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Purpose: There have been conflicting studies on the association between phosphodiesterase type 5 inhibitor (PDE5i) use and biochemical recurrence (BCR) following radical prostatectomy (RP). Our aim was to determine whether PDE5i drug exposure after RP increases the risk of BCR in patients undergoing RP., Materials and Methods: An institutional database of prostate cancer patients treated between January 2009 and December 2020 was reviewed. BCR was defined as 2 PSA measurements greater than 0.1 ng/mL. PDE5i exposure was defined using a 0 to 3 scale, with 0 representing never use, 1 sometimes use, 2 regularly use, and 3 routinely use. The risk of BCR with any PDE5i exposure, the quantity of exposure, and the duration of PDE5i exposure were assessed by multivariable Cox proportional hazards models., Results: The sample size included 4630 patients to be analyzed, with 776 patients having BCR. The median follow-up for patients without BCR was 27 (IQR 12, 49) months. Eighty-nine percent reported taking a PDE5i at any time during the first 12 months after RP, and 60% reported doing so for 6 or more months during the year after RP. There was no evidence of an increase in the risk of BCR associated with any PDE5i use (HR 1.05, 95% CI 0.84, 1.31, P = .7) or duration of PDE5i use in the first year (HR 0.98 per 1 month duration, 95% CI 0.96, 1.00, P = .055). Baseline oncologic risk was lower in patients using PDE5i, but differences between groups were small, suggesting that residual confounding is unlikely to obscure any causal association with BCR., Conclusions: Prescription of PDE5i to men after RP can be based exclusively on quality of life considerations. Patients receiving PDE5is can be reassured that their use does not increase the risk of BCR.

Introduction: Our goal was to determine whether zonal origin of anterior dominant prostate cancers is associated with clinical outcome among patients treated with radical prostatectomy., Methods: We investigated the clinical outcomes of 197 patients with previously well-characterized anterior dominant prostatic tumors on radical prostatectomy. Univariable Cox proportional hazards models were used to test for an association between anterior peripheral zone (PZ) or transition zone (TZ) tumor location and clinical outcomes., Results: Zonal origin of anterior dominant tumors: 97/197 (49%) anterior PZ, 70 (36%) TZ, 14 (7%) both zones and 16 (8%) indeterminate zone. Comparing anterior PZ and TZ tumors, there were no significant differences in Grade group, incidence of extraprostatic extension or surgical margin positivity rate. Overall, 19 (9.6%) patients experienced biochemical recurrence (BCR), including 10 with anterior PZ origin and 5 with TZ origin. Median followup time among those without BCR was 9.5 years (IQR 7.2, 12.7). BCR-free survival at 5 and 10 years was 91% and 89% for anterior PZ tumors, and 94% and 92% for TZ tumors, respectively. On univariate analysis, there was no evidence of a difference in time to BCR between anterior PZ and TZ tumor zone of origin (p=0.5)., Conclusions: In this anatomically well-characterized cohort of anterior dominant prostate cancers, long-term BCR-free survival was not significantly associated with zone of origin. Future studies utilizing zone of origin as a parameter should consider separating anterior and posterior PZ localization, as outcomes may differ.

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: The summary presented herein represents Part III of the three-part series dedicated to Clinically Localized Prostate Cancer: AUA/ASTRO Guideline, discussing principles of radiation and offering several future directions of further relevant study in patients diagnosed with clinically localized prostate cancer. Please refer to Parts I and II for discussion of risk assessment, staging, and risk-based management (Part I), and principles of active surveillance and surgery and follow-up (Part II)., Materials and Methods: The systematic review utilized to inform this guideline was conducted by an independent methodological consultant. A research librarian conducted searches in Ovid MEDLINE, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews. The methodology team supplemented searches of electronic databases with the studies included in the prior AUA review and by reviewing reference lists of relevant articles., Results: The Clinically Localized Prostate Cancer Panel created evidence- and consensus-based guideline statements to aid clinicians in the management of patients with clinically localized prostate cancer. Statements regarding management of patients using radiation therapy as well as important future directions of research are detailed herein., Conclusions: This guideline aims to inform clinicians treating patients with clinically localized prostate cancer. Continued research and publication of high-quality evidence from future trials will be essential to further improve care for these men.

Purpose: The summary presented herein represents Part II of the three-part series dedicated to Clinically Localized Prostate Cancer: AUA/ASTRO Guideline, discussing principles of active surveillance and surgery as well as follow-up for patients after primary treatment. Please refer to Parts I and III for discussion of risk assessment, staging, and risk-based management (Part I), and principles of radiation and future directions (Part III)., Materials and Methods: The systematic review utilized to inform this guideline was conducted by an independent methodological consultant. A research librarian conducted searches in Ovid MEDLINE, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews. The methodology team supplemented searches of electronic databases with the studies included in the prior AUA review and by reviewing reference lists of relevant articles., Results: The Clinically Localized Prostate Cancer Panel created evidence- and consensus-based guideline statements to aid clinicians in the management of patients with clinically localized prostate cancer. Statements regarding active surveillance, surgical management, and patient follow-up are detailed., Conclusion: This guideline aims to inform clinicians treating patients with clinically localized prostate cancer. Continued research and publication of high-quality evidence from future trials will be essential to further improve care for these men.

Purpose: The summary presented herein represents Part I of the three-part series dedicated to Clinically Localized Prostate Cancer: AUA/ASTRO Guideline, discussing risk assessment, staging, and risk-based management in patients diagnosed with clinically localized prostate cancer. Please refer to Parts II and III for discussion of principles of active surveillance, surgery and follow-up (Part II), and principles of radiation and future directions (Part III)., Materials and Methods: The systematic review utilized to inform this guideline was conducted by an independent methodological consultant. A research librarian conducted searches in Ovid MEDLINE, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews. The methodology team supplemented searches of electronic databases with the studies included in the prior AUA review and by reviewing reference lists of relevant articles., Results: The Clinically Localized Prostate Cancer Panel created evidence- and consensus-based guideline statements to aid clinicians in the management of patients with clinically localized prostate cancer. Statements regarding risk assessment, staging, and risk-based management are detailed herein., Conclusions: This guideline aims to inform clinicians treating patients with clinically localized prostate cancer. Continued research and publication of high-quality evidence from future trials will be essential to further improve care for these men.

