Androgen receptor pathway inhibitors and taxanes in metastatic prostate cancer: an outcome-adaptive randomized platform trial.

ProBio is the first outcome-adaptive platform trial in prostate cancer utilizing a Bayesian framework to evaluate efficacy within predefined biomarker signatures across systemic treatments. Prospective circulating tumor DNA and germline DNA analysis was performed in patients with metastatic castration-resistant prostate cancer before randomization to androgen receptor pathway inhibitors (ARPIs), taxanes or a physician's choice control arm. The primary endpoint was the time to no longer clinically benefitting (NLCB). Secondary endpoints included overall survival and (serious) adverse events. Upon reaching the time to NLCB, patients could be re-randomized. The primary endpoint was met after 218 randomizations. ARPIs demonstrated ~50% longer time to NLCB compared to taxanes (median, 11.1 versus 6.9 months) and the physician's choice arm (median, 11.1 versus 7.4 months) in the biomarker-unselected or 'all' patient population. ARPIs demonstrated longer overall survival (median, 38.7 versus 21.7 and 21.8 months for taxanes and physician's choice, respectively). Biomarker signature findings suggest that the largest increase in time to NLCB was observed in AR (single-nucleotide variant/genomic structural rearrangement)-negative and TP53 wild-type patients and TMPRSS2-ERG fusion-positive patients, whereas no difference between ARPIs and taxanes was observed in TP53-altered patients. In summary, ARPIs outperform taxanes and physician's choice treatment in patients with metastatic castration-resistant prostate cancer with detectable circulating tumor DNA. ClinicalTrials.gov registration: NCT03903835 .

Robot-assisted adrenalectomy: Step-by-step technique and surgical outcomes at a high-volume robotic center.

Objective: In the last years, robotic surgery was introduced in several different settings with good perioperative results. However, its role in the management of adrenal masses is still debated. In order to provide a contribution to this field, we described our step-by-step technique for robotic adrenalectomy (RA) and related modifications according to the type of adrenal mass treated. Methods: We retrospectively analyzed 27 consecutive patients who underwent RA at Onze-Lieve-Vrouw hospital (Aalst, Belgium) between January 2009 and October 2022. Demographic, intra- and post-operative, and pathological data were retrieved from our prospectively maintained institutional database. Continuous variables are summarized as median and interquartile range (IQR). Categorical variables are reported as frequencies (percentages). Results: Twenty-seven patients underwent RA were included in the study. Median age, body mass index, and Charlson's comorbidity index were 61 (IQR: 49-71) years, 26 (IQR: 24-29) kg/m2, and 2 (IQR: 0-3), respectively, and 16 (59.3%) patients were male. Median tumor size at computed tomography scan was 6.0 (IQR: 3.5-8.0) cm. Median operative time and blood loss were 105 (IQR: 82-120) min and 175 (IQR: 94-250) mL, respectively. No intraoperative complications were recorded. Overall postoperative complications rate was 11.1%, with a postoperative transfusion rate of 3.7%. A total of 10 (37.0%) patients harbored malignant adrenal masses. Among them, 3 (11.1%) had adrenocortical carcinoma, 6 (22.2%) secondary metastasis, and 1 (3.7%) malignant pheochromocytoma on final pathological exam. Only 1 (10.0%) patient had positive surgical margins. Conclusion: We described our step-by-step technique for RA, which can be safely performed even in case of high challenging settings as malignant tumors, pheochromocytoma, and large masses. The standardization of perioperative protocol should be encouraged to maximize the outcomes of this complex surgical procedure.

Transperineal vs. transrectal prostate biopsies under local anesthesia: A prospective cohort study on patient tolerability and complication rates.

