Robot-Assisted Pyeloplasty with HUGO™ Robotic System: Initial Experience and Optimal Surgical Set-Up at a Tertiary Referral Robotic Center.

Background: In February 2021 Medtronic® (Minneapolis, MN) launched the HUGO™ Robot-Assisted Surgery (RAS) System in the global market. The aim of the current study is to describe the first case series and the optimal setup of robot-assisted pyeloplasty procedure, performed with HUGO RAS system in a tertiary referral robotic center. Methods: Data from consecutive patients who underwent robot-assisted pyeloplasty at Onze-Lieve-Vrouwziekenhuis Hospital (Aalst, Belgium) were recorded. Baseline characteristics, and perioperative and surgical outcomes were collected. Results: Overall, 10 robot-assisted pyeloplasties were performed (October 2022-September 2023). Based on our expertise, the following minor setting changes have been made, relative to the official setup guide: the endoscope port and, subsequently, the left and right-hand ports were positioned more laterally. Additionally, the reserve/4th port was placed more laterally and cranially, and adjusted the arm cart's tilt angle, reducing it from -30° to -15°. The median docking time was 8 (interquartile range [IQR]: 7.2-9.8) minutes, and the median active console time was 89.5 (80.0-95.8) minutes. No conversion to open/laparoscopic surgery or perioperative complications was encountered. A single technical problem was recorded in 1 (10%) procedure. Specifically, one arm was blocked, and the procedure was accomplished with three arms without compromising the procedure success. Conclusions: This study represents the first worldwide series of robot-assisted pyeloplasty performed with the HUGO RAS system and shows promising results. The procedure might be safely performed with this robotic platform achieving optimal perioperative outcomes.

Robot-assisted Radical Prostatectomy Performed with Different Robotic Platforms: First Comparative Evidence Between Da Vinci and HUGO Robot-assisted Surgery Robots.

BACKGROUND: In the field of robotic surgery, there is a lack of comparative evidence on surgical and functional outcomes of different robotic platforms. OBJECTIVE: To assess the outcomes of patients receiving robot-assisted radical prostatectomy (RARP) at a high-volume robotic center with daVinci and HUGO robot-assisted surgery (RAS) surgical systems. DESIGN, SETTING, AND PARTICIPANTS: We analyzed the data of 542 patients undergoing RARP ± extended pelvic lymph node dissection at OLV hospital (Aalst, Belgium) between 2021 and 2023. All procedures were performed by six surgeons using daVinci or HUGO RAS robots; the use of one platform rather than the other did not follow any specific preference and/or indication. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Multivariable analyses investigated the association between robotic system (daVinci vs HUGO RAS) and surgical outcomes after adjustment for patient- and tumor-related factors. Urinary continence recovery was defined as the use of no/one safety pad. RESULTS AND LIMITATIONS: A total of 378 (70%) and 164 (30%) patients underwent RARP with daVinci and HUGO RAS surgical systems, respectively. Despite a higher rate of palpable disease in the HUGO RAS group (34% vs 25%), baseline characteristics did not differ between the groups (all p > 0.05). After adjusting for confounders, we did not find evidence of a difference between the groups with respect to operative time (estimate: 16.71; 95% confidence interval [CI]: -6.35, 39.78; p = 0.12), estimated blood loss (estimate: 3.12; 95% CI: -67.03, 73.27; p = 0.9), and postoperative Clavien-Dindo ≥2 complications (odds ratio [OR]: 1.66; 95% CI: 0.34, 8.15; p = 0.5). On final pathology, 55 (15%) and 20 (12%) men in, respectively, the daVinci and the HUGO RAS group had positive surgical margins (PSMs; p = 0.5). On multivariable analyses, we did not find evidence of an association between a robotic system and PSMs (OR: 1.08; 95% CI: 0.56, 2.07; p = 0.8). Similarly, the odds of recovering continence did not differ between daVinci and HUGO RAS cases after both 1 mo (OR: 0.78; 95% CI: 0.45, 1.38; p = 0.4) and 3 mo (OR: 1.17; 95% CI: 0.49, 2.79; p = 0.7). CONCLUSIONS: Among patients receiving RARP with daVinci or HUGO RAS surgical platforms, we did not find differences in surgical and functional outcomes between the robots. This may be a result of a standardized surgical technique that allowed surgeons to transfer their skills between robotic systems. Awaiting future investigations with longer follow-up, these results have important implications for patients, surgeons, and health care policymakers. PATIENT SUMMARY: We compared surgical and functional outcomes of patients receiving robot-assisted radical prostatectomy with daVinci versus HUGO robot-assisted surgery (RAS) robots. The two platforms were able to achieve similar outcomes, suggesting that the introduction of HUGO RAS is safe and allows for optimal outcomes after radical prostatectomy.

