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NCT Number: NCT05443412

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

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)

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Prince of Wales Hospital, Chinese University of Hong Kong

Hong Kong

Location status: Recruiting

Location contact

Peter Ka-Fung CHIU, FRCS, PhD

CONTACT

[email protected]

852-3505-2625

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

    Time frame: Through study completion, an average of 1 year

    Assessed by by machine learning algorithms utilizing clinical parameters, novel biomarkers and AI-assisted imaging

Secondary outcomes

  1. Diagnosis of any grade of prostate cancer

    Time frame: Through study completion, an average of 1 year

    Assessed by prostate biopsy

  2. Proportion of men with diagnosis of clinically insignificant prostate cancer

    Time frame: Through study completion, an average of 1 year

    Assessed by prostate biopsy

  3. Prostate biopsies that can be avoided

    Time frame: Through study completion, an average of 1 year

    Assessed by using different machine learning algorithms

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

    Time frame: Through study completion, an average of 1 year

    Assessed by using different machine learning algorithms and prostate biopsy result

Study contacts

Contact information is provided by the study sponsor or research team.

Peter Ka-Fung CHIU, FRCS, PhD

CONTACT

[email protected]

35052625

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 5, 2022
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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