Purpose: After radical prostatectomy (RP), clinical complaints of new onset storage symptoms may be related to anastomotic strictures or may accommodate for stress urinary incontinence; however, a subgroup of men will experience de novo storage symptoms in the absence of stricture or stress urinary incontinence. As therapies for overactive bladder have improved, we sought to assess the prevalence, natural history and risk factors of de novo storage dysfunction in continent men., Materials and Methods: We retrospectively analyzed urinary symptom questionnaires completed by patients who were continent prior to RP and did not have postoperative anastomotic strictures at our institution from 2002 to 2019. De novo storage dysfunction, assessed as new onset or worsening urgency or frequency, was assessed at 6, 12, 18 and 24 months after RP, and association between it and patient and preoperative factors was determined., Results: A total of 2,619 patients were included in the final analysis. An initial 34% of patients reported de novo storage symptoms at 6 months, which decreased to 26% at later followup. We found evidence that minimally invasive surgery and nonWhite race were associated with reporting worsening symptoms. The association between postoperative hematoma and worsening symptoms was less conclusive but was of clear clinical relevance (OR 3.15; 95% CI 1.04, 9.54; p=0.042)., Conclusions: A significant number of RP patients experience de novo storage symptoms. Patients who underwent minimally invasive surgery are at higher risk. At-risk patients should be counseled on the incidence of de novo storage symptoms and offered early treatment per overactive bladder guidelines.

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: We examined the demographic and clinicopathological parameters associated with the time to convert from active surveillance to treatment among men with prostate cancer., Materials and Methods: A multi-institutional cohort of 7,279 patients managed with active surveillance had data and biospecimens collected for germline genetic analyses., Results: Of 6,775 men included in the analysis, 2,260 (33.4%) converted to treatment at a median followup of 6.7 years. Earlier conversion was associated with higher Gleason grade groups (GG2 vs GG1 adjusted hazard ratio [aHR] 1.57, 95% CI 1.36-1.82; ≥GG3 vs GG1 aHR 1.77, 95% CI 1.29-2.43), serum prostate specific antigen concentrations (aHR per 5 ng/ml increment 1.18, 95% CI 1.11-1.25), tumor stages (cT2 vs cT1 aHR 1.58, 95% CI 1.41-1.77; ≥cT3 vs cT1 aHR 4.36, 95% CI 3.19-5.96) and number of cancerous biopsy cores (3 vs 1-2 cores aHR 1.59, 95% CI 1.37-1.84; ≥4 vs 1-2 cores aHR 3.29, 95% CI 2.94-3.69), and younger age (age continuous per 5-year increase aHR 0.96, 95% CI 0.93-0.99). Patients with high-volume GG1 tumors had a shorter interval to conversion than those with low-volume GG1 tumors and behaved like the higher-risk patients. We found no significant association between the time to conversion and self-reported race or genetic ancestry., Conclusions: A shorter time to conversion from active surveillance to treatment was associated with higher-risk clinicopathological tumor features. Furthermore, patients with high-volume GG1 tumors behaved similarly to those with intermediate and high-risk tumors. An exploratory analysis of self-reported race and genetic ancestry revealed no association with the time to conversion.

Purpose: We implemented an advanced practice provider (APP)-led clinic to aid in managing the growing population of men on active surveillance (AS) for prostate cancer. Our objective was to evaluate the quality and safety of an established APP-led AS clinic by comparing outcomes with urologist-led biopsies, defined in terms of adherence to scheduled visits and biopsy complications., Materials and Methods: We performed a retrospective review of 2341 consecutive patients treated in an AS clinic at a high-volume referral center between 2000-2019. We examined the rate of no-show or same-day cancellation of visits for APPs versus urologists and compared the risk of biopsy complications between these providers. Generalized estimating equations were used to account for repeated visits and biopsies., Results: There were significantly more no-shows at APP visits (odds ratio [OR] 1.40, 95% confidence interval [CI] 1.16-1.70, p <0.001); however, this only amounted to one no-show every 41 visits. There was no evidence of increased biopsy complications with APPs (OR 0.37, 95% CI 0.05-2.49, p =0.3). Patients were not prospectively assigned to APP or urologist management; therefore, unmeasured patient differences could bias our results., Conclusions: We demonstrated that in an established APP-led AS clinic at a high-volume center, APPs achieved acceptable patient adherence to scheduled visits and biopsy complications. Because patients were not continuously managed by one type of provider, further prospective studies are needed to establish equivalent pathologic outcomes in APP-managed AS.

Purpose: Men with low serum testosterone at the time of prostate cancer diagnosis are frequently considered to have more aggressive disease. We examined treatment outcomes in men with clinically localized high-risk cancer to determine if baseline testosterone level identified men at higher risk for cancer progression after treatment., Materials and Methods: Alliance/CALGB 90203 randomized men with clinically localized high-risk prostate cancer to radical prostatectomy alone or neoadjuvant chemohormonal therapy and radical prostatectomy. Men with available baseline testosterone levels who had not received androgen deprivation prior to study enrollment were studied (656). Testosterone level was examined as a continuous variable, as quartiles, and separately in men with an absolute testosterone level above/below 150 ng/dl. Outcomes evaluated were overall survival and event-free survival with events defined by biochemical recurrence, secondary treatment, prostate cancer metastasis, and death., Results: We were unable to demonstrate a difference between baseline serum testosterone level measured as a continuous variable, as quartiles, or as a dichotomous variable (above/below 150 ng/dl) with the outcomes measured. This finding was observed in both arms of the study., Conclusions: Baseline serum testosterone level did not predict outcomes in men with clinically localized high-risk prostate cancer treated with radical prostatectomy alone or neoadjuvant chemohormonal therapy and radical prostatectomy.

Introduction: An advantage of minimally invasive radical prostatectomy over open surgery is decreased blood loss. At our institution hemoglobin is routinely checked 4 and 14 hours postoperatively. We assessed the relevance of this practice in a contemporary cohort undergoing minimally invasive radical prostatectomy., Methods: We retrospectively reviewed data from patients undergoing laparoscopic or robotic radical prostatectomy at our institution between January 2010 and September 2018. We identified 3,631 patients with preoperative and postoperative hemoglobin values, and assessed the role of routine hemoglobin assessment in determining need for transfusion within 30 days. Medicare reimbursement rates for 2019 were used for cost analysis., Results: Of 3,631 patients in our cohort 44 (1.2%) required transfusion. At 4 hours following surgery the median hemoglobin decrease was 8.0% (IQR 4.8 to 11.4) for patients who did not receive transfusion and 12.5% (9.5 to 19.2) for those who received transfusion. At 14 hours the median decrease was 14.2% (IQR 10.0 to 18.4) vs 33.1% (22.6 to 38.6). Routine hemoglobin assessment had no role in the decision to transfuse in 18 patients (41%). No patient was transfused based on 4-hour values alone. Omitting 1 hemoglobin assessment could have resulted in institutional savings of $37,000 during this period., Conclusions: As transfusion following minimally invasive radical prostatectomy is rare, scheduled postoperative hemoglobin assessments in the absence of symptoms are unnecessary to recognize bleeding events. The largest hemoglobin difference between men who did vs did not receive transfusion was seen at 14 hours postoperatively. Thus, this single hemoglobin evaluation is sufficient.

