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立体性前列腺放射疗法,包括或不包括缺少雄激素的疗法,第三阶段的研究方案,多机构随机对照试验

Marco Lorenzo Bonù¹, Alessandro Magli², Davide Tomasini¹

¹Department of Radiation Oncology, Istituto del Radio O.Alberti, University of Brescia and Spedali Civili Hospital, Brescia, Italy.

|March 25, 2024

概括

这项III期试验调查了前列腺癌的类型性辐射疗法 (SRT) 的雄激素剥夺疗法 (ADT). 结果将澄清ADT在SRT中的作用,并可能建立一个新的护理标准.

科学领域:

在瘤学瘤学.
辐射瘤学辐射瘤学
临床试验临床试验

背景情况:

在局部性前列腺癌 (PC) 中,雄激素剥夺疗法 (ADT) 与立体辐射疗法 (SRT) 结合的作用尚不清楚.
目前的证据不足以指导ADT与超低分离放射治疗方案的使用.

研究的目的:

确定ADT与SRT相结合的疗效和安全性,与单独的SRT相比,在治疗不良的中期和高风险局部前列腺癌.
为这种患者群体建立潜在的新护理标准.

主要方法:

一个随机的,多机构的,III期临床试验 (SPA试验) 涉及310名患者.
患者被随机分配1:1接受SRT (36.25Gy分为5个分量),再加上一次Triptorelin (22.5mg) 或单独SRT.
主要终点是生化无疾病生存率;次要终点包括无疾病生存率,复发率,整体生存率,生活质量和毒性.

主要成果:

关于急性毒性和生活质量的数据预计在入学后6个月.
对于疗效终点和晚期毒性的成熟结果预计在最后一名患者被录取后3-5年.

结论:

该SPA试验旨在提供关于ADT与SRT结合用于局部前列腺癌的作用的关键证据.
结果将为临床决策提供信息,并可能定义中期和高风险前列腺癌中SRT的新护理标准.

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