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临床试验协议:替代疗法对激进前列腺切除术后的功能和瘤结果的影响 (ENFORCE研究)

Diederik Baas¹, Joost van Drumpt², Lambertus Kiemeney³

¹Department of Urology, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands; Prosper Prostate Cancer Clinics, Nijmegen/Eindhoven, The Netherlands; Department of Urology, Radboud University Medical Centre, Nijmegen, The Netherlands.

European urology oncology

|June 13, 2025

概括

替代疗法 (TRT) 可能增强激进前列腺切除术 (RP) 后的性功能恢复在缺乏症 (TD) 的男性. 在ENFORCE试验中评估了TRT.

科学领域:

泌尿器科泌尿器科泌尿器科泌尿器科
内分泌学在内分泌学.
在瘤学瘤学.

背景情况:

缺乏症 (TD) 影响18-38%的前列腺切除术后的男性.
替代疗法 (TRT) 被认为是安全和有效的性功能后RP,但证据有限.
该研究旨在评估TRT对RP后性恢复和瘤安全的影响.

研究的目的:

评估TRT在改善RP后TD的男性性功能恢复方面的有效性.
确定TRT在RP后生化复发 (BCR) 的瘤安全性.
评估TRT对生活质量,以及RP后的荷尔蒙和泌尿功能的影响.

主要方法:

第三阶段,多中心,随机,单盲,安慰剂对照试验 (ENFORCE研究).
招募患有TD的男性接受RP,具有最小的勃起功能.
随机分配到TRT或安慰剂从RP后6-12周到1年,随着BCR的60个月的随访.

主要成果:

主要终点:12个月后的性功能 (EPIC-26性领域).
二级终点:在6个月和24个月的性功能,生活质量,荷尔蒙和泌尿功能.
生物化学复发 (BCR) 在12,24和60个月评估.

结论:

该ENFORCE试验将提供有关TRT在RP后的好处和安全性的可靠数据.
结果可能会澄清TRT在治疗前列腺癌幸存者的性功能障碍和复发风险方面的作用.
这项研究解决了关于激进前列腺切除术后TRT使用证据的关键缺口.

关键词:

生物化学复发的发生.勃起功能障碍是因为勃起功能障碍.催产素缺陷症是什么催产素缺陷症前列腺癌是什么意思前列腺癌是什么意思生活质量生活的质量.进行激进的前列腺切除术.性功能性功能性功能测试缺乏症是什么测试替代疗法测试替代治疗

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