Fusion-guided Prostate Biopsy Research Articles

The learning curve for robotic-assisted transperineal MRI/US fusion-guided prostate biopsy

Transperineal fusion prostate biopsy has a considerable learning curve (LC). Robotic-assisted transperineal MRI/Ultrasound fusion-guided biopsy (RA-TP-FBx) may have an easier LC due to automatization. We aimed to assess the LC of RA-TP-FBx and analyze its most difficult steps. We prospectively analyzed cases randomized to a biopsy-naïve urology resident, the chief resident, and an expert urologist in RA-TP-FBx (controls). We also analyzed consecutive cases in the LC of the expert. The LC was defined by procedure time, PCa detection rate (including stratification by PI-RADS), entrustable professional activities (EPA) assessment scores, and the NASA task load index. We collectively performed 246 RA-TP-FBx with the Mona Lisa device. Procedure time for residents decreased steeply from maximum 53 min to minimum 10 min, while the mean procedure time for the expert was 9 min (range 17–5 min). PCa detection for PI-RADS-4 lesions was 57% for the naïve resident, 61% for the chief resident and 62% for the expert. There was also no difference in Pca detection for PI-RADS-4 lesions when comparing the first and second half of the experts’ biopsies (p = 0.8). Maximum EPA score was registered after 22 cases. Workload steeply declined. Proficient RA-TP-FBx performance appears feasible after 22 cases regardless of previous experience.

PSMA-based PET as an imaging biomarker of androgen receptor signaling in high-risk localized and locally advanced prostate cancer (PCa).

341 Background: The purpose of this prospective, nonrandomized, pilot imaging study (NCT02420977) is to evaluate prostate-specific membrane antigen (PSMA), [18F]DCFPyL (DCFPyL), as a PET/CT imaging biomarker of androgen receptor (AR) signaling in newly diagnosed PCa. Methods: 23 men with treatment-naïve, newly diagnosed high-risk prostate cancer were enrolled. Patients underwent DCFPyL PET/CT imaging and MRI/ultrasound fusion-guided prostate biopsy before and after 2-3 months of nADT (LHRH agonist and anti-androgen), followed by definitive IMRT. We measured the total number of lesions, lesion location, maximum standardized tumor uptake value (SUVmax), PSA, and changes in those variables between baseline and follow-up scans. Concordance between biopsy pathology results and PSMA imaging parameters before and after ADT was evaluated. Results: 3 patients were excluded after baseline PET/CT due to high-burden metastases, small cell histology, and declining to proceed further. 20 patients remained for evaluation. At baseline, 19/20 and 8/20 had at least 1 avid intraprostatic and extraprostatic lesion, respectively, with a 50 total lesions (28 prostate, 19 nodal, 3 bone); median intraprostatic and extraprostatic SUVmax were respectively 9.6 (range: 3.3-56.8) and 7.0 (range: 2.3-61.9). Post-nADT scans revealed 32 lesions (19 prostate, 11 nodes, 2 bone); median intraprostatic and extraprostatic SUVmax decreased respectively to 4.1 (range 1.9-27.8) and 3.2 (range: 1.7-8.9). 3/19 (15.8%) of the patients demonstrated complete uptake resolution of the avid intraprostatic foci, 15/19 (78.9%) showed decreased uptake (58.3% median decrease in SUVmax), and 1/19 (5.26%) showed increased SUVmax. Of the 8 patients with extraprostatic lesions, 2/8 (25%) demonstrated complete uptake resolution, 5/8 (62.5%) showed partially decreased uptake (66.67% median decrease in SUVmax), and 1/8 (12.5%) showed increased SUVmax. One of the same patients still had 2 lesions, for a total of 13 intraprostatic target lesions. Regarding concordance between pathologic results and PSMA imaging response pre- and post-nADT, 14/19 (73%) had biopsies fully concordant with PSMA scan (i.e. residual tumor and residual PET avidity), 4/19 (21%) had biopsies mostly concordant with the scan (i.e. complete pathologic response with partial PET response or vice versa), and 1/19 (5%) had a biopsy discordant with the PSMA scan (i.e. no pathology response, but complete response on PSMA). Conclusions: Post-nADT PET detected fewer PSMA-positive lesions with overall decreased or resolved tumor uptake, except for 2 separate patients with increased intra- and extraprostatic uptake. 95% of post-nADT PSMA scans were fully or mostly concordant with post-nADT biopsies, suggesting that PSMA scans may be a clinically useful, prognostic imaging biomarker for disease status evaluation post-nADT. Clinical trial information: NCT02420977 .

