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Purpose: Incisional hernias are a frequent complication following robotic radical prostatectomy. Observational data in men undergoing robotic prostatectomy suggest that transverse closure resulted in lower hernia rates than vertical closure. We sought to compare the incidence of incisional hernia after robotic radical prostatectomy after vertical and transverse extraction site closure., Materials and Methods: We conducted a clinically integrated, crossover, cluster randomized trial at a single tertiary referral center (January 2016-September 2021) comparing the rate of hernia after transverse vs vertical extraction site excision in 1356 patients treated with minimally invasive radical prostatectomy. The primary outcome was between-group incidence of incisional hernia within 15 months of prostatectomy defined by physical examination and self-reported patient surveys., Results: Overall, 197 (20%) patients developed an incisional hernia within 15 months, 797 did not have an incisional hernia within this period, and 362 had missing outcome data regarding incisional hernia. We found no significant difference in hernia rates between the 2 incision types (absolute between-group difference 1.8%; 95% CI -3.4%, 6.6%; P = .5) in the primary analysis or in the 3 sensitivity analyses. Notably, because of the inclusive definition of hernia used, these data cannot be used as an estimate of the true prevalence of incisional hernia., Conclusions: Surgeons should choose the incision and closure approach they are most comfortable with when extracting specimens. Studies of modifications to the surgical technique are best conducted as randomized comparisons, and the clinically integrated, crossover, cluster randomized trial allows large trials to be completed at a single center and at low cost., Trial Registration: ClinicalTrials.gov: NCT01407263.

Purpose: The impact of germline mutations associated with hereditary cancer syndromes in patients on active surveillance (AS) for prostate cancer is poorly defined. We examined the association between family history of prostate cancer (FHP) or family history of cancer (FHC) and risk of progression or adverse pathology at radical prostatectomy (RP) in patients on AS., Materials and Methods: Patients on AS at a single tertiary-care center between 2000-2019 were categorized by family history. Disease progression was defined as an increase in Gleason grade on biopsy. Adverse pathology was defined as upgrading/upstaging at RP. Multivariable Cox and logistic regression models were used to assess association between family history and time to progression or adverse pathology, respectively., Results: Among 3,211 evaluable patients, 669 (21%) had FHP, 34 (1%) had FHC and 95 (3%) had both; 753 progressed on AS and 481 underwent RP. FHP was associated with increased risk of progression (HR 1.31; 95% CI, 1.11-1.55; p=0.002) but FHC (HR 0.67; 95% CI, 0.30-1.50; p=0.3) or family history of both (HR 1.22; 95% CI, 0.81-1.85; p=0.3) were not. FHP, FHC or both were not associated with adverse pathology at RP (p >0.4)., Conclusions: While FHP was associated with an increased risk of progression on AS, wide confidence intervals render this outcome of unclear clinical significance. FHC was not associated with risk of progression on AS. In the absence of known genetically defined hereditary cancer syndrome, we suggest FHP and/or FHC should not be used as a sole trigger to preclude patients from enrolling on AS.

Purpose: Gleason Score 7 prostate cancer comprises a wide spectrum of disease risk, and precise substratification is paramount. Our group previously demonstrated that the total length of Gleason pattern (GP) 4 is a better predictor than %GP4 for adverse pathological outcomes at radical prostatectomy. We aimed to determine the association of GP4 length on prostate biopsy with post-prostatectomy oncologic outcomes., Materials and Methods: We compared 4 GP4 quantification methods-including maximum %GP4 in any single core, overall %GP4, total length GP4 (mm) across all cores and length GP4 (mm) in the highest volume core-for prediction of biochemical recurrence-free survival after radical prostatectomy using multivariable Cox proportional hazards regression., Results: A total of 457 men with grade group 2 prostate cancer on biopsy subsequently underwent radical prostatectomy. The 3-year biochemical recurrence-free survival probability was 85% (95% CI 81-88). On multivariable analysis, all 4 GP4 quantification methods were associated with biochemical recurrence-maximum %GP4 (HR=1.30; 95% CI 1.07-1.59; p=0.009), overall %GP4 (HR=1.61; 95% CI 1.21-2.15; p=0.001), total length GP4 (HR=2.48; 95% CI 1.36-4.52; p=0.003) and length GP4 in highest core (HR=1.32; 95% CI 1.11-1.57; p=0.001). However, we were unable to identify differences between methods of quantification with a relatively low event rate., Conclusions: These findings support further studies on GP4 quantification in addition to the ratio of GP3 and GP4 to classify prostate cancer risk. Research should also be conducted on whether GP4 quantification could provide a surrogate endpoint for disease progression for trials in active surveillance.

