Learning curve for intracorporeal robotic Padua ileal bladder: 10-year functional assessment from a high-volume single-centre series.

OBJECTIVES: To assess the impact of the learning curve (LC) on perioperative and long-term functional outcomes of a consecutive single-centre series of robot-assisted radical cystectomy with Padua intracorporeal orthotopic neobladder. PATIENTS AND METHODS: Patients treated between 2013 and 2022 were included, with ≥1 year of follow-up. The entire cohort was divided in tertiles. Categorical and continuous variables were compared. Joinpoint regression analysis was used to identify significant changes over the decade in linear slope of the 1-year day- and night-time continence. Uni- and multivariable Cox regression analyses identified predictors of day- and night-time continence recovery. Day-time continence was defined as 'totally dry' (no pads), night-time continence as pad wetness ≤50 mL (one safety pad). RESULTS: Overall, 200 patients were included. The mean hospital stay (P = 0.002) and 30-day complications (P = 0.04) significantly reduced over time; the LC significantly impacted on Trifecta achievement (P < 0.001). The 1-year day- and night-time continence probabilities displayed a significant improving trend (day-time continence annual average percentage change [AAPC] 11.45%, P < 0.001; night-time continence AAPC 10.05%, P = 0.009). The LC was an independent predictor of day- (hazard ratio [HR] 1.008; P < 0.001) and night-time continence (HR 1.004; P = 0.03) over time. CONCLUSION: Patients at the beginning of the LC had significantly longer hospitalisations, more postoperative complications, and lower Trifecta rates. At the 10-year analyses, we observed a significant improving trend for both the 1-year day- and night-time continence probabilities, highlighting the crucial role of the LC. However, we are unable to assess the case volume needed to achieve a plateau in terms of day- and night-time continence rates.

Assessing risk of lymph node invasion in complete responders to neoadjuvant chemotherapy for muscle-invasive bladder cancer.

OBJECTIVES: To investigate the lymph node invasion (LNI) rate in patients exhibiting complete pathological response (CR) to neoadjuvant chemotherapy (NAC) and to test the association of CR status with lower LNI and better survival outcomes. MATERIALS AND METHODS: We included patients with bladder cancer (BCa; cT2-4a; cN0; cM0) treated with NAC and radical cystectomy (RC) + pelvic lymph node dissection (PLND) at our institution between 2012 and 2022 (N = 157). CR (ypT0) and LNI (ypN+) were defined at final pathology. Univariable and multivariable logistic regression analysis was performed to test the association between CR and LNI after adjusting for number of lymph nodes removed (NLR). Kaplan-Meier and Cox regression analyses were used to assess overall survival (OS), metastasis-free survival (MFS) and disease free-survival (DFS) according to CR status. RESULTS: Overall CR and LNI rates were 40.1% and 19%, respectively. The median (interquartile range [IQR]) NLR was 26 (19-36). The LNI rate was lower in patients with CR vs those without CR (2 [3.2%] vs 61 [29.8%]; P < 0.001). After adjusting for NLR, CR reduced the LNI risk by 93% (odds ratio 0.07, 95% confidence interval [CI] 0.01-0.25; P < 0.001). Kaplan-Meier plots depicted better 5-year OS (69.7 vs 52.2%), MFS (68.3 vs 45.5%) and DFS (66.6 vs 43.5%) in patients with CR vs those without CR. After multivariable adjustments, CR independently reduced the risk of death (hazard ratio [HR] 0.44, 95% CI 0.24-0.81; P = 0.008), metastatic progression (HR 0.41, 95% CI 0.23-0.71; P = 0.002) and disease progression (HR 0.41, 95% CI 0.24-0.70; P = 0.001). CONCLUSION: Based on these findings, we postulate that PLND could potentially be omitted in patients exhibiting CR after NAC, due to negligible risk of LNI. Prospective Phase II trials are needed to explore this challenging hypothesis.

Comparison of Perioperative, Functional, and Oncologic Outcomes of Open vs. Robot-Assisted Off-Clamp Partial Nephrectomy: A Propensity Scored Match Analysis.

