The paper is the first to assess the learning curve of robotic assisted prostate biopsy. The paper concludes the proficient performance of Robot Assisted Transperineal Fusion Biopsies (RA TP FBx) feasible as of 22 cases regardless of previous biopsy experience and presume steady accuracy due to the automatization offered by robotic technology. This is a considerable difference from the reported learning curve of other transperineal biopsy platforms 65-125 cases.

The Learning Curve of Robotic assisted Transperineal MRI/US Fusion guided Prostate Biopsy

Vitkor Alargkof Anagnostou, Christian Engesser, Pawel Trotsenko,Hanns-Christian Breit, David Winkel, Helge Seifert, Christian Wetterauer

According to the study in this paper Robotic-assisted transperineal MRI-US-fusion guided biopsy of the prostate using Mona Lisa performed under general anesthesia is a safe and well tolerated procedure. This technique allows to omit perioperative prophylaxis and at the same time minimizes the risk of infectious complications. The paper attributed the favorable risk profile and tolerability to the minimal invasive approach via two entry points of Mona Lisa.

Safety profile of robotic-assisted transperineal MRI-US-fusion guided biopsy of the prostate

Walter, M., Trotsenko, P., Breit, H. C., Keller, N., Meyer, A., Winkel, D. J., Seifert, H. H., & Wetterauer, C.

This paper evaluated the safety and feasibility of performing stereotactic robot-assisted transperineal MRI-US fusion targeted prostate biopsy under local anaesthesia (LA) with sedation using Mona Lisa on 30 patients . 29 of 30 patients (96.7%) were discharged within 24 h of procedure. There were no immediate severe complications. Adenocarcinoma was detected in 19/30 (63.3%) cases. This pilot feasibility study showed that stereotactic robotic transperineal MRI-US fusion targeted prostate biopsy using Mona Lisa can be safely and accurately performed under LA with sedation.

Stereotactic robot-assisted transperineal prostate biopsy under local anaesthesia and sedation: moving robotic biopsy from operating theatre to clinic

Yang, X., Lee, A. Y., Law, Y. M., Sim, A. S. P., Tay, K. J., Lau, W. K. O., Ho, H. S. S., Yuen, J. S. P., & Chen, K.

This paper presents the concept of robotic- assisted target saturation biopsy. Target-saturation biopsies using Mona Lisa led to a more accurate characterization of Prostate Cancer in terms of Gleason score and reduced rates of signifcant cancer missed.

Diagnostic accuracy and clinical implications of robotic assisted MRI-US fusion guided target saturation biopsy of the prostate

Wetterauer, C., Trotsenko, P., Matthias, M. O., Breit, C., Keller, N., Meyer, A., Brantner, P., Vlajnic, T., Bubendorf, L., Winkel, D. J., Kwiatkowski, M., & Seifert, H. H.

This paper demonstrates that Transperineal prostate biopsy without antibiotic prophylaxis using Mona Lisa is a safe procedure. There was no association found between core number and complication rate.

Safety and side effects of transperineal prostate biopsy without antibiotic prophylaxis

Sigle, A., Suarez-Ibarrola, R., Pudimat, M., Michaelis, J., Jilg, C. A., Miernik, A., Grabbert, M. T., Schultze-Seemann, W., Gratzke, C., & Schlager, D.

This paper aims to determine the missed clinically significant prostate cancer (CSPC) rate for target and saturation biopsies using a robotic-assisted trans-perineal MRI-Fusion biopsy platform (TP MRI-Fusion BX) and the related complications. Mona Lisa was used for all the biopsy procedures. Robotic-assisted target and saturation biopsies had a miss rate of 2.97% CSPC. This was 2 to 3 times lower than doing target only and target plus systematic biopsy.

Optimal prostate biopsy regime for the 21st century: is it necessary to do a combined target and saturation biopsies?

