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)

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

• Prostate cancer
• Fusion biopsy
• Transperineal
• Transrectal
• Efficiency
• Complications