Off-clamp partial nephrectomy represents one of the latest developments in nephron-sparing surgery, with the goal of preserving renal function and reducing ischemia time. The aim of this study was to evaluate and compare the functional, oncologic, and perioperative outcomes between off-clamp robot-assisted partial nephrectomy (off-C RAPN) and off-clamp open partial nephrectomy (off-C OPN) through a propensity score-matched (PSM) analysis. A 1:1 PSM analysis was used to balance variables potentially affecting postoperative outcomes. To report surgical quality, 1 year trifecta was used. Univariable Cox regression analysis was performed to identify predictors of trifecta achievement. The Kaplan-Meier method was used to compare cancer-specific survival (CSS), overall survival (OS), disease-free survival (DFS), and metastasis-free survival (MFS) probabilities between groups. Overall, 542 patients were included. After PSM analysis, two homogeneous cohorts of 147 patients were obtained. The off-C RAPN cohort experienced shorter length of stay (LoS) (3.4 days vs. 5.4 days; p < 0.001), increased likelihoods of achieving 1 year trifecta (89.8% vs. 80.3%; p = 0.03), lower postoperative Clavien-Dindo ≤ 2 complications (1.3% vs. 18.3%, p < 0.001), and lower postoperative transfusion rates (3.4% vs. 12.2%, p = 0.008). At univariable analysis, the surgical approach (off-C RAPN vs. off-C OPN, OR 2.22, 95% CI 1.09-4.46, p = 0.02) was the only predictor of 1 year trifecta achievement. At Kaplan-Meier analysis, no differences were observed between the two groups in terms of OS (log-rank p = 0.451), CSS (log-rank p = 0.476), DFS (log-rank p = 0.678), and MFS (log-rank p = 0.226). Comparing RAPN and OPN in a purely off-clamp scenario, the minimally invasive approach proved to be a feasible and safe surgical approach, with a significantly lower LoS and minor rate of postoperative complications and transfusions as a result of improved surgical quality expressed by higher 1 year trifecta achievement.

Risk stratification for early biochemical recurrence of prostate cancer in the era of multiparametric magnetic resonance imagining-targeted biopsy.

BACKGROUND: Multiparametric magnetic resonance imaging (MRI) and MRI-targeted biopsy are nowadays recommended in the prostate cancer (PCa) diagnostic pathway. Ploussard and Mazzone have integrated these tools into novel risk classification systems predicting the risk of early biochemical recurrence (eBCR) in PCa patients who underwent radical prostatectomy (RP). We aimed to assess available risk classification systems and to define the best-performing. METHODS: Data on 1371 patients diagnosed by MRI-targeted biopsy and treated by RP between 2014 and 2022 at eight European tertiary referral centers were analyzed. Risk classifications systems included were the European Association of Urology (EAU) and National Comprehensive Cancer Network (NCCN) risk groups, the Cancer of the Prostate Risk Assessment (CAPRA) score, the International Staging Collaboration for Cancer of the Prostate (STAR-CAP) classification, the Ploussard and Mazzone models, and ISUP grade group. Kaplan-Meier analyses were used to compare eBCR among risk classification systems. Performance was assessed in terms of discrimination quantified using Harrell's c-index, calibration, and decision curve analysis (DCA). RESULTS: Overall, 152 (11%) patients had eBCR at a median follow-up of 31 months (interquartile range: 19-45). The 3-year eBCR-free survival rate was 91% (95% confidence interval [CI]: 89-93). For each risk classification system, a significant difference among survival probabilities was observed (log-rank test p < 0.05) except for NCCN classification (p = 0.06). The highest discrimination was obtained with the STAR-CAP classification (c-index 66%) compared to CAPRA score (63% vs. 66%, p = 0.2), ISUP grade group (62% vs. 66, p = 0.07), Ploussard (61% vs. 66%, p = 0.003) and Mazzone models (59% vs. 66%, p = 0.02), and EAU (57% vs. 66%, p < 0.001) and NCCN (57% vs. 66%, p < 0.001) risk groups. Risk classification systems demonstrated good calibration characteristics. At DCA, the CAPRA score showed the highest net benefit at a probability threshold of 9%-15%. CONCLUSIONS: The performance of risk classification systems using MRI and MRI-targeted information was less optimistic when tested in a contemporary set of patients. CAPRA score and STAR-CAP classification were the best-performing and should be preferred for treatment decision-making.

Open versus robot-assisted radical cystectomy: pentafecta and trifecta achievement comparison from a randomised controlled trial.

