Howard Jung

Association of Hematuria on Microscopic Urinalysis and Risk of Urinary Tract Cancer

PURPOSE We determined the incidence of urinary tract cancer in patients with hematuria, stratified risk by age, gender and hematuria degree, and examined current best policy recommendations. MATERIALS AND METHODS We performed a large, retrospective population based cohort study of patients who underwent microscopic urinalysis during 2004 and 2005 in a large managed care organization. Patients were followed for 3 years for urinary tract cancer. RESULTS We identified 772,002 patients who underwent urinalysis during the study period. After exclusions due to previous hematuria, age less than 18 years, pregnancy, urinary tract infection, inpatient status and prior urinary tract cancer 309,402 patients were available for analysis, of whom 156,691 had hematuria. The overall 3-year incidence of urinary tract cancer in those with hematuria was 0.68%. Older age (greater than 40 years OR 17.0, 95% CI 11.2-25.7), greater hematuria (greater than 25 red blood cells per high power field OR 4.0, 95% CI 3.5-4.5) and male gender (OR 4.8, 95% CI 4.2-5.6) were associated with a higher risk of cancer. The American Urological Association definition of microhematuria had 50% sensitivity, 84% specificity and 1.3% positive predictive value. CONCLUSIONS The incidence of urinary tract cancer is low even in individuals with microhematuria. Thus, current best policy recommendations do not perform well. Since older age, male gender and greater hematuria are associated with a higher risk of cancer, future studies should evaluate strategies that target these populations.

Impact of Robotic Training on Surgical and Pathologic Outcomes During Robot-assisted Laparoscopic Radical Prostatectomy

OBJECTIVES To prospectively compare outcomes during robotic prostatectomy between surgeons with formal training in either robotic prostatectomy (RALP) or laparoscopic prostatectomy (LRP). METHODS A total of 286 robotic prostatectomies were performed by 12 urologists between August 2008 and March 2009 as part of a new robotic surgery program at one of the largest health maintenance organizations in the United States. Four surgeons had formal training in RALP and 8 had formal training in LRP. We prospectively compared surgical and pathologic outcomes between these 2 groups of surgeons. RESULTS The 4 RALP surgeons performed 121 RALPs and the 8 LRP surgeons performed 165 RALPs. Patient demographics were similar between groups. The robot-naive group had significantly more clinical stage T1c than the robot-trained group (87.9% vs 74.4%, P = .003). Prostatectomy parameters were similar between the 2 groups of surgeons in terms of prostate size, Gleason score, pathologic stage, and estimated blood loss. The robot-trained surgeons had significantly lower overall positive margin rates (24% vs 34.6%, P = .05) and lower margin rates in T3 tumors (38.5% vs 61.8%, P = .07), which were approximately statistically significant. There was no difference in margin rates in T2 tumors. The robot-trained surgeons had significantly lower apical margin rates (8.3% vs 21.2%, P = .003) and lateral margin rates (1.7% vs 7.3%, P = .05). The robot-trained surgeons had 10%-15% shorter procedure times. There was no difference in complication rates. CONCLUSIONS Formal RALP training may be beneficial for surgical and pathologic outcomes of RALP compared with formal LRP training during the initial implementation of a new robotics program.