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

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

Transitioning from Da Vinci Si to Xi: assessing surgical outcomes at a high-volume robotic center.

PURPOSE: In the emerging field of robotics, only few studies investigated the transition between different robotic platforms in terms of surgical outcomes. We aimed at assessing surgical outcomes of patients receiving robot-assisted radical prostatectomy (RARP) and robot-assisted partial nephrectomy (RAPN) at a high-volume robotic center during the transition from Si to Xi Da Vinci surgical systems. METHODS: We analyzed data of 1884 patients undergoing RARP (n = 1437, 76%) and RAPN (n = 447, 24%) at OLV hospital (Aalst, Belgium) between 2011 and 2021. For both procedures, we assessed operative time, estimated blood loss, length of stay, and positive surgical margins. For RARP, we investigated length of catheterization and PSA persistence after surgery, whereas warm ischemia time, clampless surgery, and acute kidney injury (AKI) were assessed for RAPN. Multivariable analyses (MVA) investigated the association between robotic platform (Si vs. Xi) and surgical outcomes after adjustment for patient- and tumor-related factors. RESULTS: A total of 975 (68%) and 462 (32%) patients underwent RARP performed with the Si vs. Xi surgical system, respectively. Baseline characteristics did not differ between the groups. On MVA, we did not find evidence of a difference between the groups with respect to operative time (estimate: 1.07) or estimated blood loss (estimate: 32.39; both p > 0.05). Median (interquartile range [IQR]) length of stay was 6 (3, 6) and 4 (3, 5) days in the Si vs. Xi group, respectively (p < 0.0001). On MVA, men treated with the Xi vs. Si robot had lower odds of PSM (Odds ratio [OR]: 0.58; p = 0.014). A total of 184 (41%) and 263 (59%) patients received RAPN with the Si and Xi robotic system, respectively. Baseline characteristics, including demographics, functional data, and tumor-related features did not differ between the groups. On MVA, operative time was longer in the Xi vs. Si group (estimate: 30.54; p = 0.006). Patients treated with the Xi vs. Si system had higher probability of undergoing a clampless procedure (OR: 2.56; p = 0.001), whereas the risk of AKI did not differ between the groups (OR: 1.25; p = 0.4). On MVA, patients operated with the Xi robot had shorter length of stay as compared to the Si group (estimate: - 0.86; p = 0.003), whereas we did not find evidence of an association between robotic system and PSM (OR: 1.55; p = 0.3). CONCLUSION: We found that the Xi robot allowed for improvements in peri-operative outcomes as compared to the Si platform, with lower rate of positive margins for RARP and higher rate of off-clamp procedures for RAPN. Hospital stay was also shorter for patients operated with the Xi vs. Si robot, especially after robot-assisted partial nephrectomy. Awaiting future investigations-in particular, cost analyses-these results have important implications for patients, surgeons, and healthcare policymakers.

A comparative analysis of the HUGOTM robot-assisted surgery system and the Da Vinci® Xi surgical system for robot-assisted sacrocolpopexy for pelvic organ prolapse treatment.

BACKGROUND: We aimed to compare the outcomes of Robot-assisted sacrocolpopexy (RASC) performed using the novel HUGOTM Robot-Assisted Surgery (RAS) System with the Da Vinci® Xi surgical system. METHODS: Data from 38 women undergoing RASC for a ≥ 2-grade pelvic organ prolapse were collected (2021-2023). RESULTS: Overall, 23 (60.5%) and 15 (39.5%) procedures were performed using the DaVinci® Xi and the HUGOTM RAS system, respectively. The median total operative time was 123 (IQR:106.5-140.5) minutes for the DaVinci® Xi versus 120 (IQR:120-146) minutes for the HUGOTM RAS cases (p = 0.5). No conversion to open/laparoscopic surgery, perioperative complications, or system failures occurred. No differences were recorded according to day of catheter removal and length of stay. CONCLUSIONS: This study represents the first worldwide comparison of RASC executed using the HUGOTM RAS versus the Da Vinci® Xi System. Our data suggest that RASC might be performed with both robotic platforms with similar perioperative outcomes.