Purpose: Many patients will experience symptoms in the initial days after radical prostatectomy (RP), but early patient-reported symptoms have not been well characterized. Our objective was to illustrate the pattern of symptoms experienced after RP and the relation of severe symptoms to postoperative complications., Materials and Methods: In 2016, electronic patient-reported symptom monitoring began at our institution's ambulatory surgery center. We retrospectively reviewed patients treated with minimally invasive RP who were sent a daily questionnaire completed using a web interface until postoperative day 10. Severe symptoms automatically generate a "yellow alert," which messages the clinic, while very severe symptoms generate a "red alert," additionally prompting the patient to call. We summarized rates of moderate-to-very severe symptoms and fit local polynomial regressions. We compared rates of 30-day or 90-day complications (grade ≥2) based on the presence of alert symptoms., Results: Of 2,266 men undergoing RP, 1,942 (86%) completed surveys. Among moderate-to-very severe symptom levels, pain (72%) and dyspnea (11%) were most common. Pain, nausea and dyspnea consistently decreased over time; fever and vomiting had a flat pattern. In patients experiencing red-alert symptoms, we observed a higher risk of 30-day complications, but rates were low and differences between groups were nonsignificant (2.9% vs 1.9%; difference 1.1%; 95% CI -1.3-3.5; p=0.3). Results were similar examining 90-day complications., Conclusions: While symptoms are common after RP, substantial improvements occur over the first 10 days. Severe or very severe symptoms conferred at most a small absolute increase in complication risk, which should be reassuring to patients and clinicians.

Purpose: Prophylactic antibiotics are routinely given at the time of catheter removal post-radical prostatectomy (RP). The low rate of infectious complications entails that large sample sizes are required for randomized controlled trials, a challenge given the cost of standard randomized controlled trials. We evaluated infectious complications associated with 1 vs 3 days of prophylactic antibiotics at the time of catheter removal post-RP using a novel, clinically integrated trial with randomization at the surgeon level., Materials and Methods: Surgeons were cluster randomized for periods of 3 months to prescribe 1-day vs 3-day regimen of prophylactic antibiotics at the time of catheter removal. The primary end point was an infectious complication as routinely captured by nursing phone call within 10 days of catheter removal and defined as positive urine cultures (≥10 5 CFU) and at least 1 of the following symptoms: fever (>38°C), urgency, frequency, dysuria or suprapubic tenderness., Results: A total of 824 patients were consented and underwent RP with, respectively, 389 and 435 allocated to 1-day and 3-day antibiotics, predominantly ciprofloxacin. Accrual was achieved within 3 years: 95% vs 88% of patients received the allocated 3-day vs 1-day antibiotic regimen. There were 0 urinary tract infections (0%) in the 1-day regimen and 3 urinary tract infections (0.7%) in the 3-day regimen, meeting our prespecified criterion for declaring the 1-day regimen to be noninferior., Conclusions: A clinically integrated trial using cluster randomization accrued rapidly with no important logistical problems and negligible burden on surgeons. If surgeons choose to prescribe empiric prophylactic antibiotics after catheter removal following RP, then the duration should not exceed 1 day.

Purpose: We studied the risk of metastatic prostate cancer development in men with Grade Group 2 disease managed with active surveillance at Memorial Sloan Kettering Cancer Center., Materials and Methods: A total of 219 men with Grade Group 2 prostate cancer had disease managed with active surveillance between 2000 and 2017. Biopsy was performed every 2 to 3 years, or upon changes in magnetic resonance imaging, prostate specific antigen level or digital rectal examination. The primary outcome was development of distant metastasis. The Kaplan-Meier method was used to estimate treatment-free survival., Results: Median age at diagnosis was 67 years (IQR 61-72), median prostate specific antigen was 5 ng/ml (IQR 4-7) and most patients (69%) had nonpalpable disease. During followup 64 men received treatment, including radical prostatectomy in 36 (56%), radiotherapy in 20 (31%), hormone therapy in 3 (5%) and focal therapy in 5 (8%). Of the 36 patients who underwent radical prostatectomy 32 (89%) had Grade Group 2 disease on pathology and 4 (11%) had Grade Group 3 disease. Treatment-free survival was 61% (95% CI 52-70) at 5 years and 49% (95% CI 37-60) at 10 years. Three men experienced biochemical recurrence, no men had distant metastasis and no men died of prostate cancer during the followup. Median followup was 3.1 years (IQR 1.9-4.9)., Conclusions: Active surveillance appears to be a safe initial management strategy in the short term for carefully selected and closely monitored men with Grade Group 2 prostate cancer treated at a tertiary cancer center. Definitive conclusions await further followup.

