Race-specific prostate cancer outcomes in a cohort of low and favorable-intermediate risk patients who underwent external beam radiation therapy from 1990 to 2017.

BACKGROUND: Previous research exploring the role of race on prostate cancer (PCa) outcomes has demonstrated greater rates of disease progression and poorer overall survival for African American (AA) compared to Caucasian American (CA) men. The current study examines self-reported race as a predictor of long-term PCa outcomes in patients with low and favorable-intermediate risk disease treated with external beam radiation therapy (EBRT). METHODS: This retrospective cohort study examined patients who were consented to enrollment in the Center for Prostate Disease Research Multicenter National Database between January 01, 1990 and December 31, 2017. Men self-reporting as AA or CA who underwent EBRT for newly diagnosed National Comprehensive Cancer Network-defined low or favorable-intermediate risk PCa were included. Dependent study outcomes included: biochemical recurrence-free survival, (ii) distant metastasis-free survival, and (iii) overall survival. Each outcome was modeled as a time-to-event endpoint using race-stratified Kaplan-Meier estimation curves and multivariable Cox proportional hazards analysis. RESULTS: Of 840 men included in this study, 268 (32%) were AA and 572 (68%) were CA. The frequency of biochemical recurrence, distant metastasis, and deaths from any cause was 151 (18.7%), 29 (3.5%), and 333 (39.6%), respectively. AA men had a significantly younger median age at time of EBRT and slightly higher biopsy Gleason scores. Multivariable Cox proportional hazards analyses demonstrated no racial differences in any of the study endpoints. CONCLUSIONS: These findings reveal no racial disparity in PCa outcomes for AA compared to CA men, in a long-standing, longitudinal cohort of patients with comparable access to cancer care.

Race-specific prostate cancer outcomes in a cohort of military health care beneficiaries undergoing surgery: 1990-2017.

BACKGROUND: There is substantial variability in prostate cancer (PCa) mortality rates across Caucasian American (CA), African American (AA), Asian, and Hispanic men; however, these estimates are unable to disentangle race or ethnicity from confounding factors. The current study explores survival differences in long-term PCa outcomes between self-reported AA and CA men, and examines clinicopathologic features across self-reported CA, AA, Asian, and Hispanic men. METHODS: This retrospective cohort study utilized the Center for Prostate Disease Research (CPDR) Multi-center National Database from 1990 to 2017. Subjects were consented at military treatment facilities nationwide. AA, CA, Asian, or Hispanic men who underwent radical prostatectomy (RP) for localized PCa within the first year of diagnosis were included in the analyses. Time from RP to biochemical recurrence (BCR), BCR to metastasis, and metastasis to overall death were evaluated using Kaplan-Meier unadjusted estimation curves and adjusted Cox proportional hazards regression. RESULTS: This study included 7067 men, of whom 5155 (73%) were CA, 1468 (21%) were AA, 237 (3%) were Asian, and 207 (3%) were Hispanic. AA men had a significantly decreased time from RP to BCR compared to CA men (HR = 1.25, 95% CI = 1.06-1.48, p = 0.01); however, no difference was observed between AA and CA men for a time from BCR to metastasis (HR = 0.73, 95% CI = 0.39-1.33, p = 0.302) and time from metastasis to overall death (HR = 0.67, 95% CI = 0.36-1.26, p = 0.213). CONCLUSIONS: In an equal access health care setting, AA men had a shorter survival time from RP to BCR, but comparable survival time from BCR to metastasis and metastasis to overall death.

Prospective quality of life in men choosing open vs. robotic radical prostatectomy: long-term results from a racially diverse multi-institutional database.