Added Value of Prostate-specific Antigen Density in Selecting Prostate Biopsy Candidates Among Men with Elevated Prostate-specific Antigen and PI-RADS ≥3 Lesions on Multiparametric Magnetic Resonance Imaging of the Prostate: A Systematic Assessment by PI-RADS Score.

BACKGROUND: A significant proportion of patients with positive multiparametric magnetic resonance imaging (mpMRI; Prostate Imaging-Reporting and Data System [PI-RADS] scores of 3-5) have negative biopsy results. OBJECTIVE: To systematically assess all prostate-specific antigen density (PSAD) values and identify an appropriate cutoff for identification of patients with positive mpMRI who could potentially avoid biopsy on the basis of their PI-RADS score. DESIGN, SETTING, AND PARTICIPANTS: The study included a cohort of 1341 patients with positive mpMRI who underwent combined targeted and systematic biopsies. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Multivariable logistic regression analysis (MVA) was used to assess the association between PSAD and the risk of clinically significant prostate cancer (csPCa, grade group ≥2) after adjusting for confounders. We used locally weighted scatterplot smoothing to explore csPCa risk according to PSAD and PI-RADS scores. PSAD utility was observed only for patients with PI-RADS 3 lesions, so we plotted the effect of each PSAD value as a cutoff for this subgroup in terms of biopsies saved, csPCa cases missed, and clinically insignificant PCa (ciPCa, grade group 1) cases not detected. RESULTS AND LIMITATIONS: Overall, 667 (50%) csPCa cases were identified. On MVA, PSAD independently predicted csPCa (odds ratio 1.57; p < 0.001). For PI-RADS ≥4 lesions, the csPCa risk was ≥40% regardless of PSAD. Conversely, among patients with PI-RADS 3 lesions, csPCa risk ranged from 0% to 60% according to PSAD values, and a PSAD cutoff of 0.10 ng/ml/cm3 corresponded to a threshold probability of 10% for csPCa. Using this PSAD cutoff for patients with PI-RADS 3 lesions would have saved 32% of biopsies, missed 7% of csPCa cases, and avoided detection of 34% of ciPCa cases. Limitations include selection bias and the high experience of the radiologists and urologists involved. CONCLUSIONS: Patients with PI-RADS ≥4 lesions should undergo prostate biopsy regardless of their PSAD, while PSAD should be used to stratify patients with PI-RADS 3 lesions. Using a threshold probability of 10% for csPCa, our data suggest that the appropriate strategy is to avoid biopsy in patients with PI-RADS 3 lesions and PSAD <0.10 ng/ml/cm3. Our results also provide information to help in tailoring an appropriate strategy for every patient with positive mpMRI findings. PATIENT SUMMARY: We investigated whether a cutoff value for PSAD (prostate-specific antigen density) could identify patients with suspicious prostate lesions on MRI (magnetic resonance imaging) who could avoid biopsy according to the PI-RADS score for their scan. We found that patients with PI-RADS ≥4 should undergo prostate biopsy regardless of their PSAD. A PSAD cutoff of 0.10 should be used to stratify patients with PI-RADS 3.

In-Hospital Venous Thromboembolism and Pulmonary Embolism After Major Urologic Cancer Surgery.