Purpose: Few groups have investigated the combined effects of PTEN loss and ERG expression on the outcomes of metastasis of or death from prostate cancer in surgically treated patients. We examined the association of PTEN/ERG status with lethal prostate cancer in patients treated with radical prostatectomy., Materials and Methods: Included in analysis were 791 patients with clinically localized prostate cancer treated with radical prostatectomy at a single institution. Genetically validated immunohistochemistry assays for PTEN and ERG were performed on tissue microarrays. Multivariable Cox proportional hazard models were used to assess the association of PTEN/ERG status with lethal prostate cancer (defined as metastasis or prostate cancer specific death), adjusting for patient age, race, pathological grade and stage, and surgical margin status., Results: Median followup in the cohort was 12.8 years. Of 791 cases 203 (25%) demonstrated PTEN loss and 330 of 776 (43%) were ERG positive. On multivariable analysis PTEN loss (HR 1.9, 95% CI 1.2-3.0, p=0.012) but not ERG expression (HR 0.6, 95% CI 0.4-1.1, p=0.11) was associated with an increased risk of lethal prostate cancer. The association of PTEN loss with lethal disease only remained among men with ERG negative tumors (HR 2.3, 95% CI 1.3-4.1, p=0.005) and not ERG positive tumors (HR 1.1, 95% CI 0.6-2.1, p=0.81)., Conclusions: PTEN loss is associated with an increased risk of lethal prostate cancer after radical prostatectomy and this risk is most pronounced in the subgroup of patients with ERG negative tumors. This work corroborates the use of PTEN and ERG status for risk stratification in surgically treated patients.

Purpose: Urinary incontinence after prostate treatment (IPT) is one of the few urologic diseases that is iatrogenic, and, therefore, predictable and perhaps preventable. Evaluation of the incontinent patient, risk factors for IPT, the assessment of the patient prior to intervention, and a stepwise approach to management are covered in this guideline. Algorithms for patient evaluation, surgical management, and device failure are also provided., Materials and Methods: This guideline was developed using a systematic review from the Mayo Clinic Evidence Based Practice Center with additional supplementation by the authors. A research librarian conducted searches from 2000 to December 21 st , 2017 using Ovid, MEDLINE, Cochrane Central Register of Controlled Trials, and Cochrane Databases of Systematic Reviews. Additional references through 12/31/2018 were identified., Results: This guideline was developed by a multi-disciplinary panel to inform clinicians on the proper assessment of patients with IPT and the safe and effective management of the condition in both surgical and non-surgical contexts. Statements guiding the clinician on proper management of device failure are also included., Conclusion: Most patients who undergo radical prostatectomy (RP), and some patients who undergo radiation therapy (RT) or surgery for benign prostatic hyperplasia (BPH), will experience IPT. Although non-surgical options, such as pelvic floor muscle exercises (PFME), can hasten continence recovery, patients who remain incontinent at one-year post-procedure, or have severe incontinence at six months, may elect to undergo surgical treatment (e.g. artificial urinary sphincter). Prior to IPT surgery, the risks, benefits, alternatives, and additional likely procedures should be discussed with the patient.

Purpose: We evaluated whether the prediction of biochemical recurrence after radical prostatectomy is enhanced by any of 6 parameters, including prostate volume, total tumor volume, high grade total tumor volume, the ratio of high grade total tumor volume to total tumor volume, the ratio of total tumor volume to prostate volume and/or the ratio of high grade total tumor volume to prostate volume., Materials and Methods: A total of 1,261 patients who underwent radical prostatectomy during a 3-year period had tumor maps constructed with the Gleason pattern denoted as low-3 or high-4 or 5 and volumetric data generated using commercially available software. Univariate Cox regression models were used to assess whether each volume related parameter was associated with biochemical recurrence after radical prostatectomy. A multivariable Cox regression base model (age, prostate specific antigen, Gleason score/grade group, pathological stage and margin status) was compared with 6 additional models (base model plus each volume related parameter) to evaluate enhancement in predictive accuracy. Decision curve analysis was performed to determine the clinical utility of parameters that enhanced predictive accuracy., Results: On univariate analysis each parameter was significantly associated with biochemical recurrence except prostate volume. Predictive accuracy of the multivariable base model was high (c-index = 0.861). Adding volume related parameters marginally enhanced discrimination. Decision curve analysis failed to show added benefit even for high grade total tumor volume/total tumor volume, which was the parameter with the highest discriminative improvement., Conclusions: Tumor volume related parameters are significantly associated with radical prostatectomy but do not add important discrimination to standard clinicopathological variables for radical prostatectomy prediction or provide benefit across a range of clinically relevant decision thresholds. Volume related measurement is not warranted in routine pathological evaluation and reporting.