OBJECTIVES: To compare University of Southern California (USC) Institute of Urology pentafecta and trifecta achievement comparing open radical cystectomy (ORC) vs robot-assisted RC (RARC) with totally intracorporeal urinary diversion (iUD) from a randomised controlled trial (RCT). PATIENTS AND METHODS: Patients were eligible for randomisation if they had a diagnostic transurethral resection of bladder tumour with clinical T stage (cT)2-4, cN0, cM0, or recurrent high-grade non-muscle-invasive bladder cancer and no anaesthesia contraindications to robotic surgery. Patients were enrolled with a covariate adaptive randomisation process based on the following variables: body mass index, American Society of Anesthesiologists score, preoperative haemoglobin, planned UD, neoadjuvant chemotherapy, and cT stage. USC pentafecta was defined as the combination at 1 year after surgery of: negative soft tissue surgical margins, ≥16 lymph node (LN) yield, absence of major (Clavien-Dindo Grade ≥III) complications at 90 days, absence of UD-related long-term sequalae, and absence of clinical recurrence. Trifecta was defined as the coexistence of daytime urinary continence, absence of major complications and recurrence-free status, all assessed at 1 year. Continuous and categorical variables were compared using Student's t-test and chi-square test, respectively. Univariable logistic regression analysis was performed to assess the role of USC pentafecta and trifecta achievement on health-related quality of life (HRQoL). RESULTS: There was no statistically significant difference in USC pentafecta and trifecta achievement between groups. Among secondary outcomes, univariable logistic regression analysis was performed and both 1-year USC pentafecta and trifecta achievement were predictors of 2-year unmodified global HRQoL. CONCLUSIONS: This study supports equivalence of RARC-iUD and ORC with regard to surgical quality as described by the USC pentafecta and trifecta. We described a significant impact of USC pentafecta and trifecta achievement on global health status/HRQoL, providing a strict correlation between objective evaluation of surgical outcomes and self-reported HRQoL.

Oncological and safety profiles in patients undergoing simultaneous transurethral resection (TUR) of bladder tumour and TUR of the prostate.

OBJECTIVES: To determine the oncological impact and adverse events of performing simultaneous transurethral resection of bladder tumour (TURB) and transurethral resection of the prostate (TURP), as evidence on the outcomes of simultaneous TURB for bladder cancer and TURP for obstructive benign prostatic hyperplasia is limited and contradictory. PATIENTS AND METHODS: Patients from 12 European hospitals treated with either TURB alone or simultaneous TURB and TURP (TURB+TURP) were retrospectively analysed. A propensity score matching (PSM) 1:1 was performed with patients from the TURB+TURP group matched to TURB-alone patients. Associations between surgery approach with recurrence-free (RFS) and progression-free (PFS) survivals were assessed in Cox regression models before and after PSM. We performed a subgroup analysis in patients with risk factors for recurrence (multifocality and/or tumour size >3 cm). RESULTS: A total of 762 men were included, among whom, 76% (581) underwent a TURB alone and 24% (181) a TURB+TURP. There was no difference in terms of tumour characteristics between the groups. We observed comparable length of stay as well as complication rates including major complications (Clavien-Dindo Grade ≥III) for the TURB-alone vs TURB+TURP groups, while the latest led to longer operative time (P < 0.001). During a median follow-up of 44 months, there were more recurrences in the TURB-alone (47%) compared to the TURB+TURP group (28%; P < 0.001). Interestingly, there were more recurrences at the bladder neck/prostatic fossa in the TURB-alone group (55% vs 3%, P < 0.001). TURB+TURP procedures were associated with improved RFS (hazard ratio [HR] 0.39, 95% confidence interval [CI] 0.29-0.53; P < 0.001), but not PFS (HR 1.63, 95% CI 0.90-2.98; P = 0.11). Within the PSM cohort of 254 patients, the simultaneous TURB+TURP was still associated with improved RFS (HR 0.33, 95% CI 0.22-0.49; P < 0.001). This was also true in the subgroup of 380 patients with recurrence risk factors (HR 0.41, 95% CI 0.28-0.62; P < 0.001). CONCLUSION: In our contemporary cohort, simultaneous TURB and TURP seems to be an oncologically safe option that may, even, improve RFS by potentially preventing disease recurrence at the bladder neck and in the prostatic fossa.

Open vs robotic intracorporeal Padua ileal bladder: functional outcomes of a single-centre RCT.

PURPOSE: Functional outcomes of robot-assisted (RA) radical cystectomy (RC) with intracorporeal orthotopic neobladder (i-ON) have been poorly investigated. The study aimed to report functional outcomes of a prospective randomized controlled trial (RCT) comparing open RC (ORC) and RARC with i-ON. METHODS: Inclusion criteria were cT2-4/N0/M0, or BCG-failure high-grade urothelial carcinoma, candidate to RC with curative intent. A covariate adaptive randomization process was used, based on the following variables: BMI, ASA score, haemoglobin levels, cT-stage, neoadjuvant chemotherapy, urinary diversion. Day-time continence was defined as "totally dryness", nigh-time continence as pad wetness ≤ 50 cc. Continence recovery probabilities were compared between arms with Kaplan-Meier method and Cox regression analysis was performed to identify predictors of continence recovery. HRQoL outcomes analysis was assessed with a generalized linear mixed effect regression (GLMER) model. RESULTS: Out of 116 patients randomized, 88 received ON. Quantitative analysis of functional outcomes reported similar results in terms of day continence, while a better night continence status in ORC cohort was observed. However, 1-yr day- and night-time continence recovery probabilities were comparable. Night-time micturition frequency < 3 h was the only predictor of nigh-time continence recovery. At GLMER, 1-yr body image and sexual functioning were significantly better in RARC cohort, while urinary symptoms were comparable between arms. CONCLUSION: Despite superiority of ORC at quantitative night-time pad use analysis, we showed comparable day- and night-time continence recovery probabilities. At 1-yr analysis of HRQoL outcomes, urinary symptoms were comparable between arms, while RARC patients reported lower body image and sexual functioning worsening.