OBJECTIVES: An increasing number of urologists is switching from transrectal (TR) to transperineal (TP) biopsy procedures for the diagnosis of prostate cancer. Local anesthesia (LA) might be advantageous in terms of patient management, risks and costs. We aimed to evaluate the tolerability and complication rates of TP prostate biopsy performed under LA. METHODS: This is a monocentric, prospective, comparative, observational cohort study. Between July 2020 and July 2021 we included 128 consecutive patients (TR, n = 61; TP, n = 67), with a suspicion of prostate cancer. Transrectal vs. transperineal prostate biopsies were both performed under LA. To evaluate the tolerability we administered a validated visual analog pain score (VAS) during the different steps of the biopsy procedure as well as at 12-, 24- and 48-hours post procedure. The International Prostate Symptom Score (IPSS) questionnaire was administered before the procedure and at the same time intervals. The presence of hematuria, hematospermia, rectal blood loss, acute retention and febrile urinary tract infection (UTI) were also monitored. RESULTS: There were no significant differences in pain or IPSS between groups, except for a significantly higher pain score during the LA of the prostate in the TP group. In general, complication rates were similar, only the prevalence of hematuria at 24 hours was significantly higher in the TP group, as was rectal blood loss at 12 hours postprocedure in the TR group. CONCLUSIONS: In conclusion, our study showed that transperineal prostate biopsy under local anesthesia could be performed with similar pain scores and complication rates, compared to the transrectal procedure.

Holmium Laser Enucleation of the Prostate vs Robot-Assisted Simple Prostatectomy for Lower Urinary Tract Symptoms in Patients with Extremely Large Prostates ≥200 cc: A Comparative Analysis.

Introduction and Objectives: Robot-assisted simple prostatectomy (RASP) and holmium laser enucleation of the prostate (HoLEP) are both well-established, minimally invasive surgical treatment options for lower urinary tract symptoms caused by benign prostatic enlargement. We have reported the first comparative analysis of both techniques in patients with prostates of ≥200 cc. Materials and Methods: Between 2009 and 2020 a total of 53 patients with a prostate volume of ≥200 cc were surgically treated at OLV Hospital Aalst (Belgium): 31 underwent RASP and 22 underwent HoLEP. Preoperative and postoperative assessments included uroflowmetry with maximum urinary flow rate (Qmax) and postvoid residual volume (PVR), as well as the International Prostate Symptom Score (IPSS) and quality of life (IPSS-QoL). The complication rates were evaluated according to the Clavien-Dindo Classification. Results: Patients treated with RASP had significantly larger prostate volumes compared with HoLEP (median 226 cc vs 204.5 cc, p = 0.004). After a median follow-up of 14 months, both groups showed a significant improvement in the maximum flow rate (+10.60 mL/s vs +10.70 mL/s, p = 0.724) and a reduction of the IPSS score (-12.50 vs -9, p = 0.246) as well as improvement of the QoL (-3 vs -3, p = 0.880). Median operative time was similar in both groups (150 minutes vs 132.5 minutes, p = 0.665). The amount of resected tissue was lower in the RASP group (134.5 g vs 180 g, p = 0.029) and there was no significant difference in postoperative prostate-specific antigen (1.2 ng/mL vs 0.8 ng/mL, p = 0.112). Despite a similar median catheterization time (3 days vs 2 days, p = 0.748), the median hospitalization time was shorter in the HoLEP group (4 days vs 3 days, p = 0.052). Complication rates were similar in both groups (32% vs 36%, p = 0.987). Conclusion: Our results suggest similar outcomes for RASP and HoLEP in patients with very large prostates ≥200 cc. These findings will require external validation at other high-volume centers.

Long-term oncologic outcomes of robot-assisted radical cystectomy: update series from a high-volume robotic center beyond 10 years of follow-up.