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: We tested the latest update in the prostate cancer staging system by assessing the prognostic association of pT2 subclassification with the probability of survival related outcomes in patients who underwent radical prostatectomy., Materials and Methods: We retrospectively analyzed the records of a total of 15,305 patients who underwent radical prostatectomy at 2 referral centers between 1985 and 2016, and had pT2 disease at the final pathological evaluation. Descriptive statistics were used to compare baseline data stratified by pT2 substages (pT2a/b vs pT2c). Cox regression models were adjusted for institution analyzed differences in the rate of biochemical recurrence, metastasis, cancer specific death and overall mortality. Multivariable Cox regression models were used to evaluate the predictive value of pT2 subclassification for survival, including the linear predictor from the Stephenson nomogram., Results: Prostate specific antigen levels and Gleason score differed significantly between the pT2 substages (each p <0.0001). At a median followup of 6.0 years (IQR 3.3-10.1) 2,083 patients had biochemical recurrence, 161 had metastases, 43 had died of prostate cancer and 1,032 had died of another cause. On univariate analysis the pT2 subclassification was significantly associated with biochemical recurrence (p = 0.001) and distant metastasis (p = 0.033) but not with cancer specific death (p = 0.6) or overall mortality (p = 0.3). Multivariable analysis showed no evidence of a significant association between the pT2 subclassification and biochemical recurrence (p = 0.4) or distant metastasis (p = 0.6). Multivariable analysis of cancer specific death and overall mortality was omitted due to lack of significance on univariate analysis., Conclusions: Subclassification of pT2 prostate cancer is not a prognostic indicator of survival related outcomes after radical prostatectomy. Our results validate the elimination of pT2 substages in the updated staging system., (Copyright © 2018 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: Active surveillance is often restricted to patients with low risk prostate cancer who have 3 or fewer positive cores. We aimed to identify predictors of adverse pathology results for low risk prostate cancer treated with radical prostatectomy and determine whether a threshold number of positive cores could help the decision process for active surveillance., Materials and Methods: A total of 3,359 men with low risk prostate cancer underwent radical prostatectomy between January 2000 and August 2016. We analyzed the relationship between biopsy core features and adverse pathology at radical prostatectomy, defined as Grade Group 3 or greater, seminal vesicle invasion or lymph node involvement., Results: Of the 171 cases (5.1%) with adverse pathology findings at radical prostatectomy 144 (4.3%) were upgraded to Grade Group 3 or greater, 31 (0.9%) had seminal vesicle invasion and 15 (0.4%) had lymph node involvement. Prostate specific antigen and patient age were the only predictors of adverse pathology results. There was no significant association with the number of positive cores, the total mm of cancer or the maximum percent of cancer in any core. When we expanded the definition of adverse pathology to include Grade Group 2 and extraprostatic extension, the association between core features and outcome was statistically significant but clinically weak, and with no evidence of threshold effects., Conclusions: There is little basis for excluding patients with otherwise low risk prostate cancer on biopsy from active surveillance based on criteria such as the number of positive cores or the maximum cancer involvement of biopsy cores., (Copyright © 2018 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: 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 describe the efficacy of radical prostatectomy to achieve complete primary tumor excision while preserving erectile function in a cohort of patients with high risk features in whom surgical resection was tailored according to clinical staging, biopsy data, preoperative imaging and intraoperative findings., Materials and Methods: In a retrospective review we identified 584 patients with high risk features (prostate specific antigen 20 ng/ml or greater, clinical stage T3 or greater, preoperative Gleason grade 8-10) who underwent radical prostatectomy between 2006 and 2012. The probability of neurovascular bundle preservation was estimated based on preoperative characteristics. Positive surgical margin rates and erectile function recovery were determined in patients who had some degree of neurovascular bundle preservation., Results: The neurovascular bundles were resected bilaterally in 69 (12%) and unilaterally in 91 (16%) patients. The remaining patients had some degree of bilateral neurovascular bundle preservation. Preoperative features associated with a lower probability of neurovascular bundle preservation were primary biopsy Gleason grade 5 and clinical stage T3 disease. Among the patients with some degree of neurovascular bundle preservation 125 of 515 (24%) had a positive surgical margin, and 75 of 160 (47%) men with preoperatively functional erections and available erectile function followup had recovered erectile function within 2 years., Conclusions: High risk features should not be considered an indication for complete bilateral neurovascular bundle resection. Some degree of neurovascular bundle preservation can be done safely by high volume surgeons in the majority of these patients with an acceptable rate of positive surgical margins. Nearly half of high risk patients with functional erections preoperatively recover erectile function after radical prostatectomy., (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.)

Introduction: We evaluated the safety and efficacy of a clinical pathway designed and implemented to transition inpatient minimally invasive radical prostatectomy to a procedure with overnight observation., Methods: In April 2011 ambulatory extended recovery was implemented at our institution. This was a multidisciplinary program of preoperative teaching and postoperative care for patients undergoing minimally invasive radical prostatectomy. We compared the risk of requiring a more than 1-night hospital stay by patients treated with surgery the year before the program vs those treated after the program was initiated, adjusting for age, ASA ® status and surgery type. We also examined the rates of readmission and urgent care visits within 48 hours, and 7 and 30 days before and after the program began., Results: The proportion of patients who stayed longer than 1 night was 53% in the year before initiating the ambulatory extended recovery program vs 8% during the program, representing an adjusted absolute risk decrease of 45% (95% CI 39-50, p <0.0001). There was no important predictor of a greater than 1-night length of stay among ambulatory extended recovery patients. Rates of readmission and urgent care visits were slightly lower during the ambulatory extended recovery phase with no significant difference between the groups., Conclusions: The ambulatory extended recovery program successfully transitioned most patients to a 1-night hospital stay without resulting in an increased rate of readmission or urgent care visits.

