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真相标准方法论如何影响诊断PSMA准放射性药物评估:从第3期SPOTLIGHT研究中得出的教训

Benjamin H Lowentritt¹, Albert Chau², Phillip Davis³

¹Chesapeake Urology Research Associates, Towson, MD 21204, USA.

Diagnostics (Basel, Switzerland)

|February 26, 2025

概括

基因病理学作为真理标准 (SoT) 与成像SoT相比,显著增加了诊断放射性药物的疗效终点. 不同的SoT方法对复发性前列腺癌的临床试验结果产生影响.

科学领域:

核医学和诊断成像技术
瘤学和泌尿癌研究
临床试验方法和生物统计学

背景情况:

诊断放射性药物的临床试验依赖于特定的疗效终点.
真理标准 (SoT) 方法的选择可以影响这些终点值.
该SPOTLIGHT研究 (NCT04186845) 提供了关于复发前列腺癌患者的数据.

研究的目的:

评估各种真理标准 (SoT) 方法对诊断放射性药物试验中疗效终点的影响.
使用基因病理学,PET后确认成像和常规成像作为SoT来比较终点结果.
分析来自SPOTLIGHT研究的数据,用于复发前列腺癌患者.

主要方法:

从SPOTLIGHT研究中对297名复发前列腺癌患者 (PSA ≤5 ng/mL) 的回顾性审查.
分析18F-flotufolastat成像数据,分层分为SoT: 组织病理学,后PET成像或常规成像.
使用千平方试验,比较大多数读取的患者水平 (经过验证的检测率,患者水平的积极预测值) 和区域水平的积极预测值.

主要成果:

组织病理学SOT在所有评估指标中产生了最高的多数读取终点值.
与基线/历史常规成像相比,组织病理学SOT显示VDR高3.6倍 (77%) 和患者水平PPV高2.2倍 (79%).
前列腺/前列腺床的区域级PPV是基因病理学SOT (50%) 的3.7倍,高于传统成像 (p=0.009).

结论:

真相标准 (SoT) 方法在诊断放射性药物临床试验中显著影响疗效终点.
基于成像的SoT方法导致与基因病理学相比,显著较低的终点值.
选择SoT对于准确解释诊断放射性药物试验结果至关重要.

关键词:

18F-flotufolafolastat 的使用情况在这里,PET是PET.在PSMA上,PSMA可以在PSMA上进行交易.临床试验临床试验临床试验临床试验临床试验诊断诊断诊断的诊断诊断诊断诊断的诊断组织病理学组织病理学影像成像技术影像成像技术复发性前列腺癌复发性前列腺癌真理的标准是真理的标准.

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