straight needle advancement for anterior site sampling without a blur. However, the prostate also moves forward, backward, left, and right, and the TP approach causes a lateral prostate movement (especially far lateral) and therefore, a sampling error may occur. In the TR lateral and posterior approach, the prostate is firmly fixed with a probe and the target can be punctured directly. If there is a site where sampling error is likely to occur, there is a deflection of the needle when the target is most distal or at the easily mobile part [8, 21]. TP approach may cause sampling error on the lateral/posterior sites and the TR approach may cause errors on the apex/anterior sites. It is speculated that the deflection of the needle may have caused the sampling error.

A limitation of this study was that the BioJet® software was used for TP biopsies; however, a cognitive fusion biopsy was used for TR biopsies, which may have introduced a bias. However, both methods were performed by urologists with more than 10 years of experience, and the cancer detection rates of the TP versus TR approach for PI-RADS category 4–5 lesions were 85.1% vs. 84.2%, respectively, with no significant difference (p = 0.860), and the cancer detection rate was comparable to that of cognitive fusion biopsy.

Trinity Koelis® (Koelis, Grenoble, France) [22] is equipped with organ-based tracking® [23] and MRI/US in both the TP and TR approaches. Urologists generally master either the TP or TR approach. However, this study suggests that selecting an approach according to target site may provide benefits for patients, and thus it is necessary for urologists to be proficient in both methods.

There were no significant differences between the TP and TR approaches in the overall cancer detection rates limited to PI-RADS category 4–5 lesions in this study.

In conclusion, it is speculated that sampling errors may have occurred on the posterior site in the TP group and in the apex/anterior site in the TR group. It is necessary to prevent sampling errors and aim to improve cancer detection rate.

transperineal

transrectal

MRI/US

magnetic resonance imaging and ultrasonography

PSA

prostate-specific antigen

PSAD

prostate-specific antigen density

Mp-MRI

multiparametric magnetic resonance imaging

PI-RADS

Prostate Imaging Reporting and Data System

GGG

Gleason grading group

peripheral zone

transitional zone

Ethics approval and consent to participate:

Informed consent was obtained from all participants. This study was approved by the Ethics Committee of Kanazawa Medical University Hospital (approval number I 735).

Informed consent:

Informed consent was obtained from all patients for being included in the study.

Consent for publication:

Not applicable

Competing interests:

The authors declare that they have no competing interests.

Funding:

N/A

Author Contribution

I.C. and K.M. wrote the main manuscript text. K.K. and T. K. prepared figures and table. All authors reviewed the manuscript.

Acknowledgements:

N/A

Author’s informatin: N/A

Availability of data and materials:

Raw data were generated at Kanazawa medical university. Derived data supporting the findings of this study are available from the corresponding author I.C. on request.

