Investigation of an Intelligent Centre-adaptive Multi-modal Fusion Framework (Cad- MMFF) to Overcome Unnecessary Prostate Biopsies and Optimize MRI Utilization

August 7, 2026 updated by: NG Chi Fai, Chinese University of Hong Kong

Investigation of an Intelligent Centre-adaptive Multi-modal Fusion Framework (Cad- MMFF) to Overcome Unnecessary Prostate Biopsies and Optimize MRI Utilization: a Hybrid Retrospective-prospective Study

This study aims to investigate a novel Centre-Adaptive Multi-Modal Fusion Framework (Cad-MMFF) that integrates clinical, ultrasound, and MRI data to improve the detection of clinically significant prostate cancer (csPCa), reduce unnecessary biopsies, and optimize MRI utilization.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Approximately 400 Chinese men aged 50 years or above with suspected prostate cancer will be included.The study consists of retrospective model development and prospective model optimization and validation. Two AI models will be developed: a Clinical-US model using clinical and ultrasound data, and a Clinical-US-MRI model incorporating MRI information. The optimized models will subsequently be validated in an independent cohort.

Study Type

Observational

Enrollment (Estimated)

400

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

  • Hong Kong
      • Hong Kong, Hong Kong
        • Prince of Wales Hospital
      • Sheung Shui, Hong Kong
        • North District Hospital

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

Sampling Method

Non-Probability Sample

Study Population

The entire cohort of this study will be targeted at patients who are suspected of PCa and indicated for ultrasound-guided and/or MRI-guided targeted prostate biopsy. Brightness-modulated ultrasound data (longitudinal and transverse views with full prostate coverage), pathological outcomes (Gleason score, ISUP GG), pre-biopsy multi-parametric MRI scans, PI-RADS scores, patients demographics and clinical data, will be acquired from January 2023 to August 2026 retrospectively, and from September 2026 to March 2028 prospectively, from the existing database of the Picture Archiving and Communication System (PACS). Informed consent from subjects will be sought only for prospectively enrolled patients, while there will be no interventions involved given its nature of retrospective analysis

Description

Inclusion Criteria:

  • Ethnically Chinese men aged ≥ 50
  • Suspicion of PCa [elevated PSA (>4-ng/ml) or abnormal DRE/PHI] and indicated for prostate biopsy
  • Obtained clinical consent (for prospectively enrolled patients only)

Exclusion Criteria:

  • Prior biopsy/treatments for PCa
  • History of genitourinary cancer
  • Poor image quality
  • Incomplete imaging scans/clinical data/pathological results

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under Receiver-Operating-Curve of using the Centre-adaptive multi-modal fusion framework (Cad-MMFF)
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year
The number of unnecessary biopsy rate decreased of using the Centre-adaptive multi-modal fusion framework (Cad-MMFF)
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year
Proportion of MRI safely saved of using the Centre-adaptive multi-modal fusion framework (Cad-MMFF)
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year
Net-Benefit of using the Centre-adaptive multi-modal fusion framework (Cad-MMFF)
Time Frame: Through study completion, an average of 1 year
By Decision Curve analysis
Through study completion, an average of 1 year
Missed rate of clinically significant prostate cancer of using the Centre-adaptive multi-modal fusion framework (Cad-MMFF)
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year
Detection rate of indolent prostate cancer of using the Centre-adaptive multi-modal fusion framework (Cad-MMFF)
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Chinese University of Hong Kong

Collaborators

The Hong Kong Polytechnic University

Investigators

  • Principal Investigator: Chi Fai NG, MBChB, FRCS(Ed), MD, Chinese University of Hong Kong
  • Principal Investigator: Edmond Sai Kit LAM, PhD, The Hong Kong Polytechnic University

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

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 (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

March 31, 2030

Study Registration Dates

First Submitted

August 2, 2026

First Submitted That Met QC Criteria

August 7, 2026

First Posted (Actual)

August 12, 2026

Study Record Updates

Last Update Posted (Actual)

August 12, 2026

Last Update Submitted That Met QC Criteria

August 7, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE-2026.384

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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