Long-term oncologic data on patients undergoing robot-assisted radical cystectomy (RARC) for non-metastatic bladder cancer (BCa) are limited. The purpose of this study is to describe long-term oncologic outcomes of patients receiving robotic radical cystectomy at a high-volume European Institution. We analyzed data of 107 patients treated with RARC between 2003 and 2012 at a high-volume robotic center. Clinical, pathologic, and survival data at the latest follow-up were collected. Clinical recurrence (CR)-free survival, cancer-specific mortality (CSM)-free survival, and overall survival (OS) were plotted using Kaplan-Meier survival curves. Cox proportional hazard models investigated predictors of CR and CSM. Competing-risk regressions were utilized to depict cumulative incidences of death from BCa and death from other causes after RARC at long term. Pathologic nonorgan-confined BCa was found in 40% of patients, and 7 (7%) patients had positive soft tissue surgical margins. Median (interquartile range [IQR]) number of nodes removed was 11 (6, 14), and 26% of patients had pN + disease. Median (IQR) follow-up for survivors was 123 (117, 149) months. The 12-year CR-free, CSM-free and overall survival were 55% (95% confidence interval [CI] 44%, 65%), 62% (95% CI 50%, 72%), and 34% (95% CI 24%, 44%), respectively. Nodal involvement on final pathology was associated with poor prognosis on multivariable competing risk analysis. The cumulative incidence of non-cancer death exceeded that of death from BCa after approximately ten years after RARC. We provided relevant data on oncologic outcomes of RARC at a high-volume robotic center, with acceptable rates of clinical recurrence and cancer-specific survival at long-term. In patients treated with RARC, the cumulative incidence of death from causes other than BCa is non-negligible, and should be taken into consideration for post-operative follow-up.

Simplified PADUA renal (SPARE) nephrometry score validation and long-term outcomes after robot-assisted partial nephrectomy.

BACKGROUND: International guidelines suggest the use of anatomic scores to predict surgical outcomes after partial nephrectomy (PN). We aimed at validating the use of Simplified PADUA Renal (SPARE) nephrometry score in robot-assisted PN (RAPN). MATERIALS AND METHODS: Three hundred and sixty-eight consecutive RAPN patients were included. Primary endpoints were overall complications, postoperative acute kidney injury (AKI) and TRIFECTA achievement. Secondary endpoint was estimated glomerular filtration rate (eGFR) decrease at last follow-up. Multivariable logistic and linear regression models were used. RESULTS: Of 368 patients, 229 (62%) vs. 116 (31%) vs. 23 (6.2%) harboured low- vs. intermediate- vs. high-risk renal mass, according to SPARE classification. SPARE score predicted higher risk of overall complications (Odds ratio [OR]: 1.23, 95%CI 1.09-1.39; P < 0.001), and postoperative AKI (OR: 1.20, 95%CI 1.08-1.35; P < 0.01). Moreover, SPARE score was associated with lower TRIFECTA achievement (OR: 0.89, 95%CI 0.81-0.98; P = 0.02). Predicted accuracy was 0.643, 0.614 and 0.613, respectively. After a median follow-up of 40 (IQR: 21-66) months, eGFR decrease ranged from -7% in low-risk to -17% in high-risk SPARE. CONCLUSIONS: SPARE scoring system predicts surgical success in RAPN patients. Moreover, SPARE score is associated with eGFR decrease at long-term follow-up. Thus, the adoption of SPARE score to objectively assess tumor complexity prior to RAPN may be preferable.

Selective Suturing or Sutureless Technique in Robot-assisted Partial Nephrectomy: Results from a Propensity-score Matched Analysis.

