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.

External validation and comparison of magnetic resonance imaging-based risk prediction models for prostate biopsy stratification.

PURPOSE: Magnetic resonance imaging (MRI) is a promising tool for risk assessment, potentially reducing the burden of unnecessary prostate biopsies. Risk prediction models that incorporate MRI data have gained attention, but their external validation and comparison are essential for guiding clinical practice. The aim is to externally validate and compare risk prediction models for the diagnosis of clinically significant prostate cancer (csPCa). METHODS: A cohort of 4606 patients across fifteen European tertiary referral centers were identified from a prospective maintained database between January 2016 and April 2023. Transrectal or transperineal image-fusion MRI-targeted and systematic biopsies for PI-RADS score of ≥ 3 or ≥ 2 depending on patient characteristics and physician preferences. Probabilities for csPCa, defined as International Society of Urological Pathology (ISUP) grade ≥ 2, were calculated for each patients using eight models. Performance was characterized by area under the receiver operating characteristic curve (AUC), calibration, and net benefit. Subgroup analyses were performed across various clinically relevant subgroups. RESULTS: Overall, csPCa was detected in 2154 (47%) patients. The models exhibited satisfactory performance, demonstrating good discrimination (AUC ranging from 0.75 to 0.78, p < 0.001), adequate calibration, and high net benefit. The model described by Alberts showed the highest clinical utility for threshold probabilities between 10 and 20%. Subgroup analyses highlighted variations in models' performance, particularly when stratified according to PSA level, biopsy technique and PI-RADS version. CONCLUSIONS: We report a comprehensive external validation of risk prediction models for csPCa diagnosis in patients who underwent MRI-targeted and systematic biopsies. The model by Alberts demonstrated superior clinical utility and should be favored when determining the need for a prostate biopsy.

The impact of prostate volume estimation on the risk-adapted biopsy decision based on prostate-specific antigen density and magnetic resonance imaging score.

PURPOSE: Utility of prostate-specific antigen density (PSAd) for risk-stratification to avoid unnecessary biopsy remains unclear due to the lack of standardization of prostate volume estimation. We evaluated the impact of ellipsoidal formula using multiparametric magnetic resonance (MRI) and semi-automated segmentation using tridimensional ultrasound (3D-US) on prostate volume and PSAd estimations as well as the distribution of patients in a risk-adapted table of clinically significant prostate cancer (csPCa). METHODS: In a prospectively maintained database of 4841 patients who underwent MRI-targeted and systematic biopsies, 971 met inclusions criteria. Correlation of volume estimation was assessed by Kendall's correlation coefficient and graphically represented by scatter and Bland-Altman plots. Distribution of csPCa was presented using the Schoots risk-adapted table based on PSAd and PI-RADS score. The model was evaluated using discrimination, calibration plots and decision curve analysis (DCA). RESULTS: Median prostate volume estimation using 3D-US was higher compared to MRI (49cc[IQR 37-68] vs 47cc[IQR 35-66], p < 0.001). Significant correlation between imaging modalities was observed (τ = 0.73[CI 0.7-0.75], p < 0.001). Bland-Altman plot emphasizes the differences in prostate volume estimation. Using the Schoots risk-adapted table, a high risk of csPCa was observed in PI-RADS 2 combined with high PSAd, and in all PI-RADS 4-5. The risk of csPCa was proportional to the PSAd for PI-RADS 3 patients. Good accuracy (AUC of 0.69 and 0.68 using 3D-US and MRI, respectively), adequate calibration and a higher net benefit when using 3D-US for probability thresholds above 25% on DCA. CONCLUSIONS: Prostate volume estimation with semi-automated segmentation using 3D-US should be preferred to the ellipsoidal formula (MRI) when evaluating PSAd and the risk of csPCa.

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.

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.

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.

Diagnosis of prostate cancer with magnetic resonance imaging in men treated with 5-alpha-reductase inhibitors.

