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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07760857

Enrollment

400

Registered

2026-08-12

Start date

2026-09-01

Completion date

2030-03-31

Last updated

2026-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer (Diagnosis)

Keywords

Modelling

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

45 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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)	Through study completion, an average of 1 year	By Decision Curve analysis
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	—

Countries

Hong Kong

Contacts

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

ngcf@surgery.cuhk.edu.hk852-3505-2625

PRINCIPAL_INVESTIGATORChi Fai NG, MBChB, FRCS(Ed), MD

Chinese University of Hong Kong

PRINCIPAL_INVESTIGATOREdmond Sai Kit LAM, PhD

The Hong Kong Polytechnic University

Outcome results