Comparative Analysis of Surgical Treatment Options for Localized Prostate Cancer

描述(由调查者提供)：本申请涉及广泛的挑战领域(05)比较有效性研究(CER)和特定挑战主题05-CA-104：癌症治疗研究的比较有效性。前列腺癌是男性最常见的恶性肿瘤，据估计，2008年美国新增确诊病例18.6万例。开放或微创根治性前列腺癌切除术是治疗局限性前列腺癌最常用的方法。然而，循证医学尚未确定这些不同治疗方案的益处。尽管关于微创技术围手术期和肿瘤学结果的数据很少，但它的使用已经呈指数级增长。开放(ORP)和微创根治性前列腺切除术(MRP)之间的费用差异的信息也有限，现有的文献无法说明患者自掏腰包的费用。考虑到受影响的男性人数众多，以及与手术治疗相关的费用，这些公共卫生问题值得调查。虽然由于应计困难，不太可能对MRP和ORP进行随机比较，但基于总体的大型数据集可以为比较有效性研究提供宝贵的资源。这项研究建议使用几个大型国家数据资源和从一个大容量专科癌症中心前瞻性收集的数据，在围手术期结果和成本方面比较局限性前列腺癌的手术治疗方案(MRP和ORP)。具体目的1是比较在以人群为基础的观察队列中接受RP治疗的男性局部前列腺癌患者的围手术期结果、并发症和直接医疗费用(取自与联邦医疗保险索赔数据库相连的监测、流行病学和最终结果(SEER)基于人群的癌症登记)。比较的结果包括术后90天的发病率和死亡率、住院时间、晚期尿路和肠道并发症、大小便失禁的治疗、术后放射或雄激素剥夺治疗的使用，以及直接的医疗费用。将使用多变量方法比较不同组之间的结果，并根据社会人口学和临床协变量进行调整。RP手术技术之间的成本比较将通过将手术后一年内支付的所有医疗保险费用合计来完成。具体目标2是确定和比较RP患者在ORP和MRP治疗后的医疗、非医疗和间接成本。为此，我们将前瞻性地确定和比较来自一家大容量、综合性癌症中心的RP患者队列中的此类成本。这部分研究的数据将来自电子医疗记录和临床研究数据库(CAIIS)和按特定时间间隔进行的调查。这项调查将重点关注康复期间的家庭护理费用、大小便失禁或勃起功能障碍以及无法重返工作岗位。 公共卫生相关性：前列腺癌是美国男性最常见的癌症，手术切除前列腺癌(根治性前列腺癌)会带来巨大的经济负担，这是前列腺癌最常见的治疗方法，尚未扩散到其他组织。 前列腺癌的治疗有多种手术方法，但不幸的是，很少有高质量的研究比较不同的技术。更好地比较微创和开放根治性前列腺切除术的并发症、结果和成本，将有助于患者、医生和卫生保健政策制定者做出治疗决策，从而实现更好的患者护理和潜在的更低成本。

DESCRIPTION (provided by investigator): This application addresses broad challenge Area (05) Comparative Effectiveness Research (CER) and the specific Challenge Topic, 05-CA-104: Comparative Effectiveness of Research on Cancer Treatment. Prostate cancer is the most common malignancy in men, with an estimated 186,000 new cases diagnosed in the US in 2008. Radical prostatectomy (RP) by open or minimally invasive techniques is the most common treatment for localized prostate cancer. However, evidence-based medicine has not established the benefit of these different treatment options. Despite the paucity of data on perioperative and oncologic outcomes of the minimally invasive technique, its use has increased exponentially. There is also limited information on cost differences between open (ORP) and minimally invasive radical prostatectomy (MRP), and the available literature fails to account for patient out-of-pocket expenditures. Given the large number of men affected and the costs associated with surgical treatment, these public-health issues warrant investigation. Although a randomized comparison of MRP and ORP is unlikely to occur because of accrual difficulty, large population-based data sets can provide a valuable resource for comparative effectiveness studies. This study proposes to compare surgical treatment options for localized prostate cancer (MRP versus ORP) in terms of perioperative outcomes and cost, using several large national data resources and prospectively collected data from a large-volume specialty cancer center. Specific Aim 1 is to compare perioperative outcomes, complications, and direct medical costs between RP surgical techniques in a population-based observational cohort of men treated with RP for localized prostate cancer (taken from the Surveillance, Epidemiology and End Results (SEER) population-based cancer registry linked with Medicare claims database). The outcomes for comparison include 90-day postoperative morbidity and mortality, length of hospital stay, late urinary and bowel complications, treatment of incontinence, use of postoperative radiation or androgen deprivation therapy, and direct medical costs. Multivariable methods will be used to compare outcomes between groups, adjusting for sociodemographic and clinical covariates. The cost comparison between RP surgical techniques will be accomplished by totaling all Medicare payments made within one year of surgery. Specific Aim 2 is to identify and compare medical, nonmedical, and indirect costs following ORP and MRP in a prospective cohort of RP patients. For this aim, we will prospectively identify and compare such costs in a cohort of RP patients from a large-volume, comprehensive cancer center. Data for this portion of the study will come from an electronic medical record and clinical research database (Caisis) and from a survey administered at specific intervals. The survey will focus on expenses related to home care during recovery, incontinence or erectile dysfunction, and inability to return to work. PUBLIC HEALTH RELEVANCE: Prostate cancer is the most common cancer in American men and there is a substantial economic burden associated with surgical removal of the prostate gland (radical prostatectomy), the most common treatment for prostate cancer that has not spread to other tissues. There are various surgical approaches for treating prostate cancer, but unfortunately few high-quality studies have compared the different techniques. Better comparisons of complications, outcomes, and costs between minimally invasive and open radical prostatectomy would assist patients, physicians, and health care policy makers in treatment decisions, resulting in better patient care and potentially lower costs.