Transperineal versus Transrectal MRI/TRUS fusion-guided prostate biopsy in a large, ethnically diverse, and multiracial cohort.

To compare transperineal (TP) vs transrectal (TR) magnetic resonance imaging (MRI) and transrectal ultrasound (TRUS) fusion-guided prostate biopsy (PBx) in a large, ethnically diverse and multiracial cohort. Consecutive patients who underwent multiparametric (mp) MRI followed by TP or TR TRUS-fusion guided PBx, were identified from a prospective database (IRB #HS-13-00663). All patients underwent mpMRI followed by 12-14 core systematic PBx. A minimum of two additional target-biopsy cores were taken per PIRADS≥3 lesion. The endpoint was the detection of clinically significant prostate cancer (CSPCa; Grade Group, GG≥2). Statistical significance was defined as p<0.05. A total of 1491 patients met inclusion criteria, with 480 undergoing TP and 1011 TR PBx. Overall, 11% of patients were Asians, 5% African Americans, 14% Hispanic, 14% Others, and 56% White, similar between TP and TR (p=0.4). For PIRADS 3-5, the TP PBx CSPCa detection was significantly higher (61% vs 54%, p=0.03) than TR PBx, but not for PIRADS 1-2 (13% vs 13%, p=1.0). After adjusting for confounders on multivariable analysis, Black race, but not the PBx approach (TP vs TR), was an independent predictor of CSPCa detection. The median maximum cancer core length (11 vs 8mm; p<0.001) and percent (80% vs 60%; p<0.001) were greater for TP PBx even after adjusting for confounders. In a large and diverse cohort, Black race, but not the biopsy approach, was an independent predictor for CSPCa detection. TP and TR PBx yielded similar CSPCa detection rates; however the TP PBx was histologically more informative.

Intra-practice Urologist-level Variation in Targeted Fusion Biopsy Outcomes

To examine the extent to which the urologist performing biopsy contributes to variation in prostate cancer detection during fusion-guided prostate biopsy. All men in the Michigan Urological Surgery Improvement Collaborative (MUSIC) clinical registry who underwent fusion biopsy at Michigan Medicine from August 2017 to March 2019 were included. The primary outcomes were clinically significant cancer detection rate (defined as Gleason Grade ≥ 2) in targeted cores and clinically significant cancer detection on targeted cores stratified by PI-RADS score. Bivariate and multivariable logistic regression analyses were performed. A total of 1,133 fusion biopsies performed by five providers were included. When adjusting for patient age, PSA, race, family history, prostate volume, clinical stage, and PI-RADS score, there was no significant difference in targeted clinically significant cancer detection rates across providers (range = 38.5-46.9%, adjusted p-value = 0.575). Clinically significant cancer detection rates ranged from 11.1-16.7% in PI-RADS 3 (unadjusted p = 0.838), from 24.6-43.4% in PI-RADS 4 (adjusted p = 0.003), and from 69.4-78.8% in PI-RADS 5 (adjusted p = 0.766) lesions. There was a statistically significant difference in clinically significant prostate cancer detection in PI-RADS 4 lesions across providers. These findings suggest that even among experienced providers, variation at the urologist level may contribute to differences in clinically significant cancer detection rates within PI-RADS 4 lesions. However, the relative impact of biopsy technique, radiologist interpretation, and MR acquisition protocol requires further study.

MP66-03 LEARNING CURVE OF ROBOTIC-ASSISTED TRANSPERINEAL MRI/ULTRASOUND FUSION-GUIDED PROSTATE BIOPSY

You have accessJournal of UrologyCME1 Apr 2023MP66-03 LEARNING CURVE OF ROBOTIC-ASSISTED TRANSPERINEAL MRI/ULTRASOUND FUSION-GUIDED PROSTATE BIOPSY Vitkor Alargkof Anagnostou, Christian Engesser, Pawel Trotsenko, Hanns-Christian Breit, David Winkel, Helge Seifert, and Christian Wetterauer Vitkor Alargkof AnagnostouVitkor Alargkof Anagnostou More articles by this author , Christian EngesserChristian Engesser More articles by this author , Pawel TrotsenkoPawel Trotsenko More articles by this author , Hanns-Christian BreitHanns-Christian Breit More articles by this author , David WinkelDavid Winkel More articles by this author , Helge SeifertHelge Seifert More articles by this author , and Christian WetterauerChristian Wetterauer More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003329.03AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Robotic-assisted fusion prostate biopsy platforms promise precision, while offering user-friendliness, short procedure times and low complication rates. To date, there is no study investigating the learning curve (LC) of robotic-assisted transperineal MRI/Ultrasound fusion-guided prostate biopsy (RA-TP-FBx). A LC is essential to facilitate efficient training, maintain institutional biopsy quality and assess potential for widespread use. Herein, we are the first to assess the learning curve of RA-TP-FBx using the iSR’obot MonaLisa device (Biobot). METHODS: We prospectively analyzed consecutive RA-TP-FBx performed at the University Hospital Basel from January to October 2022. Cases were randomly assigned to the urology chief resident, a first-year biopsy-naive resident and an expert in RA-TP-FBx senior consultant. All resident cases were supervised by the expert. We used multiple parameters to define the LC: 1) efficiency – measured by time for completion of individual procedure steps, 2) accuracy – defined as detection rate of prostate cancer (PCa) and clinically significant PCa (csPCa) stratified by PI-RADS score, 3) operator and supervisor performance evaluation – measured by entrustable professional activities (EPA) questionnaires, 4) workload assessment – measured by the NASA task load index and 5) complication rates. RESULTS: We collectively performed 75 procedures. Procedure time reduction is shown in Graphic 1. The major difference in procedure time between residents and expert stemmed from probe positioning and biopsy time. PCa was detected in 62% and csPCa in 44%. csPCA detection for PI-RADS 4 was 46%. PCa detection rate for PI-RADS 4 lesions was similar between operators and over time. 13 biopsies were necessary before stable independent completion of all procedure steps. The most difficult skill for residents was ultrasound probe positioning. A transition point for workload reduction was observed at 13 biopsies. Complications rates were similar among operators and over time. CONCLUSIONS: Urology residents can quickly acquire skills to independently perform RA-TP-FBx regardless of previous biopsy experience. RA-TP-FBx is a procedure with low workload stress. Safety and accuracy are ensured during the LC when supervised by an expert. Source of Funding: Department of Surgery, University Hospital Basel © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e932 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Vitkor Alargkof Anagnostou More articles by this author Christian Engesser More articles by this author Pawel Trotsenko More articles by this author Hanns-Christian Breit More articles by this author David Winkel More articles by this author Helge Seifert More articles by this author Christian Wetterauer More articles by this author Expand All Advertisement PDF downloadLoading ...

Overall detection and identification of clinical prognosticators that determine the presence of ISUP Gleason grade group ≥2 prostate cancer in patients with multiparametric MRI PIRADS 3 lesions who underwent MRI-US fusion guided prostate biopsy

Overall detection and identification of clinical prognosticators that determine the presence of ISUP Gleason grade group ≥2 prostate cancer in patients with multiparametric MRI PIRADS 3 lesions who underwent MRI-US fusion guided prostate biopsy

A correlation between the PI-RADS score and the pathological outcome post multiparametric magnetic resonance imaging/transrectal ultrasound fusion-guided prostate biopsy

A correlation between the PI-RADS score and the pathological outcome post multiparametric magnetic resonance imaging/transrectal ultrasound fusion-guided prostate biopsy

The transition from transrectal to transperineal prostate biopsy without antibiotic prophylaxis: Cancer detection rates and complication rates.

Currently, transperineal prostate biopsy (TPB) is preferred over transrectal biopsy (TRB) because of less infectious complications and improved clinically significant prostate cancer (csPCa) detection. However, literature on omitting antibiotic prophylaxis (AP) is limited. Furthermore, previous studies did not include invasive cribriform growth/intraductal carcinoma (CR/IDC) in the definition of csPCa. Therefore, we compared the infectious complication rates between TPB without AP and TRB with AP, and we compared the csPCa detection rates between TPB and TRB including CR/IDC in the definition of csPCa. We included 729 men who were referred to Erasmus MCCancer Institute between 2013-2019 for MRI/TRUS fusion-guided prostate biopsy. Up to 2019, TRB was performed with AP, thereafter TPB was performed without AP. Data on complications were collected prospectively. We compared csPCa detection rates between the biopsy routes using multivariable logistic regressions for men without previous PCa diagnosis and mixed logistic regression for men on active surveillance. To compare the csPCa detection rates in anterior and apical lesions, and the complications rates between the biopsy routes, we used the chi-square test. Overall, we found no difference in csPCa detection between TPB and TRB (odds ratio 1.0, 95%-confidence interval (CI) 0.62-1.76, p = 0.9; for men on active surveillance: odds ratio 1.05, 95%-CI 0.58-1.88, p = 0.9). This was confirmed in anterior and apical lesions although absolute numbers were low. TPB reduced infectious complications with fever compared to TRB (1.1% vs 5.1%, difference = 4.0%, 95%-CI 1.0-7.9, p = 0.010). TPB has no different csPCa detection rate from TRB taking CR/IDC into account. TPB is, however, preferable because of less infectious complications, even if AP is omitted.

False-positive magnetic resonance imaging prostate cancer correlates and clinical implications

False-positive (FP) multiparametric magnetic resonance imaging (MPMRI) obscures and swift needless biopsies in men with a high prostate-specific antigen. This was a retrospective study, in which all patients who had been exposed to consecutive MP-MRI of the prostate combined with transrectal ultrasound-guided-magnetic resonance imaging fusion-guided prostate biopsy between 2017 and 2020 were involved in the study. The FP was measured as the number of biopsies that did not encompass prostate cancer divided by the whole number of biopsies. The percentage of FP cases was 51.1%, the highest percentage was found in Prostate Imaging-Reporting and Data System (PI-RADs) 3 (37.7%) and the lowest was detected in PI-RAD 5 (14.5%). Those with FP biopsies are younger, and their total prostate antigen (PSA) and PSA density (PSAD) are significantly lesser. The area under the curve PSAD, age, and total PSA are 0.76, 0.74, and 0.69, respectively. An optimum PSAD value of 0.135 was chosen as a cutoff because it showed the highest sum of sensitivity and specificity, 68% and 69%, respectively. FP results of mpMRI were detected in more than half of our sample, more than one-third were presented in Pi-RAD3, improved imaging techniques to decrease FP rates are highly needed.

Prostate cancer detection rate using MRI/ultrasound fusion-guided prostate biopsy in Siriraj Hospital

Objective: Systematic transrectal ultrasound (TRUS) guided biopsy has been considered a gold standard for prostate cancer diagnosis for many decades. The problem of this conventional method is the low detection rate especially in the case of repeat biopsy. This results from a limitation associated with ultrasound imaging inhibiting the visualization of cancerous lesions during the procedure. More recently, there has been increasing importance attributed to the use of multiparametric MRI for the identification of cancer inside the prostate gland. Targeted prostate biopsy, using multiparametric MRI/ultrasound (mpMRI/US) fusion-guided technology helps improve the detection of prostate cancer and has become a novel standard for tissue diagnosis. This study was conducted to investigate and report on the cancer detection rate of mpMRI/US fusion guided prostate biopsies at Siriraj Hospital. Materials and Methods: Data pertinent to patients who underwent mpMRI/US fusion guided biopsy at Siriraj Hospital between September 2017 and December 2019 was retrospectively reviewed. Results: A total of 499 men underwent mpMRI/US fusion guided biopsy, with the transperineal approach being used in the vast majority of cases (91.8%). Targeted biopsy provides a better cancer detection rate than systematic biopsy (55.3% vs 47.1%, p = 0.009). Combined targeted and systematic biopsies improved cancer detection rate compared to systematic biopsy alone (60.3% vs 47.1%, p &lt; 0.001). A subgroup analysis of men with positive biopsies showed that detection of clinically significant cancer (Gleason grade group ≥ 2) was no different between targeted and random biopsies (87.2% vs 80.8%, p = 0.11). The common complications from transperineal approach were urinary retention (5.4%) and hematuria (5.2%) while complications of infection were rare (0.2%). Conclusion: We found that targeted biopsy with mpMRI/US fusion guided technology provides a more effective option for prostate cancer diagnosis. A combination of targeted and systematic biopsy improve prostate cancer detection rate more effectively than systematic biopsy alone. The transperineal approach is a safe and effective technique with a rare incidence of infectious complications.

