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.

项目摘要/摘要 前列腺癌正在进行分子成像革命。克服长期限制 前列腺癌分期，最近批准了几个正电子发射断层扫描（PET）扫描，并 基于提高诊断准确性的证据，快速整合到临床护理中。但是， 宽度宠物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，替代端点，而不是直接证明患者益处的证据。经过 早些时 负面 - 可能因病人而异。宠物成像可能会改善生存，较少 子集中转移性癌症的症状，但也可能增加治疗毒性，心理 伯恩斯，其他人的成本。目前，没有任何信息可以帮助指导患者或利益相关者 考虑这些权衡。为了减少这些不确定性，我们的目标是开发一个决策模型 考虑了跨多个维度的宠物成像的影响。为了告知该模型，我们将生成现实 来自各种来源的世界证据。在AIM上，我们将对大型分析进行完整的分析 全国代表性的数据库评估宠物成像的有效性，重点关注协会 在全身治疗的成像倡议，进展为难治性疾病和成本之间。 第二，我们将衡量宠物成像对与患者报告的结果指标的纵向影响 心理影响（焦虑和不确定性）和与健康相关的生活质量。获得更深的观点 关于患者测试的经验，我们还将在较小的 患者的子集并整合了定量和定性来源的发现。在第三项研究目标中我们 将纳入目标1和2的投入以构建基于个体的状态转变微仿真模型 检查使用宠物成像的常见场景。这些模型的输出将包括估计的 有效性以及可能与或多或少相关的患者特征 福利或伤害。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配置 有了实用的，有关宠物成像的潜在短期和长期影响的新信息。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 将根据提高诊断准确性的替代终点的基础，很快进入临床护理，但没有 长期临床效率的证据。