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The effect of radical cystectomy (RC) on cancer-specific mortality (CSM) is unclear in non-metastatic sarcomatoid bladder cancer (SBC) patients. We aimed to test the benefit of RC in SBC, and to perform a direct comparison vs urothelial bladder cancer (UCB).Within the Surveillance, Epidemiology, and End Results database (SEER 2001-2018) all non-metastatic SBC and UBC patients were identified. Endpoint of interest was CSM. Propensity score matching (PSM), cumulative incidence plots, competing risks regression (CRR) analyses, three-months landmark analyses, and sensitivity analyses were performed. All results were stratified according to organ-confined (OC: TOf 554 SBC patients, 49 vs 51% harbored OC vs NOC stages. Of 47,741 UBC patients, 62 vs 38% harbored OC vs NOC stages. RC rates were 33 vs 67% in OC vs NOC-SBC patients, and 40 vs 60% in OC vs NOC-UBC patients. After 1:1 PSM, comparison between RC vs no-RC was performed in OC-SBC (67 patients per group), OC-UBC (7611 patients per group), NOC-SBC (63 patients per group), and NOC-UBC patients (4644 patients per group). CRR hazard ratios associated with RC vs no-RC were 0.37 (p 0.001) in OC-SBC vs 0.45 (p 0.001) in OC-UBC, and 0.56 (p = 0.01) in NOC-SBC vs 0.68 (p 0.001) in NOC-UBC. These results were replicated in sensitivity and landmark analyses.The protective effect of RC vs no-RC is stronger in SBC than UBC patients, regardless of OC vs NOC stages.

Background: survival data regarding cytoreductive nephrectomy (CN) in metastatic renal cell carcinoma (mRCC) patients according to the type and extent of tumor-associated vascular thrombus are scarce. Objective: to test for survival differences in mRCC patients treated with CN according to the type and extent of tumor-associated vascular thrombus. Design, setting, and participants: within Surveillance, Epidemiology, and End Results Research Plus (2004–2017), we identified CN mRCC patients with renal vein (pT3a-TT) versus infradiaphragmatic inferior vena cava (IVC; pT3b) versus supradiaphragmatic IVC tumor thrombus/IVC invasion (pT3c). Outcome measurements and statistical analysis: overall survival (OS) was addressed in Kaplan-Meier and Cox regression analyses, in addition to 3-mo landmark analyses. Results and limitations: Of 2170 mRCC patients, 1880 (87%), 204 (9%), and 86 (4%) harbored pT3a-TT, pT3b, and pT3c, respectively. The respective median OS periods were 21, 23, and 12 mo (p < 0.001). In multivariable Cox regression models, pT3c stage, but not pT3b stage, was an independent predictor of higher overall mortality (hazard ratio [HR]: 1.37; 95% confidence interval [CI]: 1.09–1.73; p = 0.007), as well as in 6-mo landmark analyses (HR: 1.36; 95% CI: 1.02–1.80; p = 0.04). In the sensitivity analysis, relying on all pT3a patients, the predictor status of pT3c stage remained unchanged (HR: 1.37; 95% CI: 1.09–1.71; p = 0.007). Limitations have to be addressed regarding the sample size and the retrospective design of the current study. Conclusions: although overall mortality is significantly higher in pT3c mRCC patients than in their pT3b and pT3a-TT counterparts, these individuals may still expect 12-mo or better OS after CN versus virtually 2-yr OS in their pT3a and pT3b counterparts. Patient summary: in this study, we looked at the survival outcomes of metastatic renal cell carcinoma patients who presented with tumor thrombus at cytoreductive nephrectomy. Even though these patients with most advanced tumor thrombus stage demonstrated lower survival rates, the median overall survival was still 1 yr., Benedikt Hoeh certifies that all conflicts of interest, including specific financial interests and relationships and affiliations rel-evant to the subject matter or materials discussed in the manuscript (eg, employment/affiliation, grants or funding, consultancies, honoraria, stock ownership or options, expert testimony, royalties, or patents filed, received, or pending) , are the following: Benedikt Hoeh was awarded a scholarship by the Stiftung Giersch.

Background Life expectancy (LE) is an important consideration in the clinical decision-making for T1aN0M0 renal cell cancer (RCC) patients. Objective To test the effect of race/ethnicity (Caucasian, African American, Hispanic/Latino, and Asian) on LE predictions from Social Security Administration (SSA) life tables in male and female T1aN0M0 RCC patients. Design, setting, and participants We relied on the Surveillance, Epidemiology, and End Results database. Intervention Radical nephrectomy (RN) and partial nephrectomy (PN). Outcome measurements and statistical analysis Five-year and 10-yr observed overall survival (OS) of pT1aN0M0 RCC patients treated between 2004 and 2006 were compared with the LE predicted from SSA life tables. We repeated the comparison in a more contemporary cohort (2009–2011), with 5-yr follow-up and higher PN rates. Results and limitations In the 2004–2006 cohort, PN rate was 40.7%. OS followed the predicted LE in Caucasians, Hispanics/Latinos, and Asians, but not in African Americans, in whom 5-yr OS rates were 5.0% (male) and 8.7% (female) and 10-yr rates were 4.2% (male) and 11.1% (female) lower than predicted. In the 2009–2011 cohort, PN rate was 59.4%. Same observations were made for OS versus predicted LE in Caucasians, Hispanics/Latinos, and Asians. In African Americans, 5-yr OS rates were 1.5% (male) and 4.9% (female) lower than predicted. Conclusions In RN- or PN-treated pT1aN0M0 RCC patients, LE predictions closely approximated OS of Caucasians, Hispanics/Latinos, and Asians. In African-American patients, SSA life tables overestimated LE, more in females than in males. The limitations of our study are its retrospective nature, its validity for US patients only, and the under-representation of racial/ethnic minorities. Patient summary Social Security Administration life tables can be used to estimate long-term life expectancy in patients who are surgically treated for renal cancer (≤4 cm). However, while for Caucasians, Hispanics/Latinos, and Asians, the prediction performs well, life expectancy of African Americans is generally overestimated by life table predictions. Take Home Message In the clinical decision-making process for T1aN0M0 renal cell cancer patients eligible for radical or partial nephrectomy, the important influence of patient sex and race/ethnicity on life expectancy should be taken into account, when using Social Security Administration life tables.

Background In the perioperative setting, temporary interruption of direct oral anticoagulants (DOACs) is mandatory. However, the safety of these recommendations is largely based on nonurological surgical experiences. Objective To verify the safety of these recommendations in patients undergoing radical prostatectomy (RP). Design, setting, and participants A total of 5317 patients underwent RP in our tertiary care centre between December 2017 and February 2020. Of them, 107 consecutive patients had DOACs in standard preoperative medication. DOAC intake was stopped 2–3 d before RP. Postoperatively, patients received weight- and risk-adapted low-molecular-weight heparin (LMWH). DOAC intake was restarted, and administration of LMWH was stopped the 3rd day after surgery. For comparison, we performed 1:2 propensity-score matching (DOAC:non-DOAC), which resulted in 321 consecutive patients. Outcome measurements and statistical analysis Perioperative outcomes and 30-d morbidity were compared between both cohorts. The Wilcoxon rank sum test and the Pearson’s chi-square test were used. Results and limitations The median age of patients with DOACs was 68 yr. Sixty-six patients (61.7%) stopped DOAC intake 48 h and 41 patients (38.3%) 72 h before RP. In comparison with the matching cohort, the median blood loss during RP, median duration of surgery, and median duration of hospitalisation did not differ in a statistically significant fashion. Similarly, there was no significant difference in 30-d morbidity between groups. Importantly, the rate of bleeding and thromboembolic complications did likewise not differ significantly, though it is a nonrandomised and retrospective study. Conclusions Standardised perioperative management of DOACs is important to minimise bleeding and thromboembolic complications. RP can be performed with a low perioperative complication risk if patients are adherent to our presented algorithm. Patient summary We looked at peri- and postoperative complications and compared direct oral anticoagulant (DOAC) and non-DOAC patients. We found no significant difference in thromboembolic and bleeding complications between the groups. We conclude that our regime is safe.