PURPOSE: To compare 5-year health-related quality of life (HRQoL) outcomes between prostate cancer (CaP) patients who underwent robotic-assisted laparoscopic radical prostatectomy (RALP) versus open radical retropubic prostatectomy (RRP) and assess for racial disparities between Caucasian American (CA) and African American (AA) men undergoing surgery. METHODS: A prospective cohort study of HRQoL data was conducted on patients diagnosed with CaP from 2007 to 2017 and enrolled in the Center for Prostate Disease Research (CPDR) Multicenter National Database. Using the EPIC and SF-36 instruments, changes in urinary, sexual, bowel, and hormonal domains, as well as physical and mental component summary scores were compared across surgery type (RALP versus RRP) at pre-treatment ("baseline"), and annually for 5 years. We further compared HRQoL outcomes in CA and AA men undergoing surgery. Longitudinal HRQoL patterns were modeled using generalized estimating equations (GEE), adjusting for baseline HRQoL and other characteristics. RESULTS: 448 CaP patients (22% AA) met study inclusion criteria, 66% underwent RALP and 34% underwent RRP. At baseline, HRQoL domains were comparable across treatment group (RALP vs. RRP). In the adjusted low-risk cohort, there were only three time points that met a statistically significant HRQoL difference in EPIC scores between RALP and RRP. Urinary function score during year 4 of follow-up showed a 7.5 (95% CI 3.1-11.9, P = 0.01) points difference in favor of RRP. Bowel bother scores favored RRP in year 1 with a difference of 3.1 (95% CI 0.7-5.4, P = 0.04) points, and in year 5 with a difference of 3.8 (95% CI 1.1-6.4, P = 0.03) points. In the intermediate/high-risk cohort, there were no statistically significant differences in any of the domain scores between RALP and RRP during follow-up. CONCLUSIONS: The robotic and open approach to radical prostatectomy led to comparable HRQoL outcomes at a follow-up length of 60 months. No HRQoL racial disparities were found between AA and CA men during long-term follow-up.

Minimally invasive retroperitoneal lymph node dissection for men with testis cancer: a retrospective cohort study of safety and feasibility.

PURPOSE: To describe the perioperative safety, functional and immediate post-operative oncological outcomes of minimally invasive RPLND (miRPLND) for testis cancer. METHODS: We performed a retrospective multi-centre cohort study on testis cancer patients treated with miRPLND from 16 institutions in eight countries. We measured clinician-reported outcomes stratified by indication. We performed logistic regression to identify predictors for maintained postoperative ejaculatory function. RESULTS: Data for 457 men undergoing miRPLND were studied. miRPLND comprised laparoscopic (n = 56) or robotic (n = 401) miRPLND. Indications included pre-chemotherapy in 305 and post-chemotherapy in 152 men. The median retroperitoneal mass size was 32 mm and operative time 270 min. Intraoperative complications occurred in 20 (4%) and postoperative complications in 26 (6%). In multivariable regression, nerve sparing, and template resection improved ejaculatory function significantly (template vs bilateral resection [odds ratio (OR) 19.4, 95% confidence interval (CI) 6.5-75.6], nerve sparing vs non-nerve sparing [OR 5.9, 95% CI 2.3-16.1]). In 91 men treated with primary RPLND, nerve sparing and template resection, normal postoperative ejaculation was reported in 96%. During a median follow-up of 33 months, relapse was detected in 39 (9%) of which one with port site (< 1%), one with peritoneal recurrence and 10 (2%) with retroperitoneum recurrences. CONCLUSION: The low proportion of complications or peritoneal recurrences and high proportion of men with normal postoperative ejaculatory function supports further miRPLND studies.

Learning Curve for Robotic-Assisted Laparoscopic Retroperitoneal Lymph Node Dissection.

Introduction: Robotic retroperitoneal lymph node dissection (R-RPLND) is a challenging procedure. We hypothesized that surgical times and operative complications would decrease as surgeons became more facile with R-RPLND. Materials and Methods: We retrospectively reviewed 121 consecutive R-RPLNDs performed at Naval Medical Center San Diego and Mayo Clinic Arizona by 4 fellowship trained robotic surgeons between 2008 and 2018. Linear regression was used to analyze independent predictors of setup time, operative time, and lymph node counts. Logistic regression was used to analyze open conversions, overall complications, and high-grade complications. Variables included as independent predictors were: sequential case number, surgeon, clinical stage, chemotherapy status, RPLND template, and body mass index. Univariate and multivariate analyses were conducted. Statistical significance was established at α = 0.05. Results: There was no change in setup time with case number (p = 0.317), but differences were noted between surgeons. Operative times decreased with increasing case number (p < 0.001) but were negatively affected by clinical stage III testis cancer (p = 0.029) and history of chemotherapy exposure (p = 0.050). Surgical times are predicted to decrease by 1 hour after 44 cases. Lymph node counts were dependent only on the surgeon. No factors were predictive of open conversions. Fewer overall complications occurred as experience was gained (p = 0.001), but high-grade complications could not be predicted. Conclusions: Consistent with the learning curves shown for other technologically advanced surgical techniques, experience appears to improve surgical times and lower complication rates for R-RPLND.

A prospective analysis of health-related quality of life in intermediate and high-risk prostate cancer patients managed with intensity modulated radiation therapy, with vs. without hormonal therapy.

INTRODUCTION: Combined radiotherapy and hormonal treatment are recommended for intermediate- and high-risk prostate cancer (CaP). This study compared the long-term effects on health-related quality of life (HRQoL) of intermediate- and high-risk CaP patients managed with radiation therapy (RT) with vs. without hormone therapy (HT). METHODS: Patients with intermediate- and high-risk CaP enrolled in the Center for Prostate Disease Research diagnosed from 2007 to 2017 were included. EPIC and SF-36 questionnaires were completed and HRQoL scores were compared for patients receiving RT vs. RT + HT at baseline (pretreatment), 6, 12, 24, 36, 48, and 60 months after CaP diagnosis. Longitudinal patterns of change in HRQoL were modeled using linear regression models, adjusting for baseline HRQoL, age at CaP diagnosis, race, comorbidities, National Comprehensive Cancer Network (NCCN) risk stratum, time to treatment, and follow-up time. RESULTS: Of 164 patients, 93 (56.7%) received RT alone and 71 (43.3%) received RT + HT. Both groups reported comparable baseline HRQoL. Patients receiving RT+HT were more likely to be NCCN high risk as compared to those receiving only RT. The RT + HT patients experienced worse sexual function, hormonal function, and hormonal bother than those who only received RT; however, HRQoL recovered over time for the RT + HT group. No significant differences were observed between groups in urinary and bowel domains or SF-36 mental and physical scores. CONCLUSION: Combined RT + HT treatment was associated with temporary lower scores in sexual and hormonal HRQoL compared with RT only. Intermediate- and high-risk CaP patients should be counseled about the possible declines in HRQoL associated with HT.

Effect of a Behavioral Intervention to Increase Vegetable Consumption on Cancer Progression Among Men With Early-Stage Prostate Cancer: The MEAL Randomized Clinical Trial.

Importance: Guidelines endorsing vegetable-enriched diets to improve outcomes for prostate cancer survivors are based on expert opinion, preclinical studies, and observational data. Objective: To determine the effect of a behavioral intervention that increased vegetable intake on cancer progression in men with early-stage prostate cancer. Design, Setting, and Participants: The Men's Eating and Living (MEAL) Study (CALGB 70807 [Alliance]) was a randomized clinical trial conducted at 91 US urology and medical oncology clinics that enrolled 478 men aged 50 to 80 years with biopsy-proven prostate adenocarcinoma (International Society of Urological Pathology grade group = 1 in those <70 years and ≤2 in those ≥70 years), stage cT2a or less, and serum prostate-specific antigen (PSA) level less than 10 ng/mL. Enrollment occurred from January 2011 to August 2015; 24-month follow-up occurred from January 2013 to August 2017. Interventions: Patients were randomized to a counseling behavioral intervention by telephone promoting consumption of 7 or more daily vegetable servings (MEAL intervention; n = 237) or a control group, which received written information about diet and prostate cancer (n = 241). Main Outcomes and Measures: The primary outcome was time to progression; progression was defined as PSA level of 10 ng/mL or greater, PSA doubling time of less than 3 years, or upgrading (defined as increase in tumor volume or grade) on follow-up prostate biopsy. Results: Among 478 patients randomized (mean [SD] age, 64 [7] years; mean [SD] PSA level, 4.9 [2.1] ng/mL), 443 eligible patients (93%) were included in the primary analysis. There were 245 progression events (intervention: 124; control: 121). There were no significant differences in time to progression (unadjusted hazards ratio, 0.96 [95% CI, 0.75 to 1.24]; adjusted hazard ratio, 0.97 [95% CI, 0.76 to 1.25]). The 24-month Kaplan-Meier progression-free percentages were 43.5% [95% CI, 36.5% to 50.6%] and 41.4% [95% CI, 34.3% to 48.7%] for the intervention and control groups, respectively (difference, 2.1% [95% CI, -8.1% to 12.2%]). Conclusions and Relevance: Among men with early-stage prostate cancer managed with active surveillance, a behavioral intervention that increased vegetable consumption did not significantly reduce the risk of prostate cancer progression. The findings do not support use of this intervention to decrease prostate cancer progression in this population, although the study may have been underpowered to identify a clinically important difference. Trial Registration: ClinicalTrials.gov Identifier: NCT01238172.

Race, tumor location, and disease progression among low-risk prostate cancer patients.

BACKGROUND: The relationship between race, prostate tumor location, and BCR-free survival is inconclusive. This study examined the independent and joint roles of patient race and tumor location on biochemical recurrence-free (BCR) survival. METHODS: A retrospective cohort study was conducted among men with newly diagnosed, biopsy-confirmed, NCCN-defined low risk CaP who underwent radical prostatectomy (RP) at the Walter Reed National Military Medical Center from 1996 to 2008. BCR-free survival was modeled using Kaplan-Meier estimation curves and multivariable Cox proportional hazards (PH) analyses. RESULTS: There were 539 eligible patients with low-risk CaP (25% African American, AA; 75% Caucasian American, CA). Median age at CaP diagnosis and post-RP follow-up time was 59.2 and 8.1 years, respectively. Kaplan-Meier analyses showed no significant association between race (P = .52) or predominant tumor location (P = .98) on BCR-free survival. In Cox PH multivariable analysis, neither race (HR = 1.18; 95% CI = 0.68-2.02; P = .56) nor predominant tumor location (HR = 1.13; 95% CI = 0.59-2.15; P = .71) was an independent predictor of BCR-free survival. CONCLUSIONS: Neither race nor predominant tumor location was associated with adverse oncologic outcome.

Optimizing Outcomes in Urological Surgery: Intraoperative Patient Safety and Physiological Considerations.

INTRODUCTION: Intraoperative surgical outcomes are influenced by a wide variety of patient, surgeon and institutional factors. The current literature lacks comprehensive resources that describe best practices in preventing patient safety events and optimizing patient physiology during urological surgery. METHODS: A multidisciplinary panel of subject matter experts (urologists, nurses, anesthesiologists) was convened to evaluate the existing literature, create a white paper and disseminate this to urological providers. Focusing on intraoperative patient safety and physiology, a narrative review was undertaken and relevant guidelines and practical interventions were highlighted. RESULTS: Patient safety is optimized by preventing surgical site infections, wrong site surgery, venous thromboembolism, falls/positioning injuries, laser/fire injuries, excessive radiation exposure and harm from the adoption of new technology. Goals for intraoperative physiological parameters (temperature, glucose, fluid balance) are addressed as well as analgesic and anesthetic considerations in urological patients. In addition, practical tools are provided to assist in the quality improvement process. CONCLUSIONS: This article summarizes intraoperative factors related to patient safety and optimal physiology that can impact urological surgical outcomes. This overview can be used as a practical guide for process improvement to optimize the quality of intraoperative care.

Primary robotic RLPND for nonseminomatous germ cell testicular cancer: a two-center analysis of intermediate oncologic and safety outcomes.

OBJECTIVE: To evaluate the intermediate-term oncologic outcomes and safety profile of the largest case series of primary robotic retroperitoneal lymphadenectomy for low-clinical-stage non-seminomatous germ cell testicular cancer. METHODS: This was a two-center retrospective analysis of robotic RPLND cases for low-clinical-stage (stage I-IIB) non-seminomatous germ cell testicular cancer in the primary setting. Demographic, perioperative, operative and oncologic variables were collected between March 2008 and May 2019. Descriptive analyses were performed and presented as medians with interquartile ranges for continuous variables and frequency and proportions for categorical variables. A survival analysis of time to recurrence was performed using Cox proportional hazards model. Using logistic regression, risk factors for complications were analyzed. Both univariate and multivariate analyses were performed. RESULTS: A total of 58 patients (CS 1 = 56, CS IIA = 2, CS IIB = 0) were identified. The median follow-up was 47 months and the 2-year recurrence-free survival rate was 91%. The five recurrences were all out of the performed dissection template (pelvis = 1 and lung = 4). Only five patients (29%) with occult metastasis underwent adjuvant chemotherapy. The median operative time was 319 min [interquartile range (IQR) 276-355 min], estimated blood loss was 100 ml (IQR 75-200 ml), node count was 26 (IQR 20-31), and length of stay 2 d (IQR 1-3 days). There were 2 (3.3%) intraoperative complications, 19 (32.7%) 30-day postoperative complications to include 14 (24.1%) Clavien grade I, 4 (6.9%) Clavien grade II, 1 (1.7%) Clavien grade III and 0 Clavien grade IV complications. No statistical significance was found on multivariate or univariate analysis for survival analysis of time to recurrence and risk factors for complications. CONCLUSIONS: This study represents the largest case series of primary R-RPLND for the treatment of low-stage non-seminomatous germ cell tumors (NSGCT). With 47 months of follow-up and a low rate of adjuvant chemotherapy, intermediate oncologic efficacy appears to be comparable to the gold standard open approach.

Prostatic Urethral Lift (PUL) for obstructive median lobes: 12 month results of the MedLift Study.

Evidence indicating Prostatic Urethral Lift (PUL) delivers significant improvement in symptomatic BPH with low morbidity is based on subjects with lateral lobe (LL) enlargement only. MedLift was an FDA IDE extension of the L.I.F.T. randomized study designed to examine safety and efficacy of PUL for treatment of obstructive middle lobes (OML). Inclusion criteria for this non-randomized cohort were identical to the L.I.F.T. randomized study, except for requiring an OML: ≥ 50 years of age, IPSS ≥ 13, and Qmax ≤ 12 ml/s. Primary endpoint analysis quantified improvement in IPSS over baseline and rate of post-procedure serious complications. Quantification of symptom relief, quality of life, flow rate, and sexual function occurred through 12 months. Outcomes were compared to historical L.I.F.T LL results and were combined to demonstrate the full effectiveness of PUL. Of the 71 screened subjects, 45 were enrolled. At 1, 3, 6, and 12 months, mean IPSS improved from baseline at least 13.5 points (p < 0.0001). Quality of life and BPHII were similarly improved (>60% and >70%, respectively at 3, 6, and 12 months, p < 0.0001). Mean Qmax improvement ranged from 90 to 129% (p < 0.0001). At 1 month, 86% (CI 73-94%) reported ≥70 on the Quality of Recovery scale, 80% (CI 66-89%) reported being "much" or "very much better," and 89% (CI 76-95%) would recommend the procedure. Compared to LL subjects, OML subjects' symptoms improved at least as much at every time point (OML range 13.5-15.9, LL range 9.9-11.1, p ≤ 0.01). On combining OML with LL data, >70% (range CI 63-81%) of subjects demonstrated ≥ 8 point improvement in IPSS through 12 months. Analysis of the combined dataset indicates ≥ 40% (CI 30-51%) of sexually active men improved the minimal clinically important difference in erectile function through 12 months. Prostates, including those with middle lobe obstruction, can be treated with the PUL procedure safely and effectively.

Radical prostatectomy and the effect of close surgical margins: results from the Shared Equal Access Regional Cancer Hospital (SEARCH) database.

OBJECTIVE: To evaluate biochemical recurrence (BCR) patterns amongst men undergoing radical prostatectomy (RP) with specimens having negative (NSM), positive (PSM), and close surgical margins (CSM) from the Shared Equal Access Regional Cancer Hospital (SEARCH) cohort, as PSM after RP are a significant predictor of biochemical failure and possible disease progression, with CSM representing a diagnostic challenge for surgeons. PATIENTS AND METHODS: Men undergoing RP between 1988 and 2015 with known final pathological margin status were evaluated. The cohort was divided into three groups based on margin status; NSM, PSM, and CSM. CSM were defined by distance of tumour ≤1 mm from the surgical margin. BCR was defined as a prostate-specific antigen (PSA) level of >0.2 ng/mL, two values at 0.2 ng/mL, or secondary treatment for an elevated PSA level. Predictors of BCR, metastases, and mortality were analysed using Cox proportional hazard models. RESULTS: Of 5515 men in the SEARCH database, 4337 (79%) men met criteria for inclusion in the analysis. Of these, 2063 (48%) had NSM, 1902 (44%) had PSM, and 372 (8%) had CSM. On multivariable analysis, relative to NSM, men with CSM had a higher risk of BCR (hazard ratio [HR] 1.51, 95% confidence interval [CI] 1.25-1.82; P < 0.001) but a decreased risk of BCR when compared to those men with PSM (HR 2.09, 95% CI 1.86-2.36; P < 0.001). Metastases, prostate cancer-specific mortality and all-cause mortality did not differ based on margin status alone. CONCLUSIONS: Management of men with CSM is a diagnostic challenge, with a disease course that is not entirely benign. The evaluation of other known risk factors probably provides greater prognostic value for these men and may ultimately better select those who may benefit from adjuvant therapy.

Biopsy Detected Gleason Pattern 5 is Associated with Recurrence, Metastasis and Mortality in a Cohort of Men with High Risk Prostate Cancer.

PURPOSE: We evaluated the relative risk of biochemical recurrence, metastasis and death from prostate cancer contributed by biopsy Gleason pattern 5 among men at high risk with Gleason 8-10 disease in the SEARCH (Shared Equal Access Regional Cancer Hospital) cohort. MATERIALS AND METHODS: Men with biopsy Gleason sum 8-10 prostate cancer treated with radical prostatectomy were evaluated. The cohort was divided into men with Gleason 4 + 4 vs those with any pattern 5 (ie Gleason 3 + 5, 5 + 3, 4 + 5, 5 + 4 or 5 + 5). Predictors of biochemical recurrence, metastases, and prostate cancer specific and overall survival were analyzed using Kaplan-Meier, log rank test and Cox proportional hazards models. RESULTS: We identified 634 men at high risk in the SEARCH database, of whom 394 (62%) had Gleason 4 + 4 and 240 (38%) had Gleason pattern 5 on biopsy. Baseline characteristics did not significantly differ between the groups. On multivariable analysis relative to Gleason 4 + 4 men at high risk with Gleason pattern 5 showed no difference in the risk of biochemical recurrence (HR 1.26, 95% CI 0.99-1.61, p = 0.065). However, they were at significantly greater risk for metastasis (HR 2.55, 95% CI 1.50-4.35, p = 0.001), prostate cancer specific mortality (HR 2.67, 95% CI 0.1.26-5.66, p = 0.010) and overall mortality (HR 1.60, 95% CI 1.09-2.34, p = 0.016). CONCLUSIONS: Preoperative subclassification of high risk prostate cancer by biopsy Gleason grade (4 + 4 vs any Gleason pattern 5) identified men at highest risk for progression. Any Gleason 5 on biopsy is associated with a greater risk of metastasis, and prostate cancer specific and overall mortality. Grouping all Gleason 8-10 tumors together as high risk lesions may fail to fully stratify men at highest risk for poor outcomes.

Comparison of retroperitoneal and transperitoneal robotic partial nephrectomy for Pentafecta perioperative and renal functional outcomes.