Woon Tsang, Yu Fei Qiao, Karthik Thandapani, Ming Chun Chan, Qinghui Wu, Bertrand Ang, Yee Lian Thian, Wynne Chua, Lincoln Tan, Edmund Chiong

The primary aim of this study was to determine the clinically significant cancer detection rate (csCDR) of Transperienal (TP) targeted biopsies using robotic-assisted (RA) MRI ultrasound fusion biopsy (MFB) compared to cognitive targeted biopsies (C-TB) using a grid template as this has not previously been reported. Secondary aims were to determine differences in complications between the two methods. Robot Assisted targeted biopsy using Mona Lisa results in higher CDR for clinically significant cancers and any cancer. It also suffers lower complications compared to cognitive directed TP biopsy.

Robotic-assisted magnetic resonance imaging ultrasound fusion results in higher significant cancer detection compared to cognitive prostate targeting in biopsy naive men

Patel, M. I., Muter, S., Vladica, P., & Gillatt, D.

Mona Lisa was used for performing both systematic and MRI-US fusion targeted biopsy in this retrospective study. The paper is addressing the need for systematic biopsy and the effect of the no of cores taken during systematic MRI-targeted biopsy. Reducing the number of systematic biopsies when performing an MRI-targeted biopsy leads to reduced detection of csPCa and alter the treatment plans for focal therapy, possibly limiting its oncological efficacy.

Reducing the number of systematic biopsy cores in the era of MRI targeted biopsy—implications on clinically-significant prostate cancer detection and relevance to focal therapy planning

Lee, A. Y. M., Chen, K., Tan, Y. G., Lee, H. J., Shutchaidat, V., Fook-Chong, S., Cheng, C. W. S., Ho, H. S. S., Yuen, J. S. P., Ngo, N. T., Law, Y. M., & Tay, K. J.

This paper suggest that the minimally invasive and highly precise robotic technique of Mona Lisa can spare the erectile function without limiting the extent of biopsy and without compromising diagnostic accuracy.

The impact of robotic-assisted transperineal biopsy of the prostate on erectile function

Trotsenko, P., Walter, M., Engesser, C. H., Nicola, K., Viktor, A. A., Winkel, D. J., Breit, H. C., Meyer, A., Seifert, H. H., & Wetterauer, C.

According to the study in this paper (Mona Lisa was used for the biopsy procedure) patients harboring a PI-RADS 5 lesion in a relatively small gland which is localized in the transitional zone could safely omit Systematic Biopsy.

Additionals systematic to MRI-targeted biopsy in prostate cancer diagnosis: a double-edged sword

Rodrigo Suarez-Ibarrola, Cordula A. Jilg, Markus Grabbert, Christian Gratzke, August Sigle

This paper evaluates Ginsburg Scheme using the robotic platform: Mona Lisa. Using this scheme, significant prostate cancer (sPCa) is missed in fewer men when compared regular biopsies.

Evaluation of the ginsburg scheme: where is significant prostate cancer missed?

Sigle, A., Jilg, C. A., Kuru, T. H., Binder, N., Michaelis, J., Grabbert, M., Schultze-Seemann, W., Miernik, A., Gratzke, C., Benndorf, M., & Suarez-Ibarrola, R.

The paper addressed the use of Mona Lisa for MRI US fusion transperineal biopsy. MRI-US Fusion has a fine balance with regards to accuracy, practicality and affordability. This review paper aims to describe the various uses of MP-MRI for prostate biopsy comparing different techniques of MP-MRI guided biopsy. The paper concludes that the use of MRI guidance in prostate biopsy is inevitable, subject to availability, cost, and experience. Any one of the three modalities (i.e. MRI cognitive, MRI US fusion and MRI in-bore approach) can be used.

Magnetic resonance imaging-guided prostate biopsy: a review of literature

Seetharam Bhat, K. R., Samavedi, S., Moschovas, M. C., Onol, F. F., Roof, S., Rogers, T., Patel, V. R., & Sivaraman, A.

In this review article, the authors discussed the recent methods of targeting during prostate biopsies and focused on the different platforms used to integrate the mpMRI static images with the real-time US scanning (MRI-US Fusion techniques). Mona Lisa was mentioned under the MRI US software based fusion devices for prostate biopsy.