Purpose: More than half of the men who receive treatment for prostate cancer elect radiotherapy. After radiotherapy recurrence is determined by an increase in prostate specific antigen and not usually by pathological confirmation. We describe the prevalence of persistent gradable prostate cancer in men treated with radiotherapy for prostate cancer at radical cystoprostatectomy for bladder cancer., Materials and Methods: A total of 78 patients underwent radiotherapy (brachytherapy and/or external beam radiation) before the development of bladder cancer requiring radical cystectomy at our institution. All tissues were evaluated by a specialized genitourinary pathologist., Results: Median time from radiotherapy to radical cystoprostatectomy was 77 months. Gradable prostate cancer was identified in 45% of patients. Of the tumors 69% were Gleason score 7 or greater, 17% were pT3 or greater and 5% showed positive lymph nodes. Men treated more recently were less likely to have gradable prostate cancer, including 100% before 1980, 49% between 1980 and 2000 and 10% from 2000 to the present (p=0.002) as were those who received external beam radiation alone compared to brachytherapy and combined brachytherapy/external beam radiation (58% vs 27% and 14%, respectively, p=0.005)., Conclusions: After radiotherapy 45% of men had persistent prostate cancer (37% of men with no evidence of disease). A decreased prostate cancer rate was associated with later treatment year and combined brachytherapy/external beam radiation regimens. Similar to men treated with radical cystoprostatectomy for muscle invasive bladder cancer, meticulous attention should be paid during prostate removal in men treated with radiotherapy because many may have persistent prostate cancer. In addition, markers other than prostate specific antigen should be studied in men treated with radiotherapy to better identify those with biochemical recurrence., (Copyright © 2014 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: Surgical correction of pelvic organ prolapse underwent transformation in the last decade. Training in pelvic organ prolapse surgery, the ease of mesh kit use, and Food and Drug Administration warnings about mesh have influenced practice patterns. We investigated trends in pelvic organ prolapse procedures., Materials and Methods: Case logs of pelvic organ prolapse procedures, mesh use and pessary placement were obtained from the American Board of Urology for 2003 to 2012. We evaluated associations between surgeon characteristics and the use of pelvic organ prolapse procedures., Results: Of 6,355 nonpediatric urologists applying for certification or recertification 2,192, representing a 10% annual sample of all urologists, reported performing pelvic organ prolapse procedures during the study period. The number of procedures increased steadily from 930 in 2003 to 6,978 in 2012. The number of colporrhaphies increased from 806 to 2,670 and the number of colpopexies increased from 32 to 1,414 between 2003 and 2012. The number of vaginal colpopexies increased from 24 to 1,016 during the study period. The number of sacrocolpopexies increased from 8 to 398 with exponential increases in laparoscopic sacrocolpopexy (282 cases by 2012). Mesh insertion increased from 10 cases reported by applicants in 2005 to 1,552 reported in 2012 (p <0.0005). Mesh revision, first reported in 2007 with 52 performed, consistently increased to 214 in 2012. Urologists trained in female urology performed a median of 16 pelvic organ prolapse procedures, double the number reported by surgeons trained in other urological fellowships. Urologists of the female gender also reported performing approximately 8 more procedures annually than male urologists., Conclusions: The number of pelvic organ prolapse operations done by urologists increased dramatically in the last decade with a similar increase in mesh use. More colpopexies are now performed with laparoscopic sacrocolpopexy showing an exponential increase. The recent trend of mesh revision is notable with a much faster rate of increase than mesh insertion., (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: We evaluated the relationship of progression to positive surgical margin linear length and Gleason grade at a positive surgical margin., Materials and Methods: We studied 2,150 prostatectomies done for pT2 or pT3a disease to determine grade, stage and surgical margin status. In patients with positive surgical margins we recorded the location, number, positive margin linear length and highest Gleason grade at a positive margin. The Kaplan-Meier method and log rank test were used to determine differences in progression-free probability among positive margin features. The concordance index was used to discriminate the accuracy of grouping surgical margin status as negative/positive vs positive margin linear length/highest Gleason grade., Results: A total of 207 cases (10%) showed positive surgical margins, including 93 (45%) that were pT2+ and 114 (55%) that were pT3a. Patients with pT3a and positive margins had greater prostate specific antigen and tumor volume, and Gleason score 7 or greater than those with pT2+. A total of 45 patients with positive margins progressed. We then subcategorized positive margins. Of the patients 164 (79%) had 1 positive margin. Positive margin linear length was 1 mm or less, 1.1 to 3 and greater than 3 in 104 (50%), 55 (27%) and 48 cases (23%), respectively. Two-year progression-free probability was 95%, 91%, 83% and 47% in patients with negative margins and the 3 positive margin linear length groups, respectively (p <0.001). Gleason grade at a positive margin was 3 and 4/5 in 154 (74%) and 53 patients (26%), respectively. The latter group was significantly more likely to progress (p <0.001). The overall margin status concordance index was 0.636. It was not considerably enhanced by categorizing by positive surgical margin linear length/highest Gleason grade at positive margins., Conclusions: The linear extent of and highest Gleason grade at a positive surgical margin are associated with progression. However, subcategorization does not importantly add to predictive models using margin status only. More robust markers are needed in patients with positive surgical margins to warrant routine reporting and identify those at risk for biochemical recurrence., (Copyright © 2013 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: Urinary incontinence is a frequent complication of radical prostatectomy with a detrimental impact on quality of life. We identified predictors and trends in the use of procedures for post-prostatectomy incontinence., Materials and Methods: Using SEER (Surveillance, Epidemiology and End Results) cancer registry data linked with Medicare claims, we identified men 66 years old or older who were treated with radical prostatectomy in 2000 to 2007. The primary outcome was performance of an incontinence procedure. Demographic and clinical predictors of incontinence surgery were evaluated by multivariable regression analysis., Results: Of 16,348 men treated with radical prostatectomy 1,057 (6%) had undergone at least 1 incontinence procedure by a median of 20 months after the procedure, including 61% who underwent the first incontinence procedure within 2 years of prostatectomy. Older age and residence in the South were associated with greater probability of an incontinence procedure. Black men and those living in nonmetropolitan areas were less likely than their peers to undergo an incontinence procedure. Of men treated with any incontinence procedure 15% underwent more than 1 type. Of those treated with bulking agents 39% also received a urethral sling or artificial urinary sphincter and 13% who received a sling also had an artificial urinary sphincter. In 34% of the men who underwent any incontinence surgery artificial urinary sphincter placement was the only procedure performed., Conclusions: In this population based cohort of older men with prostate cancer only 6% underwent an incontinence procedure after prostatectomy. This low rate may reflect the underuse of potentially beneficial procedures., (Copyright © 2013 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: For select men with low risk prostate cancer active surveillance is more often being considered a management strategy. In a multicenter retrospective study we evaluated the actuarial rates and predictors of remaining on active surveillance, the incidence of cancer progression and the pathological findings of delayed radical prostatectomy., Materials and Methods: A cohort of 262 men from 4 institutions met the inclusion criteria of age 75 years or younger, prostate specific antigen 10 ng/ml or less, clinical stage T1-T2a, biopsy Gleason sum 6 or less, 3 or less positive cores at diagnostic biopsy, repeat biopsy before active surveillance and no treatment for 6 months following the repeat biopsy. Active surveillance started on the date of the second biopsy. Actuarial rates of remaining on active surveillance were calculated and univariate Cox regression was used to assess predictors of discontinuing active surveillance., Results: With a median followup of 29 months 43 patients ultimately received active treatment. The 2 and 5-year probabilities of remaining on active surveillance were 91% and 75%, respectively. Patients with cancer on the second biopsy (HR 2.23, 95% CI 1.23-4.06, p = 0.007) and a higher number of cancerous cores from the 2 biopsies combined (p = 0.002) were more likely to undergo treatment. Age, prostate specific antigen, clinical stage, prostate volume and number of total biopsy cores sampled were not predictive of outcome. Skeletal metastases developed in 1 patient 38 months after starting active surveillance. Of the 43 patients undergoing delayed treatment 41 (95%) are without disease progression at a median of 23 months following treatment., Conclusions: With a median followup of 29 months active surveillance for select patients appears to be safe and associated with a low risk of systemic progression. Cancer at restaging biopsy and a higher total number of cancerous cores are associated with a lower likelihood of remaining on active surveillance. A restaging biopsy should be strongly considered to finalize eligibility for active surveillance., (Copyright © 2013 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: We describe current trends in robotic and open radical prostatectomy in the United States after examining case logs for American Board of Urology certification., Materials and Methods: American urologists submit case logs for initial board certification and recertification. We analyzed logs from 2004 to 2010 for trends and used logistic regression to assess the impact of urologist age on robotic radical prostatectomy use., Results: A total of 4,709 urologists submitted case logs for certification between 2004 and 2010. Of these logs 3,374 included 1 or more radical prostatectomy cases. Of the urologists 2,413 (72%) reported performing open radical prostatectomy only while 961 (28%) reported 1 or more robotic radical prostatectomies and 308 (9%) reported robotic radical prostatectomy only. During this 7-year period we observed a large increase in the number of urologists who performed robotic radical prostatectomy and a smaller corresponding decrease in those who performed open radical prostatectomy. Only 8% of patients were treated with robotic radical prostatectomy by urologists who were certified in 2004 while 67% underwent that procedure in 2010. Median age of urologists who exclusively performed open radical prostatectomy was 43 years (IQR 38-51) vs 41 (IQR 35-46) for those who performed only robotic