Clinical trial NCT05443412: Artificial Intelligence (AI)-Assisted Risk-based Prostate Cancer Detection
Official title: Artificial Intelligence (AI)-Assisted Risk-based Prostate Cancer Detection: A Synergy of Novel Biomarkers, Advanced Imaging, and Robotic-assisted Diagnosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-07-05
Enrollment: 510
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive men referred for elevated PSA 4-20 ng/mL

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnosis of clinically significant Prostate cancer (csPCa); • csPCa is diagnosis of ISUP Grade group ≥2 prostate cancer in at least 1 biopsy core
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Diagnosis of any grade of prostate cancer
timeFrame: Through study completion, an average of 1 year
measure: Proportion of men with diagnosis of clinically insignificant prostate cancer
timeFrame: Through study completion, an average of 1 year
measure: Prostate biopsies that can be avoided
timeFrame: Through study completion, an average of 1 year
measure: The concordance of AI-assisted TRUS & MRI diagnosis and biopsy outcomes
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital, Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Peter Ka-Fung CHIU, FRCS, PhD
role: PRINCIPAL_INVESTIGATOR
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