The Role of MRI-US Fusion Techniques in Detection of Clinically Significant Prostate Cancer

Samir Ali Muter

This paper details the first multicenter trial to investigate complications after Transperineal Biopsy (TPB) without antibiotic prophylaxis. The study itself did not find any case of sepsis thus underlying the safety advantage of Transperineal Biopsy without antibiotic prophylaxis.

Comprehensive analysis of complications after transperineal prostate biopsy without antibiotic prophylaxis: results of a multicenter trial with 30 days’ follow-up

Kohl, T., Sigle, A., Kuru, T., Salem, J., Rolfs, H., Kowalke, T., Suarez-Ibarrola, R., Michaelis, J., Binder, N., Jilg, C. A., Miernik, A., Grabbert, M. T., Schultze-Seemann, W., Gratzke, C., & Porres, D.

Mona Lisa was used for both systematic and targeted biopsy in this study. This paper evaluate the clinically-significant prostate cancer detection rate of systematic (SBx) vs. targeted biopsy (TBx), after accounting for the overlapping systematic cores within the MRI regions of interest. The overlapping systematic cores improve the clinically significant prostate cancer detection rate on TBx.

Limitations of overlapping cores in systematic and MRI-US fusion biopsy

Lee, A. Y., Yang, X. Y., Lee, H. J., Law, Y. M., Huang, H. H., Sim, A. S., Lau, W. K., Lee, L. S., Cheng, C. W., Ho, H. S., Yuen, J. S., Tay, K. J., & Chen, K.

TP MRI-fusion targeted and saturation biopsies were carried out using robotic-assisted iSR'obot Mona Lisa biopsy platform. CSPC was higher for biopsy-naïve patients for PSA<20 using TP MRI-Fusion biopsy. Thus, an up-front mpMRI scan prior to prostate biopsy should be offered to these patients and not restricted to patients with prior negative biopsy. EAU guidelines recommend mpMRI scan for prior negative biopsy and was expanded to include biopsy-naïve and Active Surveillance patients. However, the strength of recommendation was weak for biopsy-naïve patients. The aim of the study was to determine clinically significant prostate cancer (CSPC) rate for biopsy-naïve patients using Trans-perineal MRI-Fusion targeted and saturation biopsy (TP-Fusion-BX) compared to systemic biopsies with trans-rectal (TRUS-BX) and trans-perineal (TP-BX) US-guided biopsies and their complications.

Should biopsy-naïve patients be offered up-front multi-parametric MRI (MPMRI) scan and trans-perineal MRI-fusion targeted and saturation biopsies?

Woon Tsang, Yu Fei Qiao, Karthik Thandapani, Qing Hui Wu,Bertrand Ang, Wynne Chua, Yee Liang Thian, Lincoln Tan, Edmund Chiong

Combined MRI-US targeted biopsy with concurrent systematic prostate systematic biopsy using Mona Lisas robot-assisted transperineal prostate platform probably represents the optimal method for the detection of clinically significant prostate cancer.

Multiparametric MRI-ultrasonography software fusion prostate biopsy: initial results using a stereotactic robotic-assisted transperineal prostate biopsy platform comparing systematic vs targeted biopsy

Lee, A. Y. M., Yang, X. Y., Lee, H. J., Law, Y. M., Huang, H. H., Lau, W. K. O., Lee, L. S., Ho, H. S. S., Tay, K. J., Cheng, C. W. S., Yuen, J. S. P., & Chen, K.

During the use of Mona Lisa in trizonal scheme biopsy method, the percentage of positive biopsy cores detected from target, near-target and MRI-negative zones were 66%, 39% and 17%, respectively. The addition of near-target biopsy cores led to 9% increase in detection rate of clinically significant prostate cancer (csPC). The addition of near-target zone increased the final ISUP grade by a median of one in 17% of the patient. The use of near-target biopsies as part of a trizonal biopsy schema provides a novel methodology to optimize clinically significant prostate cancer detection.

