503 AN INTERNATIONAL MULTI-CENTRE STUDY EXAMINING DIAGNOSTIC CRITERIA FOR ACTIVE SURVEILLANCE IN MEN UNDERGOING RADICAL PROSTATECTOMY

503 AN INTERNATIONAL MULTI-CENTRE STUDY EXAMINING DIAGNOSTIC CRITERIA FOR ACTIVE SURVEILLANCE IN MEN UNDERGOING RADICAL PROSTATECTOMY

e206 THE JOURNAL OF UROLOGY姞 METHODS: Review was performed of patients who agreed to enroll in an IRB approved, prospective RP database between 2003...

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THE JOURNAL OF UROLOGY姞

METHODS: Review was performed of patients who agreed to enroll in an IRB approved, prospective RP database between 2003 and 2009. 12 robotic surgeons agreed to case monitoring, completed mandatory training requirements, attended regular practice improvement meetings, and received group and individual outcome reports every 6 months as part of a quality assurance program. Pre-operative, peri-operative, and post-operative data was obtained per protocol by an independent nurse funded through grant support. Patients were followed at routine intervals for PSA recurrence (defined as PSA ⬎ 0.1 ng/mL), stricture formation, continence and potency by chart review and validated patient questionnaire. Results were summarized with descriptive statistics. RESULTS: 623 patients were enrolled. Average age was 60 ⫾ 7 years and median pre-operative PSA was 4.4ng/mL (range 0.40-93.90ng/mL). Skin to skin OT was 206 ⫾ 53 minutes and median EBL was 100mL (range 0-1100mL). No surgical deaths occurred. 80.7% of patients had T2 disease on pathology while 19.3% had T3 disease. Overall rates were 3.9% for seminal vesicle involvement and 18.3% for capsular penetration. Overall, there was a 23.6% positive margin rate, with 17.7% of T2 patients having positive margins. At 12 months, PSA recurrence was 6.2%, with 87.1% of those ⬍0.4 ng/mL (n⫽496). At 24 months, recurrence was 7.6% (n⫽370). At 60 months, recurrence was 10.4% (n⫽116). When taking into account margin status, 41.5% of the PSA recurrences were found in margin positive patients. It was also found in 33.3% of patients with seminal vesicle involvement and 19.8% of patients with capsular penetration. By 24 months, strictures were found in 4.8%. An earlier analysis of the database showed at 24 months, 77% of men reported total continence (0 pads/day). Also on this same analysis, without factoring in nerve sparing procedures, 56% of men who reported good erectile function pre-operatively reported good function post-operatively at 24 months. CONCLUSIONS: We believe this study reflects realistic expectations of the expansion of RP in the general community. Monitoring outcomes, sharing practice experience, and developing best practices can optimize care in multi-user community hospitals. Source of Funding: Ministrelli Program for Urology Research and Education

502 THE IMPACT OF SURGEON VOLUME AND SURGICAL APPROACH ON POST-RADICAL PROSTATECTOMY MORBIDITY IN MARYLAND HOSPITALS Jeffrey Mullins*, Elias Hyams, Phillip Pierorazio, Zhaoyong Feng, Bruce Trock, Mohamad Allaf, Brian Matlaga, Baltimore, MD INTRODUCTION AND OBJECTIVES: Nationwide data have suggested a link between surgeon volume and post-operative outcomes for men undergoing radical prostatectomy (RP). Furthermore, single surgeon series have suggested improved patient outcomes using robotic technology. However, the interaction of surgeon volume and surgical approach on post-operative morbidity has been less well characterized. The objective of this study is to assess the impact of surgeon volume and surgical approach on post-RP morbidity. METHODS: The Maryland Health Service Cost Review Commission (HSCRC) database was queried for men undergoing RRP or RALRP from the fourth calendar quarter of 2008 to the first calendar quarter of 2011 using discharge ICD-9 codes. Patient demographic and immediate post-operative outcomes including length of hospital stay (LOS), hospital re-admission within 30 days, and need for intensive care unit admission were compared between patients undergoing surgery by high volume (⬎40 cases/year) and low volume surgeons (⬍ 40 cases/year). Multivariable logistic regression analyses were performed to test the association between operative approach and surgeon volume with post-operative outcomes. RESULTS: The study cohort consisted of 4,064 men undergoing radical prostatectomy of whom 76.6% had their surgery performed by a high volume surgeon. Patients undergoing RP by a low volume

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surgeon were more likely to have a robotic operation, be of nonCaucasian ethnicity, have a longer LOS (2.1 vs. 1.7 days, p ⬍0.001), and were more likely to be readmitted to the hospital within 30 days (1.8% vs. 0.13%, p ⬍ 0.001). Multivariable logistic regression analyses demonstrated that high surgeon volume was significantly associated with lower risk of LOS ⬎ 2 days (OR 0.3, 95% CI: 0.2 - 0.4). Furthermore, open RP was significantly associated with LOS ⬎ 2 days (OR 2.3, 95% CI: 1.8 - 3.0) and 30-day readmission (OR 20.6, 95% CI: 2.7 - 154.5). After controlling for surgical approach, high surgeon volume was significantly associated with LOS ⬎ 2 days for both robotic and open RP, but the impact of surgeon volume on LOS was significantly greater for open RP. CONCLUSIONS: Patients undergoing Robotic RP experienced shorter hospital stays and decreased rates of 30 day re-admission compared to those undergoing open RP. However, surgeon volume decreases post-operative LOS regardless of approach. When considering state-wide data, high surgeon volume and a robotic surgery improve post-operative morbidity. Source of Funding: None

503 AN INTERNATIONAL MULTI-CENTRE STUDY EXAMINING DIAGNOSTIC CRITERIA FOR ACTIVE SURVEILLANCE IN MEN UNDERGOING RADICAL PROSTATECTOMY. Lih-Ming Wong*, David Neal, Richard Johnston, Nimesh Shah, Anne Warren, Cambridge, United Kingdom; Chris Hoven, Melbourne, Australia; Larry Goldenberg, Martin Gleave, Vancouver, Canada; Anthony Costello, Niall Corcoran, Melbourne, Australia INTRODUCTION AND OBJECTIVES: There are numerous inclusion criteria for active surveillance (AS) and discrepancies reflect the uncertainty in predicting the true rate of prostate cancer with adverse features. Given that disease characteristics may display regional differences, it is possible that the application of a selection rule generated from one population may result in inaccurate estimation of disease risk when applied to different cohorts. We examined effects of Klotz and Van den Bergh (Prostate Cancer Research International: Active Surveillance, PRIAS) AS selection criteria on the detection of true low risk prostate cancer. METHODS: From three centers in UK, Canada and Australia, prospective data on men who underwent radical prostatectomy was collated. Men initially suitable for AS, according to Klotz and PRIAS criteria, had prostatectomy specimens analyzed for pathological upgrading (Gleason score ⬎7) and upstaging (⬎pT3 disease). Mann-Whitney U or Kruskal-Wallis ANOVA modelling evaluated differences in continuous variables and Pearson’s Chi-squared or Fisher’s exact test determined differences between categorical variables. Multivariable logistic regression was performed to identify predictors of high-risk disease. A nomogram was generated by logistic regression analysis, and performance characterized by ROC curves. RESULTS: 800 men met the Klotz criteria, and 410 met the more stringent PRIAS criteria. For Klotz and PRIAS groups, the rates for upgrading were 50.6%, and 42.7%, and upstaging 17.6%, 12.4% respectively. Significant predictors of high-risk disease were: - Klotz group: increasing age (OR1.04, p⫽0.02), presence of palpable disease (OR1.54, p⫽0.045), centre of diagnosis (Cambridge OR2.85, p⬍0.001) and number of positive cores (OR1.25, p⬍0.001). - PRIAS group: increasing PSA (OR1.15, p⫽0.043) and presence of palpable disease (OR1.85, p⫽0.04). Cambridge had a high pT3a rate (26% vs. 12%). To assist selection of men in the UK for AS, from the Cambridge data, we generated a nomogram predicting high-risk features in patients who meet the Klotz criteria (AUC of 0.72). CONCLUSIONS: The rate of high-risk disease in prostatectomy patients who pre-operatively meet criteria for AS varies geographically. We found higher rates of re-classification (42.7-50.6%) than previously

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reported from Europe and North America (23-35%). With more stringent selection criteria, there is less reclassification but also fewer men who may benefit from AS. Source of Funding: None.