Long-term oncologic and functional outcomes following robot-assisted radical cystectomy and intracorporeal Padua ileal bladder: results from a single high-volume center.

PURPOSE: To report long-term oncologic and functional outcomes of a large consecutive single center series of Robot-assisted radical cystectomy (RARC)- intracorporeal (IC) Urinary Diversion (UD), identifying their predicting factors. METHODS: A single center Bladder cancer (BC) database was queried for "RARC" and "ICUD", including patients treated between January 2012 and September 2020. Kaplan-Meier curves were assessed disease-free (DFS), cancer-specific (CSS) and overall survival (OS) probability. Univariable (UV) and multivariable (MV) analysis were adopted to identify predictors of DFS, CSS and OS. Kaplan-Meier method evaluated day- and night-time continence recovery probabilities; UV and MV analysis were adopted to identify predictors of Day-time continence. RESULTS: Overall, 251 patients were included. Among them, 192 patients underwent intracorporeal ileal orthotopic neobladder (ION) (76.5%). Five-year DFS, CSS and OS rates were 66.5%, 65.4% and 61.5%; pT stage ≥ 3 and pathologic nodal involvement were identified as negative independent predictors of DFS (HR 2.39, p = 0.001, HR 4.64, p ≤ 0.001), CSS (HR 2.20, p = 0.01, HR 3.97, p < 0.001) and OS (HR 2.25, p = 0.005, HR 3.95, p < 0.001). In RARC-ION patients, Trifecta rate was 64.1%. One-year day- and night-time continence rates were 78.6% and 48.3%. Age (HR 0.98, p = 0.03), female gender (HR 0.57, p = 0.008) and complications Clavien grade ≥ 3 (HR 0.55, p = 0.03) were identified as independent predictors of day-time incontinence. CONCLUSIONS: Long-term oncologic outcomes and their predicting factors seem aligned to the largest historical open series and multi-institutional robotic series data. According to the identified predicting factors undermining a proper achievement of day-time continence, this represents an objective support, in order to properly advice specific sub-group of patients.

Optimizing multiparametric magnetic resonance imaging-targeted biopsy and prostate cancer grading accuracy.

PURPOSE: To assess the most efficient biopsy method to improve International Society of Urological Pathology (ISUP) grade group accuracy with final pathology of the radical prostatectomy (RP) specimen in the era of magnetic resonance imaging (MRI)-driven pathway. METHODS: A total of 753 patients diagnosed by transrectal MRI-targeted and systematic biopsies (namely "standard method"), treated by RP, between 2016 and 2021 were evaluated. Biopsy methods included MRI-targeted biopsy, side-specific systematic biopsies relative to index MRI lesion and combination of both. Number of MRI-targeted biopsy cores and positive cores needed per index MRI lesion were assessed. Multivariable analysis was performed to analyze predictive factors of upgrading using MRI targeted and ipsilateral systematic biopsies method. RESULTS: Overall, ISUP grade group accuracy varied among biopsy methods with upgrading rate of 35%, 49%, 27%, and 24% for MRI targeted, systematic, MRI targeted and ipsilateral systematic biopsies and standard methods, respectively (p < 0.001). A minimum of two positive MRI-targeted biopsies cores per index MRI lesion were required when testing MRI targeted and ipsilateral systematic biopsies method to reach equivalent accuracy compared to standard method. Omitting contralateral systematic biopsies spared an average of 5.9 cores per patient. At multivariable analysis, only the number of positive MRI-targeted biopsy cores per index MRI lesion was predictive of upgrading. CONCLUSION: MRI targeted and ipsilateral systematic biopsies allowed an accurate definition of ISUP grade group and appears to be an interesting alternative when compared with standard method, reducing total number of biopsy cores needed.

Robotic Surgery in Urology: History from PROBOT® to HUGOTM.