Use of a trizonal schema to assess targeting accuracy in prostatic fusion biopsy

Franklin, A., Gianduzzo, T., Yaxley, J., Kua, B., Coughlin, G., Samaratunga, H., & Gianduzzo, T.

MRI/TRUS fusion targetted biopsy using Mona Lisa increased detection of clinically significant prostate cancer (CsPCa) in patients with previous negative Trans rectal ultra sound biopsies or on active surveillance.

Role of MRI guided targetted prostate biopsy in patients with previous negative TRUS biopsy or on Active Surveillance

Karthik Thandapani, Tsang Woon Chau, Thamboo Thomas Paulraj, Chiong Edmund, Speaker Tan Lincoln Gua

MRI-US fusion-guided targeted biopsy using the iSR’obot Mona Lisa and in-bore MRI targeted biopsy showed greater accuracy in detecting prostate cancer as compared to cognitive fusion targeted biopsy.

Prostate cancer detection in patients with prior negative biopsy undergoing cognitive-, robotic- or in-bore MRI target biop

Kaufmann, S., Russo, G. I., Bamberg, F., Löwe, L., Morgia, G., Nikolaou, K., Stenzl, A., Kruck, S., & Bedke, J.

In patients with suspected Prostate cancer, software-assisted biopsy using Mona Lisa detects most cancers and outperforms the cognitive approach in targeting magnetic resonance imaging-visible lesions.

Cognitive versus Software-Assisted Registration: Development of a New Nomogram Predicting Prostate Cancer at MRI-Targeted Biopsies

Kaufmann, S., Russo, G. I., Thaiss, W., Notohamiprodjo, M., Bamberg, F., Bedke, J., Morgia, G., Nikolaou, K., Stenzl, A., & Kruck, S.

Prostate biopsy using the first-generation iSR’obot Mona Lisa has demonstrated a high detection of clinically significant prostate cancer (csPC) when combined with only limited near-field sampling. The use of Mona Lisa in prostate biopsy demonstrated a clinically significant prostate cancer (csPC) detection rate of 51.2% and a clinically significant prostate cancer (csPC) detection rate of 40.1 % from centroid lesion targeting alone. The combination of both targeted and 12-zone template biopsy increased the csPC detection rate by 10.5% (additional 9 men) to 51.2%.

A prospective analysis of robotic targeted MRI-US fusion prostate biopsy using the centroid targeting approach

Miah, S., Servian, P., Patel, A., Lovegrove, C., Skelton, L., Shah, T. T., Eldred-Evans, D., Arya, M., Tam, H., Ahmed, H. U., & Winkler, M.

This study aimed to assess the first multi-centre Australian experience using the robotic device — the iSR’obot Mona Lisa — to perform MRI-US fusion transperineal biopsy. The study demonstrated that the iSR’obot Mona Lisa can perform robotic MRI-ultrasound fusion transperineal prostate biopsy via two skin punctures safely with high accuracy of targeted cores as confirmed across 3 Australian centres.

First Australian multi-centre experience of robotic MRIultrasound fusion transperineal biopsy using the Isr’obot Mona Lisa

J. Grummet, K. Begashaw, M. Harris,N. Brook, R. Miller and T. Gianduzzo

This study aimed to assess the initial multicenter experience using the robotic device — the iSR’obot Mona Lisa — to perform MRI-US fusion transperineal biopsy. The iSR’obot Mona Lisa performs robotic MRI-ultrasound fusion transperineal prostate biopsy via two skin punctures safely and with high accuracy. Overall, targeted cores detected at least as many significant cancers as template cores. Targeted and template biopsies together is most optimal for cancer grading and detection.

Robotic MRI/US fusion transperineal biopsy using the iSR’obot Mona Lisa

Patel, A. & Servian, P. & Winkler, Mathias & Tiong, L.C. & Yuen, John & Ho, Hey & Chen, Kenneth & Kruck, S. & Grummet, Jeremy.

