Effectiveness of Robotic Compared to Standard Prostatectomy for Prostate Cancer

描述(由申请人提供)：本申请涉及广泛的挑战领域(05)比较有效性研究和特定挑战主题05-EB-104机器人手术的比较有效性。我们假设，微创机器人前列腺切除术与减少初始治疗相关的发病率和相似的癌症控制有关，但总体成本高于标准侵袭性前列腺切除术。在前列腺癌的前列腺切除术中使用机器人辅助手术已经变得司空见惯，但在前瞻性的多中心研究中，其有效性还不能与标准的前列腺切除术相比较。相反，到目前为止，机器人辅助前列腺切除术的采用是基于单一外科医生系列和少数横断面、多中心的回溯性研究(后者不能调整治疗前的HRQOL差异--影响结果的关键决定因素)。我们基于人群的研究表明，微创前列腺切除术可以降低发病率，但也与后续癌症挽救治疗的更高比率相关(J Clin ONC 2008，26：2278)需要前瞻性多中心队列的临床和患者报告结果数据，以全面比较机器人前列腺切除术和标准前列腺切除术的成本效益。为了满足这一需求，我们组建了一个联合体，将两个大型、前瞻性、多中心前列腺癌患者队列(PROSTQA，在N Eng J Med 2008,358：1250中描述；CaPSURE，在癌症2007,109：518中描述)与基于人群的队列相结合。我们建议评估这些队列的目的如下：目标1：比较机器人和开放前列腺切除术的临床和患者报告的结果。这一目标将集中在1800名前列腺切除术患者(700名机器人辅助和1100名开放)，这些患者来自我们预期的PROSTQA和CAPSURE队列，在其中测量治疗前健康相关生活质量(HRQOL)以及临床因素和结果。这将包括从2004年到2007年登记的1296名已经被跟踪的患者，以及将在挑战项目的第一年登记的600名额外的前列腺切除术患者。目的2：评估外科医生在机器人辅助前列腺切除术结果演变中的作用。我们未来的Prost-QA和CaPSURE队列包括来自20个不同临床站点的60多名拥有机器人病例的泌尿科医生。这一设置独特地能够评估外科医生的经验和其他因素与结果的关系，以及机器人辅助是否减少了外科医生之间的差异。目的3：用QALY模型比较标准和机器人辅助前列腺切除术的成本和成本效果。以前还没有将成本数据与HRQOL结果相结合，以通过QALY模型比较机器人和标准前列腺切除术的成本效益。来自8831名SEER-Medicare患者的成本数据将与我们前瞻性队列中的成本和结果相结合，以建立比较成本效益的模型。这三个目标将独特地结合我们前瞻性多中心研究中超过1800名患者和8831名Medicare-SEER受试者的基础，以评估机器人前列腺切除术的比较有效性。本申请涉及广泛的挑战领域(05)比较有效性研究和具体挑战主题05-EB-104机器人手术的比较有效性：“与标准的侵入性外科手术程序相比，微创机器人手术程序有可能为包括前列腺癌在内的各种疾病提供更安全和更精确的治疗。 公共卫生相关性：将机器人程序与标准侵入性治疗进行比较，应该证明机器人干预在疾病临床治疗中的相对有效性和相对成本。为了解决这一知识差距，我们建议对在20多个中心接受机器人和标准前列腺手术专业知识治疗的1800名患者进行研究；这些患者将接受手术前后的生活质量评估，以及可能的并发症、成本和癌症控制。我们将把他们的经验信息与8831名接受标准或机器人前列腺手术的联邦医疗保险患者的护理成本信息结合起来，以确定与标准前列腺切除术相比，机器人辅助前列腺手术是否具有成本效益。我们的发现将有助于确定机器人是否像机器人在制造业中所做的那样，提高了手术室的质量和性能的一致性。

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.