BACKGROUND: Despite efforts aimed at preserving renal function, the functional decline after robot-assisted partial nephrectomy (RAPN) is not negligible. To address the risk of intraparenchymal vessel injuries during renorrhaphy, with consequent loss of functional renal parenchyma, we introduced a new surgical technique for RAPN. OBJECTIVE: To compare perioperative patient outcomes between selective-suturing or sutureless RAPN (suRAPN) and standard RAPN (stRAPN). DESIGN, SETTING, AND PARTICIPANTS: Ninety-two consecutive patients undergoing RAPN for a renal mass performed by a high-volume surgeon at a European tertiary center were included. Propensity-score matching was used to account for baseline differences between suRAPN and stRAPN patients. INTERVENTION: RAPN using a selective-suturing or sutureless technique versus standard RAPN. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Perioperative outcomes included operative time, blood loss, length of stay, and intraoperative and 30-d postoperative complications. We also evaluated trifecta achievement (warm ischemia time ≤25 min, negative surgical margins, and no perioperative complications) and the incidence of postoperative acute kidney injury (AKI). We applied χ2 tests, t tests, and Kruskal-Wallis tests to assess differences in perioperative outcomes between suRAPN and stRAPN. RESULTS AND LIMITATIONS: Overall, 29 patients (31%) were treated with suRAPN. Only one suRAPN patient experienced intraoperative complications (p = 0.9). Two suRAPN patients (6.9%) and four stRAPN patients (13.8%) experienced 30-d postoperative complications (p = 0.3). Operative time (110 vs 150 min; p < 0.01) and length of stay (2 vs 3 d; p = 0.02) were shorter for suRAPN than for stRAPN. The trifecta outcome was achieved in 25 suRAPN patients (86%) and 20 stRAPN patients (70%; p = 0.1). Only one suRAPN patient (3.4%) versus five stRAPN patients (17%) experienced postoperative AKI (p = 0.2). Finally, the decrease in the estimated glomerular filtration rate at 6-mo follow-up was lower in the suRAPN (-5.2%) than in the stRAPN group (-9.1%; p < 0.01). Lack of randomization represents the main study limitation. CONCLUSIONS: A selective-suturing or sutureless technique in RAPN is feasible and safe. Moreover, suRAPN is a lower-impact surgical procedure. We obtained promising results for trifecta and functional outcomes, but prospective randomized trials are needed to validate the impact of selective suturing or a sutureless technique on long-term functional outcomes. PATIENT SUMMARY: We assessed a new technique in robotic surgery to remove part of the kidney because of kidney cancer. Our new technique involves selective suturing or no suturing of the area from where the tumor is removed. We found that the rate of complications did not increase and the operating time and length of hospital stay were shorter using this new technique.

Transvesical Approach in Robot-Assisted Bladder Diverticulectomy: Surgical Technique and Outcome.

Objective: Treatment for bladder diverticula may become necessary in case of incomplete bladder emptying or recurrent urinary tract infections (UTIs). When bladder outlet obstruction is present, a simultaneous desobstructive procedure can be performed. In this video, we present our technique for a transvesical approach in robot-assisted bladder diverticulectomy (RABD) and discuss its outcomes. Patients and Surgical Procedure: We retrospectively analyzed the outcomes of 23 patients who underwent a transvesical RABD between March 2015 and May 2020 at the OLV hospital of Aalst. After retrograde filling, a cystotomy is performed. The orifices are identified and the bladder diverticulum is observed. The mucosa covering the diverticular neck is incised and the plane between the mucosa and the muscularis is identified. The mucosa is separated from the surrounding structures. The base of the diverticulum is transected using cautery. The defect is closed with a barbed suture. Results: Median age was 66 years (interquartile range [IQR] 60-69). The number of diverticula removed ranged from 1 to 3. Ten patients were treated with diverticulectomy alone, 12 underwent a simultaneous adenomectomy, 1 a radical prostatectomy. Median operative was 140 minutes (IQR 120-180), median estimated blood loss was 250 mL (IQR 28-438). Median catheterization time was 2 days (IQR 1-5), median hospitalization time 3 days (IQR 2-4). One patient developed urinary leakage after catheter removal, one patient developed a UTI. Median follow-up was 9 months (IQR 3.5-14). No late postoperative complications nor relapse were recorded. Average postvoid residual was 42 mL (IQR 0-111), with a median decline of 120 mL (IQR -402 to -33). Conclusions: Transvesical approach for RABD is a safe and reliable technique that gives the advantage of a quick localization of the diverticulum and orifices, and direct access to the prostate when simultaneous desobstruction is necessary. Catheterization time is short. No relapse has been observed.

Early Catheter Removal on Postoperative Day 2 After Robot-assisted Radical Prostatectomy: Updated Real-life Experience with the Aalst Technique.

