Variability of mpMRI diagnostic performance according to the upfront individual patient risk of having clinically significant prostate cancer.

BACKGROUND: To assess the variation of multiparametric magnetic resonance imaging (mpMRI) positive predictive value (PPV) according to each patient's risk of clinically significant prostate cancer (csPCa) based exclusively on clinical factors. METHODS: We evaluated 999 patients with positive mpMRI (PI-RADS ≥ 3) receiving targeted (TBx) plus systematic prostate biopsy. We built a multivariable logistic regression analysis (MVA) using clinical risk factors to calculate the individual patients' risk of harboring csPCa at TBx. A second MVA tested the association between individual patients' clinical risk and mpMRI PPV accounting for the PI-RADS score. Finally, we plotted the PPV of each PI-RADS score by the individual patient pretest probability of csPCa using a LOWESS approach. RESULTS: Overall, TBx found csPCa in 21%, 51%, and 80% of patients with PI-RADS 3, 4, and 5 lesions, respectively. At MVA, age, PSA, digital rectal examination (DRE), and prostate volume were significantly associated with the risk of csPCa at biopsy. DRE yielded the highest odds ratio (OR: 2.88; p < 0.001). The individual patient's clinical risk was significantly associated with mpMRI PPV (OR: 2.49; p < 0.001) using MVA. Plotting the mpMRI PPV according to the predicted clinical risks, we observed that for patients with clinical risk close to 0 versus patients with risk higher than 90%, the mpMRI PPV of PI-RADS 3, 4, and 5 ranged from 0% to 75%, from 0% to 96%, and from 45% to 100%, respectively. CONCLUSION: mpMRI PPV varies according to the individual pretest patient's risk based on clinical factors. These findings should be considered in the decision-making process for patients with suspect MRI findings referred for a prostate biopsy. Moreover, our data support the need for further studies to create an individualized risk prediction tool.

Intraoperative image-guidance during robotic surgery: is there clinical evidence of enhanced patient outcomes?

BACKGROUND: To date, the benefit of image guidance during robot-assisted surgery (IGS) is an object of debate. The current study aims to address the quality of the contemporary body of literature concerning IGS in robotic surgery throughout different surgical specialties. METHODS: A systematic review of all English-language articles on IGS, from January 2013 to March 2023, was conducted using PubMed, Cochrane library's Central, EMBASE, MEDLINE, and Scopus databases. Comparative studies that tested performance of IGS vs control were included for the quantitative synthesis, which addressed outcomes analyzed in at least three studies: operative time, length of stay, blood loss, surgical margins, complications, number of nodal retrievals, metastatic nodes, ischemia time, and renal function loss. Bias-corrected ratio of means (ROM) and bias-corrected odds ratio (OR) compared continuous and dichotomous variables, respectively. Subgroup analyses according to guidance type (i.e., 3D virtual reality vs ultrasound vs near-infrared fluoresce) were performed. RESULTS: Twenty-nine studies, based on 11 surgical procedures of three specialties (general surgery, gynecology, urology), were included in the quantitative synthesis. IGS was associated with 12% reduction in length of stay (ROM 0.88; p = 0.03) and 13% reduction in blood loss (ROM 0.87; p = 0.03) but did not affect operative time (ROM 1.00; p = 0.9), or complications (OR 0.93; p = 0.4). IGS was associated with an estimated 44% increase in mean number of removed nodes (ROM 1.44; p < 0.001), and a significantly higher rate of metastatic nodal disease (OR 1.82; p < 0.001), as well as a significantly lower rate of positive surgical margins (OR 0.62; p < 0.001). In nephron sparing surgery, IGS significantly decreased renal function loss (ROM 0.37; p = 0.002). CONCLUSIONS: Robot-assisted surgery benefits from image guidance, especially in terms of pathologic outcomes, namely higher detection of metastatic nodes and lower surgical margins. Moreover, IGS enhances renal function preservation and lowers surgical blood loss.

Defining the optimal target-to-background ratio to identify positive lymph nodes in prostate cancer patients undergoing robot-assisted [99mTc]Tc-PSMA radioguided surgery: updated results and ad interim analyses of a prospective phase II study.