Background After recommended restriction of the use of fluoroquinolones, the optimal antibiotic prophylaxis for transrectal prostate biopsy is still under debate. Objective To test the effectiveness of cefpodoxime as oral antibiotic prophylaxis for transrectal prostate biopsies and the complication rates relative to fluoroquinolones. Design, setting, and participants Antibiotic prophylaxis for transrectal prostate biopsies at the Department of Urology at University Hospital Frankfurt was fluoroquinolones for 342 consecutive patients in January 2018 and December 2019 and cefpodoxime for 100 patients from January 2020 to July 2020. Data were prospectively evaluated and retrospectively analyzed. Patients were followed up according to clinical routine at 6 wk after biopsy at the earliest. Patients without follow-up (n = 98) and those receiving antibiotic prophylaxis other than cefpodoxime or fluoroquinolones (n = 15) were excluded. Intervention Use of cefpodoxime or fluoroquinolones as antibiotic prophylaxis for transrectal prostate biopsies. Outcome measurements and statistical analysis Logistic regression models were used to predict biopsy-related complications according to antibiotic prophylaxis. Results and limitations Of 442 patients, 100 (22.6%) received cefpodoxime as antibiotic prophylaxis. Patient baseline and biopsy characteristics were comparable between the cefpodoxime and fluoroquinolone groups. Moreover, there were no differences in the number of prior prostate biopsies or the proportions of systematic vs. fusion biopsies (p > 0.05). There were no differences between the groups in infectious complications such as epididymitis and prostatitis after biopsy. Infectious complication rates were very low, at 2.0% in the cefpodoxime and 0.9%fluoroquinolone group. Moreover, there were no differences between the groups in patient-reported complications, such as gross hematuria occurring at more than 5 d after biopsy, hematospermia, or rectal bleeding. In multivariable analyses, after adjustment for patient and prostate biopsy characteristics, cefpodoxime was not associated with higher complication rates than fluoroquinolones (p > 0.05). Conclusions Complications after transrectal prostate biopsies are rare and cefpodoxime might be a sufficient choice as oral antibiotic prophylaxis and noninferior compared to fluoroquinolones. Patient summary Cefpodoxime might be a sufficient choice as an easily applicable oral antibiotic prophylaxis for transrectal prostate biopsy. The safety profile of cefpodoxime is comparable to the safety profile of fluoroquinolones.

Background The efficacy of tyrosine kinase inhibitor (TKI)-based therapy after previous immuno-oncology therapy (IO) failure has been addressed before. However, summary efficacy estimates have never been generated in these reports. We addressed this void. Material and methods We systematically examined TKI efficacy after IO-failure and generated weighted median progression-free survival (PFS) estimates for Pazopanib, Axitinib, Cabozantinib, Sunitinib. A systematic review according to PRISMA was conducted. PubMed and abstracts were queried. Only studies proving median PFS were included. Weighted medians were computed for each TKI alternative. Results Of 245 articles, nine eligible studies were included in the current study with 952 analysed patients. Weighted PFS medians after any previous IO-based therapy were respectively 13.7 (range from 4.6 to 24.4), 8.1 (range from 4.7 to 13.2), 8.5 (range from 4.7 to 15.2) and 6.9 months (range from 2.9 to 11.6) for Pazopanib, Axitinib, Cabozantinib, Sunitinib. Specific second-line weighted PFS median was 14.8 months (range from 5.6 to 24.4), 10.1 months (range from 6.4 to 13.2), 8.7 months (range from 4.7 to 15.2) and 6.0 months (range from 2.9 to 8.0) for Pazopanib, Axitinib, Cabozantinib, Sunitinib, respectively, after first-line IO. Conclusion Pazopanib results in the longest weighted median PFS, after previous IO-failure, regardless of treatment line, as well as in specific second-line, post-first-line IO failure settings. Pending novel studies, Pazopanib appears to represent the most promising treatment option after prior IO.

Context In response to growing concerns over rising costs and major variation in quality, improving value for patients has been proposed as a fundamentally new strategy for how healthcare should be delivered, measured, and remunerated. Objective To systematically review the literature regarding the implementation and impact of value-based healthcare in urology. Evidence acquisition A systematic review was performed to identify studies that described the implementation of one or more elements of value-based healthcare in urologic settings and in which the associated change in healthcare value had been measured. Twenty-two publications were selected for inclusion. Evidence synthesis Reorganization of urologic care around medical conditions was associated with increased use of guidelines-compliant care for men with prostate cancer, and improved outcomes for patients with lower urinary tract symptoms. Measuring outcomes for every patient was associated with improved prostate cancer outcomes, while the measurement of costs using time-driven activity-based costing was associated with reduced resource utilization in a pediatric multidisciplinary clinic. Centralization of urologic cancer care in the UK, Denmark, and Canada was associated with overall improved outcomes, although systems integration in the USA yielded mixed results among urologic cancer patients. No studies have yet examined bundled payments for episodes of care, expanding the geographic reach for centers of excellence, or building enabling information technology platforms. Conclusions Few studies have critically assessed the actual or simulated implementation of value-based healthcare in urology, but the available literature suggests promising early results. In order to effectively redesign care, there is a need for further research to both evaluate the potential results of proposed value-based healthcare interventions and measure their effects where already implemented. Patient summary While few studies have evaluated the implementation of value-based healthcare in urology, the available literature suggests promising early results.

Background The prognostic value of circulating tumor cells (CTCs) in patients with hormone-naive oligometastatic prostate cancer (HNoMPC) undergoing cytoreductive radical prostatectomy (CRP) is unknown. Objective To determine the pre- and postoperative prognostic value of CTC enumeration in patients undergoing CRP. Design, setting, and participants Thirty-three patients with HNoMPC from the prospective, single-arm ProMPT trial who underwent CRP between 2014 and 2015 at the Martini-Klinik were evaluated. Follow-up visits for all patients were conducted every 6 mo up to 36 mo after CRP and included serial detection of CTCs in 7.5 ml blood samples using the CellSearch system. Intervention CRP. Outcome measurements and statistical analysis CTC enumerations before and after CRP, and their prognostic value on metastatic castration-resistant prostate cancer–free survival and overall survival (OS) were analyzed using Kaplan-Meier plots and univariable Cox-regression analysis. Results and limitations Sixteen patients (48.5%) had positive CTCs prior to CRP. A CTC count of ≥2 before or 6 mo after CRP was a prognostic factor for worse oncologic outcome. Compared with other biomarkers (prostate-specific antigen, lactate dehydrogenase, and bone-specific alkaline phosphatase), the prognostic value of CTCs was highest using Harrell’s C for OS (0.69), while the highest C-index could be achieved for a combination of conventional markers and CTC count (0.74). After progression to metastatic castration-resistant prostate cancer, CTC enumeration of ≥5 was prognostic for OS. The main limitation is the small sample size. Conclusions CTC enumeration contributes to prognostic information, which might help select HNoMPC patients who might benefit most from CRP. Patient summary In this report, we looked at the value of circulating tumor cell (CTC) determination in patients undergoing radical prostatectomy for oligometastatic prostate cancer. We could show that the number of CTCs was a prognostic factor at all analyzed time points and was more closely associated with prognosis than other biomarkers commonly used in daily clinical practice.