BACKGROUND: This study aimed to test for temporal trends of in-hospital venous thromboembolism (VTE) and pulmonary embolism (PE) after major urologic cancer surgery (MUCS). METHODS: In the Nationwide Inpatient Sample (NIS) database (2010-2019), this study identified non-metastatic radical cystectomy (RC), radical prostatectomy (RP), radical nephrectomy (RN), and partial nephrectomy (PN) patients. Temporal trends of VTE and PE and multivariable logistic regression analyses (MLR) addressing VTE or PE, and mortality with VTE or PE were performed. RESULTS: Of 196,915 patients, 1180 (1.0%) exhibited VTE and 583 (0.3%) exhibited PE. The VTE rates increased from 0.6 to 0.7% (estimated annual percentage change [EAPC] + 4.0%; p = 0.01). Conversely, the PE rates decreased from 0.4 to 0.2% (EAPC - 4.5%; p = 0.01). No difference was observed in mortality with VTE (EAPC - 2.1%; p = 0.7) or with PE (EAPC - 1.2%; p = 0.8). In MLR relative to RP, RC (odds ratio [OR] 5.1), RN (OR 4.5), and PN (OR 3.6) were associated with higher VTE risk (all p < 0.001). Similarly in MLR relative to RP, RC (OR 4.6), RN (OR 3.3), and PN (OR 3.9) were associated with higher PE risk (all p < 0.001). In MLR, the risk of mortality was higher when VTE or PE was present in RC (VTE: OR 3.7, PE: OR  4.8; both p < 0.001) and RN (VTE: OR 5.2, PE: OR  8.3; both p < 0.001). CONCLUSIONS: RC, RN, and PN predisposes to a higher VTE and PE rates than RP. Moreover, among RC and RN patients with either VTE or PE, mortality is substantially higher than among their VTE or PE-free counterparts.

Racial/ethnic disparities in the distribution and effect of type and number of high-risk criteria on mortality in prostate cancer patients treated with radiotherapy.

Objective: To assess differences in the distribution of type and number of D'Amico high-risk criteria (DHRCs) according to race/ethnicity (R/E) and their effect on cancer-specific mortality (CSM) in prostate cancer (PCa) patients treated with external beam radiotherapy (RT). Methods: In the SEER database (2004-2016), we identified 31,002 PCa patients treated with RT with at least one DHRCs, namely PSA >20 ng/dL, biopsy Gleason Grade Group 4-5, and clinical T stage ≥T2c. Competing risks regression (CRR) model tested the association between DHRCs and 5-year CSM in all R/E subgroups. Results: Of 31,002 patients, 20,894 (67%) were Caucasian, 5256 (17%) were African American, 2868 (9.3%) were Hispanic-Latino, and 1984 (6.4%) were Asian. The distributions of individual DHRCs and combinations of two DHRCs differed according to R/E, but not for the combination of three DHRCs. The effect related to the presence of a single DHRC, and combinations of two or three DHRCs on absolute CSM rates was lowest in Asians (1.2-6.8%), followed by in African Americans (2.3-12.2%) and Caucasians (2.3-12.1%), and highest in Hispanic/Latinos (1.7-13.8%). However, the opposite effect was observed in CRR, where hazard ratios were highest in Asians vs. other R/Es: Asians 1.00-2.59 vs. others 0.5-1.83 for one DHRC, Asians 3.4-4.75 vs. others 0.66-3.66 for two DHRCs, and Asians 7.22 vs. others 3.03-4.99 for all three DHRCs. Conclusions: R/E affects the proportions of DHRCs. Moreover, within the four examined R/E groups, the effect of DHRCs on absolute and relative CSM metrics also differed. Therefore, R/E-specific considerations may be warranted in high-risk PCa patients treated with RT.

The association of the type and number of D'Amico high-risk criteria with rates of pathologically non-organ-confined prostate cancer.

Introduction: The aim of this study was to assess the association between the type and number of D'Amico high-risk criteria (DHRCs) with rates of pathologically non-organ-confined (NOC) prostate cancer in patients treated with radical prostatectomy (RP) and pelvic lymphadenectomy (PLND). Material and methods: In the Surveillance, Epidemiology, and End Results database (2004-2016), we identified 12961 RP and PLDN patients with at least one DHRC. We relied on descriptive statistics and multivariable logistic regression models. Results: Of 12 961 patients, 6135 (47%) exclusively harboured biopsy Gleason score (GS) 8-10, 3526 (27%) had clinical stage ≥T2c, and 1234 (9.5%) had prostate-specific antigen (PSA) >20 ng/mL. Only 1886 (15%) harboured any combination of 2 DHRCs. Finally, all 3 DHRCs were present in 180 (1.4%) patients. NOC rates increased from 32% for clinical T stage ≥T2c to 49% for either GS 8-10 only or PSA >20 ng/mL only and to 66-68% for any combination of 2 DHRCs, and to 84% for respectively all 3 DHRCs, which resulted in a multivariable logistic regression OR of 1.00, 2.01 (95% CI 1.85-2.19; p <0.001), 4.16 (95% CI 3.69-4.68; p <0.001), and 10.83 (95% CI 7.35-16.52; p <0.001), respectively. Conclusions: Our study indicates a stimulus-response effect according to the type and number of DHRCs. Hence, a formal risk-stratification within high-risk prostate cancer patients should be considered in clinical decision-making.

