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PERFECT临床试验方案:一项比较经会阴融合与经直肠影像引导前列腺活检的效率和耐受性的随机对照试验(CCAFU-PR1研究)。

Clinical Trial Protocol for PERFECT: A Randomised Controlled Trial Comparing the Efficiency and Tolerance of Transperineal Fusion Versus Transrectal Imaging-targeted Prostate Biopsies (CCAFU-PR1 Study).

作者信息

Touzani Alae, Fiard Gaëlle, Barret Eric, Renard-Penna Raphaële, Salin Ambroise, Pradère Benjamin, Rozet François, Beauval Jean-Baptiste, Malavaud Bernard, Giannarini Gianluca, Colin Pierre, Rouprêt Morgan, Ploussard Guillaume

机构信息

Urology Department, La Croix du Sud Hospital, Quint Fonsegrives, France.

IUCT-O, Toulouse, France.

出版信息

Eur Urol Open Sci. 2022 Oct 5;45:76-80. doi: 10.1016/j.euros.2022.09.007. eCollection 2022 Nov.

Abstract

PERFECT is a multicentre randomised controlled clinical trial that evaluates the efficiency of fusion magnetic resonance imaging-targeted biopsies in the transperineal (TP) versus transrectal (TR) approach in terms of the detection of significant cancers. Our study builds on the hypothesis that the TP approach for prostate biopsies has at least the same diagnostic accuracy as the TR approach, with lower morbidity. Here, we describe the clinical protocol, study population, and primary and secondary outcomes.

摘要

PERFECT是一项多中心随机对照临床试验,旨在评估经会阴(TP)与经直肠(TR)途径的融合磁共振成像靶向活检在检测重大癌症方面的效率。我们的研究基于这样一个假设,即TP途径进行前列腺活检至少具有与TR途径相同的诊断准确性,且发病率更低。在此,我们描述临床方案、研究人群以及主要和次要结局。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4d71/9547228/a0994308ae7b/gr1.jpg

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