Neurovascular bundle (NVB) preservation (NVBP) and surgical margin status are the main intraoperative factors influencing functional and oncologic outcomes in patients with prostate cancer undergoing radical prostatectomy (RP).To test the impact of implementing the intraoperative frozen section technique (IFST) during NVBP on the frequency of NVB procedures and its effect on positive surgical margins (PSMs).We relied on an institutional tertiary-care center database to identify patients who underwent RP (January 2014-October 2018). Until October 2017, decision for NVBP was taken based on preoperative magnetic resonance imaging, clinical characteristics, and nomograms, without the IFST. After November 2017, all patients received bilateral NVBP with the IFST, to check for a PSM in the area of the NVB. If a PSM occurred, a secondary resection of the respective NVB was performed.PSM and NVB procedures were assessed. Subgroup analyses focused on pathologic tumor stages.Overall, 346 patients were identified. Of these patients, 54.9% (n=190) versus 45.1% (n=156) underwent RP without versus with the IFST. By using the IFST during NVBP, the PSM decreased from 29.5% to 15.4% (p=0.003) in the entire cohort (14.6% vs 8.6% in pT2; 47.1% vs 29.4% in pT3). Conversely, NVBP increased from 55.3% to 95.5% (p0.001) in the entire cohort (68.9% vs 99.0% in pT2; 39.1% vs 88.2% in pT3). In multivariable logistic regressions, IFST use was an independent predictor of PSMs (odds ratio [OR]: 0.54, 95% confidence interval [CI]: 0.30-0.98; p=0.047) and NVBP (OR: 5.60, 95% CI: 3.10-10.51; p0.001) after controlling for patient and tumor characteristics.Implementation of the IFST during NVBP resulted in more frequent NVBP and was associated with a lower PSM, compared with RP without the IFST. Therefore, the IFST should be performed, if available.The intraoperative frozen section technique (IFST) during preservation of neurovascular bundles (NVBP) should be offered to patients who undergo radical prostatectomy. The IFST can reduce positive margin rates and increase the rate of NVBP.

Background Prostate cancer (PCa) staging is crucial in clinical decision making and treatment assignment. Objective To develop a predictive tool that is capable of predicting the probability of metastases at initial PCa diagnosis. Design, setting, and participants Within the Surveillance, Epidemiology, and End Results database (2010–2014), we identified patients with newly diagnosed PCa and available clinical tumor stage, prostatic-specific antigen value (PSA), and Gleason grade group (GGG), and with or without metastases. Outcome measurements and statistical analysis We relied on PSA, clinical tumor stages, and GGG to discriminate between M1 and M0 patients. Patients were randomly divided according to the registry of origin between development (n = 102 469) and validation (n = 98 755) cohorts. Logistic regression modeling coefficients were used to devise a lookup table to discriminate between M0 and M1 stages. Receiver operating characteristic-derived area under the curve was tested for model accuracy, within the validation cohort. A total of 2000 bootstrap resamples were applied to 95% confidence intervals (CIs). Decision curve analysis (DCA) and calibration plots were used to test the performance of the lookup table. Results and limitations Of 201 224 patients, 3.5% harbored metastatic PCa (mPCa). PSA >40 ng/ml, GGG5, and GGG4, in that order, represented the strongest predictors of mPCa. Overall, PSA, clinical tumor stage, and GGG were 94.3% (95% CI: 94.2–94.3%) accurate in predicting the probability of mPCa, in the external validation cohort. Up to 39.4% probability of mPCa, the model demonstrated accurate predictions in the calibration plot. In DCA, a net benefit was recorded up to a threshold probability of approximately 54%. Conclusions The proposed lookup table for the prediction of the probability of mPCa may represent a useful clinical tool based on its high accuracy, excellent calibration, and robust nature of predictions. Patient summary Our study provides a highly accurate lookup table for the prediction of the probability of metastatic prostate cancer patients. This clinical tool can be useful in staging decisions.

OBJECTIVE To assess the effects of robot-assisted radical prostatectomy in the Trendelenburg position on postoperative neurocognitive outcomes this study compared cognitive function between patients who underwent robot-assisted radical prostatectomy and those who underwent open retropubic radical prostatectomy. METHODS Objective evaluations of pre- and postoperative cognitive function were performed upon admission and before hospital discharge, by using a neuropsychological test battery. We collected self-reported data on cognitive failures at 3 months postoperatively. Binary logistic regression analysis was used to assess the effects of surgical technique on postoperative cognitive performance. RESULTS The pre- and postoperative neuropsychological assessments were completed by 367 patients with a median age of 64 years (range 44-76). The incidence of postoperative cognitive dysfunction was 23.9% after robot-assisted (39/165) and 22.3% after open radical prostatectomy (45/202). There was no significant difference in postoperative cognitive function during the early postoperative period (P = 0.758) and self-reported cognitive failures at 3 months (P = 0.303) between robot-assisted and open surgery. Surgical technique was not associated with early postoperative cognitive dysfunction in multivariable analysis (OR 1.012, 95%CI: 0.608-1.685, P = 0.962). CONCLUSION Compared with open surgery in supine position postoperative neurocognitive disorders do not occur more frequently after robot-assisted radical prostatectomy in the extreme Trendelenburg position. Based on these findings potential adverse effects on cognitive function do not have to be considered in the choice of surgical approach for radical prostatectomy.

The purpose of this study was to investigate adherence to recommended adjuvant radiotherapy (aRT) in radical prostatectomy (RP) patients with adverse pathologic features and to analyse the outcome of patients who followed or denied this recommendation.We included 1140 consecutive RP patients (2006-2015) with non-organ confined (pT3) prostate cancer and either positive surgical margins (R1) and/or lymph node involvement (pN1) and non-detectable postoperative prostate-specific antigen who received multidisciplinary aRT recommendations. Patients were stratified into adherence versus non-adherence to recommendations. Additionally, subgroups within pathologic criteria (pT3R1N0, pT3R0N1, pT3R1N1) were analyzed. Kaplan-Meier, as well as multivariable Cox regression analyses were used to assess biochemical recurrence (BCR)-free survival, metastasis-free survival, cancer-specific survival, and overall survival.Overall, 508 (44.6%) patients were non-adherent. Of those, 273 (53.6%) did not receive any RT, and 235 (46.4%) received salvage RT. At 8 years, BCR-free survival was 57.7 versus 20.1%, metastasis-free survival was 76.5 versus 75.4%, cancer-specific survival was 91.7 versus 87.4%, and overall survival was 80.4 versus 75.8% in adherent versus non-adherent patients, respectively (P .001). In multivariable Cox regression predicting BCR, metastatic progression, cancer-specific mortality, and overall mortality, non-adherence to aRT recommendation represented an independent predictor (hazard ratio [HR], 3.8; 95% confidence interval [CI], 3.1-4.5; HR, 1.6; 95% CI, 1.2-2.2; HR, 2.8; 95% CI, 1.5-5.3; and HR, 1.8; 95% CI, 1.2-2.8, respectively).Only about 55% of patients followed our multidisciplinary recommendations. Adherent patients were significantly less likely to experience BCR, metastatic progression, cancer-specific mortality, and overall mortality. Thus, patients with high risk of recurrence may be advised about the possibility of improved oncologic outcomes in case of adherence to aRT recommendations.

Background To examine the impact of different pretreatment definitions on biochemical recurrence (BCR)-free survival, metastasis-free survival, and cancer-specific survival after radical prostatectomy. Methods Overall, 26,364 patients with clinically localized disease who underwent radical prostatectomy at a single institution (1992–2017) were retrospectively analyzed. Seven pretreatment definitions of high-risk CaP (prostate-specific antigen [PSA] ≥20 ng/ml, clinical stage ≥T2c, clinical stage T3 [cT3], biopsy Gleason score [GS] 8–10 [Grade Group {GG} IV–V], biopsy GS 9 to 10 [GG V], D'Amico risk definition, National Comprehensive Cancer Network risk definition) were evaluated. Kaplan-Meier, as well as multivariable Cox regression analyses were used. Results Depending on the definition, patients with high-risk CaP comprised between 0.9% (cT3) and 20.3% (D'Amico high-risk) of the population. Ten-year BCR-free survival rates varied from 36.0% (≥cT2c) to 47.4% (National Comprehensive Cancer Network high-risk). Ten-year metastasis-free survival rates varied from 56.6% (GS 9–10/GG V) to 77.5% (PSA ≥ 20 ng/ml). Ten-year cancer-specific survival rates varied from 86.6% (cT3) to 94.5% (PSA ≥ 20 ng/ml). In multivariable analysis, all high-risk definitions were associated with significantly higher risk of BCR (hazard ratio [HR]: 3.4–3.9), metastatic progression (HR: 3.9–8.8), and cancer-specific mortality (HR: 2.8-11.2). Conclusions Variety in outcomes exists, depending on the pretreatment definition of high-risk CaP. Among the tested, GS 9 to 10 (GG V), cT2c, and cT3 were the strongest predictor for higher BCR risk, cT3 was the strongest predictor for higher metastatic progression risk and GS 9 to 10 (GG V) was the strongest predictor for higher cancer-specific mortality risk in multivariable analyses.

