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

NCT07760857 | Not Yet Recruiting

• 1 other identifier: CRE-2026.384
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Prostate Cancer (Diagnosis)

Keywords

Modelling

Outcome Measures

Primary Outcomes (6)

• Area under Receiver-Operating-Curve of using the Centre-adaptive multi-modal fusion framework (Cad-MMFF)

  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)

  Through study completion, an average of 1 year

• Proportion of MRI safely saved of using the Centre-adaptive multi-modal fusion framework (Cad-MMFF)

  Through study completion, an average of 1 year

• Net-Benefit of using the Centre-adaptive multi-modal fusion framework (Cad-MMFF)

  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)

  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)

  Through study completion, an average of 1 year

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• The Hong Kong Polytechnic University: collaborator

Study Sites (2)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

North District Hospital

Sheung Shui, Hong Kong

Location

Related Publications (26)

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MeSH Terms

Conditions

Prostatic Neoplasms; Disease

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chi Fai NG, MBChB, FRCS(Ed), MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

• Edmond Sai Kit LAM, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chi Fai NG, MBChB, FRCS (Surg), MD

CONTACT

852-3505-2625; ngcf@surgery.cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 2, 2026
• First Posted: August 12, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): March 31, 2030
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (2)