We evaluated the feasibility and impact on short- and long-term functional outcomes of very early catheter removal on postoperative day (POD) 2 after robot-assisted radical prostatectomy (RARP). To the best of our knowledge, this is the first multisurgeon study with the largest cohort on very early (POD 2) catheter removal after RARP with follow-up of >1 yr. In 255/369 patients (69%) treated with RARP ±â€¯pelvic lymph node dissection, the catheter was removed on POD 2. Among the 255 patients, 33 (13%) required recatheterisation because of acute urinary retention after catheter removal. Of these 33 patients, five (2%) also experienced anastomotic leakage after catheter removal. The early (≤3 mo) urinary continence rate was 67% and the median time to urinary continence recovery was 1 mo. After median follow-up of 18 mo (interquartile range 13-24), 236 patients (88%) were continent. No anastomotic strictures occurred. Our observations confirm the feasibility and safety of POD 2 catheter removal after RARP and support its adoption for selected patients. PATIENT SUMMARY: After removal of the prostate for cancer, patients have a urinary catheter inserted. We investigated whether earlier removal of the catheter affects long-term urinary continence. The results show that it may be safe to remove the catheter on postoperative day 2 for selected patients.

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 Cystectomy with Intracorporeal Urinary Diversion After Pelvic Irradiation for Prostate Cancer: Technique and Results from a Single High-volume Center.

BACKGROUND: Radiation therapy (RT) for prostate cancer (PCa) treatment is burdened by high rates of late urinary adverse events (UAEs). The feasibility of robot-assisted cystectomy (RAC) with intracorporeal urinary diversion (ICUD) for treatment of high-grade UAEs has never been assessed. OBJECTIVE: To report perioperative outcomes, early (≤90 d) and late (>90 d) complications among patients undergoing RAC for UAEs after RT. DESIGN, SETTING, AND PARTICIPANTS: We retrospectively evaluated 32 patients undergoing RAC with ICUD for UAEs in a single tertiary centre. SURGICAL PROCEDURE: Surgery was performed using a da Vinci Xi system with adaptation for the primary treatment. MEASUREMENTS: Perioperative outcomes included estimated blood loss (EBL), operative time (OT), intraoperative complications, and length of stay (LOS). Data for early and late postoperative complications were collected using the quality criteria recommended by the European Association of Urology. Univariate logistic regressions were performed to test the effect of baseline and perioperative characteristics on early postoperative complications. RESULTS AND LIMITATIONS: The median age-adjusted Charlson comorbidity index (ACCI) was 6 (IQR 5-7). The indication for RAC was hemorrhagic radiation cystitis in 29 cases (91%), contracted bladder in two cases (6.2%), and urinary fistula in one case (3.1%). The median EBL, OT, and LOS were 250 ml, 330 min, and 10 d, respectively. A total of 31 (97%) patients received an ileal conduit. The 90-d rate of Clavien-Dindo grade ≥IIIa complications was 28%. The late complication rate was 46% and the perioperative mortality rate was 0%. On univariate analyses, ACCI was the only parameter correlated with the risk of early complications (odds ratio 1.75, 95% confidence interval 1.05-2.9; p = 0.03). The median follow-up was 30 mo (IQR 15-40). The lack of comparison with open cystectomy represents the main limitation. CONCLUSIONS: RAC for UAEs in patients with a history of pelvic irradiation is a feasible option in high-volume centers. The use of new technologies can help to overcome some of the technical difficulties and reduce the risk of perioperative and late complications. PATIENT SUMMARY: We report our experience with robot-assisted surgery for removal of the bladder in the management of urinary problems after radiation therapy for prostate cancer. When performed by highly experienced surgeons, this is a feasible procedure with outcomes and early and late complication rates that are acceptable.

Robot-assisted segmental ureterectomy with psoas hitch ureteral reimplantation: Oncological, functional and perioperative outcomes of case series of a single centre.

