MRI-Ultrasound Fusion or Cognitive Registration in MR-targeted Prostate Biopsy — PROMUC  

Prostate Cancer Clinical Trial

Official title: PROMUC Trial-Comparison of Magnetic Resonance Imaging-Ultrasound Fusion and Cognitive Registration in MR-targeted Prostate Biopsy: A Randomized Controlled Trial

Status Not yet recruiting

Clinical Trial Summary

This randomized controlled trial aims to assess the detection rate of clinically significant and clinically insignificant cancer of MRI-ultrasound fusion targeted biopsy compared to cognitive registration targeted biopsy in men with clinical suspicion of prostate cancer who had no prior prostate biopsy.

Clinical Trial Description

Prostate biopsy with multiple samples using a standardized template (standard biopsy, SB) under transrectal ultrasound (TRUS) guidance is the current standard diagnostic approach in suspicion of prostate cancer (PCa). However, many biopsies are unnecessary or cannot detect clinically significant PCa (csPCa).

With the introduction of multiparametric magnetic resonance imaging (mpMRI) of the prostate and the improvement for PCa detection and localization, an alternative procedure, known as MRI-targeted biopsy (MRI-TB), has been shown comparable or even higher detection rates of csPCa compared to TRUS-system biopsy (SB). MRI-ultrasound fusion TB (FUS-TB) and cognitive registration TB (COG-TB) are two techniques of MRI-TB commonly used. However, the optimal methodology for targeting MRI-suspicious regions remains unknown. The accuracy of COG-TB compared with FUS-TB remains unclear.

This randomized controlled trial aims to assess the detection rate of clinically significant and clinically insignificant cancer of COG-TB compared to FUS-TB (transperineal) in men referred with clinical suspicion of prostate cancer who have had no prior prostate biopsy. ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT04953351
• Study type: Interventional
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Hongqian Guo, PhD
• Phone: 8613605171690
• Email: dr.ghq@nju.edu.cn
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2021
• Completion date: July 2022