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

February 12, 2026 updated by: CHIU Ka Fung Peter, Chinese University of Hong Kong

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

1250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MRUS arm
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.
Procedure: MRI-USG fusion approach
MRI-USG fusion approach prostate biopsy
Active Comparator: COG arm
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.
Procedure: Cognitive-guided approach
Cognitive-guided approach prostate biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of men with clinically significant Prostate cancer(csPCa)
Time Frame: When histology results available, at an expected average of 30 days post-biopsy
ISUP Grade 2 or above prostate cancer diagnosed on biopsy
When histology results available, at an expected average of 30 days post-biopsy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of men with post-biopsy adverse events within 30 days after biopsy
Time Frame: 30 days post biopsy
The severity of Adverse event is grade by Clavien-Dindo classification
30 days post biopsy
Proportion of men with a diagnosis of csPCa in MRI lesions with maximal size ≤10mm versus >10mm
Time Frame: When histology results available, at an expected average of 30 days post-biopsy
MRI lesions with maximal size ≤10mm versus >10mm
When histology results available, at an expected average of 30 days post-biopsy
Proportion of men with a diagnosis of csPCa in prostate size of ≤50ml vs >50m
Time Frame: When histology results available, at an expected average of 30 days post-biopsy
prostate size of ≤50ml vs >50ml
When histology results available, at an expected average of 30 days post-biopsy
The proportion of men with a diagnosis of csPCa only in targeted biopsy
Time Frame: When histology results available, at an expected average of 30 days post-biopsy
ISUP Grade 2 or above prostate cancer diagnosed on biopsy
When histology results available, at an expected average of 30 days post-biopsy
Proportion of men with a diagnosis of csPCa only in systemic biopsy
Time Frame: When histology results available, at an expected average of 30 days post-biopsy
ISUP Grade 2 or above prostate cancer diagnosed on biopsy
When histology results available, at an expected average of 30 days post-biopsy
Proportion of men with a diagnosis of clinically insignificant PCa,
Time Frame: When histology results available, at an expected average of 30 days post-biopsy
ISUP grade group 1 Prostate cancer diagnosed on biopsy
When histology results available, at an expected average of 30 days post-biopsy
Procedure time
Time Frame: During biopsy procedure
Total time of procedure
During biopsy procedure
Pain score on a scale of 0-10 taken after biopsy
Time Frame: Immediately After biopsy procedure
The higher the score, the more pain
Immediately After biopsy procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Collaborators

China Medical University Hospital
Kaohsiung Medical University
Queen Mary Hospital, Hong Kong
Tuen Mun Hospital Hong Kong
Nanjing Drum Tower Hospital, China
Center of Postgraduate Medical Education, Poland
Stanford Cancer Institute

Investigators

  • Principal Investigator: Peter Ka-Fungq CHIU, Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

March 5, 2024

First Submitted That Met QC Criteria

March 8, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE-2023.610

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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