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)

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

doi:10.1016/j.euros.2022.09.007

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)

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

Authors

Alae Touzani^{1

2}, Gaëlle Fiard³, Eric Barret⁴, Raphaële Renard-Penna⁵, Ambroise Salin^{1

2}, Benjamin Pradère^{1

2}, François Rozet⁴, Jean-Baptiste Beauval^{1

2}, Bernard Malavaud⁶, Gianluca Giannarini⁷, Pierre Colin⁸, Morgan Rouprêt⁹, Guillaume Ploussard^{1

2}

Affiliations

¹ Urology Department, La Croix du Sud Hospital, Quint Fonsegrives, France.
² IUCT-O, Toulouse, France.
³ Department of Urology, Grenoble Alpes University Hospital, Université Grenoble Alpes, CNRS, Grenoble INP, TIMC-IMAG, Grenoble, France.
⁴ Department of Urology, Institut Mutualiste Montsouris, Paris, France.
⁵ AP-HP, Radiology, Pitie-Salpetriere Hospital, Sorbonne University, Paris, France.
⁶ Department of Urology, Institut Universitaire du Cancer-Oncopole, Toulouse, France.
⁷ Urology Unit, Santa Maria della Misericordia Academic Medical Centre, Udine, Italy.
⁸ Department of Urology, Clinique La Louvière, Lille, France.
⁹ GRC 5 Predictive Onco-Uro, AP-HP, Urology, Pitie-Salpetriere Hospital, Sorbonne University, Paris, France.

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.

Keywords: Complications; Efficiency; Fusion biopsy; Prostate cancer; Transperineal; Transrectal.