NCT06303622

Comparing MRI-Ultrasound Fusion and Cognitive-guided Biopsy for the Detection of csPCa: the PROFUSION Trial

A Randomised Controlled Trial Comparing MRI-Ultrasound Fusion and Cognitive-guided Biopsy for the Detection of Clinically Significant Prostate Cancer: the PROFUSION Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,250 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is an international multicentre RCT to compare the linically significant prostate cancer (csPCa) detection of cognitive-guided and MRI-USG guided biopsies in men with suspicious MRI lesion.

Detailed description

This study is an international multicentre RCT to compare the csPCa detection of cognitive-guided and MRI-USG guided biopsies in men with suspicious MRI lesion. This is a phase III randomised controlled trial to evaluate the detection of clinically significant prostate cancer (csPCa) by MRI-USG fusion approach (MRUS arm) versus Cognitive-guided approach (COG arm). The study hypothesis is that MRUS arm is superior to COG arm in detecting csPCa. The result of this RCT would impact how MRI-guided prostate biopsies should be done in the future. If the MRI-USG fusion approach is superior to cognitive-guidance in csPCa detection, it should be the standard of practice in the future, and dedicated MRI-USG fusion equipment should be available in centres performing prostate biopsies.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	MRI-USG fusion approach	MRI-USG fusion approach prostate biopsy
PROCEDURE	Cognitive-guided approach	Cognitive-guided approach prostate biopsy

Timeline

• Start date: 2025-01-08
• Primary completion: 2026-12-31
• Completion: 2027-03-31
• First posted: 2024-03-12
• Last updated: 2026-02-17

Locations

1 site across 1 country: Hong Kong