INTRODUCTION: Prostate-specific membrane antigen radioguided surgery (PSMA-RGS) might identify lymph node invasion (LNI) in prostate cancer (PCa) patients undergoing extended pelvic lymph node dissection (ePLND). The optimal target-to-background (TtB) ratio to define RGS positivity is still unknown. MATERIALS & METHODS: Ad interim analyses which focused on 30 patients with available pathological information were conducted. All patients underwent preoperative PSMA positron emission tomography (PET). 99m-Technetium-PSMA imaging and surgery ([99mTc]Tc-PSMA-I&S) was administered the day before surgery. In vivo measurements were conducted using an intraoperative gamma probe. Performance characteristics and implications associated with different TtB ratios were assessed. RESULTS: Overall, 9 (30%) patients had LNI, with 22 (13%) and 80 (11%) positive regions and lymph nodes, respectively. PSMA-RGS showed uptakes in 12 (40%) vs. 7 (23%) vs. 6 (20%) patients for a TtB ratio ≥ 2 vs. ≥ 3 vs. ≥ 4. At a per-region level, sensitivity, specificity and accuracy for a TtB ratio ≥ 2 vs. ≥ 3 vs. ≥ 4 were 72%, 88% and 87% vs. 54%, 98% and 92% vs. 36%, 99% and 91%. Performing ePLND only in patients with suspicious spots at PSMA PET (n = 7) would have spared 77% ePLNDs at the cost of missing 13% (n = 3) pN1 patients. A TtB ratio ≥ 2 at RGS identified 8 (24%) suspicious areas not detected by PSMA PET, of these 5 (63%) harbored LNI, with one pN1 patient (11%) that would have been missed by PSMA PET. Adoption of a TtB ratio ≥ 2 vs. ≥ 3 vs. ≥ 4, would have allowed to spare 18 (60%) vs. 23 (77%) vs. 24 (80%) ePLNDs missing 2 (11%) vs. 3 (13%) vs. 4 (17%) pN1 patients. CONCLUSIONS: PSMA-RGS using a TtB ratio ≥ 2 to identify suspicious nodes, could allow to spare > 50% ePLNDs and would identify additional pN1 patients compared to PSMA PET and higher TtB ratios.

The association of quantitative PSMA PET parameters with pathologic ISUP grade: an international multicenter analysis.

PURPOSE: To assess if PSMA PET quantitative parameters are associated with pathologic ISUP grade group (GG) and upgrading/downgrading. METHODS: PCa patients undergoing radical prostatectomy with or without pelvic lymph node dissection staged with preoperative PSMA PET at seven referral centres worldwide were evaluated. PSMA PET parameters which included SUVmax, PSMAvolume, and total PSMA accumulation (PSMAtotal) were collected. Multivariable logistic regression evaluated the association between PSMA PET quantified parameters and surgical ISUP GG. Decision-tree analysis was performed to identify discriminative thresholds for all three parameters related to the five ISUP GGs The ROC-derived AUC was used to determine whether the inclusion of PSMA quantified parameters improved the ability of multivariable models to predict ISUP GG ≥ 4. RESULTS: A total of 605 patients were included. Overall, 2%, 37%, 37%, 10% and 13% patients had pathologic ISUP GG1, 2, 3, 4, and 5, respectively. At multivariable analyses, all three parameters SUVmax, PSMAvolume and PSMAtotal were associated with GG ≥ 4 at surgical pathology after accounting for PSA and clinical T stage based on DRE, hospital and radioligand (all p < 0.05). Addition of all three parameters significantly improved the discrimination of clinical models in predicting GG ≥ 4 from 68% (95%CI 63 - 74) to 74% (95%CI 69 - 79) for SUVmax, 72% (95%CI 67 - 76) for PSMAvolume, 74% (70 - 79) for PSMAtotal and 75% (95%CI 71 - 80) when all parameters were included (all p < 0.05). Decision-tree analysis resulted in thresholds that discriminate between GG (SUVmax 0-6.5, 6.5-15, 15-28, > 28, PSMAvol 0-2, 2-9, 9-20 and > 20 and PSMAtotal 0-12, 12-98 and > 98). PSMAvolume was significantly associated with GG upgrading (OR 1.03 95%CI 1.01 - 1.05). In patients with biopsy GG1-3, PSMAvolume ≥ 2 was significantly associated with higher odds for upgrading to ISUP GG ≥ 4, compared to PSMAvolume < 2 (OR 6.36, 95%CI 1.47 - 27.6). CONCLUSION: Quantitative PSMA PET parameters are associated with surgical ISUP GG and upgrading. We propose clinically relevant thresholds of these parameters which can improve in PCa risk stratification in daily clinical practice.

Surgical outcomes of novel retroperitoneal low anterior vs posterior and transperitoneal access in single-port partial nephrectomy.