INTRODUCTION: According to the Urology guidelines, in selected cases of distal upper tract urothelial carcinoma (UTUC) segmental ureterectomy (SU) can be offered. There is no consensus in the surgical technique of preference. Robot-assisted SU could be an option to overcome all the limitations of open and laparoscopic techniques. We describe our first experience of robot assisted SU with psoas hitch ureteral reimplantation (RAPHUR). MATERIALS AND METHODS: 11 patients underwent RAPHUR for distal UTUC between 2013 and 2017 in a single centre. Pre-, intra-, and postoperative outcomes were assessed. Conventional imaging was performed after 1, 3, 6 months and 1 year from surgery as follow up protocol. We retrospectively evaluated the technical feasibility, oncological and functional outcomes. RESULTS: Median age was 71 years (57-91). The median length of the ureteral defect was 23 mm (10-40). Median preoperative creatinine level was 1.22 mg/dl (0.7-1.85) and median eGFR was 57.5 ml/min/1.73m2 (31-80). Five (45.5%) patients were symptomatic and 7 (63.6%) had hydronephrosis. Median operative time was 185 min (120-240), with a median blood loss of 100 ml (50-300). No case required conversion to open surgery. Overall, only 1 (9%) patient developed Clavien Dindo ≥ 3 postoperative complications. Average hospital stay was 7 (2-9) days. Mean postoperative creatinine was 1.05 mg/dl (0.8-1.85) and mean postoperative eGFR was 72 (36-83). During a median follow up time of 25.5 months (12-53), 4 (36.4%) patients experienced recurrence of urothelial cancer at conventional imaging follow up and 2 (18.2%) died due to its progression. CONCLUSIONS: In our initial experience RAPHUR can be proposed to selected cases of distal ureteral carcinoma with optimal perioperative and functional outcomes. However, cancer control may be undermined compared to nephroureterectomy. Thus, further prospective studies are needed to confirm our findings.

The Impact of Previous Prostate Surgery on Surgical Outcomes for Patients Treated with Robot-assisted Radical Cystectomy for Bladder Cancer.

BACKGROUND: The feasibility and safety of robot-assisted radical cystectomy (RARC) may be undermined by unfavorable preoperative surgical characteristics such as previous prostate surgery (PPS). OBJECTIVE: To compare perioperative outcomes for patients undergoing RARC with versus without a history of PPS. DESIGN, SETTING, AND PARTICIPANTS: The study included 220 consecutive patients treated with RARC and pelvic lymph node dissection for bladder cancer at a single European tertiary centre. Of these, 43 had previously undergone PPS, defined as transurethral resection of the prostate/holmium laser enucleation of the prostate (n=21) or robot-assisted radical prostatectomy (n=22). SURGICAL PROCEDURE: RARC in patients with a history of PPS. MEASUREMENTS: Data on postoperative complications were collected according to the quality criteria for accurate and comprehensive reporting of surgical outcomes recommended by the European Association of Urology guidelines. Multivariable logistic, linear, and Poisson regression analyses were performed to test the effect of PPS on surgical outcomes. RESULTS AND LIMITATIONS: Overall, 43 patients (20%) were treated with RARC after PPS. Operative time (OT) was longer in the PPS group (360 vs 330min; p<0.001). Patients with PPS experienced higher rates of intraoperative complications (19% vs 6.8%) and higher rates of 30-d (67% vs 39%), and Clavien-Dindo >3 (33% vs 16%) postoperative complications (all p<0.05). Moreover, the positive surgical margin (PSM) rate after RARC was higher in the PPS group (14% vs 4%; p=0.03). On multivariable analyses, PPS at RARC independently predicted higher risk of intraoperative (odds ratio [OR] 2.10, 95% confidence interval [CI] 1.04-6.21; p=0.01) and 30-d complications (OR 2.26, 95% CI 1.05-5.22; p=0.02), as well as longer OT (relative risk [RR] 1.03, 95% CI 1.00-1.05; p=0.02) and length of stay (RR 1.13, 95% CI 1.02-1.26; p=0.02). Lack of randomization represents the main limitation. CONCLUSIONS: RARC in patients with a history of PPS is feasible, but it is associated with a higher risk of complications and longer OT and length of stay. Moreover, higher PSM rates have been reported for these patients. Thus, measures aimed at improving surgical outcomes appear to be warranted. PATIENT SUMMARY: We investigated the effect of previous prostate surgery (PPS) on surgical outcomes after robot-assisted removal of the bladder. We found that patients with PPS have a higher risk of complications and longer hospitalization after bladder removal. These patients deserve closer evaluation before this type of bladder operation.

