Optimizing prostate cancer care: integrating risks, benefits, and patient experiences in the new era of molecular imaging

项目摘要/摘要 前列腺癌的分子成像革命正在进行中。要克服长期存在的限制， 前列腺癌分期，几种正电子发射断层扫描(PET)最近已被批准和 根据诊断准确率提高的证据，迅速融入临床护理。然而， 广泛的PET成像的后果尚不清楚。这是因为这些测试的批准是 基于提高的诊断准确性，替代终点，而不是患者受益的直接证据。通过 更早地发现小的癌症部位，PET成像可能会带来一系列的影响--既有积极的，也有 阴性--这一点可能因患者而异。宠物成像可以提高存活率，减少 转移性癌症的症状出现在一个子集，但也可能增加治疗毒性，心理 其他人的负担和成本。目前，没有任何信息可以帮助指导患者或利益相关者何时 考虑到这些权衡。为了减少这些不确定性，我们的目标是开发一种决策模型 考虑PET成像在多个维度上的影响。为了告知这个模型，我们将生成真实的- 来自各种来源的世界证据。在第一个目标中，我们将对大型、 全国有代表性的数据库，以评估PET成像的有效性，重点是关联 在系统治疗的成像启动、进展到激素难治性疾病和成本之间。在AIM 第二，我们将测量PET成像对患者报告的结果测量的纵向影响，相关指标包括 心理影响(焦虑和不确定)和与健康有关的生活质量。为了获得更深层次的视角 关于患者的检测体验，我们还将对一家规模较小的 并将定量和定性来源的研究结果结合起来。在第三个研究目标中，我们 将整合来自目标1和目标2的输入，以构建基于个体的状态转换微模拟模型 检查PET成像使用的常见场景。这些模型的输出将包括以下估计 有效性，以及可能与或多或少程度的 是利是弊。这项研究的结果将使患者、提供者和其他前列腺癌利益相关者 具有关于PET成像潜在的短期和长期影响的实用的新信息。如果成功， 这种评估有效性的方法将适用于其他类似的分子成像方式， 将很快在诊断准确率提高的代理终点的基础上进入临床护理，但没有 长期临床疗效的证据。

PROJECT SUMMARY/ABSTRACT A molecular imaging revolution is underway in prostate cancer. To overcome longstanding limitations in prostate cancer staging, several positron-emission tomography (PET) scans have recently been approved and rapidly integrated into clinical care based on evidence of improved diagnostic accuracy. However, the consequences of widespread PET imaging are unknown. This is because the approvals of these tests are based on improved diagnostic accuracy, a surrogate endpoint, rather than direct evidence of patient benefit. By finding small sites of cancer earlier, PET imaging could introduce a cascade of effects—both positive and negative—that could vary from patient to patient. PET imaging could lead to improved survival and fewer symptoms from metastatic cancer in a subset, but could also increase treatment toxicity, psychological burdens, and costs in others. Currently, no information is available to help guide patients or stakeholders when considering these tradeoffs. To reduce these uncertainties, our goal is to develop a decision model that considers the effects of PET imaging across multiple dimensions. To inform this model, we will generate real- world evidence from a diversity of sources. In aim one, we will conduct complementary analyses of large, nationally representative databases to evaluate the effectiveness of PET imaging, focusing on the associations between imaging initiation of systemic therapy, progression to hormone-refractory disease, and costs. In aim two, we will measure the longitudinal impact of PET imaging on patient-reported outcome measures relating to psychological effects (anxiety and uncertainty) and health-related quality of life. To gain a deeper perspective about patient experiences with testing we will also conduct longitudinal qualitative interviews among a smaller subset of patients and integrate the findings from quantitative and qualitative sources. In the third study aim we will incorporate inputs from Aims 1 and 2 to construct individual-based state-transition microsimulation models examining common scenarios for PET imaging use. The outputs from these models will include estimates of effectiveness, as well as patient characteristics that may be associated with greater or lesser degrees of benefit or harm. The results of this study will equip patients, providers, and other prostate cancer stakeholders with practical, new information about the potential short and long-term effects of PET imaging. If successful, this approach for evaluating effectiveness will be applicable to other similar molecular imaging modalities that will soon enter clinical care on the basis of surrogate endpoints of improved diagnostic accuracy, but without evidence of long-term clinical efficacy.