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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age45+
SponsorChinese University of Hong Kong

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Prior biopsy/treatments for PCa

History of genitourinary cancer

Poor image quality

Incomplete imaging scans/clinical data/pathological results

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

By Decision Curve analysis

Time frame
Through study completion, an average of 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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Chinese University of Hong Kong

Lead sponsor

The Hong Kong Polytechnic University

Collaborator

This trial is not recruiting at the moment. You can still explore other options: