Effectiveness of Robotic Compared to Standard Prostatectomy for Prostate Cancer

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DESCRIPTION (provided by applicant): This application addresses broad Challenge Area (05) Comparative Effectiveness Research and specific Challenge Topic 05-EB-104 Comparative Effectiveness of Robotic Surgery. We hypothesize that minimally invasive robotic prostatectomy is associated with reduced initial treatment-related morbidity and similar cancer control, but at a higher overall cost than standard invasive prostatectomy. The use of robotic assistance in prostatectomy for prostate cancer has become commonplace, but its effectiveness has not been compared to standard prostatectomy in prospective, multi-center studies. Instead, adoption of robot-assisted prostatectomy has thus far been based on single-surgeon series and a few cross-sectional, retrospective multi-center studies (the latter cannot adjust for pretreatment HRQOL differences - pivotal determinants of outcome). Our population-based studies showed that minimally invasive prostatectomy can be associated with reduced morbidity, but is also associated with higher rates of subsequent salvage cancer treatment (J Clin Onc 2008, 26:2278) Clinical as well as patient-reported outcome data from prospective, multi-center cohorts are needed for comprehensive comparison of cost-effectiveness between robotic and standard prostatectomy. To address this need, we assembled a consortium that combines two large, prospective, multi-center prostate cancer patient cohorts (PROSTQA, described in N Eng J Med 2008, 358:1250 and CaPSURE, described in Cancer 2007, 109:518) with a population-based cohort. We propose to evaluate these cohorts for the following Aims: Aim 1: To compare clinical as well as patient-reported outcomes between robotic and open prostatectomy. This Aim will focus on 1800 prostatectomy patients (700 robot-assisted and 1100 open) from our prospective PROSTQA and CaPSURE cohorts in whom pretreatment health-related quality of life (HRQOL) and clinical factors and outcome are measured. This will include 1296 patients enrolled from 2004-7 who are already being followed, and 600 additional prostatectomy patients to be enrolled in the 1st year of the Challenge project. Aim 2: To assess surgeon effects in the evolution of robot-assisted prostatectomy outcomes. Our prospective PROST-QA and CaPSURE cohorts combined include over 60 urologists with robotic cases enrolled from 20 separate clinical sites. This setting uniquely enables evaluating how surgeon experience and other factors relate to outcomes, and whether robotic assistance reduces variance between surgeons. Aim 3: To compare costs and cost effectiveness by QALY models between standard and robot-assisted prostatectomy. Cost data has not been combined with HRQOL outcomes before to compare robotic and standard prostatectomy cost effectiveness via QALY models. Cost data from 8831 SEER-Medicare patients will be combined with costs and outcomes in our prospective cohorts to model comparative cost-effectiveness. These 3 Aims will uniquely combine a foundation of over 1800 patients in our prospective multi-center studies with 8831 Medicare-SEER subjects to assess the comparative effectiveness of robotic prostatectomy. This application addresses broad Challenge Area (05) Comparative Effectiveness Research and specific Challenge Topic 05-EB-104 Comparative Effectiveness of Robotic Surgery: "Compared to standard invasive surgical procedures, minimally-invasive robotic surgical procedures have the potential to provide a safer and more precise treatment for a variety of conditions including prostate cancer. PUBLIC HEALTH RELEVANCE: Comparison of robotic procedures with standard invasive treatments should demonstrate the comparative effectiveness and comparative cost of robotic interventions for the clinical treatment of disease." To address this knowledge gap, we propose study of 1800 patients treated at more than 20 centers with expertise in robotic and standard prostate surgery; these patients will have been evaluated for quality of life before and after surgery, and for possible complications, costs, and cancer control. We will combine information from their experience with information regarding costs of care among 8831 Medicare patients undergoing standard or robotic prostate surgery to determine whether robotic assistance for prostate surgery is cost effective as compared to standard prostatectomy. Our findings will help determine whether robots improve quality and consistency of performance in the operating room as robots are known to have accomplished in manufacturing.