An interventional study of AI modal and Standard review in Prostate Cancer, sponsored by Chinese University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-06.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Diagnostic
It is a prospective paired-cohort study for diagnostic test evaluation. The study aim to determine the accuracy of AI review and investigate whether AI review could detect MRI visible significant cancer as effective as radiologist review. MRI image of about 368 men recommended for biopsy will be reviewed by an AI model and an experienced radiologist, respectively. AI review (index) and radiologist review (standard) will be blinded to each other, while biopsy urologists will be well-informed of the findings of both AI review and radiologist review and make personalized biopsy plan by combining both findings. The pathological results of MRI-ultrasound fusion biopsy (reference) will serve as the gold standard to assess the diagnostic accuracy.
ProstateAI is a prospective paired-cohort study for diagnostic test evaluation. ProstateAI will determine the accuracy of AI review and investigate whether AI review could detect MRI visible significant cancer as effective as radiologist review. MRI image of about 368 men recommended for biopsy will be reviewed by an AI model and an experienced radiologist, respectively. AI review (index) and radiologist review (standard) will be blinded to each other, while biopsy urologists will be well-informed of the findings of both AI review and radiologist review and make personalized biopsy plan by combining both findings. The pathological results of MRI-ultrasound fusion biopsy (reference) will serve as the gold standard to assess the diagnostic accuracy.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 368 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.
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Exclusion Criteria:
self-paired design, AI review (index)
Diagnostic Test: AI modal
self-paired design, radiologist review (standard)
Diagnostic Test: Standard review
The MRI image will be reviewed by radiologist and AI model(s) respectively. The urologist will combine the results of the two approaches to optimize the biopsy strategy which is expected to result in more accurate diagnosis.
The MRI image will be reviewed by radiologist.
Prostate Cancer detection rate of ISUP grade group ≥2
Assessed by AI review, Radiologist review, and Biopsy (Targeted).
Time frame: Through study completion, an average of 1 year
Diagnosis of any grade of prostate cancer
Assessed by prostate biopsy
Time frame: Through study completion, an average of 1 year
Plan to share: No
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Chinese University of Hong Kong