Regular Nonsteroidal Anti-Inflammatory Drug Use and Erectile Dysfunction

PURPOSE Previous data suggest a potential relationship between inflammation and erectile dysfunction. If it is causal, nonsteroidal anti-inflammatory drug use should be inversely associated with erectile dysfunction. To this end we examined the association between nonsteroidal anti-inflammatory drug use and erectile dysfunction in a large, ethnically diverse cohort of men enrolled in the California Mens Health Study. MATERIALS AND METHODS This prospective cohort study enrolled male members of the Kaiser Permanente managed care plans who were 45 to 69 years old beginning in 2002. Erectile dysfunction was assessed by questionnaire. Nonsteroidal anti-inflammatory drug exposure was determined by automated pharmacy data and self-reported use. RESULTS Of the 80,966 men in this study 47.4% were considered nonsteroidal anti-inflammatory drug users based on the definitions used and 29.3% reported moderate or severe erectile dysfunction. Nonsteroidal anti-inflammatory drug use and erectile dysfunction strongly correlated with age with regular drug use increasing from 34.5% in men at ages 45 to 49 years to 54.7% in men 60 to 69 years old with erectile dysfunction increasing from 13% to 42%. The unadjusted OR for the association of nonsteroidal anti-inflammatory drugs and erectile dysfunction was 2.40 (95% CI 2.27, 2.53). With adjustment for age, race/ethnicity, smoking status, diabetes mellitus, hypertension, hyperlipidemia, peripheral vascular disease, coronary artery disease and body mass index, a positive association persisted (adjusted OR 1.38). The association persisted when using a stricter definition of nonsteroidal anti-inflammatory drug exposure. CONCLUSIONS These data suggest that regular nonsteroidal anti-inflammatory drug use is associated with erectile dysfunction beyond what would be expected due to age and comorbidity.

Rapid implementation of a robot-assisted prostatectomy program in a large health maintenance organization setting.

PURPOSE We present the rapid implementation of a robot-assisted surgery program by one of the largest health maintenance organizations (HMOs) in the United States. MATERIALS AND METHODS A core group of 10 urologists were offered access to a new da Vinci S surgical system. A core group of five ancillary staff was assembled and trained at an Intuitive Surgical-designated training site. An experienced robotic surgeon acted as a proctor. Data regarding patient demographics, preoperative parameters, operative times, pathologic outcomes, and EPIC-26 quality-of-life questionnaires were collected prospectively and reviewed. All procedures were recorded on digital video disc as part of a quality assurance protocol. The core group reviewed complications monthly and received feedback on surgical techniques and pathologic outcomes. RESULTS A total of 100 robot-assisted laparoscopic radical prostatectomies were performed from August to October 2008. The patient demographics, preoperative parameters, operative times, and pathologic outcomes of these first 100 procedures are outlined. CONCLUSIONS We demonstrate the rapid implementation of an efficient multisurgeon HMO-based robot-assisted prostatectomy program with promising initial outcomes.

Impact of median lobe anatomy: does its presence affect surgical margin rates during robot-assisted laparoscopic prostatectomy?

PURPOSE To measure and describe the impact of median lobe anatomy on surgical margin status after robot-assisted laparoscopic prostatectomy (RALP). PATIENTS AND METHODS We prospectively collected median lobe status, surgical margin status, and other perioperative data on 791 patients who underwent RALP at our institution by 12 surgeons between August 2008 and December 2010. We performed univariable and multivariable analysis to measure the association between median lobe status and positive surgical margin rates, including site. RESULTS Compared with patients without a median lobe (n=672), patients with a median lobe (n=119) were less likely to have a positive surgical margin (16% vs 24.4%). They had a higher prostate-specific antigen (PSA) level (6.1 ng/dL vs 5.4 ng/dL), lower Gleason scores (<7, 58.1% vs 42.1%), lower pathologic stages (T(2), 87.4% vs 75.4%), and larger prostates (64 g vs 48 g) (all P<0.05). In our multivariable model, the effect of median lobe anatomy on surgical margin status, after adjusting for these factors, was not statistically significant (relative risk 0.97, 95% confidence interval, 0.64-1.47, P=0.88). Lower PSA level, Gleason score, and pathologic stage and larger prostates, however, predicted decreased positive surgical margin rates (P<0.01). CONCLUSION Although presence of median lobe anatomy is not an independent predictor of positive surgical margins in RALP, it is associated with favorable pathologic characteristics that are known to predict decreased positive surgical margins.

Health-related quality of life outcomes from a contemporary prostate cancer registry in a large diverse population

To assess the health‐related quality of life (HRQoL) of patients with prostate cancer up to 24 months after treatment in a contemporary large diverse population.

Racial and ethnic differences in time to treatment for patients with localized prostate cancer.