The advent of robotic surgical systems had a significant impact on every surgical area, especially urology, gynecology, and general and cardiac surgery. The aim of this article is to delineate robotic surgery, particularly focusing on its historical background, its evolution, its present status, and its future perspectives. A comprehensive literature review was conducted upon PubMed/MEDLINE, using the keywords "robotic surgical system", "robotic surgical device", "robotics AND urology". Additionally, the retrieved articles' reference lists were investigated. Analysis concentrated on urological surgical systems for laparoscopic surgery that have been given regulatory approval for use on humans. From the late 1980s, before daVinci® Era in 2000s, ancestor platform as Probot® and PUMA 560 were described to outline historical perspective. Thus, new robotic competitors of Intuitive Surgical such as Senhance®, Revo-I®, Versius®, Avatera®, Hinotori®, and HugoTM RAS were illustrated. Although daVinci® had high level competitiveness, and for many years represented the most plausible option for robotic procedures, several modern platforms are emerging in the surgical market. Growing competition through unique features of the new robotic technologies might extend applications fields, improve diffusion, and increase cost-effectiveness procedures. More experiences are needed to identify the role of these new advancements in surgical branches and in healthcare systems.

Serum levels of chromogranin are not predictive of poorly differentiated prostate cancer: Results from a multicenter radical prostatectomy cohort.

BACKGROUND: Recently a possible link between elevated Chromogranin A (CgA) levels and poorly differentiated prostate cancer has been proposed. The aim of our study was to explore the association of CgA levels and the risk of poorly differentiated prostate cancer (PCa) in men undergoing radical retropubic prostatectomy (RRP). MATERIALS AND METHODS: From 2012 onwards, 335 consecutive men undergoing RRP for PCa at three centers in Italy were enrolled into a prospective database. Body mass index (BMI) was calculated before RRP. Blood samples were collected and tested for total prostate-specific antigen (PSA) levels and chromogranin A (CgA). We evaluated the association between serum levels of CgA and upstaging and upgrading using logistic regression analyses. RESULTS: Median age and preoperative PSA levels were 65 years (interquartile range [IQR]: 60-69) and 7.2 ng/ml (IQR: 5.3-10.4), respectively. Median BMI was 26.1 kg/m2 (IQR: 24-29) with 56 (16%) obese (BMI ≥ 30 kg/m2 ). Median CgA levels were 51 (39/71). Overall, 129/335 (38,5%) presented an upstaging, and 99/335 (30%) presented an upgrading. CgA was not a predictor of upstaging or upgrading on RP. CONCLUSIONS: In our multicenter cohort of patients, CgA is not a predictor of poorly differentiated PCa on radical prostatectomy. According to our experience, CgA should not be considered a reliable marker to predict poorly differentiated or advanced prostate cancer.

Open Radical Cystectomy versus Robot-Assisted Radical Cystectomy with Intracorporeal Urinary Diversion: Early Outcomes of a Single-Center Randomized Controlled Trial.

PURPOSE: Radical cystectomy (RC) with urinary diversion (UD) is still considered a complex surgery associated with significant morbidity. Open RC (ORC) remains the reference option of treatment, even if adoption of robot-assisted RC (RARC) is rapidly increasing. To date, all the available randomized controlled trials were characterized by an extracorporeal approach in performing UD, undermining potential benefits of a totally minimally invasive procedure. In this study, we aimed to report perioperative and 6-month outcomes from the first RCT comparing ORC and RARC with totally intracorporeal UD. MATERIALS AND METHODS: Patients were eligible for randomization if they had a diagnostic transurethral resection of bladder tumor with cT2-4, cN0, cM0 or recurrent high-grade nonmuscle-invasive bladder cancer and no anesthesiological contraindications to robotic surgery. Patients were enrolled with a covariate adaptive randomization process based on the following variables: body mass index, American Society of Anesthesiologists® score, baseline hemoglobin, planned UD, neoadjuvant chemotherapy and cT stage. The primary end point was to demonstrate the superiority of RARC with intracorporeal UD in terms of a 50% transfusion rate reduction. RESULTS: Overall, 116 consecutive patients (58 RARC, 58 ORC) were enrolled. Among primary endpoint, overall perioperative transfusion rates were significantly lower in the RARC cohort (RARC: 22% vs ORC: 41%; p=0.046). CONCLUSIONS: This prospective randomized trial observed 22% and 41% overall perioperative transfusion rates in patients treated by RARC and ORC, respectively, confirming a significant benefit in favor of RARC with intracorporeal UD. However, perioperative complications, hospital stay and 6-month health-related quality of life were largely comparable between groups. Oncologic and functional outcomes will be assessed at longer followup to observe potential differences between arms.