radical prostatectomy., Conclusions: While the rate was not as high as the greater than 85% industry estimate, 67% of radical prostatectomies were done robotically among urologists who underwent board certification or recertification in 2010. Total radical prostatectomy volume almost doubled during the study period. These data provide nonindustry based estimates of current radical prostatectomy practice patterns and further our understanding of the evolving surgical treatment of prostate cancer., (Copyright © 2012 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: We determined the frequency and distribution of metastases to pelvic lymph nodes in a contemporary American radical prostatectomy series., Materials and Methods: In 642 consecutive patients with clinically localized prostate cancer treated by a single surgeon between 2002 and 2009 pelvic lymph nodes were removed and submitted to the pathologist in separate packets (external iliac, obturator and hypogastric). We assessed the total number of nodes and the number with metastases in each packet., Results: Complete pathological information was available for 427 patients, who had a median of 16 lymph nodes removed. Of the patients 35 (8.2%) had lymph node metastases, including 1.7% with low, 8.6% with intermediate and 23.9% with high risk cancer. Of those with nodal metastases 24 (69%) had positive lymph nodes in only 1 of the 3 areas, including the external iliac in 4 (11%), the obturator in 9 (26%) and the hypogastric in 11 (31%). Only 37% of the patients had positive nodes only in the external iliac area above the obturator nerve while 60% and 49% had at least 1 positive node in the obturator and the hypogastric area, respectively. Of the patients 80% had only 1 (49%) or 2 (31%) positive nodes., Conclusions: In contemporary American patients with clinically localized prostate cancer lymph node metastases were found more often and frequently exclusively in the obturator and hypogastric areas than in the external iliac area. Pelvic lymph node dissection limited to the external iliac area above the obturator nerve would identify and remove lymph node metastases in only a third of the patients with positive nodes found at full pelvic lymph node dissection., (Copyright © 2012 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: We determined whether pelvic soft tissue and bony dimensions on endorectal magnetic resonance imaging influence the recovery of continence after radical prostatectomy, and whether adding significant magnetic resonance imaging variables to a statistical model improves the prediction of continence recovery., Materials and Methods: Between 2001 and 2004, 967 men undergoing radical prostatectomy underwent preoperative magnetic resonance imaging. Soft tissue and bony dimensions were retrospectively measured by 2 raters blinded to clinical and pathological data. Patients who received neoadjuvant therapy, who were preoperatively incontinent or had missing followup for continence were excluded from study, leaving 600 patients eligible for analysis. No pad use defined continent. Logistic regression was used to identify variables associated with continence recovery at 6 and 12 months. We evaluated whether the predictive accuracy of a base model was improved by adding independently significant magnetic resonance imaging variables., Results: Urethral length and urethral volume were significantly associated with the recovery of continence at 6 and 12 months. Larger inner and outer levator distances were significantly associated with a decreased probability of regaining continence at 6 or 12 months, but they did not reach statistical significance for other points. Addition of these 4 magnetic resonance imaging variables to a base model including age, clinical stage, prostate specific antigen and comorbidities marginally improved the discrimination (12-month AUC improved from 0.587 to 0.634)., Conclusions: Membranous urethral length, urethral volume, and an anatomically close relation between the levator muscle and membranous urethra on preoperative magnetic resonance imaging are independent predictors of continence recovery after radical prostatectomy. The addition of magnetic resonance imaging variables to a base model improved the predictive accuracy for continence recovery, but the predictive accuracy remains low., (Copyright © 2012 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: Anastomotic strictures are relatively common after radical prostatectomy and are associated with significant morbidity, often requiring multiple surgical interventions. There is controversy in the literature regarding which factors predict the development of anastomotic strictures. In this study we determined predictors of symptomatic anastomotic strictures following contemporary radical prostatectomy., Materials and Methods: Between 1999 and 2007, 4,592 consecutive patients underwent radical prostatectomy without prior radiotherapy at our institution. Data were collected from prospective surgical and institutional morbidity databases, and retrospectively from inpatient and outpatient medical and billing records. Cases were assigned a Charlson score to account for comorbidities. Complications were graded according to the modified Clavien classification., Results: Open radical prostatectomy was performed in 3,458 men (75%) and laparoscopic radical prostatectomy was performed in 1,134 (25%). The laparoscopic radical prostatectomy group included 97 robotic-assisted cases. Median patient age was 59.5 years (IQR 54.7, 64.2). Symptomatic anastomotic strictures developed in 198 patients (4%) after a median postoperative followup of 3.5 months (IQR 2.1, 6.1). On multivariate analysis significant predictors included patient age, body mass index, Charlson score, renal insufficiency, individual surgeon, surgical approach and the presence of postoperative urine leak or hematoma., Conclusions: Patient factors as well as technical factors influence the development of symptomatic anastomotic strictures following contemporary radical prostatectomy. The impact of these factors is influenced by the individual surgeon and the approach used., (Copyright © 2011 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: Long-term prostate cancer specific mortality after radical prostatectomy is poorly defined in the era of widespread screening. An understanding of the treated natural history of screen detected cancers and the pathological risk factors for prostate cancer specific mortality are needed for treatment decision making., Materials and Methods: Using Fine and Gray competing risk regression analysis we modeled clinical and pathological data, and followup information on 11,521 patients treated with radical prostatectomy at a total of 4 academic centers from 1987 to 2005 to predict prostate cancer specific mortality. The model was validated on 12,389 patients treated at a separate institution during the same period. Median followup in the modeling and validation cohorts was 56 and 96 months, respectively., Results: The overall 15-year prostate cancer specific mortality rate was 7%. Primary and secondary Gleason grade 4-5 (each p<0.001), seminal vesicle invasion (p<0.001) and surgery year (p=0.002) were significant predictors of prostate cancer specific mortality. A nomogram predicting 15-year prostate cancer specific mortality based on standard pathological parameters was accurate and discriminating with an externally validated concordance index of 0.92. When stratified by patient age at diagnosis, the 15-year prostate cancer specific mortality rate for pathological Gleason score 6 or less, 3+4, 4+3 and 8-10 was 0.2% to 1.2%, 4.2% to 6.5%, 6.6% to 11% and 26% to 37%, respectively. The 15-year prostate cancer specific mortality risk was 0.8% to 1.5%, 2.9% to 10%, 15% to 27% and 22% to 30% for organ confined cancer, extraprostatic extension, seminal vesicle invasion and lymph node metastasis, respectively. Only 3 of 9,557 patients with organ confined, pathological Gleason score 6 or less cancer died of prostate cancer., Conclusions: Poorly differentiated cancer and seminal vesicle invasion are the prime determinants of prostate cancer specific mortality after radical prostatectomy. The prostate cancer specific mortality risk can be predicted with remarkable accuracy after the pathological features of prostate cancer are known., (Copyright © 2011 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: We evaluated predictors of progression after starting active surveillance, especially the role of prostate specific antigen and immediate confirmatory prostate biopsy., Materials and Methods: A total of 238 men with prostate cancer met active surveillance eligibility criteria and were analyzed for progression with time. Cox proportional hazards regression was used to evaluate predictors of progression. Progression was evaluated using 2 definitions, including no longer meeting 1) full and 2) modified criteria, excluding prostate specific antigen greater than 10 ng/ml as a criterion., Results: Using full criteria 61 patients progressed during followup. The 2 and 5-year progression-free probability was 80% and 60%, respectively. With prostate specific antigen included in progression criteria prostate specific antigen at confirmatory biopsy (HR 1.29, 95% CI 1.14-1.46, p <0.0005) and positive confirmatory biopsy (HR 1.75, 95% CI 1.01-3.04, p = 0.047) were independent predictors of progression. Of the 61 cases 34 failed due to increased prostate specific antigen, including only 5 with subsequent progression by biopsy criteria. When prostate specific antigen was excluded from progression criteria, only 32 cases progressed, and 2 and 5-year progression-free probability was 91% and 76%, respectively. Using modified criteria as an end point positive confirmatory biopsy was the only independent predictor of progression (HR 3.16, 95% CI 1.41-7.09, p = 0.005)., Conclusions: Active surveillance is feasible in patients with low risk prostate cancer and most patients show little evidence of progression within 5 years. There is no clear justification for treating patients in whom prostate specific antigen increases above 10 ng/ml in the absence of other indications of tumor progression. Patients considering active surveillance should undergo confirmatory biopsy to better assess the risk of progression., (Copyright © 2011 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: Radical prostatectomy has significant side effects. Preoperative information predicting its long-term outcome would be valuable to patients and physicians. We determined whether pretreatment endorectal magnetic resonance imaging/magnetic resonance spectroscopic imaging predicts biochemical recurrence after radical prostatectomy., Materials and Methods: Of 202 patients who underwent endorectal magnetic resonance imaging/magnetic resonance spectroscopic imaging from January 2000 to December 2002 before radical prostatectomy 130 satisfied study inclusion criteria and were included in analysis. We compared imaging factors with potential predictive capability to biochemical recurrence data, including magnetic resonance imaging risk score based on local disease extent and magnetic resonance spectroscopic imaging index lesion characteristics, such as the number of voxels and degree of metabolic abnormality (magnetic resonance spectroscopic imaging grade). We evaluated associations of these imaging variables with time to biochemical recurrence by Cox proportional hazards regression adjusted for known predictors of biochemical recurrence, such as stage, grade and prostate specific antigen., Results: At a median 68-month followup there were 26 biochemical failures. Risk