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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Artificial Intelligence (AI)-Assisted Risk-based Prostate Cancer Detection: A Synergy of Novel Biomarkers, Advanced Imaging, and Robotic-assisted Diagnosis

Conditions
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Prostate Cancer

Intervention / Treatment
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* Diagnostic Test: Diagnostic test for prostate cancer


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Diagnostic test for prostate cancer|All recruited patients will undergo investigations including urine for spermine, blood for miRNA, TRUS, and MRI prostate. Patients with high suspicion of Clinically significant prostate cancer in any one step (urine, blood, ultrasound, OR MRI) will be offered an image-guided prostate biopsy.|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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