PURPOSE: Single-Port Robot-Assisted Partial Nephrectomy (SP-RAPN) can be performed by transperitoneal and retroperitoneal approaches. However, there is a lack of surgical outcomes for novel Retroperitoneal Low Anterior Access (LAA) in SP-RAPN. The study compared outcomes of the standard approach (SA), considering transperitoneal (TP) and posterior retroperitoneal (RP) access vs LAA in SP-RAPN series. METHODS: 102 consecutive patients underwent SP-RAPN between 2019 and 2023 at a tertiary referral robotic center were identified. Baseline characteristics, peri- and post-operative outcomes were collected. Patients were stratified according to surgical approach into standard (RP or TP) vs LAA and, subsequently, RP vs LAA. Multivariable logistic regression analysis was used to test the probability of the same-day discharge adjusting for comorbidity indexes. RESULTS: Overall, 102 consecutive patients were included in this study (68 SA - 26 TP and 42 posterior RP vs 34 LAA). Median age was 60 (IQR 51.5-66) years and median BMI was 31 (IQR 26.3-37.6). No baseline differences were observed. LAA exhibited significantly shorter length of stay (LOS) (median 10 [IQR 8-12] vs 24 [IQR 12-30.2.] hours, p < .0001), reduced post-operative pain (p < .0001) and decreased narcotic use on 0-1 PO Day (p < .001) compared to SA and RP only. Multivariate analysis, adjusting for comorbidities, identified LAA as a strong predictor for Same-Day Discharge. CONCLUSION: LAA is an effective approach as well as RP and TP, regardless of the renal mass location, whether it is anterior or posterior, upper/mid or lower pole, yielding favorable outcomes in LOS, post-operative pain and decreased narcotics use compared to SA in SP-RAPN.

Identifying low cancer-specific mortality risk lymph node-positive radical prostatectomy patients.

OBJECTIVES: To identify low cancer-specific mortality (CSM) risk lymph node-positive (pN1) radical prostatectomy (RP) patients. METHODS: Within Surveillance, Epidemiology and End Results database (2010-2015) pN1 RP patients were identified. Kaplan-Meier plots and multivariable Cox-regression (MCR) models were used. Pathological characteristics were used to identify patients at lowest CSM risk. RESULTS: Overall, 2197 pN1 RP patients were identified. Overall, 5-year cancer-specific survival (CSS) rate was 93.3%. In MCR models ISUP GG1-2 (hazard ratio [HR]: 0.12, p < 0.001), GG3 (HR: 0.14, p < 0.001), GG4 (HR: 0.35, p = 0.002), pT2 (HR: 0.27, p = 0.012), pT3a (HR: 0.28, p = 0.003), pT3b (HR: 0.39, p = 0.009), and 1-2 positive lymph nodes (HR: 0.64, p = 0.04) independently predicted lower CSM. Pathological characteristics subgroups with the most protective hazard ratios were used to identify low-risk (ISUP GG1-3 and pT2-3a and 1-2 positive lymph nodes) patients versus others (ISUP GG4-5 or pT3b-4 or ≥3 positive lymph nodes). In Kaplan-Meier analyses, 5-year CSS rates were 99.3% for low-risk (n = 480, 21.8%) versus 91.8% (p < 0.001) for others (n = 1717, 78.2%). CONCLUSIONS: Lymph node-positive RP patients exhibit variable CSS rates. Within this heterogeneous group, those at very low risk of CSM may be identified based on pathological characteristics, namely ISUP GG1-3, pT2-3a, and 1-2 positive lymph nodes. Such stratification scheme might be of value for individual patients counseling, as well as in design of clinical trials.

Delphi consensus project on prostate-specific membrane antigen (PSMA)-targeted surgery-outcomes from an international multidisciplinary panel.

PURPOSE: Prostate-specific membrane antigen (PSMA) is increasingly considered as a molecular target to achieve precision surgery for prostate cancer. A Delphi consensus was conducted to explore expert views in this emerging field and to identify knowledge and evidence gaps as well as unmet research needs that may help change practice and improve oncological outcomes for patients. METHODS: One hundred and five statements (scored by a 9-point Likert scale) were distributed through SurveyMonkey®. Following evaluation, a consecutive second round was performed to evaluate consensus (16 statements; 89% response rate). Consensus was defined using the disagreement index, assessed by the research and development project/University of California, Los Angeles appropriateness method. RESULTS: Eighty-six panel participants (72.1% clinician, 8.1% industry, 15.1% scientists, and 4.7% other) participated, most with a urological background (57.0%), followed by nuclear medicine (22.1%). Consensus was obtained on the following: (1) The diagnostic PSMA-ligand PET/CT should ideally be taken < 1 month before surgery, 1-3 months is acceptable; (2) a 16-20-h interval between injection of the tracer and surgery seems to be preferred; (3) PSMA targeting is most valuable for identification of nodal metastases; (4) gamma, fluorescence, and hybrid imaging are the preferred guidance technologies; and (5) randomized controlled clinical trials are required to define oncological value. Regarding surgical margin assessment, the view on the value of PSMA-targeted surgery was neutral or inconclusive. A high rate of "cannot answer" responses indicates further study is necessary to address knowledge gaps (e.g., Cerenkov or beta-emissions). CONCLUSIONS: This Delphi consensus provides guidance for clinicians and researchers that implement or develop PSMA-targeted surgery technologies. Ultimately, however, the consensus should be backed by randomized clinical trial data before it may be implemented within the guidelines.

