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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 400
- Locations
- 2
- Primary Endpoint
- Proportion of MRI safely saved of using the Centre-adaptive multi-modal fusion framework (Cad-MMFF)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 45 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
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
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
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
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
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
Secondary Outcomes
No secondary outcomes reported
Investigators
NG Chi Fai
Professor
Chinese University of Hong Kong