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NCT Number: NCT07760857

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

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.

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Key information

Conditions

Prostate Cancer (Diagnosis) Disease Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

45 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Prince of Wales Hospital, Hong Kong

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

    Time frame: Through study completion, an average of 1 year

    By Decision Curve analysis

  5. 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

  6. 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

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

852-3505-2625

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Collaborators

  • The Hong Kong Polytechnic University

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2030
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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