T1 Mapping of the Prostate Using Single-Shot T1FLASH: A Clinical Feasibility Study to Optimize Prostate Cancer Assessment.

The aim of this study was to assess the clinical feasibility of magnetic resonance imaging (MRI) T1 mapping using T1FLASH for assessment of prostate lesions. Participants with clinical suspicion for prostate cancer (PCa) were prospectively enrolled between October 2021 and April 2022 with multiparametric prostate MRI (mpMRI) acquired on a 3 T scanner. In addition, T1 mapping was accomplished using a single-shot T1FLASH technique with inversion recovery, radial undersampling, and iterative reconstruction. Regions of interest (ROIs) were manually placed on radiologically identified prostate lesions and representative reference regions of the transitional zone (TZ), benign prostate hyperplasia nodules, and peripheral zone (PZ). Mean T1 relaxation times and apparent diffusion coefficient (ADC) values (b = 50/b = 1400 s/mm 2 ) were measured for each ROI. Participants were included in the study if they underwent ultrasound/MRI fusion-guided prostate biopsy for radiologically or clinically suspected PCa. Histological evaluation of biopsy cores served as reference standard, with grading of PCa according to the International Society of Urological Pathology (ISUP). ISUP grades 2 and above were considered clinically significant PCa for the scope of this study. Histological results of prostate biopsy cores were anatomically mapped to corresponding mpMRI ROIs using biopsy plans. T1 relaxation times and ADC values were compared across prostate regions and ISUP groups. Across different strata, T1 relaxation time, ADC values, and diagnostic accuracy (area under the curve [AUC]) were compared using statistical methods accounting for clustered data. Of 67 eligible participants, a total of 40 participants undergoing ultrasound/MRI fusion-guided prostate biopsy were included. Multislice T1 mapping was successfully performed in all participants at a median acquisition time of 2:10 minutes without evident image artifacts. A total of 71 prostate lesions was radiologically identified (TZ 49; PZ 22). Among those, 22 were histologically diagnosed with PCa (ISUP groups 1/2/3/4 in n = 3/15/3/1 cases, respectively). In the TZ, T1 relaxation time was statistically significantly lower for PCa compared with reference regions ( P = 0.029) and benign prostate hyperplasia nodules ( P < 0.001). Similarly, in the PZ, PCa demonstrated shorter T1 relaxation times versus reference regions ( P < 0.001). PCa also showed a trend toward shorter T1 relaxation times (median, 1.40 seconds) compared with radiologically suspicious lesions with benign histology (median, 1.47 seconds), although statistical significance was not reached ( P = 0.066). For discrimination of PCa from reference regions and benign prostate lesions, T1 relaxation times and ADC values demonstrated AUC = 0.80 and AUC = 0.83, respectively ( P = 0.519). Discriminating PCa from radiologically suspicious lesions with benign histology, T1 relaxation times and ADC values showed AUC = 0.69 and AUC = 0.62, respectively ( P = 0.446). T1FLASH-based T1 mapping yields robust results for quantification of prostate T1 relaxation time at a short examination time of 2:10 minutes without evident image artifacts. Associated T1 relaxation times could aid in discrimination of significant and nonsignificant PCa. Further studies are warranted to confirm these results in a larger patient cohort, to assess the additional benefit of T1FLASH maps in conjunction with mpMRI sequences in the setting of deep learning, and to evaluate the robustness of T1FLASH maps compared with potentially artifact-prone diffusion-weighted imaging sequences.

