NCT04953351

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 470 (estimated)
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	Cognitive registration targeted biopsy and TRUS-system biopsy	Cognitive registration is a visual guidance technique in which the surgeon samples a visually estimated location on ultrasound that corresponds to the MRI suspicious regions location. TRUS-system biopsy includes 12 biopsy cores.
PROCEDURE	MRI-ultrasound fusion targeted biopsy and TRUS-system biopsy	MRI-ultrasound fusion targeted biopsy is conducted with an mpMRI-TRUS biopsy system that provides realtime fusion of TRUS images and MRI images to guide the biopsy needles. TRUS-system biopsy includes 12 biopsy cores.

Timeline

• Start date: 2021-08-01
• Primary completion: 2022-02-01
• Completion: 2022-07-01
• First posted: 2021-07-07
• Last updated: 2021-07-07

Locations

1 site across 1 country: China