The use of Mona Lisa in this study in prostate biopsy has a prostate cancer (PC) detection rate of 61%, a clinically significant prostate cancer (csPC) detection rate of 51.2% and a csPC detection rate of 40.1% from targeted biopsy alone. While Robot Assisted targeted biopsy (RA-TB) and systematic biopsy (SB) both showed similar clinically significant prostate cancer detection rates under primary and repeat biopsy settings, RA-TB using Mona Lisa offered 50% reduction in biopsy cores. Thus, omitting RA-SB can pose substantial risk in missing clinically significant prostate cancer.

Targeted vs systematic robot-assisted transperineal magnetic resonance imaging-transrectal ultrasonography fusion prostate biopsy

Mischinger, J., Kaufmann, S., Russo, G. I., Harland, N., Rausch, S., Amend, B., Scharpf, M., Loewe, L., Todenhoefer, T., Notohamiprodjo, M., Nikolaou, K., Stenzl, A., Bedke, J., & Kruck, S.

Biopsies were performed via transperineal route under general anaesthesia with iSR’obot Mona Lisa, a robotic platform with maximal coverage of prostate using real-time 3D-ultrasound technology. Both systematic template biopsy followed by targeted biopsy by cognitive fusion was both performed using Mona Lisa. The paper investigated if a strategy of transperineal template biopsy with magnetic resonance imaging (MRI)-targeted biopsy identifies significant prostate cancer amongst men initially diagnosed with low-risk prostate cancer. A combination of MRI-targeted and template biopsy may optimally risk-classify “low-risk” patients diagnosed on initial conventional transrectal ultrasonography (TRUS) prostate biopsy.

Outcomes of combination MRI-targeted and transperineal template biopsy in restaging low-risk prostate cancer for active surveillance

Chen, K., Tay, K. J., Law, Y. M., Aydin, H., Ho, H., Cheng, C., & Yuen, J. S. P.

Robot-assisted transperineal targeted biopsies using Mona Lisa detect clinically significant prostate cancer (spa) reliably, while biopsies in MRI-negative regions are not significant.

First report of robot‑assisted transperineal fusion versus off‑target biopsy in patients undergoing repeat prostate biopsy

Kaufmann, S., Mischinger, J., Amend, B., Rausch, S., Adam, M., Scharpf, M., Fend, F., Kramer, U., Notohamiprodjo, M., Nikolaou, K., Stenzl, A., Bedke, J., & Kruck, S.

This study compared prostate cancer detection rates between MRI-TRUS fusion targeted and systematic biopsies using a robot-guided, software based transperineal approach using Mona Lisa. Transperineal biopsy approach using Mona Lisa allows for optimal coverage of high-risk areas of the prostate and hence increases detection rates.

Diagnostic Accuracy of Robot-Guided, Software Based Transperineal MRI/TRUS Fusion Biopsy of the Prostate in a High Risk Population of Previously Biopsy Negative Men

Kroenig, M., Schaal, K., Benndorf, M., Soschynski, M., Lenz, P., Krauss, T., Drendel, V., Kayser, G., Kurz, P., Werner, M., Wetterauer, U., Schultze-Seemann, W., Langer, M., & Jilg, C. A.

Biopsies were performed via transperineal route under general anaesthesia with iSR’obot Mona Lisa, a robotic platform with maximal coverage of prostate using real-time 3D-ultrasound technology. The paper investigated if a strategy of combination staging-biopsy (CSB) of robotic transperineal saturation biopsy (rTPB) and MRI-targeted biopsy (MRI-TB) better classifies patients for treatment options. MRI-targeted biopsy in tandem with robotic transperineal systematic biopsy with Mona Lisa upgrades Gleason score.

Early outcomes of combintation MRI-targeted and saturation trans-perineal biopsy in restaging low-risk prostate cancer for active surveillance

Kae Jack Tay, Kenneth Chen, Yan Mee Law, Henry Ho, John Yuen, Christopher Cheng