OBJECTIVE To investigate the racial/ethnic differences in the time to treatment among patients with prostate cancer. MATERIALS AND METHODS All 3448 men diagnosed with localized prostate cancer at Kaiser Permanente Southern California from 2006 to 2007 were identified. The patients were passively followed up through their electronic health records until definitive treatment, defined as the first treatment given with curative intent within 1 year of diagnosis. Cox proportional hazard models, with PROC SURVEYPHREG procedures, were used to account for the variability in time to the different treatments within multiple medical centers. RESULTS The overall median time to treatment was 102 days, with modest differences for whites (100 days), blacks (104 days), and Hispanics (99 days). In the adjusted model, black men had a significantly longer time to surgery (adjusted hazard ratio 0.74, 95% confidence interval 0.56-0.91) compared with white men. Hispanic men (adjusted hazard ratio 1.44, 95% confidence interval 1.07-1.74) experienced significantly shorter times to radiotherapy compared with white men. No difference was found in the time to radiotherapy or brachytherapy for black men relative to white men. CONCLUSION These data suggest that minimal racial/ethnic differences exist in the time to treatment after the diagnosis of prostate cancer in this equal-access setting. This is encouraging, but does not mean that all men were satisfied with their treatment choice.

Achieving proficiency with robot-assisted radical prostatectomy: Laparoscopic-trained versus robotics-trained surgeons.

BACKGROUND Initiating a robotics program is complex, in regards to achieving favourable outcomes, effectively utilizing an expensive surgical tool, and granting console privileges to surgeons. We report the implementation of a community-based robotics program among minimally-invasive surgery (MIS) urologists with and without formal robotics training. METHODS From August 2008 to December 2010 at Kaiser Permanente Southern California, 2 groups of urologists performing robot-assisted radical prostatectomy (RARP) were followed since the time of robot acquisition at a single institution. The robotics group included 4 surgeons with formal robotics training and the laparoscopic group with another 4 surgeons who were robot-naïve, but skilled in laparoscopy. The laparoscopic group underwent an initial 7-day mentorship period. Surgical proficiency was measured by various operative and pathological outcome variables. Data were evaluated using comparative statistics and multivariate analysis. RESULTS A total of 420 and 549 RARPs were performed by the robotics and laparoscopic groups, respectively. Operative times were longer in the laparoscopic group (p = 0.002), but estimated blood loss was similar. The robotics group had a significantly better overall positive surgical margin rate of 19.9% compared to the laparoscopic group (27.8%) (p = 0.005). Both groups showed improvements in operative and pathological parameters as they accrued experience, and achieved similar results towards the end of the study. CONCLUSIONS Robot-naïve laparoscopic surgeons may achieve similar outcomes to robotic surgeons relatively early after a graduated mentorship period. This study may apply to a community-based practice in which multiple urologists with varied training backgrounds are granted robot privileges.

361 QUALITY OF LIFE OUTCOMES IN MEN UNDERGOING TREATMENT OF LOCALIZED PROSTATE CANCER: INITIAL RESULTS FROM THE KAISER PERMANENTE SOUTHERN CALIFORNIA REGION

INTRODUCTION AND OBJECTIVES: Risk-stratification based on preoperative data cannot reliably predict organ-confined disease. This is of particular relevance for selecting patients for nerve-sparing (NS) radical prostatectomy (RP). We assessed the impact of our intraoperative neurovascular structure adjacent frozen section examination (NeuroSAFE) guided nerve-sparing approach on the frequency of nerve-sparing and surgical margin rates in D’Amico low-, intermediate-, and high-risk patients, applying a novel score (SAFE-R), combining surgical margin status (SM) and extend of NS. METHODS: From January 2002 to January 2011, 9,674 consecutive RPs were performed at our center. Of these, 4,518 (47%) were conducted with NeuroSAFE. Proportions of NS, SM-status were assessed. Subsequently, a score for oncological safe NS (SAFE-R) was developed. SAFE-R was categorized as 3 (for negative SM and bilateral NS), 2 (for negative SM and unilateral NS), 1 (for negative SM without NS) and 0 (for patients with positive SM), respectively. The impact of NeuroSAFE on SAFE-R was analyzed by chi-square test and confirmed with a multinominal logistic regression, controlling for preoperative risk-factors. All analyses were stratified for patients of lowintermediateor high-risk according to the D’Amico classification. RESULTS: D’Amico high-, intermediateand low-risk profile was found in 1,319 (13.6%), 4,245 (43.9%) and 4,110 (42.5%) of all patients respectively. Within the low-risk group, a SAFE-R-0 (positive SM) was significantly less prevalent and SAFE-R scores of 2 or 3 (unior bilateral NS and negative SM) were more prevalent in patients undergoing neuroSAFE, compared to non-neuroSAFE patients (10.5 vs. 13.2%, and 88.1 vs. 85.7%, respectively, p 0.001). Similarly, in intermediate and high-risk patients, neuroSAFE resulted in lower proportions of SAFE-R score 0 (15.9 vs. 19.9% and 27.6 vs. 33.6%) and higher proportions of SAFE-R score 3 (53.7 vs. 44.1% and 32.4 vs. 17.3%, respectively, all p 0.001). Linkage between the neuroSAFE approach and SAFE-R was confirmed after multinominal logistic adjustment for preoperative risk factors. CONCLUSIONS: SAFE-R represents a novel score to assess and report on oncological safe nerve-sparing in RP. Frozen section navigated nerve-sparing (NeuroSAFE) is associated with enhanced SAFE-R-scores without compromising oncological safety, even in highrisk patients.

80 OSTEOPOROSIS MANAGEMENT PROGRAM DECREASES THE INCIDENCE OF HIP FRACTURES IN PATIENTS WITH PROSTATE CANCER ON ANDROGEN SUPPRESSION

INTRODUCTION AND OBJECTIVES: Androgen suppression as a treatment for prostate cancer can cause osteoporosis, which can result in hip fractures. Kaiser Permanente Southern California (KPSC) has pioneered an osteoporosis disease management program, Healthy Bones Program (HBP), which has shown to reduce hip fracture rates in the osteoporotic population. However, it is currently unknown if patients who are on androgen suppression due to prostate cancer would also experience a lower rate of hip fracture if enrolled in HBP. METHODS: Since 2002, the Healthy Bones Program has been implemented at all KPSC hospitals for any patient who has the risk of developing osteoporosis. HBP patients undergo a dual x-ray absorptiometry scan (DEXA), and are started on oral Vitamin D/calcium and/or bisphosphonate therapy based on their initial T score. Using the KPSC Cancer Registry, we performed a retrospective review of 2,182 patients who were diagnosed with prostate cancer between January 2003 and December 2007 and are on leuprolide androgen suppression up to September 2008. Patients who were in the HBP were identified by the presence of DEXA scans, whereas patients who were not followed by the protocol did not have DEXA scans. Exclusion criteria included: patients who had less than 6 months of health plan membership, were younger than 50 years of age, had a DEXA scan performed greater than 3 months prior to the first leuprolide dose, had less than 6 months of follow up, had a previous hip fracture, and patients who had only one dose of leuprolide. The number of hip fractures was recorded. RESULTS: A final group of 1,482 patients was identified. There were 1,025 patients in the HBP cohort, and 457 patients in the nonHBP group. The mean age was older in the HBP group, 74 vs. 71 years, respectively (p 0.01). The mean total number of leuprolide dosages given was also higher for the HBP group, 6.3 vs. 4.8, respectively (p 0.01). The racial breakdown was similar between the two groups (p 0.5). The incidence rate of hip fractures per 1,000 person years was lower for the HBP group, 4.44 vs. 11.96, respectively. For patients who sustained hip fractures, median time from first leuprolide dose to hip fracture was longer for the HBP group, 834 days to 390 days, respectively. CONCLUSIONS: Hip fracture incidence rates are reduced by nearly one third when castrated prostate cancer patients are enrolled in the HBP. Due to the high healthcare costs, morbidity and mortality of hip fractures, this finding may have a significant implication in the management of this population of patients on androgen suppression for prostate cancer.