Artificial Intelligence (AI)-Assisted Risk-based Prostate Cancer Detection

Recruiting

• Conditions: Prostate Cancer

• Registration Number: NCT05443412
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

This is a prospective clinical study recruiting 510 men at risk of PCa to undergo urine, blood, AI-assisted ultrasound and AI-assisted MRI investigations to stratify risk of clinically significant PCa (csPCa). (sample size calculation in section 5)

Detailed Description

All recruited patients will undergo investigations including urine for spermine, blood for miRNA, TRUS, and MRI prostate. Patients with high suspicion of csPCa in any one step (urine, blood, ultrasound, OR MRI) will be offered an image-guided prostate biopsy. This will be followed by machine learning techniques to find the best combination in predicting csPCa.

Study Timeline

• Study First Submitted: 2022-06-22
• Study First Submitted QC: 2022-06-30
• Study First Posted: 2022-07-05
• Study Start: 2023-08-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-03
• Last Update Posted: 2024-01-05
• Primary Completion: 2026-07-31
• Study Completion: 2026-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 510

Inclusion Criteria

• Men ≥18 years of age
• Clinical suspicion of prostate cancer
• Serum Prostate-specific antigen (PSA) 4-20 ng/mL
• Digital rectal examination ≤ cT2 (organ confined cancer)
• Able to provide written informed consent

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Exclusion Criteria

• Prior prostate biopsy
• Past or current history of prostate cancer
• Contraindicated to undergo plain MRI scan (e.g. pacemaker in-situ, claustrophobia)
• Contraindicated to transperineal prostate biopsy: active urinary tract infection, fail TRUS probe insertion or lithotomy position, uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnosis of clinically significant Prostate cancer (csPCa); • csPCa is diagnosis of ISUP Grade group ≥2 prostate cancer in at least 1 biopsy core	Through study completion, an average of 1 year	Assessed by by machine learning algorithms utilizing clinical parameters, novel biomarkers and AI-assisted imaging

Secondary Outcome Measures

Name	Time	Method
Diagnosis of any grade of prostate cancer	Through study completion, an average of 1 year	Assessed by prostate biopsy
Proportion of men with diagnosis of clinically insignificant prostate cancer	Through study completion, an average of 1 year	Assessed by prostate biopsy
Prostate biopsies that can be avoided	Through study completion, an average of 1 year	Assessed by using different machine learning algorithms
The concordance of AI-assisted TRUS & MRI diagnosis and biopsy outcomes	Through study completion, an average of 1 year	Assessed by using different machine learning algorithms and prostate biopsy result

Trial Locations

Locations (1)

Prince of Wales Hospital, Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong