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PI-02 A SYSTEMATIC APPROACH TO DISCUSSING ACTIVE SURVEILLANCE TO PATIENTS WITH LOW-RISK PROSTATE CANCER
THE JOURNAL OF UROLOGYâ
Vol. 195, No. 4S, Supplement, Saturday, May 7, 2016
follow-up among survivors was 3.86 years. P-MIBC patients had significantly worse OS (p ¼ 0.026), RFS (p ¼ 0.002), and CSS (p ¼ 0.022) on univariable analysis as compared to DN-MIBC patients (Fig. 1). After adjusting for pathologic T stage on multivariable analysis, P-MIBC associations with OS and CSS were no longer significant; however, P-MIBC remained associated with a significantly increased risk of recurrence compared to DN-MIBC (HR: 2.40, 95% CI¼ 1.38- 4.19, p ¼ 0.002). CONCLUSIONS: Patients with P-MIBC appear less likely to respond to NAC than DN-MIBC, though these findings should be confirmed in prospective studies. The mechanisms for platinum resistance in P-MIBC are under investigation, but the benefits of earlier surgical intervention before progression to MIBC cannot be overstated.
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through May 2015 who were newly diagnosed with Gleason 3+3 prostate cancer. We compared the rate at which patients selected AS during the 24-month period before the training program for surgeons (August 2014) with the rate after the intervention, controlling for trends occurring in the time period prior to the intervention as well as for case mix (age, comorbidity, ethnicity, pathologic factors and PSA level). Observed rates of AS after the intervention were compared to those predicted based on patient and tumor characteristics. RESULTS: We collected data from 937 consecutive patients with Gleason 3+3 prostate cancer seen by one of the participating surgeons during the study period. 67% of patients met the Epstein criteria for very low risk disease. The proportion of patients who selected AS increased from 69% before the training intervention to 82% afterwards. After adjusting for time trends, the absolute improvement was 9.3% (95% CI -0.2%,0.19%), a relative reduction in the risk of unnecessary curative treatment of 30%. CONCLUSIONS: A systematic approach to counseling men with prostate cancer using appropriate framing principles can be taught to physicians and effectively integrated in clinic to promote AS. This novel approach provides the framework to advance the patient-physician relationship and help improve the dilemma of cancer screeningrelated overtreatment that occurs across medicine. Source of Funding: Supported by the Sidney Kimmel Center for Prostate and Urologic Cancers and by NIH Cancer Center Support Grant P30 CA008748 to PI: Craig B. Thompson, MD.
PI-03 A RANDOMIZED STUDY OF INTRA-OPERATIVE AUTOLOGOUS RETROPUBIC URETHRAL SLING ON URINARY CONTROL AFTER ROBOT ASSISTED RADICAL PROSTATECTOMY Hao Nguyen*, Michael Leapman, San Francisco, CA; Sanoj Punnen, Miami, FL; Janet Cowan, San Francisco, CA; Clint Cary, Indianapolis, IN; Christopher Welty, Matthew Cooperberg, Maxwell Meng, Kirsten Greene, Sima Porten, Maurice Garcia, Peter Carroll, San Francisco, CA Source of Funding: Supported by the Sidney Kimmel Center for Prostate and Urologic Cancers at Memorial Sloan Kettering Cancer Center, Pin Down Bladder Cancer, and the Michael A. and Zena Wiener Research and Therapeutics Program in Bladder Cancer.
PI-02 A SYSTEMATIC APPROACH TO DISCUSSING ACTIVE SURVEILLANCE TO PATIENTS WITH LOW-RISK PROSTATE CANCER Behfar Ehdaie*, Melissa Assel, Nicole Benfante, New York, NY; Deepak Malhotra, Boston, MA; Andrew Vickers, New York, NY INTRODUCTION AND OBJECTIVES: A majority of men with screen-detected prostate cancer have low-risk tumors that can be safely monitored with active surveillance (AS). Although underuse of AS has often been ascribed to misaligned incentives amongst physicians, patient preference for aggressive management also plays a role. Advocates of AS often report difficulty counseling patients regarding the merits of this approach. We developed a novel standardized approach for physicians to counsel patients on AS, using appropriate framing derived from behavioral science principles commonly studied by negotiation scholars, and tested the effectiveness of the intervention to increase acceptance of AS for management of low risk prostate cancer. METHODS: We outlined a conceptual framework of factors influencing treatment selection for low risk prostate cancer based on a review of relevant literature. We used this to develop a systematic counseling approach for physicians comprised of appropriate framing techniques, derived from a review of behavioral science research. Six surgeons were recruited to participate in a training program. We collected data for all patients with a clinical visit from August 2012
INTRODUCTION AND OBJECTIVES: The effectiveness of retropubic urethral sling to reduce post-prostatectomy incontinence has not been evaluated previously in a large randomized trial, despite continued use. We evaluated whether placement of a retropubic urethral sling fashioned from autologous vas deferens at the time of robotassisted radical prostatectomy (RARP) improved recovery of urinary control post-surgery in a randomized clinical trial. METHODS: In a phase-2, single-blinded trial, 203 patients were randomized to undergo RARP by multiple surgeons with or without sling placement. The primary endpoint was complete continence (requiring 0 urinary pads per day) 6 months after RARP. Secondary outcomes included time to continence (0 or 1 pad per day) and differences in urinary quality of life using patient-reported EPIC and IPSS scores. Logrank test and Cox proportional hazards regression were used to evaluate time to continence. RESULTS: Of 195 patients, 95 were randomized to undergo sling placement and 100 to no sling at RARP. At 6 months after surgery, 66% non-sling vs. 65% sling patients reached complete continence (0 pads) (chi-square p¼0.84). 85% non-sling and 78% sling patients achieved continence (0 or 1 pad per day) by 6 months (log-rank p¼0.90). Mean time to continence was 9 weeks for non-sling and 10 weeks for sling patients. IPSS and EPIC scores did not differ significantly between groups. Incidence of severe urinary symptoms (IPSS 20-35) was 4% in non-sling vs. 1% in sling patients. Rate of urinary retention requiring short term catheter was 4% in the non-sling vs. 8% in sling group. Only individual surgeon was associated with improved continence (HR 2.08, 1.19-3.64 95% CI, p¼<0.01), adjusting for age, BMI, prostate volume, complete nerve sparing and other baseline characteristics. CONCLUSIONS: This randomized trial failed to demonstrate that placing an autologous retropubic urethral sling at time of RARP improved time to continence as measured at 6 months. However,
Vol. 195, No. 4S, Supplement, Saturday, May 7, 2016
follow-up among survivors was 3.86 years. P-MIBC patients had significantly worse OS (p ¼ 0.026), RFS (p ¼ 0.002), and CSS (p ¼ 0.022) on univariable analysis as compared to DN-MIBC patients (Fig. 1). After adjusting for pathologic T stage on multivariable analysis, P-MIBC associations with OS and CSS were no longer significant; however, P-MIBC remained associated with a significantly increased risk of recurrence compared to DN-MIBC (HR: 2.40, 95% CI¼ 1.38- 4.19, p ¼ 0.002). CONCLUSIONS: Patients with P-MIBC appear less likely to respond to NAC than DN-MIBC, though these findings should be confirmed in prospective studies. The mechanisms for platinum resistance in P-MIBC are under investigation, but the benefits of earlier surgical intervention before progression to MIBC cannot be overstated.
e409
through May 2015 who were newly diagnosed with Gleason 3+3 prostate cancer. We compared the rate at which patients selected AS during the 24-month period before the training program for surgeons (August 2014) with the rate after the intervention, controlling for trends occurring in the time period prior to the intervention as well as for case mix (age, comorbidity, ethnicity, pathologic factors and PSA level). Observed rates of AS after the intervention were compared to those predicted based on patient and tumor characteristics. RESULTS: We collected data from 937 consecutive patients with Gleason 3+3 prostate cancer seen by one of the participating surgeons during the study period. 67% of patients met the Epstein criteria for very low risk disease. The proportion of patients who selected AS increased from 69% before the training intervention to 82% afterwards. After adjusting for time trends, the absolute improvement was 9.3% (95% CI -0.2%,0.19%), a relative reduction in the risk of unnecessary curative treatment of 30%. CONCLUSIONS: A systematic approach to counseling men with prostate cancer using appropriate framing principles can be taught to physicians and effectively integrated in clinic to promote AS. This novel approach provides the framework to advance the patient-physician relationship and help improve the dilemma of cancer screeningrelated overtreatment that occurs across medicine. Source of Funding: Supported by the Sidney Kimmel Center for Prostate and Urologic Cancers and by NIH Cancer Center Support Grant P30 CA008748 to PI: Craig B. Thompson, MD.
PI-03 A RANDOMIZED STUDY OF INTRA-OPERATIVE AUTOLOGOUS RETROPUBIC URETHRAL SLING ON URINARY CONTROL AFTER ROBOT ASSISTED RADICAL PROSTATECTOMY Hao Nguyen*, Michael Leapman, San Francisco, CA; Sanoj Punnen, Miami, FL; Janet Cowan, San Francisco, CA; Clint Cary, Indianapolis, IN; Christopher Welty, Matthew Cooperberg, Maxwell Meng, Kirsten Greene, Sima Porten, Maurice Garcia, Peter Carroll, San Francisco, CA Source of Funding: Supported by the Sidney Kimmel Center for Prostate and Urologic Cancers at Memorial Sloan Kettering Cancer Center, Pin Down Bladder Cancer, and the Michael A. and Zena Wiener Research and Therapeutics Program in Bladder Cancer.
PI-02 A SYSTEMATIC APPROACH TO DISCUSSING ACTIVE SURVEILLANCE TO PATIENTS WITH LOW-RISK PROSTATE CANCER Behfar Ehdaie*, Melissa Assel, Nicole Benfante, New York, NY; Deepak Malhotra, Boston, MA; Andrew Vickers, New York, NY INTRODUCTION AND OBJECTIVES: A majority of men with screen-detected prostate cancer have low-risk tumors that can be safely monitored with active surveillance (AS). Although underuse of AS has often been ascribed to misaligned incentives amongst physicians, patient preference for aggressive management also plays a role. Advocates of AS often report difficulty counseling patients regarding the merits of this approach. We developed a novel standardized approach for physicians to counsel patients on AS, using appropriate framing derived from behavioral science principles commonly studied by negotiation scholars, and tested the effectiveness of the intervention to increase acceptance of AS for management of low risk prostate cancer. METHODS: We outlined a conceptual framework of factors influencing treatment selection for low risk prostate cancer based on a review of relevant literature. We used this to develop a systematic counseling approach for physicians comprised of appropriate framing techniques, derived from a review of behavioral science research. Six surgeons were recruited to participate in a training program. We collected data for all patients with a clinical visit from August 2012
INTRODUCTION AND OBJECTIVES: The effectiveness of retropubic urethral sling to reduce post-prostatectomy incontinence has not been evaluated previously in a large randomized trial, despite continued use. We evaluated whether placement of a retropubic urethral sling fashioned from autologous vas deferens at the time of robotassisted radical prostatectomy (RARP) improved recovery of urinary control post-surgery in a randomized clinical trial. METHODS: In a phase-2, single-blinded trial, 203 patients were randomized to undergo RARP by multiple surgeons with or without sling placement. The primary endpoint was complete continence (requiring 0 urinary pads per day) 6 months after RARP. Secondary outcomes included time to continence (0 or 1 pad per day) and differences in urinary quality of life using patient-reported EPIC and IPSS scores. Logrank test and Cox proportional hazards regression were used to evaluate time to continence. RESULTS: Of 195 patients, 95 were randomized to undergo sling placement and 100 to no sling at RARP. At 6 months after surgery, 66% non-sling vs. 65% sling patients reached complete continence (0 pads) (chi-square p¼0.84). 85% non-sling and 78% sling patients achieved continence (0 or 1 pad per day) by 6 months (log-rank p¼0.90). Mean time to continence was 9 weeks for non-sling and 10 weeks for sling patients. IPSS and EPIC scores did not differ significantly between groups. Incidence of severe urinary symptoms (IPSS 20-35) was 4% in non-sling vs. 1% in sling patients. Rate of urinary retention requiring short term catheter was 4% in the non-sling vs. 8% in sling group. Only individual surgeon was associated with improved continence (HR 2.08, 1.19-3.64 95% CI, p¼<0.01), adjusting for age, BMI, prostate volume, complete nerve sparing and other baseline characteristics. CONCLUSIONS: This randomized trial failed to demonstrate that placing an autologous retropubic urethral sling at time of RARP improved time to continence as measured at 6 months. However,