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

优化前列腺癌护理：在分子成像新时代整合风险、收益和患者体验

• 批准号: 10712074
• 负责人: Michael Stuart Leapman
• 金额: $ 66.04万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-13 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10712074
• 关键词: Accounting; Affect; Aftercare; Age; Anxiety; Benefits and Risks; Biological; Cancer Etiology; Cessation of life; Characteristics; Clinical; Clinical Management; Clinical effectiveness; Complex; Data; Databases; Decision Making; Decision Modeling; Diagnostic; Diagnostic Neoplasm Staging; Dimensions; Disease; Disease Management; Disease Outcome; Disease Progression; Disseminated Malignant Neoplasm; Early Diagnosis; Effectiveness; Electronic Health Record; Evaluation; Funding; Goals; Harm Reduction; Health Care Costs; Hormones; Image; Individual; Institution; Interview; Knowledge; Lead; Life Expectancy; Long-Term Effects; Malignant neoplasm of prostate; Measures; Modeling; Motion; Outcome; Outcome Measure; Output; PSA level; Pathway interactions; Patient Outcomes Assessments; Patient Preferences; Patients; Performance; Physicians; Positron-Emission Tomography; Provider; Radiation; Refractory Disease; Risk; Risk Assessment; Role; Screening for Prostate Cancer; Source; Staging; Surrogate Endpoint; Systemic Therapy; Test Result; Testing; Time; Tracer; Treatment-related toxicity; Uncertainty; United States; United States Food and Drug Administration; Vacuum; Work; X-Ray Computed Tomography; androgen deprivation therapy; bone imaging; cancer care; cancer site; cancer type; castration resistant prostate cancer; clinical care; clinical efficacy; clinical risk; cost; cost effectiveness; data integration; diagnostic accuracy; effectiveness evaluation; experience; health related quality of life; holistic approach; imaging agent; imaging modality; improved; innovation; insight; men; models and simulation; molecular imaging; patient subsets; preference; psychologic; reduce symptoms; treatment duration

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.

项目概要/摘要 前列腺癌领域正在进行分子成像革命，以克服前列腺癌长期存在的局限性。 前列腺癌分期，几种正电子发射断层扫描 (PET) 扫描最近已获得批准，并且 基于诊断准确性提高的证据，迅速融入临床护理。 广泛使用 PET 成像的后果尚不清楚，因为这些测试的批准尚未确定。 基于诊断准确性的提高（替代终点），而不是患者获益的直接证据。 PET 成像可以更早地发现小范围的癌症部位，从而带来一系列积极的和积极的影响。 阴性——这可能因患者而异，可能会提高生存率并减少生存率。 一部分转移性癌症的症状，但也可能增加治疗毒性、心理 目前，没有任何信息可以帮助指导患者或利益相关者。 考虑到这些权衡，我们的目标是开发一个决策模型，以减少这些不确定性。 考虑 PET 成像在多个维度上的影响 为了告知该模型，我们将生成真实的 来自不同来源的世界证据 在目标一中，我们将对大量的、 评估 PET 成像有效性的全国代表性数据库，重点关注关联 全身治疗的影像学启动、激素难治性疾病的进展和费用之间的关系。 第二，我们将衡量 PET 成像对患者报告的与以下相关的结果测量的纵向影响 心理影响（焦虑和不确定性）和健康相关的生活质量以获得更深入的视角。 关于患者的测试体验，我们还将在较小的范围内进行纵向定性访谈 在第三项研究中，我们的目标是对患者子集进行整合，并整合定量和定性来源的研究结果。 将结合目标 1 和 2 的输入来构建基于个体的状态转换微观模拟模型 检查 PET 成像使用的常见场景。这些模型的输出将包括估计值。 有效性以及可能与或多或少程度相关的患者特征 这项研究的结果将为患者、提供者和其他前列腺癌利益相关者提供帮助。 提供有关 PET 成像潜在短期和长期影响的实用新信息 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模式 很快将在诊断准确性提高的替代终点的基础上进入临床护理，但没有 长期临床疗效的证据。