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

NCT05443412 | Recruiting

• 1 other identifier: CRE 2022.245
• Study Type: observational
• Target: 510
• Locations: 1 country
• Sites: 1

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)

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Diagnosis of any grade of prostate cancer

  Through study completion, an average of 1 year

• Proportion of men with diagnosis of clinically insignificant prostate cancer

  Through study completion, an average of 1 year

• Prostate biopsies that can be avoided

  Through study completion, an average of 1 year

• The concordance of AI-assisted TRUS & MRI diagnosis and biopsy outcomes

  Through study completion, an average of 1 year

Interventions

Diagnostic test for prostate cancer DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive men referred for elevated PSA 4-20 ng/mL

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital, Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Related Publications (24)

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MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Diagnostic Tests, Routine

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Peter Ka-Fung CHIU, FRCS, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Ka-Fung CHIU, FRCS, PhD

CONTACT

35052625; peterchiu@surgery.cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: July 5, 2022
• Study Start: August 1, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)