PURPOSE: The primary aim of this study was to evaluate if exposure to 5-alpha-reductase inhibitors (5-ARIs) modifies the effect of MRI for the diagnosis of clinically significant Prostate Cancer (csPCa) (ISUP Gleason grade ≥ 2). METHODS: This study is a multicenter cohort study including patients undergoing prostate biopsy and MRI at 24 institutions between 2013 and 2022. Multivariable analysis predicting csPCa with an interaction term between 5-ARIs and PIRADS score was performed. Sensitivity, specificity, and negative (NPV) and positive (PPV) predictive values of MRI were compared in treated and untreated patients. RESULTS: 705 patients (9%) were treated with 5-ARIs [median age 69 years, Interquartile range (IQR): 65, 73; median PSA 6.3 ng/ml, IQR 4.0, 9.0; median prostate volume 53 ml, IQR 40, 72] and 6913 were 5-ARIs naïve (age 66 years, IQR 60, 71; PSA 6.5 ng/ml, IQR 4.8, 9.0; prostate volume 50 ml, IQR 37, 65). MRI showed PIRADS 1-2, 3, 4, and 5 lesions in 141 (20%), 158 (22%), 258 (37%), and 148 (21%) patients treated with 5-ARIs, and 878 (13%), 1764 (25%), 2948 (43%), and 1323 (19%) of untreated patients (p < 0.0001). No difference was found in csPCa detection rates, but diagnosis of high-grade PCa (ISUP GG ≥ 3) was higher in treated patients (23% vs 19%, p = 0.013). We did not find any evidence of interaction between PIRADS score and 5-ARIs exposure in predicting csPCa. Sensitivity, specificity, PPV, and NPV of PIRADS ≥ 3 were 94%, 29%, 46%, and 88% in treated patients and 96%, 18%, 43%, and 88% in untreated patients, respectively. CONCLUSIONS: Exposure to 5-ARIs does not affect the association of PIRADS score with csPCa. Higher rates of high-grade PCa were detected in treated patients, but most were clearly visible on MRI as PIRADS 4 and 5 lesions. TRIAL REGISTRATION: The present study was registered at ClinicalTrials.gov number: NCT05078359.

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.

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.

Adjuvant chemotherapy is ineffective in patients with bladder cancer and variant histology treated with radical cystectomy with curative intent.

OBJECTIVES: Adjuvant chemotherapy (ACT) is recommended for non-organ-confined bladder cancer (BCa) after radical cystectomy (RC) and pelvic lymph node dissection (PLND), but there are sparse data regarding its specific efficacy in patients with histological variants. The aim of our study was to evaluate the role of ACT on survival outcomes in patients with variant histology in a large multicenter cohort. MATERIALS AND METHODS: We retrospectively evaluated data of 3963 patients with BCa treated with RC and bilateral PLND with curative intent at several institutions between 1999 and 2018. The histological type was classified into six groups: pure urothelial carcinoma (PUC) or squamous, sarcomatoid, micropapillary, glandular and neuroendocrine differentiation. Multivariable competing risk analysis was applied to assess the role of ACT on recurrence and cancer-specific mortality (CSM) in each histological subtype. RESULTS: Of the 3963 patients included in the study, 23% had variant histology at RC specimen and 723 (18%) patients received ACT. ACT was found to be significantly associated with reduced risk of recurrence (sub-hazard ratio [SHR]: 0.55, confidence interval [CI] 0.42-0.71, p < 0.001) and CSM (SHR: 0.58, CI 0.44-0.78, p < 0.001) in the PUC only, while no histological subtype received a significant benefit on survival outcomes (all p > 0.05) from administration of ACT. The limitation of the study includes the retrospective design, the lack of a central pathology review and the number of ACT cycles. CONCLUSION: In our study, the administration of ACT was associated with improved survival outcomes in PUC only. No histological subtype found a benefit in overall recurrence and CSM from ACT.

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.

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.

On-clamp versus off-clamp partial nephrectomy: Propensity score-matched comparison of long-term functional outcomes.