BACKGROUND: We compared quality outcomes between transperitoneal (TRPN) and retroperitoneal robotic partial nephrectomy (RRPN). METHODS: Two-center retrospective analysis of TRPN and RRPN from 10/2009 to 10/2015. Perioperative/renal function outcomes were analyzed. Primary endpoint was Pentafecta, a composite measure of quality [negative margin, no 30-day complication, ischemia time ≤25 min, return of glomerular filtration rate (eGFR) to >90% from baseline at last follow-up, and no chronic kidney disease upstaging]. Multivariable analysis (MVA) for factors associated with lack of optimal outcome was performed. RESULTS: 404 patients (TRPN 263, RRPN 141) were analyzed. Comparing TRPN vs. RRPN, mean tumor size (3.1 vs. 2.9 cm, p = 0.122) and RENAL score (7.4 vs. 7.2, p = 0.503) were similar. Most TRPN were anterior (65.0%) and most RRPN posterior (65.3%, p < 0.001). Operative time (p = 0.001) was less for RRPN. No significant differences between TRPN vs. RRPN were noted for ischemia time (23.1 vs. 22.8 min, p = 0.313), blood loss (p = 0.772), positive margins (p = 0.590), complications (p = 0.537), length of stay (p = 0.296), ΔeGFR (p = 0.246), eGFR recovery to >90% (55.9 vs. 57.4%, p = 0.833), and lack of CKD upstaging (84.0 vs. 87.2%, p = 0.464). Pentafecta rates were not significantly different (TRPN 33.9 vs. RRPN 43.3%, p = 0.526). MVA revealed increasing RENAL score (OR 1.5, p < 0.001) and decreasing baseline eGFR (OR 2.4, p = 0.017) as predictive for lack of Pentafecta. CONCLUSIONS: TRPN and RRPN have similar quality outcomes, though RRPN may offer modest benefit for operative time and have utility in posterior tumors. Association of increasing RENAL score and decreased baseline eGFR with lack of Pentafecta suggests dominant role of non-modifiable factors.

An Update of the American Urological Association White Paper on the Prevention and Treatment of the More Common Complications Related to Prostate Biopsy.

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.

Ablative Fractional Laser Resurfacing: A Promising Adjunct to Surgical Reconstruction.

Ablative fractional laser resurfacing (AFLR) is emerging as a safe and effective treatment option for the mitigation of cosmetic and functional deficits resulting from traumatic scars and scar contractures. Military centers of excellence engaged in the multidisciplinary rehabilitation of wounded warriors have been instrumental in the widening acceptance of the technique in both the military and civilian realms. Despite the end of large-scale combat operations, AFLR remains a promising complement to surgical reconstruction and a novel option in challenging clinical situations that defy resolution with traditional methods. Herein, we present the case of a man in his 50s who underwent extensive genital and perineal debridement related to Fournier's gangrene. Despite successful reconstruction including extensive skin grafting, the patient suffered from intractable discomfort related to developing scar contractures that responded rapidly to a course of AFLR. This case serves to highlight the potential benefits of AFLR for postoperative wound management, and the importance of a multidisciplinary approach for the care of complex injuries.

Robotic-assisted fluorescence sentinel lymph node mapping using multimodal image guidance in an animal model.

OBJECTIVE: To investigate positron emission tomography/computed tomography (PET/CT) preoperative imaging and intraoperative detection of a fluorescent-labeled receptor-targeted radiopharmaceutical in a prostate cancer animal model. MATERIALS AND METHODS: Three male beagle dogs underwent an intraprostatic injection of fluorescent-tagged tilmanocept, radiolabeled with both gallium Ga-68 and technetium Tc-99m. One hour after injection, a pelvic PET/CT scan was performed for preoperative sentinel lymph node (SLN) mapping. The definition of SLN was a standardized uptake value that exceeded 5% of the lymph node with the highest standardized uptake value. Thirty-six hours later, we performed robotic-assisted SLN dissection using a fluorescence-capable camera system. Fluorescent lymph nodes were clipped, the abdomen was opened, and the pelvic and retroperitoneal nodes were excised. All excised nodal packets were assayed by in vitro nuclear counting and reported as the percentage of injected dose. RESULTS: Preoperative PET/CT imaging identified a median of 3 SLNs per animal. All SLNs (100%) identified by the PET/CT were fluorescent during robotic-assisted lymph node dissection. Of all fluorescent nodes visualized by the camera system, 9 of 12 nodes (75%) satisfied the 5% rule defined by the PET/CT scan. The 2 lymph nodes that did not qualify accumulated <0.002% of the injected dose. CONCLUSION: Fluorescent-labeled tilmanocept has optimal logistic properties to obtain preoperative PET/CT and subsequent real-time intraoperative confirmation during robotic-assisted SLN dissection.

Diffusion of surgical innovations, patient safety, and minimally invasive radical prostatectomy.

