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

The Chinese University of Hong Kong

Status: Not yet enrolling

Conditions: Prostate Cancer

Treatments: Procedure: Cognitive-guided approach; Procedure: MRI-USG fusion approach

Study type: Interventional

Funder types: Other

Identifiers

NCT06303622

CRE-2023.610

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,250 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,250 participants in 2 patient groups

MRUS arm

Experimental group

Description:

Targeted biopsies will be performed by software-assisted MRI-ultrasound fusion registration . Software-based fusion targeted biopsy of 4 cores per target followed by 12-core systematic biopsy will be performed. The fusion or overlay of 3D MRI and USG images create a detailed 3D prostate image with both targeted and systematic biopsy core locations recorded.

Treatment:

Procedure: MRI-USG fusion approach

COG arm

Active Comparator group

Description:

The biopsy operator reviews the MR images and creates a mental three-dimensional representation of the prostate and the lesion within it to guide biopsy. Cognitive registration is a visual guidance technique in which the surgeon samples a visually estimated location on transrectal ultrasound (TRUS) corresponding to the MRI suspicious regions. Cognitive-guided biopsy is performed by taking 4 cores from each target followed by 12-core systematic biopsies.

Treatment:

Procedure: Cognitive-guided approach