Diagnostic performance of fusion (US/MRI guided) prostate biopsy: propensity score matched comparison of elastic versus rigid fusion system.

PURPOSE: Many software for US/MRI guided fusion prostate biopsy (FPB), have been developed in the last years. However, there are few data comparing diagnostic accuracy of different fusion systems. We assessed diagnostic performance of elastic (EF) versus rigid fusion (RF) PB in a propensity score matched (PSM) analysis. METHODS: A total of 314 FPB were prospectively collected from two different centers. All patients were biopsy naïve and all mpMRI reported a single suspicious area. Overall, 211 PB were performed using a RF system and 103 using an EF software. The two groups were compared for the main clinical features. A 1:1 PSM analysis was employed to reduce covariate imbalance to < 10%. Detection rate (DR) for any prostate cancer (PCa) and clinically significant (cs) PCa were compared and stratified for PI-RADS Score. A per target univariable and multivariable regression analyses were applied to identity predictors of anyPCa and csPCa. RESULTS: After applying the PSM, two cohorts of 83 cases were selected. DR of any PCa cancer and csPCa were comparable between the two cohorts (all p > 0.077) as well as DR of csPCa for every PIRADS score. At univariable regression analysis lesion size, PI-RADS Score, PSA Density and EF system were predictors of any PCa (all p < 0.001); however, at multivariable analysis only PI-RADS Score was independent predictor of any PCa (p = 0.027). At multivariable analysis only PI-RADS score was independent predictor of csPCa. CONCLUSIONS: Fusion PB guarantees high diagnostic accuracy for csPCa, regardless of the fusion technology. Prospective randomized study is needed to confirm these data.

Expanding the limits of nephron-sparing surgery: Surgical technique and mid-term outcomes of purely off-clamp robotic partial nephrectomy for totally endophytic renal tumors.

OBJECTIVES: To report surgical technique, perioperative, oncological, and mid-term functional outcomes in a single-center purely off-clamp robotic partial nephrectomy series for totally endophytic masses. METHODS: A retrospective analysis of a prospectively collected, institutional review board-approved renal cancer database was carried out to include patients with a totally endophytic renal tumor treated with off-clamp robotic partial nephrectomy between January 2013 and December 2020 at our center. Our database was queried to identify cases that had been assigned 3 points for the "E" domain of the R.E.N.A.L. nephrometry score and 3 points for the "exophytic rate" domain of the PADUA (Preoperative Aspects and Dimensions Used for an Anatomical) nephrometry score. Preoperative indocyanine green renal mass marking was performed in 33 patients, in whom the tumor was vascularized by a specific feeding artery. Surgical steps, perioperative, oncological and functional data were reported. RESULTS: Fifty-six consecutive patients with totally endophytic renal masses were treated. The median tumor diameter was 3 cm, and median PADUA and R.E.N.A.L. scores were both 10. The median operative time was 82 min. Low-grade Clavien complications occurred in two patients (3.6%) and high-grade Clavien complications were observed in four patients (7.1%). Positive surgical margins were detected in one patient; 2-year recurrence-free, cancer-specific, and overall survival rates were 100%, 100%, and 98.2%, respectively. At a median follow-up of 24 months, new onset of chronic kidney disease stage 3b occurred in one patient. At last follow-up, the median estimated glomerular filtration rate was 77 mL/min, with a median estimated glomerular filtration rate percent decrease of 5.5%. Trifecta was achieved in 91% of patients. CONCLUSIONS: Purely off-clamp robotic partial nephrectomy is a feasible and safe surgical approach, even in totally endophytic renal tumors, providing a favorable perioperative complications rate, excellent oncological outcomes, and negligible impact on renal function at mid-term follow-up. Indocyanine green preoperative marking of endophytic renal tumors represents a useful tool for rapid intraoperative identification of the mass, real-time control of resection margins, and a more precise dissection.

Perioperative and 1-year patient-reported outcomes of Freyer versus Millin versus Madigan robot-assisted simple prostatectomy.