Purpose: We report oncologic outcomes for men with Grade Group 1 prostate cancer managed with active surveillance at a tertiary cancer center., Materials and Methods: A total of 2,907 patients were managed with active surveillance between 2000 and 2017, of whom 2,664 had Grade Group 1 disease. Patients were recommended confirmatory biopsy to verify eligibility and were followed semiannually with prostate specific antigen, digital rectal examination and review of symptoms. Magnetic resonance imaging was increasingly used in recent years. Biopsy was repeated every 2 to 3 years or after a sustained prostate specific antigen increase or changes in magnetic resonance imaging/digital rectal examination. The Kaplan-Meier method was used to estimate probabilities of treatment, progression and development of metastasis., Results: Median patient age at diagnosis was 62 years. For men with Grade Group 1 prostate cancer the treatment-free probability at 5, 10 and 15 years was 76% (95% CI 74-78), 64% (95% CI 61-68) and 58% (95% CI 51-64), respectively. At 5, 10 and 15 years there were 1,146, 220 and 25 men at risk for metastasis, respectively. Median followup for those without metastasis was 4.3 years (95% CI 2.3-6.9). Distant metastasis developed in 5 men. Upon case note review only 2 of these men were deemed to have disease that could have been cured on immediate treatment. The risk of distant metastasis was 0.6% (95% CI 0.2-2.0) at 10 years., Conclusions: Active surveillance is a safe strategy over longer followup for appropriately selected patients with Grade Group 1 disease following a well-defined monitoring plan.

Purpose: The SPARED CRN (Study of Prostate Ablation Related Energy Devices Coordinated Registry Network) is a private-public partnership between academic and community urologists, the FDA (U.S. Food and Drug Administration), the Medical Device Epidemiology Network and device manufacturers to examine the safety and effectiveness of technologies for partial gland ablation in men with localized prostate cancer., Materials and Methods: We report on a recent workshop at the FDA with thought leaders to discuss a critical framework for partial gland ablation, focusing on patient selection, surgical planning, followup, study design and appropriate comparators in terms of adverse events and cancer control outcomes. We summarize salient points from experts in urology, oncology and epidemiology that were presented and discussed in an open forum., Results: Given the challenges in achieving patient and physician equipoise to perform a randomized trial, as well as an inherent paradigm shift when comparing partial gland ablation (inability to assess prostate specific antigen recurrence) to whole gland treatments, the group focused on objective performance criteria and goals as a platform to guide the creation of single arm studies in the SPARED CRN., Conclusions: This summit lays the foundation for prospective, multi-center data collection and evaluation of novel medical devices and drug/device combinations for partial gland ablation.

Purpose: To our knowledge the ideal methodology of quantifying secondary Gleason pattern 4 in men with Grade Group 2/Gleason score 3 + 4 = 7 on biopsy remains unknown. We compared various methods of Gleason pattern 4 quantification and evaluated associations with adverse pathology findings at radical prostatectomy., Materials and Methods: A total of 457 men with Grade Group 2 prostate cancer on biopsy subsequently underwent radical prostatectomy at our institution. Only patients with 12 or more reviewed cores were included in analysis. We evaluated 3 methods of quantifying Gleason pattern 4, including the maximum percent of Gleason pattern 4 in any single core, the overall percent of Gleason pattern 4 (Gleason pattern 4 mm/total cancer mm) and the total length of Gleason pattern 4 in mm across all cores. Adverse pathology features at radical prostatectomy were defined as Gleason score 4 + 3 = 7 or greater (Grade Group 3 or greater), and any extraprostatic extension, seminal vesical invasion and/or lymph node metastasis. A training/test set approach and multivariable logistic regression were used to determine whether Gleason pattern 4 quantification methods could aid in predicting adverse pathology., Results: On multivariable analysis all Gleason pattern 4 quantification methods were significantly associated with an increased risk of adverse pathology (p <0.0001) and an increased AUC beyond the base model. The largest AUC increase was 0.044 for the total length of Gleason pattern 4 (AUC 0.728, 95% CI 0.663-0.793). Decision curve analysis demonstrated an increased clinical net benefit with the addition of Gleason pattern 4 quantification to the base model. The total length of Gleason pattern 4 clearly provided the largest net benefit., Conclusions: Our findings support the inclusion of Gleason pattern 4 quantification in the pathology reports and risk prediction models of patients with Grade Group 2/Gleason score 3 + 4 = 7 prostate cancer. The total length of Gleason pattern 4 across all cores provided the strongest benefit to predict adverse pathology features.