Impact of prostate MRI central review over the diagnostic performance of MRI-targeted biopsy: should we routinely ask for an expert second opinion?

PURPOSE: There is substantial variability in multiparametric MRI (mpMRI) protocols and inter-readers' agreement. We tested the effect of a central mpMRI review on the detection of clinically significant PCa (csPCa) in a tertiary referral center. METHODS: We retrospectively analyzed a cohort of 364 consecutive men with a positive externally performed mpMRI (PI-RADS ≥ 3) who underwent a targeted biopsy (TBx) plus a systematic biopsy at a single tertiary referral center (2018-2020). Of those mpMRIs, 32% (n = 116) were centrally reviewed. We compared the detection of csPCa between the non-central-reviewed vs reviewed group. Multivariable logistic regression models (MVA) tested the relationship between mpMRI central review and the detection of csPCa at TBx. RESULTS: The detection of csPCa at TBx in non-central-reviewed vs central-reviewed group was 41 vs 63%, respectively (p = 0.001). The distribution of PI-RADS 2, 3, 4, and 5 at initial assessment vs after mpMRI central review was 0, 37, 47, and 16% vs 39, 9, 35, and 16%, respectively (p < 0.004). Of 43 patients with initial PI-RADS 3 score, respectively 67, 21, and 12, and 0% had a revised PI-RADS score of ≤ 2, 3, 4, and 5. At MVA, mpMRI central review (OR: 1.65, CI 0.85-0.98) was significantly associated with higher csPCa detection at TBx. CONCLUSIONS: We demonstrated that a central review of external mpMRIs may decrease the overcall of equivocal lesions, namely PI-RADS 3, and should be considered to maximize the clinical benefit of TBx in terms of increasing the detection of csPCa and eventually decreasing the rate of unnecessary biopsies.

Oncological and perioperative outcomes of surgery with or without metastasis-directed therapy as part of a multimodal treatment in men with de-novo oligometastatic prostate cancer.

PURPOSE: To investigate the feasibility, safety, and oncological outcomes of Radical Prostatectomy (RP; either Robot-Assisted [RARP] or Open RP [ORP]) in oligometastatic prostate cancer (omPCa). Additionally, we assessed whether there was an added benefit of metastasis-directed therapy (MDT) in these patients in the adjuvant setting. METHODS: Overall, 68 patients with omPCa (≤ 5 skeletal lesions at conventional imaging) treated with RP and pelvic lymph node dissection between 2006 and 2022 were included. Additional therapies (androgen deprivation therapy [ADT] and MDT) were administered according to the treating physicians' judgment. MDT was defined as metastasis surgery/radiotherapy within 6 months of RP. We assessed Clinical Progression (CP), Biochemical Recurrence (BCR), post-operative complications and overall mortality (OM) of RP and the impact of adjuvant MDT + ADT versus RP + ADT alone. RESULTS: Median follow-up was 73 months (IQR 62-89). RARP reduced the risk of severe complications after adjusting for age and CCI (OR 0.15; p = 0.02). After RP, 68% patients were continent. Median 90-days PSA after RP was 0.12 ng/dL. CP and OM-free survival at 7 years were 50% and 79%, respectively. The 7-years OM-free survival rates were 93 vs. 75% for men treated with vs. without MDT (p = 0.04). At regression analyses, MDT after surgery was associated with a 70% decreased mortality rate (HR 0.27, p = 0.04). CONCLUSIONS: RP appeared to represent a safe and feasible option in omPCa. RARP reduced the risk of severe complications. Integrating MDT with surgery in the context of a multimodal treatment might improve survival in selected omPCa patients.

External validation of yonsei nomogram predicting chronic kidney disease development after partial nephrectomy: An international, multicenter study.