Technical Refinements in Superextended Robot-assisted Radical Prostatectomy for Locally Advanced Prostate Cancer Patients at Multiparametric Magnetic Resonance Imaging.

BACKGROUND: The feasibility and efficacy of robot-assisted radical prostatectomy (RARP) in locally advanced prostate cancer (PCa) patients with iT3 lesion at magnetic resonance imaging (MRI) are currently not explored. OBJECTIVE: To describe our revised RARP technique (ie, superextended RARP [SE-RARP]) for PCa patients with posterior iT3a or iT3b at MRI. DESIGN, SETTING, AND PARTICIPANTS: Data from 89 patients with posterior iT3a or T3b disease who underwent SE-RARP at a single high-volume centre between 2015 and 2018 were analysed. SURGICAL PROCEDURE: RARP was performed using a DaVinci Xi system. The surgical approach provided an inter- or extrafascial RARP where Denonvilliers' fascia and perirectal fat were dissected free and left on the posterior surface of the seminal vesicles. MEASUREMENTS: Perioperative outcomes, and intra- and postoperative complications were assessed. Postoperative outcomes were assessed in patients with complete follow-up data (n = 78). Biochemical recurrence (BCR) was defined as two consecutive prostate-specific antigen values of ≥0.2 ng/ml. Urinary continence (UC) recovery was defined as the use of zero or one safety pad. Kaplan-Meier and multivariable Cox regression models were used. RESULTS AND LIMITATIONS: The median operative time, blood loss, and length of stay were 204 min, 300 ml, and 5 d, respectively. The median bladder catheterisation time was 5 d. Overall, 28%, 28%, and 27% of patients had pathological grade group (GG) 4-5, pT3b, and positive surgical margins (PSMs), respectively. Three patients (3.4%) experienced intraoperative complications. Among patients with available follow-up data (n = 78), 14 (18%) experienced 30-d postoperative complications. The median follow-up was 19 mo. Overall, 11 patients received additional treatment. At 2 yr of follow-up, BCR-free and additional treatment-free survival were 55% and 66%, respectively. Pathological GG 4-5 (hazard ratio [HR] 3.2) and PSM (HR 5.8) were independent predictors of recurrence, as well as of additional treatment use (HR 5.6 for GG 4-5 and 5.2 for PSM). The 1-yr UC recovery was 84%. CONCLUSIONS: We presented our revised RARP technique applicable to patients with posterior iT3a or iT3b at preoperative MRI. This technique is associated with good morbidity and continence recovery rates, and might guarantee biochemical control of the disease and postpone the use of additional treatments in patients with low-grade and negative surgical margins. PATIENT SUMMARY: A revised robot-assisted radical prostatectomy technique applicable to prostate cancer patients with posterior iT3a or iT3b lesion at magnetic resonance imaging was described. This novel technique is feasible and safe in expert hands.

The Effect of Surgical Experience on Perioperative and Oncological Outcomes After Robot-assisted Radical Cystectomy with Intracorporeal Urinary Diversion: Evidence from a Referral Centre with Extensive Experience in Robotic Surgery.