Purpose: Active surveillance is the preferred management of low risk prostate cancer. Cancer specific anxiety during active surveillance remains under studied. We evaluated long-term anxiety in men on active surveillance to determine whether interventions must be tailored to improve adherence., Materials and Methods: A total of 413 men enrolled in active surveillance at a single tertiary care center completed quality of life surveys as part of routine care. A modified version of the MAX-PC (Memorial Anxiety Scale for Prostate Cancer) was used to determine cancer specific anxiety. Generalized estimating equations were applied to evaluate the association between anxiety and the duration on surveillance. Additionally, we examined associations between anxiety and patient age, marital status, Gleason score, the number of positive cores, family history and overall health., Results: Median patient age was 61 years, median prostate specific antigen at diagnosis was 4.4 ng/ml and 95% of the patients had Gleason 6 disease. Median time from the initiation of active surveillance to the last survey was 3.7 years. There was a 29% risk of reporting cancer specific anxiety within year 1. Anxiety significantly decreased with time (OR 0.87, 95% CI 0.79-0.95, p = 0.003). Pathological and demographic characteristics were not associated with anxiety after adjusting for time on surveillance., Conclusions: In men undergoing active surveillance we observed a moderate risk of cancer specific anxiety which significantly decreases with time. Those considering conservative management can be informed that, although it is common to experience some anxiety initially, most patients rapidly adjust and report low anxiety levels within 2 years., (Copyright © 2018 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: The accumulation of data through a prospective, multicenter coordinated registry network is a practical way to gather real world evidence on the performance of novel prostate ablation technologies. Urological oncologists, targeted biopsy experts, industry representatives and representatives of the FDA (Food and Drug Administration) convened to discuss the role, feasibility and important data elements of a coordinated registry network to assess new and existing prostate ablation technologies., Materials and Methods: A multiround Delphi consensus approach was performed which included the opinion of 15 expert urologists, representatives of the FDA and leadership from high intensity focused ultrasound device manufacturers. Stakeholders provided input in 3 consecutive rounds with conference calls following each round to obtain consensus on remaining items. Participants agreed that these elements initially developed for high intensity focused ultrasound are compatible with other prostate ablation technologies. Coordinated registry network elements were reviewed and supplemented with data elements from the FDA common study metrics., Results: The working group reached consensus on capturing specific patient demographics, treatment details, oncologic outcomes, functional outcomes and complications. Validated health related quality of life questionnaires were selected to capture patient reported outcomes, including the IIEF-5 (International Index of Erectile Function-5), the I-PSS (International Prostate Symptom Score), the EPIC-26 (Expanded Prostate Cancer Index Composite-26) and the MSHQ-EjD (Male Sexual Health Questionnaire for Ejaculatory Dysfunction). Group consensus was to obtain followup multiparametric magnetic resonance imaging and prostate biopsy approximately 12 months after ablation with additional imaging or biopsy performed as clinically indicated., Conclusions: A national prostate ablation coordinated registry network brings forth vital practice pattern and outcomes data for this emerging treatment paradigm in the United States. Our multiple stakeholder consensus identifies critical elements to evaluate new and existing energy modalities and devices., (Copyright © 2018 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: In this white paper update we identify and discuss the prevalence and prevention of common complications of prostate needle biopsy., Materials and Methods: A literature review was performed on prostate biopsy complications via queries of PubMed and EMBASE ® databases for prostate biopsy complications from January 1, 2010 until June 1, 2015. We focused on infection, bleeding, urinary retention, needle tract seeding and erectile dysfunction. A total of 346 articles were identified for full text review and 119 are included in the final data synthesis., Results: Infection is the most common complication of prostate biopsy with fluoroquinolone resistant Escherichia coli having a prominent role. Reported rates of infectious complications range from 0.1% to 7.0%, and sepsis rates range from 0.3% to 3.1% depending on antibiotic prophylaxis regimens. Mild, self-limiting and transient bleeding is also a common complication. Other complications are extremely rare., Conclusions: This white paper provides a concise reference document for the more common prostate biopsy complications and prevention strategies. Risk assessment should be performed for all patients to identify known risk factors for harboring fluoroquinolone resistance. If infection incidence increases check the local antibiogram, current equipment and cleaning practices, and consider alternate approaches to antibiotic prevention such as needle cleaning, risk basked augmentation, rectal culture with targeted prophylaxis and transperineal biopsy. If infection occurs, actively re-situate the patient and start empiric intravenous treatment with carbapenems, amikacin or second and third generation cephalosporins., (Copyright © 2017 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: We compared the diagnostic outcomes of magnetic resonance-ultrasound fusion and visually