OBJECTIVE: To externally validate Yonsei nomogram. METHODS: From 2000 through 2018, 3526 consecutive patients underwent on-clamp PN for cT1 renal masses at 23 centers were included. All patients had two kidneys, preoperative eGFR ≥60 ml/min/1.73 m2, and a minimum follow-up of 12 months. New-onset CKD was defined as upgrading from CKD stage I or II into CKD stage ≥III. We obtained the CKD-free progression probabilities at 1, 3, 5, and 10 years for all patients by applying the nomogram found at https://eservices.ksmc.med.sa/ckd/. Thereafter, external validation of Yonsei nomogram for estimating new-onset CKD stage ≥III was assessed by calibration and discrimination analysis. RESULTS AND LIMITATION: Median values of patients' age, tumor size, eGFR and follow-up period were 47 years (IQR: 47-62), 3.3 cm (IQR: 2.5-4.2), 90.5 ml/min/1.73 m2 (IQR: 82.8-98), and 47 months (IQR: 27-65), respectively. A total of 683 patients (19.4%) developed new-onset CKD. The 5-year CKD-free progression rate was 77.9%. Yonsei nomogram demonstrated an AUC of 0.69, 0.72, 0.77, and 0.78 for the prediction of CKD stage ≥III at 1, 3, 5, and 10 years, respectively. The calibration plots at 1, 3, 5, and 10 years showed that the model was well calibrated with calibration slope values of 0.77, 0.83, 0.76, and 0.75, respectively. Retrospective database collection is a limitation of our study. CONCLUSIONS: The largest external validation of Yonsei nomogram showed good calibration properties. The nomogram can provide an accurate estimate of the individual risk of CKD-free progression on long-term follow-up.

Does previous prostate surgery affect multiparametric magnetic resonance imaging accuracy in detecting clinically significant prostate cancer? Results from a single institution series.

BACKGROUND: Multiparametric MRI (mpMRI) has demonstrated high diagnostic accuracy for clinically significant PCa (csPCa). However, the accuracy of this test in men that received a previous prostatic surgery is still controversial. We aimed at assessing the effect of previous prostatic surgery on the detection of csPCa in a tertiary referral center. METHOD: We relied on a cohort of 311 men with a positive mpMRI (prostate imaging - reporting and data system [PI-RADS] ≥ 3) who underwent a targeted (TBx) plus concomitant systematic random biopsy (SBx) at a single tertiary referral center between 2017 and 2020. The study outcome was to compare the detection of csPCa (Gleason score ≥ 3 + 4) between the two groups (no previous prostate surgery [Group 1] vs. previous prostate surgery [Group 2]). Multivariable logistic regression analysis (MVA) was used to assess the relationship between previous prostate surgery and the detection of csPCa at TBx, after taking into account potential clinical confounders. RESULTS: Overall, 24 (8%) patients received a previous prostate surgery before undergoing mpMRI. Median prostate-specific antigen density was 0.15 versus 0.08 ng/ml/cc, in Group 1 versus 2, respectively. The most frequent finding at mpMRI was in Group 1 versus 2, PI-RADS 4 (55%) versus PI-RADS 3 and 4 (42% each). The majority of patients were biopsy naïve in both Groups 1 (66%) and 2 (71%). The overall detection of csPCa in Group 1 versus 2 was 83% versus 75%, respectively. Differently, the detection of csPCa at TBx in Groups 1 versus 2 was 76% versus 71%, respectively. At MVA, previous prostate surgery (odds ratio: 0.65; p = 0.02) was significantly associated with lower csPCa detection at TBx, after accounting for potential confounders. CONCLUSION: The presence of previous prostate surgery significantly decreases the accuracy of mpMRI in detecting csPCa. These results should be taken into account when assessing patients with a history of prostatic surgery and a suspicious lesion at mpMRI, to better select those who might avoid an unnecessary biopsy.

Not All Adverse Pathology Features Are Equal: Identifying Optimal Candidates for Adjuvant Radiotherapy Among Patients With Adverse Pathology at Radical Prostatectomy.

PURPOSE: Recent studies reported a potential benefit associated with adjuvant radiotherapy for patients with adverse pathology features of prostate cancer. We hypothesized that not all the patients with adverse features may benefit from adjuvant radiotherapy and, therefore, observation ± early salvage radiotherapy may still be considered in a subgroup of these patients. MATERIALS AND METHODS: Among 8,362 patients treated with radical prostatectomy at a single center between 1987 and 2020, 926 eligible patients with adverse pathology features (ie, grade group 4-5 with ≥pT3a stage and/or lymph node invasion) were identified. Cox models were used to assign a score to each feature. Patients were then stratified in low-, intermediate-, and high-risk groups, and interaction term analyses tested the impact of adjuvant radiotherapy for each risk subgroup after adjusting for inverse probability of treatment weighting. RESULTS: Overall, 538 (58%) vs 89 (10%) vs 299 (32%) patients received adjuvant radiotherapy vs early salvage radiotherapy vs observation. The 10-year overall survival rate was 90%. A significant interaction between adjuvant radiotherapy and high-risk group was recorded (HR 0.21, P = .04). After risk stratification and propensity-score weighting, survival analyses depicted comparable 10-year overall survival in low- and intermediate-risk patients treated with adjuvant radiotherapy or observation ± early salvage radiotherapy. Conversely, in high-risk patients, adjuvant radiotherapy was associated with significant improvement in 10-year overall survival compared to observation ± early salvage radiotherapy (76% vs 63%, P = .038). CONCLUSIONS: Among patients with adverse pathology features, we identified 3 subclassifications of risk. When testing the effect of adjuvant radiotherapy vs observation with or without early salvage radiotherapy on survival, only patients included in the high-risk group seemed to benefit from adjuvant radiotherapy.