score, lesion volume and high grade voxels each correlated with time to biochemical recurrence. In a model combining clinical parameters risk score, lesion volume and at least 1 high grade voxel the magnetic resonance spectroscopic imaging variables remained significant but the magnetic resonance imaging score dropped out., Conclusions: Index lesion volume on magnetic resonance spectroscopic imaging and high grade magnetic resonance spectroscopic imaging voxels correlate with time to biochemical recurrence after radical prostatectomy even when adjusted for clinical data. Results suggest the preoperative predictive usefulness of endorectal magnetic resonance imaging/magnetic resonance spectroscopic imaging in patients considering radical prostatectomy., (Copyright © 2010 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: We evaluated predictors of freedom from biochemical recurrence in patients with pelvic lymph node metastasis at radical prostatectomy., Materials and Methods: Of 207 patients with lymph node metastasis treated with radical prostatectomy and bilateral pelvic lymph node dissection 45 received adjuvant androgen deprivation therapy and 162 did not. Cox proportional hazards regression models were used to investigate predictors of biochemical recurrence after radical prostatectomy. Recurrence probability was estimated using the Kaplan-Meier method., Results: A median of 13 lymph nodes were removed. Of the patients 122 had 1, 44 had 2 and 41 had 3 or greater positive lymph nodes. Of patients without androgen deprivation therapy 103 had 1, 35 had 2 and 24 had 3 or greater positive lymph nodes while 69 experienced biochemical recurrence. Median time to recurrence in patients with 1, 2 and 3 or greater lymph nodes was 59, 13 and 3 months, respectively. Only specimen Gleason score and the number of positive lymph nodes were independent predictors of biochemical recurrence. Recurrence-free probability 2 years after prostatectomy in men without androgen deprivation with 1 positive lymph node and a prostatectomy Gleason score of 7 or less was 79% vs 29% in those with Gleason score 8 or greater and 2 or more positive lymph nodes., Conclusions: Prognosis in patients with lymph node metastasis depends on the number of positive lymph nodes and primary tumor Gleason grade. Of all patients with lymph node metastasis 80% had 1 or 2 positive nodes. A large subset of those patients had a favorable prognosis. Full bilateral pelvic lymph node dissection should be done in patients with intermediate and high risk cancer to identify those likely to benefit from metastatic node removal., (Copyright (c) 2010 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: Salvage radical prostatectomy is associated with a higher complication rate than radical prostatectomy without prior radiotherapy but the magnitude of the increase is not well delineated., Materials and Methods: A total of 3,458 consecutive patients underwent open radical prostatectomy and 98 underwent open salvage radical prostatectomy from January 1999 to June 2007. Data were collected from prospective surgical and institutional morbidity databases, and retrospectively from billing records and medical records. Medical and surgical complications were captured, graded by the modified Clavien classification and classified by time of onset., Results: Median followup after salvage radical prostatectomy and radical prostatectomy was 34.5 and 45.5 months, respectively. Patients with salvage had significantly higher median age, modified Charlson comorbidity score, clinical and pathological stage, and Gleason score. They were less likely to have organ confined disease and more likely to have seminal vesicle invasion and nodal metastasis. There was no significant difference in median operative time, blood loss or transfusion rate. The salvage group had a higher adjusted probability of medical and surgical complications, including urinary tract infection, bladder neck contracture, urinary retention, urinary fistula, abscess and rectal injury. Only 1 of 4 potent patients with salvage prostatectomy who underwent bilateral nerve sparing recovered erection adequate for intercourse. The 3-year actuarial recovery of continence was 30% (95% CI 19-41)., Conclusions: Medical and surgical complications of prostatectomy are significantly increased in the setting of prior radiotherapy. Understanding the magnitude of this increased risk is important for patient counseling., (Copyright (c) 2010 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: Surgeons routinely evaluate and modify their surgical technique to improve patient outcome. It is also common for surgeons to analyze results before and after a change in technique to determine whether the change led to better results. Simple comparison of results before and after surgical modification may be confounded by the surgical learning curve. We developed a statistical method applicable to analyzing before/after surgical studies., Materials and Methods: We used simulation studies to compare different statistical analyses of before/after studies. We evaluated a simple 2-group comparison of results before and after the modification by the chi-square test and a novel bootstrap method that adjusts for the surgical learning curve., Results: In the presence of the learning curve a simple 2-group comparison almost always showed an ineffective surgical modification to be of benefit. When the surgical modification was harmful, leading to a 10% decrease in the success rate, 2-group comparison nonetheless showed a statistically significant improvement in outcome about 80% of the time. The bootstrap method had only moderate power but did not show that ineffective surgical modifications were beneficial more than would be expected by chance., Conclusions: Simplistic approaches to the analysis of before/after surgical studies may lead to grossly erroneous results under the surgical learning curve. A straightforward alternative statistical method allows investigators to separate the effects of the learning curve from those of the surgical modification., (Copyright (c) 2010 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: Enthusiasm for laparoscopic surgical approaches to prostate cancer treatment has grown despite limited evidence of improved outcomes compared with open radical prostatectomy. We compared laparoscopic prostatectomy with or without robotic assistance vs open radical prostatectomy in terms of postoperative outcomes and subsequent cancer directed therapy., Materials and Methods: Using a population based cancer registry linked with Medicare claims we identified men 66 years old or older with localized prostate cancer who underwent radical prostatectomy from 2003 to 2005. Outcome measures were general medical/surgical complications and mortality within 90 days after surgery, genitourinary/bowel complications within 365 days, radiation therapy and/or androgen deprivation therapy within 365 days and length of hospital stay., Results: Of the 5,923 men 18% underwent laparoscopic radical prostatectomy. Adjusting for patient and tumor characteristics, there were no differences in the rate of general medical/surgical complications (OR 0.93 95% CI 0.77-1.14) or genitourinary/bowel complications (OR 0.96 95% CI 0.76-1.22), or in postoperative radiation and/or androgen deprivation (OR 0.80 95% CI 0.60-1.08). Laparoscopic prostatectomy was associated with a 35% shorter hospital stay (p <0.0001) and a lower bladder neck/urethral obstruction rate (OR 0.74, 95% CI 0.58-0.94). In laparoscopic cases surgeon volume was inversely associated with hospital stay and the odds of any genitourinary/bowel complication., Conclusions: Laparoscopic prostatectomy and open radical prostatectomy have similar rates of postoperative morbidity and additional treatment. Men considering prostate cancer surgery should understand the expected benefits and risks of each technique to facilitate decision making and set realistic expectations., (Copyright (c) 2010 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: Complications and functional outcomes after prostate surgery vary among surgeons to a greater extent than may be accounted for by chance. This excessive variation is known as heterogeneity. We explored whether there is also heterogeneity among high volume surgeons with respect to cancer control after surgery., Materials and Methods: The study cohort consisted of 7,725 patients with clinically localized prostate cancer treated with open radical prostatectomy at 4 major American academic medical centers from 1987 to 2003 by 1 of 54 surgeons. We defined biochemical recurrence as serum prostate specific antigen 0.4 ng/ml or greater followed by a higher level. Multivariate random effects models were used to evaluate prostate cancer recurrence heterogeneity among surgeons after adjusting for case mix (prostate specific antigen, pathological stage and grade), surgery year and surgeon experience., Results: We found statistically significant heterogeneity in the prostate cancer recurrence rate independent of surgeon experience (p = 0.002). Seven experienced surgeons had an adjusted 5-year prostate cancer recurrence rate of less than 10% while another 5 had a rate that exceeded 25%. Significant heterogeneity remained on sensitivity analysis adjusting for possible differences in followup, patient selection and stage migration., Conclusions: Patient risk of recurrence may differ depending on which of 2 surgeons is seen even if the surgeons have similar experience levels. Surgical randomized trials are imperative to determine and characterize the roots of these variations., (2010 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: Positive surgical margins increase the risk of biochemical recurrence after radical prostatectomy by 2 to 4-fold. The risk of biochemical recurrence may be influenced by the anatomical location and extent of positive surgical margins. In a multicenter study we analyzed the predictive usefulness of several subclassifications of positive surgical margins., Materials and Methods: The clinical information and followup data of 7,160 patients treated with radical prostatectomy alone at 1 of 3 institutions between 1995 and 2006 were modeled using Cox proportional hazards regression analysis for biochemical recurrence. Positive surgical margins were analyzed as solitary vs multiple, focal vs extensive and apical location vs other. The usefulness of these subclassifications was assessed by the improvement in predictive accuracy of nomograms containing these parameters compared to one in which the surgical margin was modeled simply as positive vs negative., Results: The 7-year progression-free probability was 60% in patients with positive surgical margins. A positive surgical margin was significantly associated with biochemical recurrence (HR 2.3, p <0.001) after adjusting for age, prostate specific antigen, pathological Gleason score, pathological stage and year of surgery. An increased risk of biochemical recurrence was associated with multiple vs solitary positive surgical margins (adjusted HR 1.4, p = 0.002) and extensive vs focal positive surgical margins (adjusted HR 1.3, p = 0.004) on multivariable analysis. However, neither parameter improved the predictive accuracy of a nomogram compared to one in which surgical margin status was modeled as positive vs negative (concordance index 0.851 vs 0.850 vs 0.850)., Conclusions: The number and extent of positive surgical margin significantly influence the risk of biochemical recurrence after radical prostatectomy. However, the empirical prognostic usefulness of subclassifications of positive surgical margins is limited.