targeted biopsy for targeting regions of interest on prostate multiparametric magnetic resonance imaging., Materials and Methods: Patients presenting for prostate biopsy with regions of interest on multiparametric magnetic resonance imaging underwent magnetic resonance imaging targeted biopsy. For each region of interest 2 visually targeted cores were obtained, followed by 2 cores using a magnetic resonance-ultrasound fusion device. Our primary end point was the difference in the detection of high grade (Gleason 7 or greater) and any grade cancer between visually targeted and magnetic resonance-ultrasound fusion, investigated using McNemar's method. Secondary end points were the difference in detection rate by biopsy location using a logistic regression model and the difference in median cancer length using the Wilcoxon signed rank test., Results: We identified 396 regions of interest in 286 men. The difference in the detection of high grade cancer between magnetic resonance-ultrasound fusion biopsy and visually targeted biopsy was -1.4% (95% CI -6.4 to 3.6, p=0.6) and for any grade cancer the difference was 3.5% (95% CI -1.9 to 8.9, p=0.2). Median cancer length detected by magnetic resonance-ultrasound fusion and visually targeted biopsy was 5.5 vs 5.8 mm, respectively (p=0.8). Magnetic resonance-ultrasound fusion biopsy detected 15% more cancers in the transition zone (p=0.046) and visually targeted biopsy detected 11% more high grade cancer at the prostate base (p=0.005). Only 52% of all high grade cancers were detected by both techniques., Conclusions: We found no evidence of a significant difference in the detection of high grade or any grade cancer between visually targeted and magnetic resonance-ultrasound fusion biopsy. However, the performance of each technique varied in specific biopsy locations and the outcomes of both techniques were complementary. Combining visually targeted biopsy and magnetic resonance-ultrasound fusion biopsy may optimize the detection of prostate cancer., (Copyright © 2016 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: Partial prostate gland ablation is a strategy to manage localized prostate cancer. Irreversible electroporation can ablate localized soft tissues. We describe 30 and 90-day complications and intermediate term functional outcomes in men undergoing prostate gland ablation using irreversible electroporation., Materials and Methods: We reviewed the charts of 25 patients with prostate cancer who underwent prostate gland ablation using irreversible electroporation as a primary procedure and who were followed for at least 6 months., Results: Median followup was 10.9 months. Grade 3 complications occurred in 2 patients including epididymitis (1) and urinary tract infection (1). Fourteen patients experienced grade 2 or lower complications, mainly transient urinary symptoms, hematuria and urinary tract infections. Of 25 patients 4 (16%) had cancer in the zone of ablation on routine followup biopsy at 6 months. Of those with normal urinary function at baseline 88% and 94% reported normal urinary function at 6 and 12 months after prostate gland ablation, respectively. By 12 months only 1 patient with normal erectile function at baseline reported new difficulty with potency and only 2 patients (8%) required a pad for urinary incontinence., Conclusions: Prostate gland ablation with irreversible electroporation is feasible and safe in selected men with localized prostate cancer. Intermediate term urinary and erectile function outcomes appear reasonable. Irreversible electroporation is effective in the ablation of tumor bearing prostate tissue as a majority of men had no evidence of residual cancer on biopsy 6 months after prostate gland ablation., Competing Interests: of Potential Conflicts of Interest: None, (Copyright © 2016 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: We determined whether multiparametric magnetic resonance imaging targeted biopsies may replace systematic biopsies to detect higher grade prostate cancer (Gleason score 7 or greater) and whether biopsy may be avoided based on multiparametric magnetic resonance imaging among men with Gleason 3+3 prostate cancer on active surveillance., Materials and Methods: We identified men with previously diagnosed Gleason score 3+3 prostate cancer on active surveillance who underwent multiparametric magnetic resonance imaging and a followup prostate biopsy. Suspicion for higher grade cancer was scored on a standardized 5-point scale. All patients underwent a systematic biopsy. Patients with multiparametric magnetic resonance imaging regions of interest also underwent magnetic resonance imaging targeted biopsy. The detection rate of higher grade cancer was estimated for different multiparametric magnetic resonance imaging scores with the 3 biopsy strategies of systematic, magnetic resonance imaging targeted and combined., Results: Of 206 consecutive men on active surveillance 135 (66%) had a multiparametric magnetic resonance imaging region of interest. Overall, higher grade cancer was detected in 72 (35%) men. A higher multiparametric magnetic resonance imaging score was associated with an increased probability of detecting higher grade cancer (Wilcoxon-type trend test p <0.0001). Magnetic resonance imaging targeted biopsy detected higher grade cancer in 23% of men. Magnetic resonance imaging targeted biopsy alone missed higher grade cancers in 17%, 12% and 10% of patients with multiparametric magnetic resonance imaging scores of 3, 4 and 5, respectively., Conclusions: Magnetic resonance imaging targeted biopsies increased the detection of higher grade cancer among men on active surveillance compared to systematic biopsy alone. However, a clinically relevant proportion of higher grade cancer was detected using only systematic biopsy. Despite the improved detection of disease progression using magnetic resonance imaging