Initial Experience of Robot-Assisted Simple Prostatectomy with Hugo Robot-Assisted Surgery System: Step-by-Step Description of Two Different Techniques.

Introduction: There are only a few clinical data on nononcologic procedures performed with the new Hugo™ robot-assisted surgery (RAS) system. Robot-assisted simple prostatectomy (RASP) is a minimally invasive treatment option for benign prostatic hyperplasia, and it demonstrated equal early functional and better perioperative outcomes as compared with open simple prostatectomy. In this article, we reported the first large series of RASP performed with Hugo RAS system. Methods: This Supplementary Video S1 is a step-by-step description of two different techniques for RASP. We analyzed the data of 20 consecutive patients who underwent RASP at OLV Hospital (Belgium) between February 2022 and March 2023. Patients baseline characteristics, perioperative and pathologic, and 1-month postoperative outcomes were reported, using the median (interquartile range [IQR]) and frequencies, as appropriate. Results: Median age (IQR) and preoperative prostate specific antigen (PSA) were 72 (67-76) years, and 7.7 (5.0-13.4) ng/mL, respectively. A total of 11 patients experienced an episode of preoperative acute urinary retention, and 8 men had an indwelling bladder catheter at the time of the surgery. No intraoperative complication occurred, and there was no need for conversion to open surgery. Median operative and console time were 165 (121-180) and 125 (101-148) minutes. On the first postoperative day the urethral catheter was removed in 80% of the patients. Median length of stay was 3 (3-4) days. Three patients had minor postoperative complications. On final pathology report, median prostate volume was 120 (101-154) g. On postoperative uroflowmetry, median Qmax and postvoid residual were 16 (13-26) mL/s and 15 (0-34) mL, respectively. Conclusions: This series represents the first report of surgical outcomes of RASP executed with Hugo RAS system. Awaiting study with longer follow-up, our study suggests that Hugo RAS has multiple applications, and it can ensure optimal outcomes in nononcologic procedures.

Impact of the time elapsed between prostate biopsy and surgery on the accuracy of nomograms predicting lymph node invasion in patients with clinically localized prostate cancer.

We aimed to investigate whether the performance characteristics of available nomograms predicting lymph node invasion (LNI) in prostate cancer patients undergoing radical prostatectomy (RP) change according to the time elapsed between diagnosis and surgery. We identified 816 patients who underwent RP with extended pelvic lymph node dissection (ePLND) after combined prostate biopsy at 6 referral centers. We plotted the accuracy (ROC-derived area under the curve [AUC]) of each Briganti nomogram according to the time elapsed between biopsy ad RP. We then tested whether discrimination of the nomograms improved after accounting for the time elapsed between biopsy ad RP. The median time between biopsy and RP was 3 months. The LNI rate was 13%. The discrimination of each nomogram decreased with increasing time elapsed between biopsy and surgery, where the AUC of the 2019 Briganti nomogram was 88% vs. 70% for men undergoing surgery <2 vs. >6 months from the biopsy. The addition of the time elapsed between biopsy ad RP improved the accuracy of all available nomograms (P < 0.003), with the Briganti 2019 nomogram showing the highest discrimination. Clinicians should be aware that the discrimination of available nomograms decreases according to the time elapsed between diagnosis and surgery. The indication of ePLND should be carefully evaluated in men below the LNI cut-off who had a diagnosis more than 6 months before RP. This has important implications when considering the longer waiting lists related to the impact of COVID-19 on healthcare systems.

Regional differences in total hospital costs for radical cystectomy in the United States.

OBJECTIVES: To test for regional differences in total hospital costs (THC) across the United States in bladder cancer patients treated with open radical cystectomy (ORC) or robotic-assisted radical cystectomy (RARC). MATERIALS: We relied on the National Inpatient Sample (NIS) database (2016-2019) and stratified RC patients according to census region (Midwest, Northeast, South, West). Primary statistical analyses consisted of THC-trend analyses and multivariable log-link linear regression models, after adjustment for hospital clustering (Generalized Estimating Equation function) and discharge disposition weighting. Finally, sensitivity analysis, relying on most favorable patient cohort, was performed. RESULTS: Of 5280 eligible patients, 1441 (27%), 1031 (20%), 1854 (35%) and 954 (18%) underwent RC in the Midwest, Northeast, South and West, respectively. Median THC was 28,915$ and differed significantly between regions (Midwest: 28,105$; Northeast: 28,886$; South: 26,096$; West: 38,809$; p < 0.001). After stratification between ORC and RARC, highest THC was invariably recorded in the West: ORC 36,137$ vs 23,941-28,850$ and RARC 43,119$ vs 28,425-29,952$ (both p < 0.05). In multivariable log-link linear regression models, surgery in the West was independently associated with higher THC: ORC (Exponent beta [Exp[ß]]: 1.39; 95%-CI: 1.32-1.47; p < 0.001) and RARC (Exp[ß]: 1.46; 95%-CI: 1.38-1.55; p < 0.001). Results remained unchanged when analyses were refitted in most favorable patient subgroup. CONCLUSIONS: Important regional differences in ORC and RARC THC distinguish the West from other United States regions. The THC discrepancy clearly requires closer examination to identify underlying processes that contribute to inflated costs in the West.

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

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

The Effect of Sex on Disease Stage and Survival after Radical Cystectomy in Non-Urothelial Variant-Histology Bladder Cancer.

BACKGROUND: Female sex in patients treated by radical cystectomy (RC) is associated with more advanced stage and worse survival. However, studies supporting these findings mostly or exclusively relied on urothelial carcinoma of the urinary bladder (UCUB) and did not address non-urothelial variant-histology bladder cancer (VH BCa). We hypothesized that female sex is associated with a more advanced stage and worse survival in VH BCa, similarly to that of UCUB. MATERIALS AND METHODS: Within the SEER database (2004-2016), we identified patients aged ≥18 years, with histologically confirmed VH BCa, and treated with comprehensive RC. Logistic regression addressing the non-organ-confined (NOC) stage, as well as cumulative incidence plots and competing risks regression addressing CSM for females vs. males, were fitted. All analyses were repeated in stage-specific and VH-specific subgroups. RESULTS: Overall, 1623 VH BCa patients treated with RC were identified. Of those, 38% were female. Adenocarcinoma (n = 331, 33%), neuroendocrine tumor (n = 304, 18%), and other VH (n = 317, 37%) were less frequent in females but not squamous cell carcinoma (n = 671, 51%). Across all VH subgroups, female patients had higher NOC rates than males did (68 vs. 58%, p < 0.001), and female sex was an independent predictor of NOC VH BCa (OR = 1.55, p = 0.0001). Overall, five-year cancer-specific mortality (CSM) were 43% for females vs. 34% for males (HR = 1.25, p = 0.02). CONCLUSION: In VH BC patients treated with comprehensive RC, female sex is associated with a more advanced stage. Independently of stage, female sex also predisposes to higher CSM.

The association of type and number of high-risk criteria with cancer specific mortality in prostate cancer patients treated with radiotherapy.

BACKGROUND: To assess the association between of type and number of D'Amico high-risk criteria (DHRCs) with rates of cancer-specific mortality (CSM) in prostate cancer (PCa) patients treated with external beam radiotherapy (RT). METHODS: In the Surveillance, Epidemiology, and End Results database (2004-2016), we identified 34,908 RT patients with at least one DHRCs, namely prostate-specific antigen (PSA) >20 ng/dL (hrPSA), biopsy Grade Group (hrGG) 4-5, clinical T stage (hrcT) ≥T2c. Multivariable Cox regression models (CRM), as well as competing risks regression (CRR) model, which further adjust for other cause mortality, tested the association between DHRCs and 5-year CSM. RESULTS: Of 34,908 patients, 14,777 (42%) exclusively harbored hrGG, 5641 (16%) hrPSA, 4390 (13%) had hrcT. Only 8238 (23.7%) harbored any combination of two DHRCs and 1862 (5.3%) had all three DHRCs. Five-year CSM rates ranged from 2.4% to 5.0% when any individual DHRC was present (hrcT, hrPSA, hrGG, in that order), versus 5.2% to 10.5% when two DHRCs were present (hrPSA+hrcT, hrcT+hrGG, hrPSA+hrGG, in that order) versus 14.4% when all three DHRCs were identified. In multivariable CRM hazard ratios relative to hrcT ranged from 1.07 to 1.76 for one DHRC, 2.20 to 3.83 for combinations of two DHRCs, and 5.11 for all three DHRCs. Multivariable CRR yielded to virtually the same results. CONCLUSIONS: Our study indicates a stimulus-response effect according to the type and number of DHRCs. This indicates potential for risk-stratification within HR PCa patients that could be applied in clinical decision making to increase or reduce treatment intensity.

Cancer specific mortality in patients with collecting duct vs. clear cell renal carcinoma.

BACKGROUND: Collecting duct carcinoma (CDC) is biologically more aggressive than clear cell renal cell carcinoma (ccRCC). We tested for differences in cancer specific mortality (CSM) rates according to CDC vs. ISUP (International Society of Urological Pathology) 4 ccRCC histological subtype. We hypothesized that the survival disadvantage still applies, even after most detailed adjustments. METHODS: Within Surveillance, Epidemiology, and End Results database (2004-2018), we identified 380 CDC vs. 6273 ISUP 4 ccRCC patients of all stages. Propensity score matching (age, sex, race/ethnicity, T, N, and M stages, nephrectomy, and systemic therapy status), Kaplan-Meier plots and multivariable Cox regression models were used. RESULTS: All 380 CDC were matched (1:2) with 760 ISUP4 ccRCC patients. Prior to matching CDC patients exhibited higher rates of lymph node invasion (37.6 % vs. 14.7 %, p < 0.001), and of distant metastases (40.8 % vs. 30.4 %, p < 0.001). Systemic therapy rates were higher in CDC (29.5 % vs. 20.5 %, p < 0.001). However, nephrectomy rates were higher in ISUP4 ccRCC patients (97.5 % vs. 84.7 %, p < 0.001). After matching, in multivariable Cox regression models addressing CSM, CDC was associated with a HR of 1.5 (p < 0.001) in the overall population vs. 1.9 (p = 0.014) in stage I-II vs. 1.4 (p = 0.022) in stage III vs. 1.6 in stage IV (p < 0.001), relative to ISUP4 ccRCC. CONCLUSION: CDC patients exhibited 40-90 % higher CSM than their ISUP4 ccRCC counterparts in the overall analysis, as well as in stage specific analyses. The CSM disadvantage applies despite higher rates of systemic therapy in CDC patients.

The effect of chemotherapy in sarcomatoid bladder cancer patients treated with radical cystectomy.

INTRODUCTION: Data about the role of chemotherapy in sarcomatoid bladder cancer (SBC) are limited. We addressed the effect of chemotherapy in non-metastatic SBC patients treated with radical cystectomy (RC). METHODS: Using the Surveillance, Epidemiology, and End Results database (2001-2018), we identified 331 patients with non-metastatic muscle-invasive or higher SBC (T2-4N0-3M0). Kaplan-Meier plots and Cox regression models tested cancer-specific mortality (CSM ). Sample size and power analyses tested for power limitations. RESULTS: Of 331 SBC patients, 129 (38.9%) were exposed to chemotherapy. The rate of organ-confined stage (T2N0M0) was 33% in both chemotherapy-exposed and chemotherapy-naive patients. In the overall cohort, median CSM-free survival was 84 months (interquartile range [IQR] 21-NA) vs. 26 months (IQR 17-84) in chemotherapy exposed vs. chemotherapy-naive patients, respectively. In multivariable Cox regression models, chemotherapy was associated with lower CSM, without reaching statistical significance (hazard ratio [HR ] 0.72, confidence interval [CI] 0.51-1.01, p=0.054). In subgroup analyses, chemotherapy exposure in organ-confined (n=110) vs. non-organ-confined (n=221) patients resulted in a HR of 0.51 (p=0.12) vs. 0.77 (p=0.17), respectively. Power analyses, based on two-sided α=0.05, revealed values of 52%, 14%, and 43% in the entire population, organ-confined, and nonorgan-confined subgroups, respectively. CONCLUSIONS: In non-metastatic SBC treated with RC, the association between chemotherapy and lower CSM is particularly strong in organ-confined stage. A substantially larger cohort would be required to confirm the statistical significance of the recorded protective effect of chemotherapy.