P028 - Comparison between transrectal and transperineal fusion guided prostate biopsy for the diagnosis of prostate cancer

P028 - Comparison between transrectal and transperineal fusion guided prostate biopsy for the diagnosis of prostate cancer

Multiparametric MRI Fusion-Guided Prostate Biopsy for Detection of Clinically Significant Prostate Cancer Eliminates the Systemic Prostate Biopsy

The primary objective of this study was to demonstrate the high accuracy of multiparametric magnetic resonance imaging and ultrasound fusion (mpMRI/US)-guided targeted prostate biopsy for the detection of clinically significant prostate cancer (PCa) and to show that adapted systematic biopsy (AdSB) does not provide additional benefit in detecting clinically significant prostate cancer (PCa). In total, 283 patients have been included in the study. All patients underwent the mpMRI/US biopsies, which have been performed with the “BioJet” fusion system (D&amp;K Technologies, Barum, Germany) using the transperineal approach by a single interventional radiologist. Lesion-targeted and systematic biopsies have been done when 2–4 cores have been taken from each PI-RADS 3–5 lesion, followed by AdSB. This study demonstrated that targeted prostate biopsy is sufficient for safe and sensitive identification of clinically significant PCa in primary biopsy-naïve cases without the need to perform adapted systematic biopsy.

MRI vs Transrectal Ultrasound to Estimate Prostate Volume and PSAD: Impact on Prostate Cancer Detection

To compare multiparametric magnetic resonance imaging (mpMRI) and transrectal ultrasound (TRUS) to estimate prostate volume and prostate specific antigen density (PSAD) as well as subsequent impact on prostate cancer (PCa) detection. Patients referred for mpMRI prior to mpMRI-TRUS fusion-guided prostate biopsy between 2015 and 2020 were identified. Volume and calculated PSAD by mpMRI and TRUS were compared. Associations with presence of any PCa and clinically significant PCa (csPCa; Gleason ≥3+4) were evaluated using linear regression (interaction by volume quartile), logistic regression, and receiver operating characteristics. Among 640 men, TRUS underestimated prostate volume relative to mpMRI (median 49.2cc vs. 54.1cc) with 8% lower volume per cc up to 77.5cc (First-third quartile) and 39% lower volume per additional cc above 77.5cc (fourth quartile). For men undergoing radical prostatectomy, mpMRI had a higher correlation coefficient relative to TRUS (0.913 vs 0.878) when compared to surgical pathology. mpMRI PSAD had slightly higher odds vs TRUS PSAD for detecting any PCa (OR 2.94 and OR 2.78, both P <.001) or csPCa (OR 4.20 and OR 4.02, both P <.001). AUC improvements were of borderline significance for mpMRI vs. TRUS PSAD for any PCa (0.689 vs 0.675, P=.05) and not significant for csPCa (0.732 vs 0.722, P=.20). PSAD was not associated with PCa detection for prostates ≥77.5cc. TRUS underestimates prostate volume relative to mpMRI. PSAD based on mpMRI may be better associated with detection of PCa compared to TRUS, but utility of PSAD may be limited for larger prostates.

Early Experience with MRI-Ultrasound Fusion-Guided Prostate Biopsy in Our Institution

A total of 100 patients were retrospectively analyzed with magnetic resonance imaging-ultrasonography (MRI-US) fusion biopsy(KOELIS, TRINITY®) at our institution between October 2019 and May 2020. The median patient age was 71 years, median prostate specific antigen (PSA) level was 7.4 ng/ml, and median PSA-density was 0.183 mg/ml. Sixty-one of the patients were positive for cancer ; 14 of them were positive by targeted biopsy only, 9 were positive by systematic biopsy only, and 38 were positive by both. Clinically significant prostate cancer (CPSC ; Gleason Score ≥3＋4 and % core ≥50%) was detected by target biopsies in 46 patients and by systematic biopsies in 33 patients. The positive core detection rate for CSPC was 32.5% for targeted biopsies and 7.0% for systematic biopsies(P＜0.0001), with a significantly higher rate for targeted biopsies. These results indicate that in MRI-US fusion biopsy, targeted biopsy has a higher detection rate for cancer and a significantly higher detection rate for clinically significant prostate cancer compared with systematic biopsy.