targeted biopsy, systematic biopsy cannot be excluded as part of surveillance for men with low risk prostate cancer., (Copyright © 2016 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: We evaluated whether initial diagnostic parameters could predict the confirmatory biopsy result in patients initiating active surveillance for prostate cancer, to determine whether some men at low risk for disease reclassification could be spared unnecessary biopsy., Materials and Methods: The cohort included 392 men with Gleason 6 prostate cancer on initial biopsy undergoing confirmatory biopsy. We used univariate and multivariable logistic regression to assess if high grade cancer (Gleason 7 or greater) on confirmatory biopsy could be predicted from initial diagnostic parameters (prostate specific antigen density, magnetic resonance imaging result, percent positive cores, percent cancer in positive cores and total tumor length)., Results: Median patient age was 62 years (IQR 56-66) and 47% of patients had a dominant or focal lesion on magnetic resonance imaging. Of the 392 patients 44 (11%) had high grade cancer on confirmatory biopsy, of whom 39 had Gleason 3+4, 1 had 4+3, 3 had Gleason 8 and 1 had Gleason 9 disease. All predictors were significantly associated with high grade cancer at confirmatory biopsy on univariate analysis. However, in the multivariable model only prostate specific antigen density and total tumor length were significantly associated (AUC 0.85). Using this model to select patients for confirmatory biopsy would generally provide a higher net benefit than performing confirmatory biopsy in all patients, across a wide range of threshold probabilities., Conclusions: If externally validated, a model based on initial diagnostic criteria could be used to avoid confirmatory biopsy in many patients initiating active surveillance., (Copyright © 2016 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: Active surveillance is increasingly recommended for older men with low risk prostate cancer. Although older men have higher all cause mortality, they also have higher prostate cancer specific mortality. We hypothesized that older age is associated with an increased risk of Gleason score upgrading at confirmatory biopsy when controlling for prostate volume., Materials and Methods: We retrospectively reviewed data on 1,130 patients with prostate cancer who were treated with active surveillance from 1991 through 2011. We included 646 patients with clinical Gleason 6 or less, stage T2a or less prostate cancer, a confirmatory biopsy within 2 years of diagnostic biopsy and prostate magnetic resonance imaging before confirmatory biopsy. The primary outcome was Gleason score upgrading to 7 or greater on confirmatory biopsy. We used logistic regression to estimate the effect of age on upgrading, adjusting for magnetic resonance imaging prostate volume and other potential confounders., Results: Median age was 66 years (IQR 61-72) and median magnetic resonance imaging prostate volume was 41 ml (IQR 29-55). At confirmatory biopsy disease was upgraded in 55 of 646 patients (9%) and unchanged in 290 (45%) and biopsy was negative in 297 (46%). Older age was associated with higher odds of upgrading (adjusted OR 1.05, 95% CI 1.01-1.09, p=0.009). Larger prostate volume was associated with lower odds of upgrading (adjusted OR 0.80/10 ml increase, 95% CI 0.7-0.9, p=0.012)., Conclusions: Our findings suggest that older age is associated with an increased risk of misclassification on diagnostic biopsy. Older men who are interested in active surveillance should be counseled about the risks and benefits of confirmatory biopsy., (Copyright © 2015 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: The impact of modifiable environmental factors on kidney cancer specific outcomes is under studied. We evaluated the impact of smoking exposure on cancer specific survival in patients with clear cell renal cell carcinoma treated with surgery., Materials and Methods: From a prospectively maintained database at a single center we collected the characteristics of 1,625 patients with clear cell renal cell carcinoma treated with surgery between 1995 through 2012. We determined the associations of smoking status with advanced disease, defined as AJCC (American Joint Committee on Cancer) stage greater than 2, and with cancer specific survival., Results: The prevalence rate of current, former and never smoking at diagnosis was 16%, 30% and 54%, respectively. Of the patients 62% reported a smoking history of 20 pack-years or greater. Median followup in survivors was 4.5 years (IQR 2.2-7.9). On univariable analysis a smoking history of 20 pack-years or greater was associated with a significantly increased risk of advanced disease (OR 1.43, 95% CI 1.02-2.00). However, it did not achieve an independent association after adjusting for age and gender. Pathological stage and Fuhrman grade adversely affected cancer specific survival on multivariable competing risks analysis. Although the association between smoking and cancer specific survival did not achieve statistical significance on multivariable analysis, the direction of the central estimate (HR 1.5, 95% CI 0.89-2.52) suggested that smoking adversely impacts cancer specific survival. Current smokers faced a higher risk of death from another cause than never smokers (HR 1.93, 95% CI 1.29-2.88)., Conclusions: Smoking exposure substantially increases the risk of death from another cause and adversely impacts cancer specific survival in patients with clear cell renal cell carcinoma. Treatment plans to promote smoking cessation are recommended for these patients., (Copyright © 2014 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: Prostate biopsy related infectious complications are associated with significant morbidity. The risk of infectious complications in patients with prostate cancer on active surveillance