Prostate-specific membrane antigen (PSMA)-based radioguidance for salvage lymph node dissection (sLND) in recurrent prostate cancer has shown promising early oncological outcomes. However, long-term outcomes are still undetermined. Future studies are needed before introducing PSMA positron emission tomography-based sLND into routine clinical practice outside of clinical trials or registries.

Background Transrectal prostate biopsy (pbx) is the most frequent outpatient procedure in the urological field. Septic complications are a major health issue. Objective To evaluate complication rates with or without an antimicrobial lubricant. Design, setting, and participants A total of 1000 patients received pbx between 2013 and 2015. Information about complications was collected by a 3-wk questionnaire. Return rate was 73.2% (n = 732). Intervention Randomization for pbx with the instillation of an antimicrobial lubricant (intervention group, n = 385) or the standard lubricant (control group, n = 347) was performed. Outcome measurements and statistical analysis Multivariable analyses assessed the association between infectious complications at biopsy and use of an antimicrobial lubricant, International Prostate Symptom Score (IPSS), history of urogenitourinary infections, and several other confounders. Results and limitations The use of an antimicrobial lubricant did not reduce infection rate. Overall complication rate was very low. Of all patients, 69.3% described the procedure as pain free. Fever ≥38.5 °C was reported in overall 1.9% of patients. Urinary retention with catheterization occurred in 3.1%. Most common complications were hematospermia (47.4%), macrohematuria (23.8%), and rectal bleeding (7.4%). Readmission rate was 1% (n = 7). In multivariable analyses, IPSS and previous infectious complications were associated with a higher risk of infectious complications. Our results stem from a large German single center and therefore are limited to this patient group. Conclusions No significant reduction was shown in infectious complications in the intervention group with the antimicrobial agent. Low incidence of those complications may be the underlying cause. Severe morbidity at pbx is uncommon. Specifically, the rate of infection was very low. Patient summary Severe complications at prostate biopsy are rare. Among participants, 69.3% had no pain. Fever was rare (1.9% of patients). Voiding issues with catheterization occurred in 3.1%. Most common complications were blood in the semen (47.4%), urine (23.8%), or stool (7.4%). Men with voiding issues or previous infectious complications had a higher risk of infectious complications.

Background: We examined the changes over time in other-cause mortality (OCM) rates in patients with clinically localized prostate cancer (PCa) as an indicator of patient selection. Patients and Methods: Within the Surveillance, Epidemiology, and End Results database (1987-2011), we identified patients with PCa treated with either radical prostatectomy (RP) (n = 230,969; 62.8%) or external beam radiation therapy (EBRT) (n = 136,915; 37.2%). Temporal trends and multivariable Cox regression analyses assessed OCM at 5 years using stratification according to year of diagnosis (1987-1991 vs. 1992-1996 vs. 1997-2001 vs. 2002-2006 vs. 2007-2011), age group, and ethnicity. Results: In patients who had undergone RP, the OCM rates at 5 years of follow-up decreased over time from 7.9% to 2.4% (slope, −0.25%/year) versus from 15.2% to 9.9% after EBRT (slope, −0.29%/year). The greatest decrease in 5-year OCM rates over time was recorded in patients ≥ 75 years (16.0%-12.0%; slope, −0.25%/year), followed by younger age categories (70-74 years, −0.21%/year; 65-69 years, −0.17%/year; 60-64 years, −0.10%/year; < 60 years, −0.07%/year), as well as in African-American men (11.0%-5.1%; slope, −0.32%/year), followed by Caucasian (7.6%-3.4%; slope, −0.21%/year) and Hispanic men (7.0%-3.1%; slope, −0.20%/year; all P

Background: Marital status rates may have changed over time in prostate cancer (PC) patients and may have affected cancer-specific mortality (CSM) and other-cause mortality (OCM). Methods: Within the Surveillance, Epidemiology, and End Results database (2004–2015), we identified PC patients who were either married (n = 326,664) or unmarried (n = 106,533). Temporal trends, cumulative incidence plots, as well as multivariable competing risks regression analyses focused on (1) the overall population, (2) D'Amico low-risk N0M0 PC, (3) D'Amico intermediate-risk N0M0 PC, (4) D'Amico high-risk N0M0 PC, (5) N1M0 PC, and (6) M1 PC patients. Results: Of all, 24.6 % were unmarried and increased trend over time (23.0%–26.9%, P < 0.001). Unmarried men experienced higher CSM rates (9.8% vs. 6.3% in married men, P < 0.001) and OCM rates (24.3% vs. 17.1% in married men, P < 0.001) in the overall population, as well as in all subgroup analyses. Unmarried status represented an independent predictor of higher CSM (hazard ratio: 1.19, P < 0.001) and OCM (hazard ratio: 1.41, P < 0.001) in the overall cohort, as well as in all subgroup analyses except for the N1M0 subgroup, where marital status did not reach independent predictor status for CSM. Conclusions: Unmarried PC patients are at higher risk of CSM and OCM. This relationship applies to all stage subgroups, except for the N1M0 subgroup. Consequently, unmarried individuals should ideally benefit of improved counseling, closer follow-up, as well as of other measures aimed at reducing the CSM and OCM disadvantages.

Background: The incidence of pT0 prostate cancer (CaP) at radical prostatectomy (RP) is extremely rare. We performed the first population-based analysis of pT0 CaP at RP. Methods: Within the Surveillance, Epidemiology, and End Results database (2004–2015), we tested for clinical and pathological characteristics according to pT0 vs. non-pT0 CaP and included a multivariable logistic regression model. Results: pT0 was identified in 358 (0.2%) out of 160,532 clinically localized RP patients. The majority of pT0 patients presented with initial prostate-specific antigen (PSA)

Backround: Accurate life expectancy estimation is crucial in clinical decision-making including management and treatment of clinically localized prostate cancer (PCa). Objective: We hypothesized that Social Security Administration (SSA) life tables’ derived survival estimates closely follow observed survival of PCa patients. To test this relationship, we examined 10-yr overall survival rates in patients with clinically localized PCa and compared it with survival estimates derived from the SSA life tables. Patients and methods: Within the Surveillance, Epidemiology, and End Results database (2004), we identified patients aged >50– < 90 yr. Follow-up was at least 10 yr for patients who did not die of disease or other causes. Outcome measurements and statistical analysis: Monte Carlo method was used to define individual survival in years, according to the SSA life tables (2004–2014). Subsequently, SSA life tables’ predicted survival was compared with observed survival rates in Kaplan-Meier analyses. Subgroup analyses were stratified according to treatment type and D'Amico risk classification. Results and limitations: Overall, 39 191 patients with localized PCa were identified. At 10-yr follow-up, the SSA life tables’ predicted survival was 69.5% versus 73.1% according to the observed rate (p < 0.0001). The largest differences between estimated versus observed survival rates were recorded for D'Amico low-risk PCa (8.0%), brachytherapy (9.1%), and radical prostatectomy (8.6%) patients. Conversely, the smallest differences were recorded for external beam radiotherapy (1.7%) and unknown treatment type (1.6%) patients. Conclusions: Overall, SSA life tables’ predicted life expectancy closely approximate observed overall survival rates. However, SSA life tables’ predicted rates underestimate by as much as 9.1% the survival in brachytherapy patients, as well as in D'Amico low-risk and radical prostatectomy patients. In these patient categories, an adjustment for the degree of underestimation might be required when counseling is provided in clinical practice. Patient summary: Social Security Administration (SSA) life tables’ predicted life expectancy closely approximate observed overall survival rates. However, SSA life tables’ predicted rates underestimate by as much as 9.1% the survival in brachytherapy patients, as well as in D'Amico low-risk and radical prostatectomy patients. Social Security Administration life tables’ predicted life expectancy closely approximate observed survival rates. However, life tables’ predicted rates underestimate by as much as 9.1% the overall survival in brachytherapy patients as well as in D'Amico low-risk and radical prostatectomy patients.