Purpose: We compared prostate cancer detected in transition zone directed needle biopsies with those in corresponding radical prostatectomy specimens., Materials and Methods: We reviewed needle biopsy and radical prostatectomy slides from 61 patients in whom cancer was present on transition zone directed needle biopsy. We assessed needle biopsy cancer features as well as transition zone lesions and dominant tumor sites on radical prostatectomy., Results: Prostate cancer was detected in 25 of 61 left (41%), 23 of 61 right (38%) and 13 of 61 bilateral (21%) transition zone directed needle biopsies. On radical prostatectomy 24 of 61 cases (39.5%) had no tumor in the transition zone, 24 of 61 (39.5%) had nondominant transition zone cancer and 13 of 61 (21%) had a dominant transition zone lesion. Of cases with cancer in the left and right transition zone directed needle biopsy 18 of 38 (47%) and 17 of 36 (47%), respectively, had no transition zone tumor or showed tumor in the contralateral transition zone only at radical prostatectomy. In 8 cases the transition zone directed core was the only one with cancer on needle biopsy and 2 of 8 (25%) such cases showed dominant transition zone cancer at radical prostatectomy., Conclusions: Cancer identified in transition zone directed needle biopsy cores was not from the transition zone or did not reflect a dominant transition zone lesion in almost 80% of cases. Cancer identified in a left or right transition zone directed needle biopsy did not predict ipsilateral transition zone cancer in almost 50% of cases. These findings suggest that such biopsies do not adequately characterize transition zone tumors. Thus, care should be taken in their interpretation.