Proficiency-based progression training for robotic surgery skills training: a randomized clinical trial.

OBJECTIVE: To determine whether proficiency-based progression (PBP) training leads to better robotic surgical performance compared to traditional training (TT), given that the value of PBP training for learning robotic surgical skills is unclear. MATERIALS AND METHODS: The PROVESA trial is a multicentric, prospective, randomized and blinded clinical study comparing PBP training with TT for robotic suturing and knot-tying anastomosis skills. A total of 36 robotic surgery-naïve junior residents were recruited from 16 training sites and 12 residency training programmes. Participants were randomly allocated to metric-based PBP training or the current standard of care TT, and compared at the end of training. The primary outcome was percentage of participants reaching the predefined proficiency benchmark. Secondary outcomes were the numbers of procedure steps and errors made. RESULTS: Of the group that received TT, 3/18 reached the proficiency benchmark versus 12/18 of the PBP group (i.e. the PBP group were ~10 times as likely to demonstrate proficiency [P = 0.006]). The PBP group demonstrated a 51% reduction in number of performance errors from baseline to the final assessment (18.3 vs 8.9). The TT group demonstrated a marginal improvement (15.94 vs 15.44) in errors made. CONCLUSIONS: The PROVESA trial is the first prospective randomized controlled trial on basic skills training in robotic surgery. Implementation of a PBP training methodology resulted in superior surgical performance for robotic suturing and knot-tying anastomosis performance. Compared to TT, better surgical quality could be obtained by implementing PBP training for basic skills in robotic surgery.

Assessing the need for systematic biopsies in addition to targeted biopsies according to the characteristics of the index lesion at mpMRI. Results from a large, multi-institutional database.

PURPOSE: We hypothesized that systematic biopsies (SBx) value for clinically significant PCa (csPCa) detection, in addition to mpMRI targeted biopsies (TBx), may vary significantly according to mpMRI index lesion (IL) characteristics. METHODS: We identified 1350 men with an mpMRI suspicious lesion (PI-RADS ≥ 3), defined as IL, who underwent TBx and SBx at three referral centres. The outcome was SBx added value in csPCa (grade group ≥ 2 PCa detected at SBx and missed by TBx) detection. To this aim, we performed multivariable logistic regression analyses (MVA). Furthermore, we explored the interaction between IL volume and SBx csPCa added value, across different PI-RADS categories, using lowess function. RESULTS: Overall, 569 (42%) men had csPCa at TBx and 78 (6%) csPCa were identified at SBx only. At MVA PSA (OR 0.90; p < 0.05) and IL volume (OR 0.58; p < 0.05) were associated with SBx csPCa added value. At interaction analyses, a nonlinear correlation between PI-RADS and SBx csPCa added value was identified with a decrease from roughly 10 to 4% followed by a substantial plateau at 1.2 ml and 0.6 ml for PI-RADS 3 and 4, respectively. For PI-RADS 5 lesions SBx csPCa added was constantly lower than 4%. CONCLUSIONS: Increasing IL volume in PI-RADS 3 and 4 lesions is associated with reduction in SBx csPCa added value. For diagnostic purposes, SBx could be omitted in men with IL larger than 1.2 ml and 0.6 ml for PI-RADS 3 and 4, respectively. Conversely, for PI-RADS 5, SBx csPCa added value was minimal regardless of IL volume.

Development and Validation of the Metric-Based Assessment of a Robotic Dissection Task on an Avian Model.

INTRODUCTION: The introduction of robot-assisted surgical devices requires the application of objective performance metrics to verify performance levels. OBJECTIVE: To develop and validate (face, content, response process, and construct) the performance metrics for a robotic dissection task using a chicken model. METHODS: In a procedure characterization, we developed the performance metrics (i.e., procedure steps, errors, and critical errors) for a robotic dissection task, using a chicken model. In a modified Delphi panel, 14 experts from four European Union countries agreed on the steps, errors, and critical errors (CEs) of the task. Six experienced surgeons and eight novice urology surgeons performed the robotic dissection task twice on the chicken model. In the Delphi meeting, 100% consensus was reached on five procedure steps, 15 errors and two CEs. Novice surgeons took 20 min to complete the task on trial 1 and 14 min during trial two, whereas experts took 8.2 min and 6.5 min. On average, the Expert Group completed the task 56% faster than the Novice Group and made 46% fewer performance errors. RESULTS: Sensitivity and specificity for procedure errors and time were excellent to good (i.e., 1.0-0.91) but poor (i.e., 0.5) for step metrics. The mean interrater reliability for the assessments by two robotic surgeons was 0.91 (Expert Group inter-rater reliability = 0.92 and Novice Group = 0.9). CONCLUSIONS: We report evidence which supports the demonstration of face, content, and construct validity for a standard and replicable basic robotic dissection task on the chicken model.

