Trends in Surveillance for Localized Prostate Cancer and Barriers to its Use

描述（由申请人提供）：由于许多前列腺癌是非致死性的，并且具有长期的自然病史，因此观察局限性前列腺癌通常是立即确定性治疗的合理替代方案。在前瞻性队列研究中，主动监测（AS）与低风险临床局限性前列腺癌管理中近100%的疾病特异性生存率相关，近年来已被推广为阻止低风险疾病过度治疗的一种手段。然而，AS在前列腺癌的治疗中似乎是一种未被充分利用的策略，部分原因可能是它与被动观察策略（称为观察等待（WW））有关，后者在过去几十年中更常被推荐用于老年和体弱男性。而AS旨在识别疾病进展的迹象，并在发现进展时提供明确的治疗（放疗或手术），WW旨在允许前列腺癌进展，假设患者更有可能死于其他原因，并且仅提供姑息性干预以缓解症状。观察 前列腺癌在欧洲和加拿大比在美国获得了更广泛的接受，在美国，低风险患者的使用率保持在10%或更低。为了扩大接受和坚持AS管理低风险临床局限性前列腺癌，它可能是必要的，以区分它从WW在共同的临床实践，并确定患者层面的因素和医生的沟通风格，影响选择AS的决定。我们建议使用来自两项大型，以社区为基础的前瞻性队列研究的数据，研究设计相似的局限性前列腺癌男性（前列腺癌结局研究[PCOS]和手术和放射的比较有效性分析[CEASAR]），以比较两个时代（20世纪90年代的PCOS和2010年代的CEASAR）之间监测的使用。我们的目的是确定是否有证据表明AS是积极治疗的安全替代方案，导致其在低风险疾病男性中的使用增加，以及在两个时代中年轻，健康男性中的使用增加（表明从WW过渡到AS）。其次，我们将使用CEASAR基线问卷来确定医生沟通方式对AS选择的影响程度，以支持其他目前可用的治疗方法。拟议研究的结果将为泌尿外科质量合作组织（一个由美国中西部、大西洋中部和东南部的7家泌尿外科诊所组成的多机构小组）内的AS利用计划研究提供基础。使用一个既定的质量评估，质量改进模型，我们的目标是前瞻性地评估医生和患者层面的障碍，以AS;然后执行教育干预与医生，努力增加使用AS在适当的临床场景;然后重新评估，以评估干预的有效性。由于前列腺癌是男性中最常见的癌症，因此增加AS使用的潜在公共卫生影响是巨大的。

DESCRIPTION (provided by applicant): Observation of localized prostate cancer is often a reasonable alternative to immediate definitive treatment because many prostate cancers are non-lethal and have a protracted natural history. Active surveillance (AS) is associated with nearly 100% disease-specific survival in the management of low-risk clinically localized prostate cancer in prospective cohort studies and has been promoted in recent years as a means of stemming over-treatment of low-risk disease. However, AS seems to be an underutilized strategy in the management of prostate cancer, perhaps in part because of its association with the passive observation strategy known as watchful waiting (WW), which was more commonly recommended in elderly and infirmed men in past decades. Whereas AS seeks to identify signs of disease progression and offers definitive therapy (radiation or surgery) if progression is found WW is designed to allow prostate cancer to progress, assuming that the patient is more likely to die of other causes, and only palliative intervention is offered for symptom relief. Observation of prostate cancer has gained wider acceptance in Europe and Canada than it has in the US, where utilization remains at 10% or less among low-risk patients. In order to expand the acceptance of and adherence to AS for management of low-risk clinically localized prostate cancer, it may be necessary to distinguish it from WW in common clinical practice and to identify patient-level factors and physician communication styles that impact the decision to select AS. We propose using data from two large, community-based prospective cohort studies of men with localized prostate cancer with similar study designs (Prostate Cancer Outcomes Study [PCOS] and Comparative Effectiveness Analysis of Surgery And Radiation [CEASAR]), to compare the use of surveillance between two eras (1990s for PCOS and 2010s for CEASAR). Our aim is to determine whether the evidence demonstrating that AS is a safe alternative to active treatment has led to an increase in its use among men with low-risk disease and to increased use among younger, healthier men across the two eras (suggesting a transition from WW to AS). Secondly, we will use the CEASAR baseline questionnaire to determine the extent to which physician communication style influences the selection of AS in favor of other currently available treatments. The results of the proposed study will provide the foundation for a planned study of AS utilization within the Urological Surgery Quality Collaborative, a multi-institutional group of 7 urology practices throughout the Mid- West, Mid-Atlantic and Southeastern United States. Using an established quality assessment, quality improvement model, we aim to assess prospectively the physician and patient level barriers to AS; then perform an educational intervention with physicians in an effort to increase use of AS in appropriate clinical scenarios; then reassess to evaluate the effectiveness of the intervention. Because prostate cancer is the most commonly diagnosed cancer among men, the potential public health impact of increasing AS use is enormous.