IMPORTANCE: Surgical innovations disseminate in the absence of coordinated systems to ensure their safe integration into clinical practice, potentially exposing patients to increased risk for medical error. OBJECTIVE: To investigate associations of patient safety with the diffusion of minimally invasive radical prostatectomy (MIRP) resulting from the development of the da Vinci robot. DESIGN, SETTING, AND PARTICIPANTS: A cohort study of 401 325 patients in the Nationwide Inpatient Sample who underwent radical prostatectomy during MIRP diffusion between January 1, 2003, and December 31, 2009. MAIN OUTCOMES AND MEASURES: We used Agency for Healthcare Research and Quality Patient Safety Indicators (PSIs), which measure processes of care and surgical provider performance. We estimated the prevalence of MIRP among all prostatectomies and compared PSI incidence between MIRP and open radical prostatectomy in each year during the study. We also collected estimates of MIRP incidence attributed to the manufacturer of the da Vinci robot. RESULTS: Patients who underwent MIRP were more likely to be white (P = .004), have fewer comorbidities (P = .02), and have undergone surgery in higher-income areas (P = .005). The incidence of MIRP was substantially lower than da Vinci manufacturer estimates. Rapid diffusion onset occurred in 2006, when MIRP accounted for 10.4% (95% CI, 10.2-10.7) of all radical prostatectomies in the United States. In 2005, MIRP was associated with an increased adjusted risk for any PSI (adjusted odds ratio, 2.0; 95% CI, 1.1-3.7; P = .02) vs open radical prostatectomy. Stratification by hospital status demonstrated similar patterns: rapid diffusion onset among teaching hospitals occurred in 2006 (11.7%; 95% CI, 11.3-12.0), with an increased risk for PSI for MIRP in 2005 (adjusted odds ratio, 2.7; 95% CI, 1.4-5.3; P = .004), and onset among nonteaching hospitals occurred in 2008 (27.1%; 95% CI, 26.6-27.7), with an increased but nonsignificant risk for PSI in 2007 (adjusted odds ratio, 2.0; 95% CI, 0.8-5.2; P = .14). CONCLUSIONS AND RELEVANCE: During its initial national diffusion, MIRP was associated with diminished perioperative patient safety. To promote safety and protect patients, the processes by which surgical innovations disseminate into clinical practice require refinement.

Determinants of renal functional decline after open partial nephrectomy: a comparison of warm, cold, and non-ischemic modalities.

INTRODUCTION: Renal functional decline after partial nephrectomy (PN) may be related to a variety of nonmodifiable and modifiable factors, including ischemia time (IT) and modality. We sought to determine the impact of these factors on renal functional degeneration after PN. MATERIALS AND METHODS: Multicenter retrospective analysis (n = 347) was performed, identifying patients who underwent open PN using warm, cold, and non-ischemic techniques. Primary outcome was development of de novo chronic kidney disease (CKD), (estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2), at 1 year follow up. Univariate and multivariable analysis (MVA) were performed examining factors associated with ischemia technique and the development of de novo CKD. RESULTS: Median follow up 34.7 months. Two hundred and forty-one patients underwent warm ischemic, 31 cold ischemic, and 75 clampless PN. Patient characteristics were similar between groups. Clampless group had lower mean RENAL scores (6.4) than cold (7.9, p = 0.005) and warm (7, p = 0.037) ischemia groups. Cold ischemia cohort had longer median IT than the warm cohort (50min versus 25 min, p = 0.001). There were no significant differences in proportion of patients developing de novo CKD (warm 14.9%, cold 15%, clampless 8.7%, p = 0.422). MVA demonstrated that neither ischemic modality nor IT ≥ 30 minutes was associated with development of de novo CKD, while RENAL scores of increasing complexity (RENAL score 7-9 OR 4.32, p = 0.003; RENAL score ≥ 10 OR 15.42, p < 0.001) were independently associated with de novo CKD. CONCLUSIONS: Increasing tumor complexity, as indicated by the RENAL score, was an overriding determinant of post PN renal functional outcome. Prospective investigation is requisite to elucidate risk and protective factors for renal functional degeneration after PN.