Dysregulation of S100A8 is described in many different human tumor types, but its role in prostate cancer is unknown. To evaluate the clinical relevance of S100A8 expression in prostate cancer, a tissue microarray containing 13,665 tumors was analyzed by immunohistochemistry. Cytoplasmic S100A8 staining was compared to prostate cancer phenotype, patient prognosis and molecular features including TMPRSS2:ERG fusion status and deletions of PTEN, 3p, 5q and 6q. S100A8 immunostaining was typically seen in normal prostate tissue but lost in 60% of 9786 interpretable prostate cancers. In the remaining tumors, S100A8 was considered weak in 17.9%, moderate in 17.8% and strong in 5.4% of cases. Loss of S100A8 expression was linked to advanced tumor stage, high Gleason grade, positive nodal status, positive surgical margin and high preoperative PSA (P

Persistent prostate-specific antigen (PSA) represents a poor prognostic factor for recurrence after radical prostatectomy (RP).To investigate the impact of persistent PSA at 6wk after RP on long-term oncologic outcomes and to assess patient characteristics associated with persistent PSA.Within a high-volume center database we identified patients who harbored persistent (≥0.1ng/ml) versus undetectable PSA (0.1ng/ml) at 6wk after RP. Patients with neo- and/or adjuvant androgen-deprivation therapy (ADT) were excluded.Logistic regression models tested for prediction of persistent PSA. Kaplan-Meier analyses and Cox regression models tested the effect of persistent PSA on metastasis-free survival (MFS), overall survival (OS), and cancer-specific survival (CSS) rates. Propensity score matching (PSM) was performed to test the impact of salvage radiotherapy (SRT) on OS and CSS in patients with persistent PSA.Of 11 604 identified patients, 8.8% (n=1025) harbored persistent PSA. At 15yr after RP, MFS, OS, and CSS were 53.0% versus 93.2% (p0.001), 64.7% versus 81.2% (p0.001), and 75.5% versus 96.2% (p0.001) for persistent versus undetectable PSA, respectively. In multivariable Cox regression models, persistent PSA represented an independent predictor for metastasis (hazard ratio [HR]: 3.59, p0.001), death (HR: 1.86, p0.001), and cancer-specific death (HR: 3.15, p0.001). SRT was associated with improved OS (HR: 0.37, p=0.02) and CSS (HR: 0.12, p0.01) after 1:1 PSM. Main limitation is missing data on postoperative PSA and duration of salvage ADT.Persistent PSA is associated with worse oncologic outcome after RP, namely, metastasis, death, and cancer-specific death. In patients with persistent PSA, SRT resulted in improved OS and CSS.We assessed the impact of persistent prostate-specific antigen (PSA) at 6wk after radical prostatectomy on oncologic outcomes. Early persistent PSA was associated with worse metastasis-free survival, overall survival, and cancer-specific survival. Salvage radiotherapy may result in a survival benefit in well-selected patients.

The impact of biochemical recurrence (BCR) after radical treatment of prostate cancer on oncological outcomes remains unclear. A new European Association of Urology BCR risk stratification (low and high risk) has been proposed. To validate these risk groups, we retrospectively analyzed data for 1125 post-radical prostatectomy (RP) BCR patients (surgery between 1992 and 2006). Univariable Kaplan-Meier plots and multivariable Cox regression models with time-dependent covariates were used to test the independent predictor status of the risk grouping on metastatic progression (MP) and prostate cancer-specific mortality (PCSM). The 5-yr MP-free and PCSM-free survival rates were significantly higher among patients with low BCR risk compared to their high-risk counterparts. In multivariable analyses, the BCR risk grouping reached independent predictor status for MP (hazard ratio [HR] 3.46; p

Not infrequently patients are diagnosed with clinically localized prostate based on a single positive biopsy core exhibiting Gleason grade group 1 (GGG1) with variable prostate-specific antigen (PSA) levels. We investigated treatment patterns and hypothesized that regardless of PSA in cT1- to cT2-stage patients, presence of GGG3/GGG4/GGG5 and/or non-organ confined stage will rarely be identified.Within the Surveillance, Epidemiology, and End Results database (2010-2015), clinically localized prostate cancer (CaP) patients with PSA ≤ 50 ng/ml and a single positive GGG1 biopsy core were identified. Overall treatment rates were examined, estimated annual percentage changes and logistic regression analyses were fitted to test for no-local treatment. Subsequently, rates of upgrading (GGG3/GGG4/GGG5) and/or upstaging (≥pT3 and/or pN1) were investigated in radical prostatectomy patients.13,342 clinically localized CaP patients harbored single GGG1 positive biopsy core at diagnosis. No local treatment was recorded in 5,235 (53.0%) cT1-stage vs. in 1,039 (49.0%) cT2-stage patients. No local treatment rates increased over time from 35.0% to 67.0% vs. 34.0% to 63.0% in cT1 vs. cT2 patients, observations were confirmed in logistic regression analyses (cT1: multivariable odds ratio [mOR]: 1.39; cT2: mOR: 1.33). In radical prostatectomy treated cT1-patients (n = 2,293) and cT2-patients (n = 659), upgrading vs. upstaging vs. upgrading/upstaging combined was 6.1%, 6.5%, 11.0% and 6.2%, 5.0%, 9.9% respectively.In single GGG1 positive biopsy core CaP patients, the combined proportion of upgrading and upstaging should be expected in one tenth. In consequence, the overwhelming majority harbors favorable grade and stage that is compatible with no local treatment.

To test for survival differences in metastatic urothelial carcinoma of the urinary bladder (mUCUB) patients, according to years of diagnosis, age, sex, and race/ethnicity over time and for the effect of chemotherapy on overall mortality (OM).Within the Surveillance, Epidemiology, and End Results (2000-2016), we identified 6860 mUCUB patients. Of those, 3,249 were exposed to chemotherapy. Kaplan-Meier plots and Cox regression models focused on OM. First, we tested the effect of years of diagnosis (historical [2000-2005] vs. intermediate [2006-2011] vs. contemporary [2012-2016]) in chemotherapy exposed mUCUB patients. Second, we tested the effect of chemotherapy in all mUCUB patients.In chemotherapy exposed mUCUB patients according to historical vs. intermediate vs. contemporary years, median overall survival was 11 vs. 13 vs. 14 months respectively, which translated into hazard ratios (HR) of 0.86 (P = 0.005) and 0.75 (P0.001) in intermediate and contemporary vs. historical, respectively. Subgroup analyses in70 years old, males and Caucasians were in agreement regarding statistically significant differences between historical vs. intermediate vs. contemporary, respectively. In multivariable Cox regression models fitted in the entire mUCUB cohort, chemotherapy exposure reduced OM (HR: 0.46; P0.001). Virtually the same results were recorded in age, sex, and race/ethnicity subgroups analyses.Contemporary chemotherapy exposed mUCUB patients exhibited better survival than their historical and intermediate counterparts. Chemotherapy reduced mortality by half, across all patient types.

The first results on 99mTechnetium prostate-specific membrane antigen-radioguided surgery (99mTc-PSMA- RGS) showed promising outcome. Here, we sought to evaluate if this targeted molecular surgical approach might be more effective than conventional salvage lymph node dissection (sLND). We prospectively analysed 42 consecutive patients who underwent sLND based on preoperative 68Gallium (68Ga)-PSMA-positron emission tomography (PET) imaging between 2015 and 2018. In 29 patients, the dissection field was based solely 68Ga-PSMA-PET imaging (conventional surgical approach [CSA]), whereas 13 patients underwent 99mTc-PSMA-RGS. Preoperative characteristics of both groups were similar. Final pathology revealed no metastases in nine CSA patients (31%), whereas all visible lesions on preoperative 68Ga-PSMA-PET were removed in patients who underwent RGS. A PSA decline in general, >50% and >90% within 6 wk was seen in 50%, 29%, and 7% versus 100%, 92%, and 53% in CSA versus RGS groups, respectively (all p

Imaging modalities with high accuracy are essential for proper selection of patients for salvage lymph node dissection (sLND). Unlike nodal staging before radical prostatectomy, data on prostate-specific membrane antigen (PSMA) positron emission tomography (PET) before sLND are scarce. We analyzed 23 patients undergoing 68Ga-PSMA-PET before sLND and compared the imaging findings with histopathology at sLND. Altogether, 29/109 resected lymph node (LN) fields harbored histologically confirmed LN metastases (26.6%)., The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were 89.5%, 74.1%, 70.8%, 90.9%, and 80.4% in side-based analysis, and 75.9%, 87.5%, 68.8%, 90.9%, and 84.4%, respectively, in LN field-based analysis. In contrast to existing studies, sensitivity in particular was lower. This might be because of referral for sLND on the basis of PSMA-PET from 13 different nuclear medicine centers. However, this could still provide more realistic data if sLND should become widely used. Second, our pathologists routinely used immunohistochemistry, resulting in a higher yield of smaller metastases, increasing the accuracy of histopathology. Despite its acceptable accuracy in a real-world scenario, sLND should not only focus on PSMA-PET–positive fields, as small PSMA-PET–negative metastases may be present. Patient summary We analyzed the accuracy of prostate-specific membrane antigen positron emission tomography (PSMA-PET) before salvage lymph node dissection in a real-world situation. Although the accuracy is reasonable, resection should not exclusively focus on PSMA-PET–positive fields.

Cytoreductive radical prostatectomy (CRP) may offer a survival advantage, according to several retrospective analyses. However, few data are available regarding the morbidity of radical prostatectomy in the metastatic setting. We addressed intra- and postoperative complications of CRP relative to radical prostatectomy for nonmetastatic prostate cancer (nmRP). Within the National Inpatient Sample database (2008–2013), we identified patients who underwent CRP versus nmRP. Propensity score matching to reduce the effect of inherent differences between CRP and nmRP patients, multivariable logistic regression models, Poisson regression models, and linear regression models were used. Of 76 378 patients, 1.2% (n = 953) underwent CRP. CRP resulted in higher rates of overall (odds ratio [OR]: 1.34, p = 0.01), intraoperative (OR: 2.61, p = 0.005), and miscellaneous surgical complications (OR: 1.69, p = 0.02). Moreover, CRP was associated with longer stay (OR: 1.07, p = 0.01) and higher total hospital charges ($810 more per surgery, p = 0.0004). Intra- and postoperative complications associated with CRP are higher than those of nmRP. Similarly, an increase in total hospital charges is associated with CRP. Nonetheless, CRP complication profile validates its safety and feasibility. Patient summary: In this population-based study, we recorded higher intra- and postoperative complications rates for CRP versus nmRP. Nonetheless, CRP complication rates appear manageable but require explicit discussion at counseling. Perioperative complications associated with cytoreductive radical prostatectomy are moderately higher than those of radical prostatectomy in nonmetastatic prostate cancer patients. Similarly, total hospital charges are marginally higher. Nonetheless, the complication profile of cytoreductive radical prostatectomy validates its safety and feasibility in highly selected patients.

Background: The use of primary androgen deprivation therapy (PADT) is common in elderly men with early-stage prostate cancer (PCa), despite the absence of guideline recommendations. Objective: To examine survival patterns of octo- and nonagenarian men with organ-confined PCa exposed to PADT, to assess whether their life expectancy warrants androgen deprivation therapy use. Design, setting, and participants: In the Surveillance, Epidemiology, and End Results-Medicare-linked database, we identified 14 785 octo- and nonagenarian organ-confined PCa patients treated with PADT between 1991 and 2009. Outcome measurements and statistical analysis: The smoothed cumulative incidence method was used to examine 10-yr overall mortality, cancer-specific mortality (CSM), and other-cause mortality (OCM) rates. Multivariable Cox regression analyses focused on the combined effect of age and Charlson comorbidity index (CCI) after adjusting for different confounders. Results and limitations: Of all the deaths observed during the study period, 80% were due to non-cancer causes and 20% were due to PCa. The 10-yr overall survival (OS) rate in the overall population was 15.4%. The 10-yr OS rates ranged from 19.9% in patients aged 80-84 yr to 3.1% in those aged ≥90 yr. Similarly, the 10-yr OS rates ranged from 18.7% in patients with CCI = 0 to 11.5% in those with CCI. ≥. 2. The 10-yr OCM rate in the overall population was 68.2%. The 10-yr OCM rates ranged from 64.6% in patients aged 80-84 yr to 77.2% in patients aged ≥90 yr. Similarly, the 10-yr OCM rates ranged from 62.1% in patients with CCI = 0 to 75.2% in those with CCI. ≥. 2. The 10-yr CSM rate in the overall population was 16.4%. The 10-yr CSM rates ranged from 15.5% in patients aged 80-84 yr to 19.7% in those aged ≥90 yr, and from 19.2% in patients with CCI = 0 to 13.3% in those with CCI. ≥. 2. Conclusions: Of the elderly patients with organ-confined PCa exposed to PADT, only 15% survive at 10-yr follow-up. Mortality related to non-cancer causes is the leading cause of death in the same follow-up period. These figures question the rationale for PADT in elderly men with organ-confined PCa. Patient summary: In this study, we looked at the survival patterns of octo- and nonagenarians treated with primary androgen deprivation therapy for organ-confined prostate cancer. We found that a small proportion of patients who received primary androgen deprivation therapy remain alive at 10-yr follow-up, and the leading cause of death was not attributable to prostate cancer. A small proportion of octo- and nonagenarians with organ-confined prostate cancer exposed to primary androgen deprivation therapy (PADT) remain alive at 10-yr follow-up. Moreover, the main cause of death in these patients is related to non-prostate cancer. Such findings question the rationale for PADT in these patients.

Rectal injury (RI) during radical prostatectomy (RP) is a severe complication. So far, only limited data describing the incidence, risk factors, management, and complications of RI are available. In an analysis of data for 24178 patients, we identified 113/24076 patients (0.47%) undergoing open or robotic RP and 7/102 patients (6.86%) after salvage RP who experienced an RI. Besides salvage RP, local tumor stage, Gleason grade, lymph node status, and surgical experience, but not surgical approach (robotic vs open), could be identified as risk factors for RI in univariate and multivariate analysis. Intraoperative management of RI comprised closure with two to three layers. In 13/109 patients (11.9%), a diverting colostomy/ileostomy was carried out. Some 12% of men with closure of an RI developed a recto-anastomosis fistula, and 57% of those who had an additional diverting enterostomy. Thus, the overall incidence of recto-anastomosis fistula after RP was0.1%. The extent of rectal laceration, prior radiation, and intraoperative signs of rectal infiltration were associated with the development of a subsequent recto-anastomosis fistula. Some 83% of patients with a recto-anastomosis fistula needed further intervention. PATIENT SUMMARY: We analyzed the incidence, risk factors, management, and complications of rectal injury during radical prostatectomy. Overall, the incidence of rectal injury and subsequent development of recto-anastomosis fistulas is low unless the patient has significant risk factors.

Enhanced recovery after surgery protocols (ERAS) have been developed and implemented as of 2001. However, no previous analyses targeted length of stay (LOS) changes over time after major surgical oncological procedures (MSOPs).Between 2003 and 2013, we retrospectively identified patients, who underwent prostatectomy, colectomy, cystectomy, mastectomy, gastrectomy, hysterectomy, nephrectomy, oophorectomy, lung resection or pancreatectomy within the Nationwide Inpatient Sample. A total of 3 431 602 assessable patients were identified. We examined temporal trends of LOS after ten MSOPs, as well as LOS determinants and the impact of LOS on total hospital charges (THCGs). Univariable and multivariable linear, log-linear, logistic (MLR) and Poisson regression (MPR) analyses were used.Mean and median LOS were respectively 6 and 4 days (IQR 2-7). During the study span, LOS decreased [Estimated annual percentage change (EAPC): -1.89%, p = 0.0002]. Of the ten examined MSOPs, nine showed a decrease that ranged from -4.47% in prostatectomy to -0.7% in mastectomy. Conversely, no decrease in LOS was recorded for colectomy (EAPC:+0.37, p = 0.015). In MPR analyses, robotic [Relative risk (RR):0.68, p = 0.0003] and laparoscopic (RR: 0.90, p 0.0001) surgical approaches were associated with shorter LOS. LOS was directly related to THCGs.Since the implementation of ERAS protocols, LOS has decreased for nine out of ten MSOPs in a significant fashion. Although these gains may appear marginal on an annual basis, their cumulative effect, over the study span, ranges for 7.7%-49.2%, which can hardly be interpreted as marginal. LOS decrease directly translates in THCGs savings.

Background: Two recent European studies showed an increasing proportion of non–organ-confined (NOC; pathologic stages T3–4) prostate cancer (PCa) in radical prostatectomy (RP) specimens. Objective: To determine if the trend for NOC and pT3–4 PCa is also evident among contemporary North American patients. Design, setting, and participants: Within the Surveillance, Epidemiology, and End Results database (2010–2014), we identified 58 558 patients with clinically localized PCa treated with RP. Only patients with clinical stage T1–2 and biopsy Gleason grade group (GGG) 1–3 PCa were included. Outcome measurements and statistical analysis: Annual trend analyses and multivariable logistic regression models focused on the rate of NOC PCa, the rate of primary pathologic Gleason ≥4 PCa, and the rate of either NOC PCa and/or primary pathologic Gleason ≥4 PCa. Adjustment was made for clinical tumor characteristics (prostatic specific antigen [PSA], clinical stage, and biopsy GGG). Results and limitations: The rate of NOC PCa increased during the study period (18.7% vs 24.2%; p = 0.002) and remained significant after adjustment (16.9% vs 22.3%; p = 0.001) Similarly, the rate of pathologic primary Gleason ≥4 PCa increased during the study period (16.8% vs 23.0%, p = 0.001) and remained significant after multivariable adjustment (10.8% vs 14.2%; p = 0.002). Moreover, virtually the same findings were recorded when both endpoints were combined. Our results were confirmed in multivariable logistic regression analyses in which year of diagnosis was modeled as a continuous variable or a categorical variable or when a cubic spline approach was used. Conclusions: Rates of NOC PCa and primary Gleason ≥4 PCa increased over time among contemporary North American patients treated with RP. This finding may be related to better acceptance of active surveillance and watchful waiting by North American patients. Patient summary: In this report, we looked at pathologic outcomes for contemporary North American patients treated with radical prostatectomy. We found an increase in non–organ-confined and more aggressive prostate cancer. Rates of non–organ-confined prostate cancer and primary Gleason ≥4 increased over time in a contemporary cohort of North American patients treated with radical prostatectomy. This finding may be associated with better acceptance of active surveillance and watchful waiting by North American prostate cancer patients.

Background Presence of small (tertiary) Gleason 5 pattern is linked to a higher risk of biochemical recurrence in prostate cancer. It is unclear, however, how to integrate small Gleason 5 elements into clinically relevant Gleason grade groups. Objective To analyze the prognostic impact of Gleason 5 patterns in prostate cancer and to develop a method for integrating tertiary Gleason 5 patterns into a quantitative Gleason grading system. Design, setting, and participants Prostatectomy specimens from 13 261 consecutive patients and of 3295 matched preoperative biopsies were available. Percentages of Gleason 3, 4, and 5 had been recorded for each cancer. Outcome measurements and statistical analysis: Results and limitations Our data demonstrate that minimal Gleason 5 areas have strong prognostic impact in Gleason 7 carcinomas, while further expansion of the Gleason 5 pattern population has less impact. We thus defined an integrated quantitative Gleason score (IQ-Gleason) by adding a lump score of 10 to the percentage of unfavorable Gleason pattern (Gleason 4/5) if any Gleason 5 was present and by adding another 7.5 points in case of a Gleason 5 fraction >20%. There was a continuous increase of the risk of prostate-specific antigen recurrence with increasing IQ-Gleason. This was also true for subgroups with identical Cancer of the Prostate Risk Assessment Postsurgical scores ( p p Conclusions The IQ-Gleason represents a simple and efficient approach for combining both quantitative Gleason grading and tertiary Gleason grades in one highly prognostic numerical variable. Patient summary Prostatectomy specimens (13 261) were analyzed to estimate the relevance of small Gleason 5 elements in prostate cancers. Even the smallest Gleason 5 areas markedly increased the risk of prostate-specific antigen recurrence after surgery. Larger fractions of Gleason 5 patterns had less further impact on prognosis. Based on this, a numerical Gleason score (integrated quantitative Gleason score) was defined by the percentages of Gleason 4 and 5 patterns, enabling a refined estimate of patient prognosis.

Introduction Controversy regarding cancer-specific mortality (CSM) of elderly and very elderly patients with muscle-invasive, non-metastatic, urothelial carcinoma of the urinary bladder (UCUB) undergoing radical cystectomy (RC) vs radiotherapy (RT) still exists. Materials and methods In the 2004-2016 Surveillance, Epidemiology and End Results (SEER) database, we identified 2663 UCUB patients aged 75-79 (1808 RC vs 855 RT) and 3569 UCUB patients aged 80-89 (1551 RC vs 2018 RT). After stratification for concomitant chemotherapy, propensity score matching (PSM) between RC and RT was applied and competing-risks regression models addressed CSM and OCM. Results In the cohort aged 75-79, five-year CSM rates were 22.0 vs 49.0% for RC only vs RT only and yielded a HR of 0.41 (95% confidence interval (CI) 0.30-0.57, p Conclusions In elderly and very elderly patients, radical cystectomy is associated with virtually half the CSM rate than radiotherapy, regardless of concomitant chemotherapy administration.

Background The aim of this study was to compare 11 active surveillance (AS) protocols in contemporary European men treated with radical prostatectomy (RP) at the Martini-Clinic Prostate Cancer Center. Patients and Methods Analyzed were 3498 RP patients, from 2005 to 2016, who underwent ≥ 10 core biopsies and fulfilled at least 1 of 11 examined AS entry definitions. We tested proportions of AS eligibility, ineligibility, presence of primary Gleason 4/5, upstage, and combinations thereof at RP, as well as 5-year biochemical recurrence-free survival (BFS). Results The most and least stringent criteria were very low risk National Comprehensive Cancer Network and Royal Marsden with 18.8% and 96.1% of AS-eligible patients, respectively. Rates of primary Gleason 4/5 at RP, upstaging, or both features, respectively, ranged from 2.3% to 6.7%, 6.1% to 18.2%, and 7.1% to 21.0% for those 2 AS entry definitions. The range of individuals deemed AS-ineligible between the same 2 AS entry definitions, despite not harboring unfavorable pathology (primary Gleason pattern 4/5, upstage, or both), was 80.3% to 3.7%, 78.3% to 3.4%, and 77.8% to 3.4%, respectively. BFS rates showed narrow variability, with a range of 85.9% to 91.8%. Conclusion Use of stringent AS entry definitions reduces the number of AS-eligible patients, which is related to a select range in individual entry parameters. Moreover, rates of unfavorable pathology at RP as much as tripled between most and least stringent AS entry definitions. However, less stringent AS entry definitions result in the lowest AS-ineligibility rates, in men without unfavorable pathology. BFS rates were virtually invariably high. Clinicians should know differences in key parameters underlying each AS entry definition, associated effect on rates of eligibility, and potential misclassification of individuals.