remains under studied., Materials and Methods: A total of 591 consecutive men who underwent prostate biopsy were prospectively enrolled in a study evaluating prostate biopsy related complications between January 2011 and January 2012. Of these men 403 were previously diagnosed with prostate cancer and were included in this study. They underwent a 14-core transrectal ultrasound guided prostate biopsy as part of an active surveillance regimen. A nurse contacted all men within 14 days of biopsy, and information was collected on potential complications, antibiotics received and bacterial culture results., Results: Fourteen patients (3.5%) had infectious complications including 13 requiring hospitalization. Five patients had positive urine cultures, and fluoroquinolone resistant isolates were identified in 4 patients, including 2 with extended spectrum beta-lactamase producing isolates. We evaluated the impact of risk factors including diabetes, benign prostatic hyperplasia and antibiotic regimen. However, only the number of previous prostate biopsies was significantly associated with an increased risk of infectious complications (p = 0.041). For every previous biopsy the odds of an infection increased 1.3 times (OR 1.33, 95% CI 1.01-1.74)., Conclusions: In men with prostate cancer on active surveillance the number of previous prostate biopsies is associated with a significant risk of infectious complications and every previous biopsy increases the risk of infectious complication. Fluoroquinolone resistant and extended spectrum beta-lactamase producing isolates represent the most commonly identified organisms. Men with prostate cancer on active surveillance should be informed of the risks associated with serial repeat prostate biopsies., (Copyright © 2014 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: The number of radical prostatectomies has increased. Many urologists have shifted from the open surgical approach to minimally invasive techniques. It is not clear whether the risk of post-prostatectomy incisional hernia varies by surgical approach., Materials and Methods: In the linked Surveillance, Epidemiology and End Results (SEER)-Medicare data set we identified men 66 years old or older who were treated with minimally invasive or open radical prostatectomy for prostate cancer diagnosed from 2003 to 2007. The main study outcome was incisional hernia repair, as identified in Medicare claims after prostatectomy. We also examined the frequency of umbilical, inguinal and other hernia repairs., Results: We identified 3,199 and 6,795 patients who underwent minimally invasive and open radical prostatectomy, respectively. The frequency of incisional hernia repair was 5.3% at a median 3.1-year followup in the minimally invasive group and 1.9% at a 4.4-year median followup in the open group, corresponding to an incidence rate of 16.1 and 4.5/1,000 person-years, respectively. Compared to the open technique, the minimally invasive procedure was associated with more than a threefold increased risk of incisional hernia repair when controlling for patient and disease characteristics (adjusted HR 3.39, 95% CI 2.63-4.38, p<0.0001). Minimally invasive radical prostatectomy was associated with an attenuated but increased risk of any hernia repair compared with open radical prostatectomy (adjusted HR 1.48, 95% CI 1.29-1.70, p<0.0001)., Conclusions: Minimally invasive radical prostatectomy was associated with a significantly increased risk of incisional hernia compared with open radical prostatectomy. This is a potentially remediable complication of prostate cancer surgery that warrants increased vigilance with respect to surgical technique., (Copyright © 2013 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: Surgical treatment options for renal masses include radical vs partial nephrectomy and the open vs laparoscopic approach. Using American Board of Urology (ABU) case log data, we investigated contemporary trends in these treatment options, and how surgeon and practice characteristics may influence these trends., Materials and Methods: Annualized case log data for nephrectomy were obtained from the ABU for all urologists certifying or recertifying from 2002 to 2010. We evaluated trends in nephrectomy use. Logistic regression was used to evaluate surgeon and practice characteristics as predictors of partial and laparoscopic procedures., Results: From the 3,852 case logs submitted by nonpediatric urologists we analyzed a total of 48,384 nephrectomies. From 2002 to 2010 the proportion of annual nephrectomies performed as open radical nephrectomy gradually decreased from 54% to 29%. During the same period, there was a moderate gradual increase in laparoscopic radical nephrectomies (from 30% to 39%). The proportion of open partial nephrectomies remained stable at 15%, while laparoscopic partial nephrectomy increased from 2% to 17%. On multivariable analysis the use of partial nephrectomy and laparoscopy was predicted by urologist annual nephrectomy volume, initial or recertification status, subspecialty, practice area size and geographic region., Conclusions: Since 2002, the use of laparoscopic nephrectomy and partial nephrectomy has increased. However, the diffusion of these techniques is not uniform. Initial certification, higher surgical volume, and practicing in areas with more than 1,000,000 population and in the Northeast region were associated with greater use of laparoscopy and partial nephrectomy. Factors that affect the adoption of these techniques require further research., (Copyright © 2013 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: We compared clinical outcomes, and identified predictors of cancer specific and overall survival after radical cystectomy in patients with urothelial carcinoma with squamous differentiation and those with pure squamous cell carcinoma., Materials and Methods: We reviewed data on 2,031 