RecruitingNot ApplicableNCT06303622

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

Sponsor

Chinese University of Hong Kong

Enrollment

1,250 participants

Start Date

Jan 8, 2025

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer

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.

Eligibility

Sex: MALEMin Age: 18 Years

Inclusion Criteria6

Men ≥18 years of age
Clinical suspicion of prostate cancer and indicated for prostate biopsy
Serum Prostate-specific antigen (PSA) \< 20 ng/mL
Digital rectal examination ≤ cT2 (organ-confined cancer)
Able to provide written informed consent
MRI prostate (contrast or plain) showing 1-3 suspicious lesion(s) with PI-RADS score 3-5

Exclusion Criteria4

Prior prostate biopsy in the 2 years before screening visit
Prior diagnosis of prostate cancer
Contraindicated to prostate biopsy: active urinary tract infection, failed insertion of transrectal ultrasound probe into rectum (abdominal perineal resection, anal stenosis), uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped (continue low-dose aspirin before and after biopsy is permitted)
Patient refusal for biopsy