PURPOSE: Robotic-assisted simple prostatectomy (RASP) is an established surgical procedure for the management of obstructive symptoms caused by large adenomas. Traditionally, this is performed according to the trans-vescical (Freyer) or trans-capsular (Millin) technique. We recently described a novel urethra-sparing (Madigan) robotic technique which showed promising preliminary results. In this study, we compared the above techniques for perioperative and 1-year patient-reported outcomes. METHODS: We retrospectively collected data from patients who underwent RASP across the three techniques, performed by two experienced surgeons in our center. We assessed patient self-reported pre-operative and post-operative functional outcomes with validated questionnaires: IPSS, IIEF short form, ICIQ short form, MSHQ Short Form. Continuous and categorical variables were compared between groups using the Mood's median test and the Chi-square tests, respectively. RESULTS: Millin, Madigan and Freyer procedures were performed in 23 (51%), 14 (31%) and 8 (18%) cases, respectively. No significant differences were observed for baseline ASA score, BMI, prostate volume, IPSS, IIEF, ICIQ and MSHQ scores (all p ≥ 0.2), as well as post-operative obstructive symptoms relief (IPSS: p = 0.25), continence (ICIQ: p = 0.54), complication rates (p = 0.32) and hospital stay (p = 0.23). Operative time was longer for Madigan procedures (p = 0.05). The 1-year MSHQ and IIEF scores were significantly higher in the Madigan cohort (p = 0.008 and p = 0.04, respectively). CONCLUSION: RASP proved to be a safe surgical approach, providing an effective and durable relief of obstructive symptoms at mid-term follow-up regardless of the technique used. The Madigan technique provided significant benefits in terms of self-assessed quality of sexual function.

Delaying BCG immunotherapy onset after transurethral resection of non-muscle-invasive bladder cancer is associated with adverse survival outcomes.

PURPOSE: This study was carried out to assess whether a prolonged time between primary transurethral resection of non-muscle-invasive bladder cancer (TURB) and implementation of bacillus Calmette-Guerin (BCG) immunotherapy (time to BCG; TTBCG) is associated with adverse oncological survival in patients with T1 high-grade (HG) non-muscle-invasive bladder cancer (NMIBC). MATERIALS AND METHODS: Data on 429 patients from 13 tertiary care centers with primary T1HG NMIBC treated with reTURB and maintenance BCG between 2001 and 2019 were retrospectively reviewed. Change-point regression was applied following Muggeo's approach. The population was divided into subgroups according to TTBCG, whereas the recurrence-free survival (RFS) and progression-free survival (PFS) were estimated with log-rank tests. Additionally, Cox regression analyses were performed. Due to differences in baseline patient characteristics, propensity-score-matched analysis (PSM) and inverse-probability weighting (IPW) were implemented. RESULTS: The median TTBCG was 95 days (interquartile range (IQR): 71-127). The change-point regression analysis revealed a gradually increasing risk of recurrence with growing TTBCG. The risk of tumor progression gradually increased until a TTBCG of approximately 18 weeks. When the study population was divided into two subgroups (time intervals: ≤ 101 and > 101 days), statistically significant differences were found for both RFS (p = 0.029) and PFS (p = 0.005). Furthermore, in patients with a viable tumor at reTURB, there were no differences in RFS and PFS. After both PSM and IPW, statistically significant differences were found for both RFS and PFS, with worse results for longer TTBCG. CONCLUSION: This study shows that delaying BCG immunotherapy after TURB of T1HG NMIBC is associated with an increased risk of tumor recurrence and progression.

Long-term oncologic outcomes of robot-assisted radical cystectomy (RARC) with totally intracorporeal urinary diversion (ICUD): a multi-center study.

PURPOSE: To report survival outcomes after robot-assisted radical cystectomy (RARC) with intracorporeal urinary diversion (ICUD) for recurrent/muscle-invasive non-metastatic bladder cancer. METHODS: Prospectively maintained databases were queried for "robotic cystectomy AND ICUD". Patients treated after October 2013 and those treated without curative intent were excluded. Kaplan-Meier method was used to plot stage-specific survival outcomes, computed at 1, 2, and 5 years after surgery. Univariable and multivariable Cox analyses assessed predictors of recurrence-free (RFS), cancer-specific (CSS) and overall (OS) survival. RESULTS: 113 consecutive patients were included, mostly men (82%). Neoadjuvant chemotherapy was performed in 23% of cases, median lymph node (LN) yield was 36 (IQR 28-45) and the rate of positive surgical margins (PSM) was 8%. Orthotopic ileal neobladder was the preferred ICUD type (57%). An organ-confined disease was observed in 51% of cases and 21% were pT0 on final histology. Overall, 5-year RFS, CSS and OS probabilities were 58 ± 5%, 61 ± 5% and 54 ± 5%, respectively. At Kaplan-Meier method, tumor stage group was a significant predictor of survival probabilities (all p < 0.001) and this was confirmed at multivariable Cox regression analysis (RFS-OR 2.29; 95% CI 1.58-3.32; p < 0.001) (CSS-OR 1.82; 95% CI 1.3-2.53; p < 0.001) (OS-OR 2.14; 95% CI 1.46-3.14; p < 0.001). PSM status was associated to CSS (OR 2.54; 95% CI 1.13-5.69; p = 0.024) and OS (OR 2.82; 95% CI 1.17-6.77; p = 0.021), but did not predict RFS (p = 0.062). CONCLUSIONS: Long-term oncologic outcomes after RARC with ICUD appear similar to recent robotic series with extracorporeal diversion and historical open experiences.