Learning curve for magnetic resonance imaging/ultrasound fusion prostate biopsy in detecting prostate cancer using cumulative sum analysis.

Targeted magnetic resonance (MR) with ultrasound (US) fusion-guided biopsy has been shown to improve detection of prostate cancer. The implementation of this approach requires integration of skills from radiologists and urologists. Objective methods for assessment of learning curves, such as cumulative sum (CUSUM) analysis, may be helpful in identifying the presence and duration of a learning curve. The aim of this study is to determine the learning curve for MR/US fusion-guided biopsy in detecting clinically significant prostate cancer using CUSUM analysis. Retrospective analysis was performed in this institutional review board-approved study. Two urologists implemented an MR/US fusion-guided prostate biopsy program between March 2015 and September 2017. The primary outcome measure was cancer detection rate (CDR) stratified by Prostate Imaging Reporting and Data System (PI-RADS) scores assigned on the MR imaging. Cumulative sum analysis quantified actual cancer detection versus a predetermined target satisfactory CDR of MR/US fusion biopsies in a sequential case-by-case basis. For this analysis, satisfactory performance was defined as >80% CDR in patients with PI-RADS 5, >50% in PI-RADS 4, and <20% in PI-RADS 1-3. Complete data were available for MR/US fusion-guided biopsies performed on 107 patients. The CUSUM learning curve analysis demonstrated intermittent underperformance until approximately 50 cases. After this inflection point, there was consistently good performance, evidence that no further learning curve was being encountered. At a new center implementing MR/US fusion-guided prostate biopsy, the learning curve was approximately 50 cases before a consistently high performance for prostate cancer detection.

895 Ensuring Quality Standard in the Introduction of a New Prostate Biopsy Service

Abstract Aim With the introduction of a fusion-guided prostate biopsy service at a university hospital, it was important to ensure that quality standards were being maintained. Cancer detection rates (CDR) of fusion-guided prostate biopsy were compared against the established precision point prostate biopsy service in the quality improvement project. Method Data was collected from patients undergoing precision point prostate biopsy between April - December 2020 to identify the quality standard. Data was collected for patients undergoing fusion-guided prostate biopsy at University Hospital Southampton between May - September 2021. Clinically significant cancer was defined according to Epstein criteria. Results The study included 514 precision point and 25 fusion-guided biopsies. 202 prostate cancers were identified from precision point biopsies setting a quality standard cancer detection rate of 39%, of which 88.6% were clinically significant. Fusion-guided biopsy detected 17 cancers giving a CDR of 68%, of which 32% were clinically significant. Conclusions This study demonstrated that fusion-guided prostate biopsy has a high cancer detection rate. However, more cancers were detected at earlier stages when compared with previous precision point biopsy. Further study is required to assess the long-term effects this will have on the cancer service.

Combination of PI-RADS score and mRNA urine test-A novel scoring system for improved detection of prostate cancer.

Available tests to detect clinically significant prostate cancer frequently lead to overdiagnosis and overtreatment. Our study assessed the feasibility of combining a urinary biomarker-based risk score (SelectMDx®) and multiparametric MRI outcomes in order to identify patients with prostate cancer on prostate biopsy with increased accuracy and reliability. Samples of 74 men with suspicion of prostate cancer and available multiparametric MRI were analysed in a prospective cross-sectional study design. First-voided urine for determination of HOXC6 and DLX1 mRNA levels was collected after digital rectal examination and prior to MRI/ultrasound fusion-guided prostate biopsy. All multiparametric MRI images were centrally reviewed by two experienced radiologists blinded for urine test results and biopsy outcome. The PI-RADS v2 was used. SelectMDx® score, PI-RADS and Gleason Sore were obtained. Associations between Gleason Score, PI-RADS scores and SelectMDx® were assessed using ANOVA and t-test. Sensitivity and specificity were assessed and evaluated as area-under-the-curve of the receiver operating characteristic. Upon biopsy, 59.5% of patients were diagnosed with prostate cancer, whereby 40.6% had high-grade prostate cancer (GS ≥ 7a). SelectMDx® scores were significantly higher for patients with positive biopsy findings (49.07 ± 25.99% vs. 22.00 ± 26.43%; p < 0.001). SelectMDx® scores increased with higher PI-RADS scores. Combining SelectMDx®, history of prior biopsy with benign histology and PI-RADS scores into a novel scoring system led to significant prostate cancer detection rates with tiered detection rate of 39%, 58%, 81% and 100% for Gleason grade group II, III, IV, and V, respectively. The area-under-the-curve for our novel sum score in receiver operating characteristic analysis was 0.84. The synergistic combination of two non-invasive tests into a sum score with increased sensitivity may help avoiding unnecessary biopsies for initial prostate cancer diagnosis. For confirmation, further prospective studies with larger sample sizes and univariate and multivariate regression analyses and decision curve analyses are required.

