Prostate Cancer
Conditions
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.
Interventions
DIAGNOSTIC_TESTDiagnostic 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.
Sponsors
Chinese University of Hong Kong
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Hong Kong
Contacts
Primary ContactPeter Ka-Fung CHIU, FRCS, PhD
Outcome results
None listed