Introduction Long-term outcomes of prostate cancer (CaP) patients treated with radical prostatectomy (RP) from European cohorts are under-reported. We report on 22,843 RP patients from the Martini-Klinik Prostate Cancer Centre treated between 1992 and 2017. Patients and Methods Biochemical recurrence (BCR) free survival, metastasis free survival (MFS), and cancer specific survival (CSS) were stratified according to National Comprehensive Cancer Network (NCCN) risk categories, pT, and pN stages, RP Gleason Grade Groups (GGG), and surgical margin status (R0/R1). For time to event analyses, uni- and multivariable Cox's proportional hazards models and univariable Kaplan-Meier analyses were applied. Results Median follow up was 68 months. Most favourable 20-year survival rates were exhibited in NCCN low risk (78.7% BCR-free, 96.8% MFS, 90.1% CSS) and pT2, GGG 1 to 2, R0 patients (83.1% BCR-free, 96.7% MFS, 92.6% CSS). 20-year follow up was not constantly reached in patients with aggressive CaP features. For example, NCCN very high-risk patients exhibited 15-year BCR-free survival of 30.5%, while 20-year MFS and CSS in these individuals was reached (64.1% and 60.8%, respectively). Lowest 10-year BCR-free survival (35.6%) was exhibited in pT3b, GGG 4 to 5, R0. Lowest 10-year MFS (49.5%) was exhibited in pT2, GGG 4 to 5, R1. Lowest 10-year CSS (69.8%) was exhibited in pT3b, GGG 4 to 5, R1 patients. In separate pN1 analyses, lowest 10-year BCR-free survival (14.5%), MFS (56.9%), and CSS (71.9%) were exhibited in patients with 3 or more positive lymph nodes. Conclusion Oncological outcomes after RP can be excellent for individuals with favorable CaP characteristics, also after 20 years of follow up.

Background Intermediate risk (IR) prostate cancer (PCa) is a highly heterogeneous entity and can be distinguished into favorable and unfavorable IR PCa according to biopsy, PSA and cT-stage characteristics. These differences may translate into differences in treatment type. Methods We tested for differences in PCa tumor characteristics and differences in active treatment rates (radical prostatectomy [RP], external beam radiotherapy [EBRT]) according to Surveillance, Epidemiology and End Results (SEER) registry (2010−2015) in favorable and unfavorable IR PCa. Data were stratified according to individual SEER registries. Further analyses additionally adjusted for PCa baseline characteristics (PSA, cT stage, biopsy Gleason group grading [GGG], percentage of positive biopsy cores). Results Tabulations according to SEER registries showed that, in favorable IR vs. unfavorable IR, the rates of RP and EBRT respectively ranged from 30.0 to 54.3% vs. 30.3–55.5 % and 8.3–44.7 % vs. 11.5–45.5 %. Differences in age and baseline PCa tumor characteristics also existed in both favorable and unfavorable IR across SEER registries. After adjustment for those baseline patient and PCa characteristics (PSA, cT stage, GGG, percentage of positive biopsy cores), RP and EBRT rates exhibited virtually no residual differences across individual SEER registries, in both favorable (36.0–41.0 % and 26.8–28.1 %) and unfavorable IR PCa (39.2−42.0% and 31.1–33.5 %). Conclusion Important differences may be identified in treatment rates within the examined 18 SEER registries in favorable and in unfavorable IR PCa. However, the observed differences are virtually entirely explained by differences in baseline PCa characteristics.

The impact of cytoreductive radical prostatectomy (CRP) on oncological outcomes in patients with prostate cancer (PCa) and distant metastases has been demonstrated by retrospective data with their potential selection bias. Using prospective institutional data, we compared the outcomes between 43 PCa patients with low-volume bone metastases (1–3 lesions) undergoing CRP (median follow-up 32.7 mo) and 40 patients receiving best systemic therapy (BST; median follow-up 82.2 mo). The inclusion criteria for both cohorts were identical. So far, no significant difference in castration resistant–free survival ( p =0.92) or overall survival ( p =0.25) has been detected. Compared to recent reports, the outcomes for our control group are more favorable, indicating a potential selection bias in the previous retrospective studies. Therefore, the unclear oncological effect has to be weighed against the potential risks of CRP. However, patients benefit from a significant reduction in locoregional complications (7.0% vs 35%; p Patient summary In this study we analyzed the impact of surgery in patients with prostate cancer and bone metastases. Using prospective data, we could not show a significant benefit of surgery on survival, but the rate of locoregional complications was lower. Therefore, patients should be treated within prospective trials evaluating the role of cytoreductive prostatectomy in low-volume, bone metastatic prostate cancer.

Background Radical prostatectomy (RP) is the gold standard for clinically localized prostate cancer (PCa) patients with life expectancy (LE) of at least 10 years. We examined long-term survival of men aged 80 years or older treated with RP and we attempted to identify criteria based on age and comorbidities that could predict survival of at least 10 years after RP, to identify those that might be considered for RP. Patients and methods In Surveillance Epidemiology and End Results (SEER)-Medicare-linked database, we identified 234 octo- and nonagenarians with clinical T1, T2 or T3 PCa treated with RP between 1991 and 2009. Kaplan–Meier analyses examined 10-year survival patterns. Multivariable Cox regression analyses focused on the combined effect of age and/or Charlson Comorbidity Index (CCI) after adjusting for different confounders. Results The 10-year overall survival (OS) and cancer specific mortality (CSM) rates in the overall population were 51 and 9.9%. In individuals aged 80–81 years old, the 10-year OS was 62.4 vs. 39.6% in older patients (p = 0.001). Moreover, combination of age 80–81 with CCI = 0 yielded 10-year OS of 67.9 vs. 28.5% in older and sicker patients (p < 0.001). Age 80–81, absence of comorbidities and the combination of age 80–81 with CCI = 0, represented independent predictors of lower overall mortality (all p ≤ 0.01). Conclusions Two out of three individuals selected for RP aged 80–81 years and without comorbidities, fulfill the criterion of LE of 10 years or more. Therefore, elderly PCa individuals can be suitable for surgical management, if appropriately selected, based on LE criterion.

Background While the diagnostic value of pelvic lymph node dissection (PLND) during radical prostatectomy (RP) is undisputed, its therapeutic benefit remains a matter of debate. Objective To investigate the association between total and positive lymph node (LN) counts and oncological outcomes in pN1 patients at RP. Design, setting, and participants The records of 706 LN-positive patients undergoing RP and PLND between 1998 and 2012 in a single center were analyzed. The median follow-up was 47.8 mo. Intervention RP and PLND. Outcome measurements and statistical analysis The number of harvested and positive LNs and their influence on biochemical recurrence-free survival, metastasis-free survival, and cancer-specific survival was evaluated using univariate and multivariate Cox regressions. The number of harvested LNs was used as a continuous and dichotomous variable with a cut-off of 13 LNs. Results and limitations The mean (median) number of removed LNs was 15.0 (13) and the mean (median) number of positive LNs was 2.4 (1). In multivariate analysis, the number of removed LNs did not significantly influence oncologic outcomes (biochemical recurrence, metastasis-free survival, or cancer-specific survival). The occurrence of metastasis and cancer-specific mortality significantly increased with higher number of positive LNs. The main limitation was the retrospective nature of the study. Conclusions While a higher number of positive LNs were significantly associated with worse oncological outcomes, the number of removed LNs was not a significant predictor. Patient summary We found that only the number of positive lymph nodes (LNs) but not the total number of removed LNs was a factor adversely influencing oncological outcomes in LN-positive patients undergoing radical prostatectomy.