Saddle block anesthesia with 20 mg prilocaine hydrochloride 2% hyperbaric solution and intravenous fentanyl administration for transperineal MRI/US fusion-guided prostate biopsy

Introduction: MRI-Ultrasound (MRI/US) fusion-guided transperineal prostate biopsy (TPB) is gaining popularity in the diagnostic algorithm of prostate cancer. It is associated with higher pain score than the other methods of prostate biopsy. Effective analgesia is a key point for providing patient comfort and preventing his movement in response to pain with subsequent mismatch of the fused MRI/ US images. The mismatch could lead to inaccurate targeting of suspected cancer lesions. The preferred method of analgesia in an outpatient setting is topical intrarectal administration of lidocaine and periprostatic nerve block, but the pain and the discomfort from the procedure are not completely eliminated. Hypothetically, saddle block anesthesia has an expected better efficacy in relieving the pain from the MRI/US-TPB. Aim: To evaluate the efficacy and safety of saddle block anesthesia in patients undergoing MRI/US-TPB and сomparative analysis between patients who have received and have not received intravenous fentanyl Material and methods: A prospective randomized study was conducted on 12 consecutive patients undergoing MRI/US-TPB. Saddle block anesthesia was performed with 20 mg prilocaine hydrochloride 2% hyperbaric solution to all patients. 6 patients received intravenous fentanyl at a dose of 1mcg/kg (Group 1) and 6 patients did not receive intravenous fentanyl. It was examined: patient’s age, weight, height, BMI and ASA class; duration from the dural puncture to the end of the surgical intervention; taken number of prostate biopsies; presence of intraoperative pain; motor blockage; presence of a difference of more than 20%, before and after saddle block anesthesia, of non-invasively measured blood pressure and heart rate; additional medication; presence of early postoperative complications and recovery time from anesthesia Results: The comparative analysis of the preoperative characteristics of the both groups did not reveal significant statistical difference. There were comparatively similar indicators for surgical intervention and regional anesthesia in both groups. The both anesthesia techniques showed safety profile with hemodynamic stability, without additional medicine administration and lack of early post-anesthesia complications. Pain did not occur during inserting and moving the US probe into the anal canal and puncturing the perineal skin and the underlying tissues. 50% (3) of the patients in Group 2 had pain during the puncture of the prostate gland and biopsy extraction, while in Group 1 - 0% (0) of the patients reported presence of pain. There was a slightly delayed onset of the first postoperative pain in Group 1 - 113.17 ± 15.11 min. compared to Group 2 - 99.83 ± 11.51 min. Conclusion: The saddle block anesthesia with 20 mg prilocaine hydrochloride 2% hyperbaric solution in combination with intravenous fentanyl at a dose of 1 mcg/kg is a safe anesthesia technique, associated with excellent analgesic profile, low incidence of anesthesia-related complications and rapid recovery in patients undergoing MRI/US-TPB. Key words: saddle block, transperineal MRI/US fusion-guided prostate biopsy, prilocaine hydrochloride 2% hyperbaric solution

51 - Assessment of MRI/ultrasound fusion-guided prostate biopsy using transrectal and transperineal approaches to diagnose clinically significant prostate cancer at the VUH SK

51 - Assessment of MRI/ultrasound fusion-guided prostate biopsy using transrectal and transperineal approaches to diagnose clinically significant prostate cancer at the VUH SK