OBJECTIVES: To compare long-term functional outcomes of off-clamp or on-clamp partial nephrectomy patients of two high-volume centers with cT1-2/N0 M0 renal tumors and baseline estimated glomerular filtration rate >60 mL/min. METHODS: A 3:1 propensity score-matched analysis was used to select two homogeneous cohorts to compare off-clamp versus on-clamp partial nephrectomy. Joinpoint regression analysis was used to compare the 2-8-year probabilities of estimated glomerular filtration rate modifications in both selected cohorts. The Kaplan-Meier method assessed the risk of developing a stage ≥3b chronic kidney disease during follow up. Multivariable analyses aimed to identify predictors of renal function deterioration. Perioperative complications and oncological outcomes were compared. RESULTS: Overall, 1073 patients were included (588 on-clamp and 485 off-clamp). After applying the propensity score-matched analysis, the two cohorts of 157 on-clamp and 472 off-clamp patients did not differ for all covariates, except for warm ischemia time and last estimated glomerular filtration rate. At joinpoint analysis, the off-clamp group showed higher probabilities of maintaining an unmodified estimated glomerular filtration rate (P = 0.02). The probability of developing a stage ≥3b chronic kidney disease was significantly higher (P < 0.001) in the on-clamp cohort. At multivariable analysis, estimated glomerular filtration rate at discharge and off-clamp approach were independent predictors of improved functional outcomes. Perioperative complications were comparable among the two cohorts (P = 0.67). There were not any statistically significant differences in terms of cancer-specific survival (P = 0.26) and overall survival (P = 0.18). CONCLUSIONS: Off-clamp partial nephrectomy seems to offer a higher probability of maintaining 100% estimated glomerular filtration rate after surgery. In our cohort, patients undergoing on-clamp partial nephrectomy presented a 7.3-fold increased risk of developing a severe chronic kidney disease during follow up.

Purely off-clamp robotic partial nephrectomy: Preliminary 3-year oncological and functional outcomes.

OBJECTIVES: To describe our surgical technique and to report perioperative, 3-year oncological and functional outcomes of a single-center series of purely off-clamp robotic partial nephrectomy. METHODS: A prospective renal cancer institutional database was queried, and data of consecutive patients treated with purely off-clamp robotic partial nephrectomy between 2010 and 2015 in a high-volume center were collected. Perioperative complications, and 3-year oncological and functional outcomes were assessed. Univariable and multivariable analyses were carried out to identify independent predictors of renal function deterioration. RESULTS: Out of 308 patients treated, 41 (13.3%) experienced perioperative complications, 2.9% of which were Clavien grade ≥3. The 3-year local recurrence-free survival and renal cell carcinoma-specific survival rates were 99.5% and 97.9%, respectively. No patient with preoperative chronic kidney disease stage ≤3B developed severe renal function deterioration (chronic kidney disease stage 4) at 1-year follow up. At multivariable analysis, preoperative estimated glomerular filtration rate (P = 0.005) was the only independent predictor of a new-onset chronic kidney disease stage ≥3 in patients with preoperative chronic kidney disease stages 1 or 2. CONCLUSIONS: Off-clamp robotic partial nephrectomy is a safe surgical approach in tertiary referral centers, with adequate oncological outcomes and negligible impact on renal function.

Accuracy of elastic fusion biopsy in daily practice: Results of a multicenter study of 2115 patients.

OBJECTIVES: To assess the accuracy of Koelis fusion biopsy for the detection of prostate cancer and clinically significant prostate cancer in the everyday practice. METHODS: We retrospectively enrolled 2115 patients from 15 institutions in four European countries undergoing transrectal Koelis fusion biopsy from 2010 to 2017. A variable number of target (usually 2-4) and random cores (usually 10-14) were carried out, depending on the clinical case and institution habits. The overall and clinically significant prostate cancer detection rates were assessed, evaluating the diagnostic role of additional random biopsies. The cancer detection rate was correlated to multiparametric magnetic resonance imaging features and clinical variables. RESULTS: The mean number of targeted and random cores taken were 3.9 (standard deviation 2.1) and 10.5 (standard deviation 5.0), respectively. The cancer detection rate of Koelis biopsies was 58% for all cancers and 43% for clinically significant prostate cancer. The performance of additional, random cores improved the cancer detection rate of 13% for all cancers (P < 0.001) and 9% for clinically significant prostate cancer (P < 0.001). Prostate cancer was detected in 31%, 66% and 89% of patients with lesions scored as Prostate Imaging Reporting and Data System 3, 4 and 5, respectively. Clinical stage and Prostate Imaging Reporting and Data System score were predictors of prostate cancer detection in multivariate analyses. Prostate-specific antigen was associated with prostate cancer detection only for clinically significant prostate cancer. CONCLUSIONS: Koelis fusion biopsy offers a good cancer detection rate, which is increased in patients with a high Prostate Imaging Reporting and Data System score and clinical stage. The performance of additional, random cores seems unavoidable for correct sampling. In our experience, the Prostate Imaging Reporting and Data System score and clinical stage are predictors of prostate cancer and clinically significant prostate cancer detection; prostate-specific antigen is associated only with clinically significant prostate cancer detection, and a higher number of biopsy cores are not associated with a higher cancer detection rate.