Shen PF, Zhu YC, Wei WR, Li YZ, Yang J, Li YT, et al. The results of transperineal versus transrectal prostate biopsy: a systematic review and meta-analysis. Asian J Androl. 2012;14:310–5.
Borkowetz A, Platzek I, Toma M, Laniado M, Baretton G, Froehner M, et al. Comparison of systematic transrectal biopsy to transperineal magnetic resonance imaging/ultrasound-fusion biopsy for the diagnosis of prostate cancer. BJU Int. 2015;116:873–9.
Xiang J, Yan H, Li J, Wang X, Chen H, Zheng X. Transperineal versus transrectal prostate biopsy in the diagnosis of prostate cancer: a systematic review and meta-analysis. World J Surg Oncol. 2019;17:31.
Lo KL, Chui KL, Leung CH, Ma SF, Lim K, Ng T, et al. Outcomes of transperineal and transrectal ultrasound-guided prostate biopsy. Hong Kong Med J. 2019;25:209–15.
Byun HJ, Shin TJ, Jung W, Ha JY, Kim BH, Kim YH. The value of magnetic resonance imaging and ultrasonography (MRI/US)-fusion biopsy in clinically significant prostate cancer detection in patients with biopsy-naïve men according to PSA levels: A propensity score matching analysis. Prostate Int. 2022;10:45–9.
Kasivisvanathan V, Rannikko AS, Borghi M, Panebianco V, Mynderse LA, Vaarala MH, et al. MRI-targeted or standard biopsy for prostate-cancer diagnosis. N Engl J Med. 2018;378:1767–77.
Winoker JS, Wajswol E, Falagario U, Maritini A, Moshier E, Voutsinas N, et al. Transperineal versus transrectal targeted biopsy with use of electromagnetically-tracked MR/US fusion guidance platform for the detection of clinically significant prostate cancer. Urology. 2020;146:278–86.
Ber Y, Segal N, Tamir S, Benjaminov O, Yakimov M, Sela S, et al. A noninferiority within-person study comparing the accuracy of transperineal to transrectal MRI–US fusion biopsy for prostate-cancer detection. Prostate Cancer Prostatic Dis. 2020;23:449–56.
Weinerb JC, Barentsz JO, Choyke PL, et al. Eur Urol. 2016;69:16–40. PI-RADS Prostate Imaging- Reporting and Data System: 2015, version 2.
Shoji S. Magnetic resonance imaging-transrectal ultrasound fusion image-guided prostate biopsy: current status of the cancer detection and the prospects of tailor-made medicine of the prostate cancer. Investig Clin Urol. 2019;60:4–13.
Kanda Y. Investigation of the freely available easy-to-use software 'EZR’ for medical statistics. Bone Marrow Transpl. 2013;48:452–8.
Hodge KK, McNeal JE, Terris MK, Stamey TA. Random systematic versus directed ultrasound guided transrectal core biopsies of the prostate. J Urol. 1989;142:71–4. discussion 74.
Stewart CS, Leibovich BC, Weaver AL, Lieber MM. Prostate cancer diagnosis using a saturation needle biopsy technique after previous negative sextant biopsies. J Urol. 2001;166:86–91. discussion 91.
Eichler K, Hempel S, Wilby J, Myers L, Bachmann LM, Kleijnen J. Diagnostic value of systematic biopsy methods in the investigation of prostate cancer: a systematic review. J Urol. 2006;175:1605–12.
Nelson AW, Harvey RC, Parker RA, Kastner C, Doble A, Gnanapragasam VJ. Repeat prostate biopsy strategies after initial negative biopsy: meta-regression comparing cancer detection of transperineal, transrectal saturation and MRI guided biopsy. PLoS ONE. 2013;8:e57480.
Ouzzane A, Puech P, Lemaitre L, Leroy X, Nevoux P, Betrouni N, et al. Combined multiparametric MRI and targeted biopsies improve anterior prostate cancer detection, staging, and grading. Urology. 2011;78:1356–62.
Murphy IG, NiMhurchu E, Gibney RG, McMahon CJ. MRI-directed cognitive fusion-guided biopsy of the anterior prostate tumors. Diagn Interv Radiol. 2017;23:87–93.
Grummet JP, Weerakoon M, Huang S, Lawrentschuk N, Frydenberg M, Moon DA, et al. Sepsis and ‘superbugs’: should we favour the transperineal over the transrectal approach for prostate biopsy? BJU Int. 2014;114:384–8.
Udeh EI, Amu OC, Nnabugwu II, Ozoemena II. Transperineal versus transrectal prostate biopsy: our findings in a tertiary health institution. Niger J Clin Pract. 2015;18:110–4.
National Cancer Common Terminology Criteria for Adverse Events. NCI-CTCAE) version 5.0. United States Department of Health and Human Services; 2017.
Halstuch D, Baniel J, Lifshitz D, Sela S, Ber Y, Margel D. Assessment of needle tip deflection during transrectal guided prostate biopsy: implications for targeted biopsies. J Endourol. 2018;32:252–6.
Cornud F, Brolis L, Delongchamps NB, Portalez D, Malavaud B, Renard-Penna R, et al. TRUS–MRI image registration: a paradigm shift in the diagnosis of significant prostate cancer. Abdom Imaging. 2013;38:1447–63.
Knaub RJ, Allaf ME, Gorin MA. Freehand transperineal prostate biopsy with three-dimensional ultrasound organ-based tracking. J Endourol. 2021;35:S7–16.

Table 1 and 2 are available in the Supplementary Files section.

No competing interests reported.

TableVer.1.0.pdf

Download PDF

Reviewers invited by journal
17 Oct, 2024
Editor invited by journal
06 Sep, 2024
Editor assigned by journal
29 Aug, 2024
Submission checks completed at journal
29 Aug, 2024
First submitted to journal
14 Aug, 2024

You are reading this latest preprint version

Anatomical approach in magnetic resonance imaging and ultrasonography fusion biopsy for prostate cancer detection: a cross-sectional study

Status:

Version 1

Abstract

Background

Methods

Results

Conclusions

Figures

Background

Methods

Study population

Multiparametric magnetic resonance imaging (mp-MRI)

Biopsy procedure

Data extraction

Statistical analysis

Ethics

Results

Patient characteristics

GGG and cancer detection rate using the PI-RADS categories

Target lesion and cancer detection rates in PI-RADS category 4–5

Discussion

Conclusions

Abbreviations

Declarations

Competing interests:

Funding:

Author Contribution

Acknowledgements:

Availability of data and materials:

References

Tables

Additional Declarations

Supplementary Files

Status:

Version 1