patients treated with radical cystectomy and pelvic lymph node dissection at a single high volume referral center. Of these patients 78 had squamous cell carcinoma and 67 had squamous differentiation. Survival estimates by histological subtype were described using Kaplan-Meier methods. Within histological subtypes pathological stage, nodal invasion, soft tissue margins, age and gender were evaluated as predictors of cancer specific survival and overall survival using univariate Cox regression., Results: Median followup was 44 months. Of 104 patient deaths 60 died of their disease. We did not find a statistically significant difference between survival curves of patients with squamous cell carcinoma and squamous differentiation (log rank overall survival p = 0.6, cancer specific survival p = 0.17). Positive soft tissue margins were associated with worse cancer specific survival (HR 6.92, 95% CI 2.98-16.10, p ≤0.0005) and overall survival (HR 3.68, 95% CI 1.84-7.35, p ≤0.0005) in patients with pure squamous cell carcinoma. Among patients with squamous differentiation, pelvic lymphadenopathy was associated with decreased overall survival (HR 2.52, 95% CI 1.33-4.77, p = 0.004) and cancer specific survival (HR 3.23, 95% CI 1.57-6.67, p = 0.002)., Conclusions: There appears to be no evidence of a difference in cancer specific survival or overall survival between patients with squamous cell carcinoma and those with squamous differentiation treated with radical cystectomy and pelvic lymph node dissection. Patients with squamous differentiation and tumor metastases to pelvic lymph nodes should be followed more closely, and adjuvant treatment should be considered to improve survival. Wide surgical resection is critical to achieve local tumor control and improve survival in patients with squamous cell carcinoma., (Copyright © 2012 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: The relationship between body mass index and urothelial carcinoma is poorly understood. We investigated the association between body mass index and oncological outcomes in patients with upper tract urothelial carcinoma., Materials and Methods: We retrospectively reviewed the records of 520 patients treated with radical nephroureterectomy for upper tract urothelial carcinoma. Univariate Cox regression analysis was done to evaluate estimated recurrence-free, cancer specific and overall survival. We created a multivariate model based on preoperative and postoperative characteristics., Results: Median patient body mass index was 27.9 kg/m(2) (IQR 6.7). Patients with a higher body mass index were more likely to have infiltrative architecture (p <0.001) and lymphovascular invasion (p = 0.012). In the preoperative model body mass index 25 to 29 (HR 2.25, 95% CI 1.3-3.8, p = 0.003) and 30 kg/m(2) or greater (HR 3.72, 95% CI 2.2-6.3, p <0.001) was associated with disease recurrence. Body mass index 30 kg/m(2) or greater (HR 4.24, 95% CI 2.4-7.5, p <0.001) was associated with cancer specific death. In the postoperative model tumor stage (p <0.001), positive lymph nodes (HR 2.52, 95% CI 1.59-4.0, p <0.001), and body mass index 25 to 29 (HR 2.18, 95% CI 1.27-3.73, p = 0.005) and 30 kg/m(2) or greater (HR 3.52, 95% CI 2.08-5.95, p <0.001) were associated with disease recurrence. Tumor stage (p <0.001), positive lymph nodes (HR 3.1, 95% CI 1.84-5.21, p <0.001) and body mass index 30 kg/m(2) or greater (HR 4.13, 95% CI 2.32-7.36, p <0.001) were associated with worse cancer specific and overall survival., Conclusions: Higher body mass index is associated with worse recurrence-free, cancer specific and overall survival in patients treated with radical nephroureterectomy for upper tract urothelial carcinoma. Improving oncological outcomes by also focusing on patient modifiable factors such as body mass index has significant individual and public health implications in patients with upper tract urothelial carcinoma., (Copyright © 2011 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: Renal transplant recipients have an increased incidence of bladder cancer. It is unknown whether these cancers are more aggressive than those in nontransplanted cases and whether this is also true for cases with end stage renal disease without renal transplantation., Materials and Methods: Surveillance, Epidemiology and End Results-Medicare data identified 97,942 patients with bladder cancer diagnosed between 1988 and 2002. We compared gender, race, tumor stage and histology at diagnosis among patients with a renal transplant, end stage renal disease or neither condition. The statistical significance of differences in the distribution of patient and tumor variables was assessed using the chi-square statistic (categorical variables) and single factor ANOVA tests of difference in means (continuous variables)., Results: Renal transplant recipients (58) were younger at diagnosis than those with end stage renal disease (400) or with neither diagnosis (97,484) (p <0.0001). Muscle invasive disease (stage T2 or greater) at presentation was more common in renal transplant recipients (37%, p = 0.04) and patients with end stage renal disease (33%, p = 0.0001) than in patients without these conditions (24%). Most renal transplant recipients were diagnosed with bladder cancer within 4 years of transplantation. Patients with a renal transplant (17%, p = 0.001) and end stage renal disease (12%, p <0.0001) also had a higher proportion of nonurothelial tumors than the remaining population (6.5%)., Conclusions: Renal transplant recipients and patients with end stage renal disease present with higher stage bladder cancer than those without these conditions despite closer medical supervision. Since most renal transplant recipients were diagnosed with bladder cancer within 4 years of undergoing renal transplantation, consideration should be given to bladder cancer screening of such patients in this period.