504 PATHOLOGIC OUTCOMES OF RADICAL PROSTATECTOMY FOLLOWING ACTIVE SURVEILLANCE Raj Satkunasivam*, Girish Kulkarni, Robin Kalnin, John Trachtenberg, Neil Fleshner, Michael Jewett, Alexandre Zlotta, Michael Robinette, Antonio Finelli, Toronto, Canada INTRODUCTION AND OBJECTIVES: We examined prostatectomy pathology outcomes of men on active surveillance (AS) for prostate cancer. First, to determine the impact of time on AS on final pathology, we compared AS patients ultimately treated with radical prostatectomy (RP) to men undergoing immediate radical prostatectomy after a diagnosis of low-risk disease who would have otherwise have been candidates for AS. Second, we compared AS patients progressing to Gleason 7 disease to men treated with similar de novo disease to determine whether AS patients have potentially worse pathologic outcome. METHODS: Upon research ethics approval, we queried our center’s prospective active surveillance database to identify active surveillance (AS) progressors treated by radical prostatectomy (ASRP). We then identified age- and PSA-matched controls from our institution’s prostate cancer database who underwent immediate RP (⬍ 6 months) after the diagnosis of low-risk disease (Group 1). We also compared men progressing to Gleason 7 disease while on AS to an age- and PSA-matched cohort of de novo Gleason 7 disease treated with immediate (⬍ 6 months) RP (Group 2). RESULTS: A total of 42 (14.5%) patients out of 288 underwent radical prostatectomy after AS for grade progression (69%), cancer volume progression without grade progression (12%), PSA elevation without grade progression (7%), anxiety (10%) and LUTS or symptoms (2%). The median time on active surveillance prior to radical prostatectomy was 35.2 months. Demographic and pathologic characteristics of the ASRP group in comparison to Group 1 (n⫽132) and Group 2 (n⫽73) are shown in Table 1. On univariate analysis, the ASRP group had adverse pathologic stage, Gleason grade and rates of extracapsular extension compared to low risk patients undergoing immediate prostatectomy. By comparison, AS patients treated by radical prostatectomy after progression to Gleason 7 did not show any adverse pathologic outcomes compared to Group 2. CONCLUSIONS: Radical prostatectomy after a period of active surveillance does not appear to result in adverse pathologic outcomes when compared to patients with similar preoperative pathology. However, when compared to low risk patients undergoing immediate RP, the former were more likely to have higher grade disease and extracapsular extension.

Source of Funding: None

505 “INDEX LESION” MAPPING BY 3D IMAGE-GUIDED TRUS BIOPSY: CORRELATION WITH STEP-SECTIONED RADICAL PROSTATECTOMY (RP) SPECIMENS Osamu Ukimura*, Pierre-Marie Lewandowski, Scott Leslie, Arnauld Villers, Mitchell Gross, Eric Huang, Andre Luis de Castro Abreu, Sunao Shoji, Monish Aron, Mihir Desai, Inderbir Gill, Los Angeles, CA INTRODUCTION AND OBJECTIVES: Cancer mapping by realtime 3D TRUS tracking of each biopsy trajectory (Urostation®, Koelis, France) provides a novel opportunity to pre-operatively document the actual geographic location of biopsy-proven cancer within the prostate (J Urol 2012 in press). The objective of this study is to determine the accuracy of such 3D TRUS biopsy-based cancer mapping by comparing it with step-sectioned analyses of RP specimens. Index lesion was defined as the lesion with the largest volume or highest Gleason score on RP specimen. METHODS: Of 113 consecutive patients undergoing outpatient real-time 3D TRUS-tracking biopsy, 25 were diagnosed with cancer and underwent robotic radical prostatectomy. In the 25 patients, morphometry and volumetry of each cancer focus was performed from 3 mm step-sectioned RP specimens. Data were collected prospectively: median age (63.2yrs), PSA (7.7 ng/ml), clinical stage T1c/T2 (20/5), biopsy Gleason score 6/7/8/9/10 (8/11/1/4/1), and number of systematic vs. image-targeted biopsy cores per each biopsy session (12 vs. 2.8). For all biopsies and RP specimens, we designated cancer location per 27 regions-of-interest schema of prostate anatomy (Eur Urol 59: 477, 2011). RESULTS: For index/2nd/3rd cancer foci in the RP specimens, morphometrically-calculated median volume was 1.57cc (0.03-7.4), 0.42cc (0.02-1.13), and 0.22cc (0.03-0.49) (p⬍0.01) and median Gleason score was 7, 6, and 6, respectively. Of the total 359 biopsy cores, 103 (28.6%) were positive for cancer. Of the 103 positive cores, 85 (82.5%) hit the index lesion in RP specimens, 12 (12.6%) hit the 2nd lesion, and 5 (4.8%) hit the 3rd lesion. Maximum median cancer core length from index lesion (n⫽25) was 7.5mm (1.8-14.4) and from 2nd/ 3rd lesions (n⫽14) was 3mm (0.75-7.5) (p⬍0.01). In 21 of 25 patients (84%), the spatially documented biopsy with maximum cancer needle core length occurred from the index lesions. In all 25 patients, location of the biopsy with the highest Gleason score corresponded with the index lesion (100%). In no patient was the biopsy Gleason score upgraded at RP.