Fred Hutchinson Cancer Center, Seattle, Washington (R.G., R.E.).
Fred Hutchinson Cancer Center and Comparative Health Outcomes, Policy, and Economics (CHOICE) Institute, University of Washington, Seattle, Washington (B.J.).
Ann Intern Med. 2024 Jul;177(7):871-881. doi: 10.7326/M23-1504. Epub 2024 Jun 4.
BACKGROUND: Contemporary prostate cancer (PCa) screening uses first-line prostate-specific antigen (PSA) testing, possibly followed by multiparametric magnetic resonance imaging (mpMRI) for men with elevated PSA levels. First-line biparametric MRI (bpMRI) screening has been proposed as an alternative. OBJECTIVE: To evaluate the comparative effectiveness and cost-effectiveness of first-line bpMRI versus PSA-based screening. DESIGN: Decision analysis using a microsimulation model. DATA SOURCES: Surveillance, Epidemiology, and End Results database; randomized trials. TARGET POPULATION: U.S. men aged 55 years with no prior screening or PCa diagnosis. TIME HORIZON: Lifetime. PERSPECTIVE: U.S. health care system. INTERVENTION: Biennial screening to age 69 years using first-line PSA testing (test-positive threshold, 4 µg/L) with or without second-line mpMRI or first-line bpMRI (test-positive threshold, PI-RADS [Prostate Imaging Reporting and Data System] 3 to 5 or 4 to 5), followed by biopsy guided by MRI or MRI plus transrectal ultrasonography. OUTCOME MEASURES: Screening tests, biopsies, diagnoses, overdiagnoses, treatments, PCa deaths, quality-adjusted and unadjusted life-years saved, and costs. RESULTS OF BASE-CASE ANALYSIS: For 1000 men, first-line bpMRI versus first-line PSA testing prevented 2 to 3 PCa deaths and added 10 to 30 life-years (4 to 11 days per person) but increased the number of biopsies by 1506 to 4174 and the number of overdiagnoses by 38 to 124 depending on the biopsy imaging scheme. At conventional cost-effectiveness thresholds, first-line PSA testing with mpMRI followed by either biopsy approach for PI-RADS 4 to 5 produced the greatest net monetary benefits. RESULTS OF SENSITIVITY ANALYSIS: First-line PSA testing remained more cost-effective even if bpMRI was free, all men with low-risk PCa underwent surveillance, or screening was quadrennial. LIMITATION: Performance of first-line bpMRI was based on second-line mpMRI data. CONCLUSION: Decision analysis suggests that comparative effectiveness and cost-effectiveness of PCa screening are driven by false-positive results and overdiagnoses, favoring first-line PSA testing with mpMRI over first-line bpMRI. PRIMARY FUNDING SOURCE: National Cancer Institute.
背景：当前的前列腺癌（PCa）筛查使用一线前列腺特异性抗原（PSA）检测，对于 PSA 水平升高的男性可能会进行多参数磁共振成像（mpMRI）检查。一线双参数磁共振成像（bpMRI）筛查已被提议作为替代方法。
目的：评估一线 bpMRI 与基于 PSA 的筛查相比的有效性和成本效益。
设计：使用微模拟模型的决策分析。
数据来源：监测、流行病学和最终结果数据库；随机试验。
目标人群：年龄在 55 岁且没有既往筛查或 PCa 诊断的美国男性。
时间范围：终身。
视角：美国医疗保健系统。
干预措施：每两年筛查一次，至 69 岁，使用一线 PSA 检测（检测阳性阈值为 4μg/L），或联合二线 mpMRI 或一线 bpMRI（检测阳性阈值为 PI-RADS [前列腺成像报告和数据系统] 3 至 5 或 4 至 5），随后根据 MRI 或 MRI 加经直肠超声引导进行活检。
结果测量：筛查检测、活检、诊断、过度诊断、治疗、PCa 死亡、调整和未调整后的生命年数以及成本。
基础分析结果：对于 1000 名男性，一线 bpMRI 与一线 PSA 检测相比，预防了 2 至 3 例 PCa 死亡，并增加了 10 至 30 个生命年（每人 4 至 11 天），但活检数量增加了 1506 至 4174 例，过度诊断数量增加了 38 至 124 例，具体取决于活检成像方案。在常规的成本效益阈值下，对于 PI-RADS 4 至 5 的男性，首先进行 PSA 检测，然后联合 mpMRI 检测，最后根据检测结果选择活检方式，可带来最大的净货币收益。
敏感性分析结果：即使 bpMRI 是免费的，所有低危 PCa 患者都接受监测，或者筛查每四年进行一次，一线 PSA 检测仍然具有更高的成本效益。
局限性：一线 bpMRI 的性能基于二线 mpMRI 数据。
结论：决策分析表明，PCa 筛查的有效性和成本效益取决于假阳性结果和过度诊断，因此一线 PSA 检测联合 mpMRI 优于一线 bpMRI。
主要资金来源：美国国立癌症研究所。
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