10-year Comparative Effectiveness and Harms of Treatments for Prostate Cancer

项目摘要 关于管理选项的比较有效性和比较危害的可用文献 对于局限性前列腺癌来说，不足以为患者之间的共同决策过程提供动力， 提供商现有的少数随机试验在重要方面存在缺陷，留下了关于 如何最好地管理新诊断的前列腺癌，以及副作用和疗效之间可能的权衡 手术放射和主动监视一项执行良好的长期、基于人群的研究， 在一个不同的队列中的真实世界的结果将大大增加文献，并可以克服一些 早期随机临床试验的局限性。手术与非手术治疗的疗效对比分析 辐射（CEASAR）队列是一项基于人群的队列研究，约有3000名男性（超过25%为非白人） 患有局限性前列腺癌的患者纵向患者报告的数据已收集出来， 到5年，并在诊断后12个月进行病历审查。该队列提供了一个 研究比较长期肿瘤学和生活质量结果的宝贵机会。另外它的 多样性和广泛性使得研究患者特征的影响成为理想的队列，例如 基线疾病风险分层，种族，年龄和合并症，对这些下游结果的影响。具体目标 是： 1.比较手术、放射和主动监测的临床结果（癌症结果和 并发症）。 2.比较这些治疗方案的患者报告结局与疾病特异性和 一般生活质量结局、财务毒性和定性结局 3.探索基线患者特征对肿瘤学和生活质量结局的影响。 为了实现这些目标，我们将在10年后进行患者调查和病历审查。 诊断，我们将进行结构化的定性研究访谈的一个子集的病人。拟议 这项研究借鉴了CEASAR调查人员的经验，他们自2009年以来成功合作， 规划和执行几轮数据收集、分析和公布工作。本研究结果 将用于告知共享决策过程，以提高治疗之间的一致性 患者的偏好和优先级。

Project Summary The available literature regarding comparative effectiveness and comparative harms of management options for localized prostate cancer is inadequate to power a shared decision-making process between patients and providers. The few randomized trials that exist are flawed in important ways, leaving enormous uncertainty about how best to manage newly diagnosed prostate cancer, and possible trade-offs between side-effects and efficacy of surgery, radiation and active surveillance. A well-executed long-term, population-based study that assesses real-world outcomes in a diverse cohort would add considerably to the literature and could overcome some of the limitations of earlier randomized clinical trials. The Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) cohort is a population-based cohort study of approximately 3000 men (over 25% non-white) with localized prostate cancer, accrued in 2011-12. Longitudinal patient-reported data have been collected out to 5 years, and a medical chart review was performed 12 months after diagnosis. This cohort provides an invaluable opportunity to study comparative long-term oncologic and quality of life outcomes. In addition, its diversity and breadth make in an ideal cohort in which to study the influence of patient characteristics, such as baseline disease risk stratum, race, age and comorbidity, on these downstream outcomes. The Specific Aims are to: 1. Compare the clinical outcomes of surgery, radiation and active surveillance (cancer outcomes and complications). 2. Compare patient-reported outcomes of these management options with respect to disease-specific and general quality of life outcomes, financial toxicity, and qualitative outcomes 3. Explore the influence of baseline patient characteristics on the oncologic and quality of life outcomes. In order to accomplish these Aims, we will perform a patient survey and medical chart review 10 years after diagnosis, and we will perform structured qualitative research interviews with a sub-set of patients. The proposed study draws on the experience of the CEASAR investigators who have collaborated successfully since 2009 on the planning and execution of several rounds of data collection, analysis and publication. The results of this study will be utilized to inform the shared decision-making process, in order to improve concordance between treatment decisions and patient preferences and priorities.