BACKGROUND: Evidence on the learning curve for robot-assisted radical cystectomy (RARC) with intracorporeal urinary diversion (ICUD) is limited. OBJECTIVE: To assess the effect of surgical experience (SE) on perioperative and intermediate-term oncological outcomes in a large contemporary cohort of RARC patients after accounting for the impact of intersurgeon variability. DESIGN, SETTING, AND PARTICIPANTS: The study cohort included 164 patients treated with RARC and ICUD by two surgeons between 2004 and 2017 at a single European referral centre. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: For each patient, SE was defined as the total number of RARCs performed by each surgeon before the patient's operation. The relationship between SE and operative time (OT), lymph node yield (LNY), positive surgical margins (PSMs), Clavien-Dindo grade ≥2 30-d postoperative complication (CD≥2), and oncological outcomes (18-mo recurrence rate) was evaluated in multivariable linear and logistic regression models, clustering at a single-surgeon level. RESULTS AND LIMITATIONS: After adjusting for case mix, SE was associated with shorter OT (p= 0.003), lower probability of postoperative CD≥2 rates (p= 0.01), and lower 18-mo recurrence rates (p= 0.002). Conversely, SE did not predict lower PSM rates (p= 0.3) and higher LNY (p= 0.4). The relationship between SE and OT was nonlinear, with a plateau observed after 50 cases. Conversely, the relationship between SE and CD≥2 and 18-mo recurrence was linear without reaching a plateau after 88 procedures. CONCLUSIONS: SE affects perioperative and oncological outcomes after RARC with ICUD in a linear fashion, and its beneficial effect does not reach a plateau. Conversely, after 50 cases, no further improvement was observed for OT. PATIENT SUMMARY: Robot-assisted radical cystectomy with intracorporeal urinary diversion is a complex surgical procedure with a relatively long learning curve.

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.

The Impact of Surgical Strategy in Robot-assisted Partial Nephrectomy: Is It Beneficial to Treat Anterior Tumours with Transperitoneal Access and Posterior Tumours with Retroperitoneal Access?

Available comparison of transperitoneal robot-assisted partial nephrectomy (tRAPN) and retroperitoneal robot-assisted partial nephrectomy (rRAPN) does not consider tumour's location. The aim of this study was to compare perioperative morbidity, and functional and pathological outcomes after tRAPN and rRAPN, with the specific hypothesis that tRAPN for anterior tumours and rRAPN for posterior tumours might be a beneficial strategy. A large global collaborative dataset of 1169 cT1-2N0M0 patients was used. Propensity score matching, and logistic and linear regression analyses tested the effect of tRAPN versus rRAPN on perioperative outcomes. No differences were observed between rRAPN and tRAPN with respect to complications, operative time, length of stay, ischaemia time, median 1-yr estimated glomerular filtration rate (eGFR), and positive surgical margins (all p>0.05). Median estimated blood loss and postoperative eGFR were 50 versus100ml (p<0.0001) and 82 versus 78ml/min/1.73 m2 (p=0.04) after rRAPN and tRAPN, respectively. At interaction tests, no advantage was observed after tRAPN for anterior tumours and rRAPN for posterior tumours with respect to complications, warm ischaemia time, postoperative eGFR, and positive surgical margins (all p>0.05). The techniques of rRAPN and tRAPN offer equivalent perioperative morbidity, and functional and pathological outcomes, regardless of tumour's location. PATIENT SUMMARY: Robot-assisted partial nephrectomy can be performed with a transperitoneal or a retroperitoneal approach regardless of the specific position of the tumour, with equivalent outcomes for the patient.

Time to Move On: The Impending Need for a New Disease-specific Comorbidity Index for Bladder Cancer Patients Undergoing Robot-assisted Radical Cystectomy.

The Charlson comorbidity index is an outdated comorbidity assessment tool which is not disease specific and is not applicable to contemporary BCa patients.

Phase II open-label study investigating apalutamide in patients with biochemical progression after radical prostatectomy.

Apalutamide, a competent inhibitor of the androgen receptor, has shown promising clinical efficacy results for patients with advanced prostate cancer. Here, we describe the rationale and design for the SAVE trial, a multi-center, Phase II study, wherein 202 men with biochemical progression after radical prostatectomy are randomly assigned 1:1 to apalutamide plus salvage radiotherapy (SRT) or androgen-deprivation therapy with an luteinizing hormone-releasing hormone agonist or antagonist plus SRT. The primary objective is to compare sexual function between the two treatment arms based on the expanded prostate cancer index-26 sexual domain score at nine months after start of hormonal treatment. The key secondary objectives are to assess quality of life, to evaluate the safety profile and the short-term efficacy of apalutamide in combination with SRT. ClinicalTrials.gov identifier: NCT03899077.