A Systematic Review and Meta-analysis on the Impact of Proficiency-based Progression Simulation Training on Performance Outcomes.

OBJECTIVE: To analyze all published prospective, randomized, and blinded clinical studies on the proficiency-based progression (PBP) training using objective performance metrics. BACKGROUND: The benefit of PBP methodology to learning clinical skills in comparison to conventional training is not settled. METHODS: Search of PubMed, Cochrane library's Central, EMBASE, MEDLINE, and Scopus databases, from inception to 1st March 2020. Two independent reviewers extracted the data. The Medical Education Research Study Quality Instrument (MERSQI) was used to assess the methodological quality of included studies. Results were pooled using biased corrected standardized mean difference and ratio-of-means. Summary effects were evaluated using a series of fixed and random effects models. The primary outcome was the number of procedural errors performed comparing PBP and non-PBP-based training pathways. Secondary outcomes were the number of procedural steps completed and the time to complete the task/procedure. RESULTS: From the initial pool of 468 studies, 12 randomized clinical studies with a total of 239 participants were included in the analysis. In comparison to the non-PBP training, ratio-of-means results showed that PBP training reduced the number of performance errors by 60% (P < 0.001) and procedural time by 15% (P = 0.003) and increased the number of steps performed by 47% (P < 0.001). CONCLUSIONS AND RELEVANCE: Our systematic review and meta-analysis confirms that PBP training in comparison to conventional or quality assured training improved trainees' performances, by decreasing procedural errors and procedural time, while increasing the number of correct steps taken when compared to standard simulation-based training.

Objective assessment of intraoperative skills for robot-assisted radical prostatectomy (RARP): results from the ERUS Scientific and Educational Working Groups Metrics Initiative.

OBJECTIVE: To develop and seek consensus from procedure experts on the metrics that best characterise a reference robot-assisted radical prostatectomy (RARP) and determine if the metrics distinguished between the objectively assessed RARP performance of experienced and novice urologists, as identifying objective performance metrics for surgical training in robotic surgery is imperative for patient safety. MATERIALS AND METHODS: In Study 1, the metrics, i.e. 12 phases of the procedure, 81 steps, 245 errors and 110 critical errors for a reference RARP were developed and then presented to an international Delphi panel of 19 experienced urologists. In Study 2, 12 very experienced surgeons (VES) who had performed >500 RARPs and 12 novice urology surgeons performed a RARP, which was video recorded and assessed by two experienced urologists blinded as to subject and group. Percentage agreement between experienced urologists for the Delphi meeting and Mann-Whitney U- and Kruskal-Wallis tests were used for construct validation of the newly identified RARP metrics. RESULTS: At the Delphi panel, consensus was reached on the appropriateness of the metrics for a reference RARP. In Study 2, the results showed that the VES performed ~4% more procedure steps and made 72% fewer procedure errors than the novices (P = 0.027). Phases VIIa and VIIb (i.e. neurovascular bundle dissection) best discriminated between the VES and novices. LIMITATIONS: VES whose performance was in the bottom half of their group demonstrated considerable error variability and made five-times as many errors as the other half of the group (P = 0.006). CONCLUSIONS: The international Delphi panel reached high-level consensus on the RARP metrics that reliably distinguished between the objectively scored procedure performance of VES and novices. Reliable and valid performance metrics of RARP are imperative for effective and quality assured surgical training.

Robot-assisted Boari flap and psoas hitch ureteric reimplantation: technique insight and outcomes of a case series with ≥1 year of follow-up.

OBJECTIVE: To describe step-by-step surgical techniques and report outcomes of the largest single-centre series of patients with distal ureteric disease exclusively treated with robot-assisted ureteric reimplantation with Boari flap (RABFUR) and psoas hitch (RAPHUR), with a minimum follow-up of 1 year and complete postoperative data. PATIENTS AND METHODS: A total of 37 patients with distal ureteric disease were treated between 2010 and 2018. Of these, 81% and 19% underwent RAPHUR and RABFUR, respectively. Intra-, peri- and postoperative outcomes were assessed. The 90-day postoperative complications were reported according to the standardised methodology proposed by the European Association of Urology Ad Hoc Panel. Functional outcomes (creatinine, estimated glomerular filtration rate [eGFR]) and postoperative symptoms (visual analogue pain scale) were assessed. RESULTS: The median operating time and blood loss were 180 min and 100 mL, respectively. There were no conversions to open surgery and no intraoperative transfusions. The median length of stay, bladder catheter indwelling time and stent removal were 4, 7 and 30 days, respectively. The median follow-up was 24 months. Overall, 10 patients (27%) had postoperative complications and of these, eight (22%) and two (5.4%) were Clavien-Dindo Grade I-II and III, respectively. At the last follow-up, the median postoperative creatinine level and eGFR were 0.9 mg/dL and 73.5 mL/min/1.73 m2 , respectively. At the last follow-up, five (13.5%) and three (8%) patients had Grade 1 hydronephrosis and mild urinary symptoms, respectively. The study limitations include its retrospective nature. CONCLUSION: In the present study, we present our RABFUR and RAPHUR techniques. We confirm the feasibility and safety profile of both approaches in patients with distal ureteric disease relying on the largest single-centre series with ≥1 year of follow-up.

Robot-assisted radical cystectomy with intracorporeal urinary diversion decreases postoperative complications only in highly comorbid patients: findings that rely on a standardized methodology recommended by the European Association of Urology Guidelines.

INTRODUCTION: The available studies comparing robot-assisted radical cystectomy (RARC) with intracorporeal (ICUD) vs. extracorporeal (ECUD) urinary diversion have not relied on a standardized methodology to report complications and did not assess the effect of different approaches on postoperative outcomes. MATERIALS: Two hundred and sixty seven patients treated with RARC at a single center were assessed. A retrospective analysis of data prospectively collected according to a standardized methodology was performed. Multivariable logistic regression models (MVA) assessed the impact of ICUD vs. ECUD on intraoperative complications, prolonged length of stay (LOS), 30-day Clavien Dindo (CD) ≥ 2 complications and readmission rate. Interaction terms tested the impact of the approach on different patient subgroups. Lowess graphically depicted the probability of CD ≥ 2 after ICUD or ECUD according to patient baseline characteristics. RESULTS: Overall, 162 ICUD vs 105 ECUD (61 vs. 39%) were performed. Intraoperative complications were recorded in 24 patients. The median LOS and readmission rate were 11 vs. 13 (p = 0.02) and 24 vs. 22% (p = 0.7) in ICUD vs. ECUD, respectively. Overall, 227 postoperative complications were recorded. The overall rate of CD ≥ 2 was 35 and 43% in patients with ICUD vs. ECUD, respectively (p = 0.2). At MVA, the approach type was not an independent predictor of any postoperative outcomes (all p ≥ 0.4). Age-adjusted Charlson Comorbidity Index (ACCI) was associated with an increased risk of CD ≥ 2 (OR: 1.2, p = 0.006). We identified a significant interaction term between ACCI and approach type (p = 0.04), where patients with ICUD had lower risk of CD ≥ 2 relative to those with ECUD with increasing ACCI. CONCLUSIONS: Relying on a standardized methodology to report complications, we observed that highly comorbid patients who undergo ICUD have lower risk of postoperative complications relative to those patients who received ECUD.

Development and validation of the objective assessment of robotic suturing and knot tying skills for chicken anastomotic model.

BACKGROUND: To improve patient safety, there is an imperative to develop objective performance metrics for basic surgical skills training in robotic surgery. OBJECTIVE: To develop and validate (face, content, and construct) the performance metrics for robotic suturing and knot tying, using a chicken anastomotic model. DESIGN, SETTING AND PARTICIPANTS: Study 1: In a procedure characterization, we developed the performance metrics (i.e., procedure steps, errors, and critical errors) for robotic suturing and knot tying, using a chicken anastomotic model. In a modified Delphi panel of 13 experts from four EU countries, we achieved 100% consensus on the five steps, 18 errors and four critical errors (CE) of the task. Study 2: Ten experienced surgeons and nine novice urology surgeons performed the robotic suturing and knot tying chicken anastomotic task. The mean inter-rater reliability for the assessments by two experienced robotic surgeons was 0.92 (95% CI, 0.9-0.95). Novices took 18.5 min to complete the task and experts took 8.2 min. (p = 0.00001) and made 74% more objectively assessed performance errors than the experts (p = 0.000343). CONCLUSIONS: We demonstrated face, content, and construct validity for a standard and replicable basic anastomotic robotic suturing and knot tying task on a chicken model. Validated, objective, and transparent performance metrics of a robotic surgical suturing and knot tying tasks are imperative for effective and quality assured surgical training.