Accuracy of magnetic resonance imaging to identify pseudocapsule invasion in renal tumors.

PURPOSE: To evaluate accuracy of MRI in detecting renal tumor pseudocapsule (PC) invasion and to propose a classification based on imaging of PC status in patients with renal cell carcinoma. METHODS: From January 2017 to June 2018, 58 consecutive patients with localized renal cell carcinoma were prospectively enrolled. MRI was performed preoperatively and PC was classified, according to its features, as follows: MRI-Cap 0 (absence of PC), MRI-Cap 1 (presence of a clearly identifiable PC), MRI-Cap 2 (focally interrupted PC), and MRI-Cap 3 (clearly interrupted and infiltrated PC). A 3D image reconstruction showing MRI-Cap score was provided to both surgeon and pathologist to obtain complete preoperative evaluation and to compare imaging and pathology reports. All patients underwent laparoscopic partial nephrectomy. In surgical specimens, PC was classified according to the renal tumor capsule invasion scoring system (i-Cap). RESULTS: A concordance between MRI-Cap and i-Cap was found in 50/58 (86%) cases. ρ coefficient for each MRI-cap and iCap categories was: MRI-Cap 0: 0.89 (p < 0.0001), MRI-Cap1: 0.75 (p < 0.0001), MRI-Cap 2: 0.76 (p < 0.0001), and MRI-Cap3: 0.87 (p < 0.0001). Sensitivity, specificity, positive predictive value, negative predictive value, and AUC were: MRI-Cap 0: Se 97.87% Spec 83.3%, PPV 95.8%, NPV 90.9%, and AUC 90.9; MRI-Cap 1: Se 77% Spec 95.5%, PPV 83.3%, NPV 93.5%, and AUC 0.86; MRI-Cap 2- iCap 2: Se 88% Spec 90%, PPV 79%, NPV 95%, and AUC 0.89; MRI-Cap 3: Se 94% Spec 95%, PPV 88%, NPV 97%, and AUC 0.94. CONCLUSIONS: MRI-Cap classification is accurate in evaluating renal tumor PC features. PC features can provide an imaging-guided landmark to figure out where a minimal margin could be preferable during nephron-sparing surgery.

Managing lines of therapy in castration-resistant prostate cancer: real-life snapshot from a multicenter cohort.

PURPOSE: To provide a snapshot of toxicities and oncologic outcomes of Abiraterone (AA) and Enzalutamide (EZ) in a chemo-naïve metastatic castration-resistant prostate cancer (mCPRC) population from a longitudinal real-life multicenter cohort. METHODS: We prospectively collected data on chemo-naïve mCRPC patients treated with AA or EZ. Primary outcomes were PSA response, oncologic outcomes and toxicity profile. The Kaplan-Meier method was used to compare differences in terms of progression-free survival (PFS) between AA vs EZ and high- vs low-volume disease cohorts. Univariable and multivariable Cox regression analyses were performed to identify predictors of PFS. Toxicity, PSA response rates and oncologic outcomes on second line were compared with those observed on first line. RESULTS: Out of 137 patients, 88 received AA, and 49 EZ. On first line, patients receiving EZ had significantly higher PSA response compared with AA (95.9% vs 67%, p < 0.001), comparable toxicity rate (10.2% vs 16.3%, p = 0.437) and PFS probabilities (p = 0.145). Baseline PSA and high-volume disease were predictors of lower PFS probabilities at univariable analysis (p = 0.027 and p = 0.007, respectively). Overall, 28 patients shifted to a second-line therapy (EZ or radiometabolic therapy). Toxicity and PSA response rates on second line were comparable to those observed on first line (11.1% vs 12.4%, p = 0.77; 73.1% vs 77.4%, p = 0.62, respectively); 2-year PFS, cancer-specific and overall survival probabilities were comparable to those displayed in first-line cohort (12.1% vs 16.2%, p = 0.07; 85.7% vs 86.4%, p = 0.98; 71% vs 80.3%, p = 0.66, respectively). CONCLUSIONS: Toxicity profile, PSA response rate and oncological outcomes were comparable between first-line and second-line courses in patients treated with either AA or EZ for mCRPC. Our findings showed the tolerability and oncological effectiveness, when feasible, of two lines of therapy other than chemotherapy.