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NCT Number: NCT06360523

To Evaluate an MRI-based Optimized Prostate Cancer Diagnostic Pathway Powered by Artificial Intelligence

It is a prospective paired-cohort study for diagnostic test evaluation. The study aim to determine the accuracy of AI review and investigate whether AI review could detect MRI visible significant cancer as effective as radiologist review. MRI image of about 368 men recommended for biopsy will be reviewed by an AI model and an experienced radiologist, respectively. AI review (index) and radiologist review (standard) will be blinded to each other, while biopsy urologists will be well-informed of the findings of both AI review and radiologist review and make personalized biopsy plan by combining both findings. The pathological results of MRI-ultrasound fusion biopsy (reference) will serve as the gold standard to assess the diagnostic accuracy.

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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

Interventional

Phase

Not applicable

Primary location

Prince of Wales Hospital, Chinese University of Hong Kong

Hong Kong

Location status: Recruiting

Location contact

Peter Ka Fung CHIU, MBChB

CONTACT

[email protected]

852-3505-2625

About this study

ProstateAI is a prospective paired-cohort study for diagnostic test evaluation. ProstateAI will determine the accuracy of AI review and investigate whether AI review could detect MRI visible significant cancer as effective as radiologist review. MRI image of about 368 men recommended for biopsy will be reviewed by an AI model and an experienced radiologist, respectively. AI review (index) and radiologist review (standard) will be blinded to each other, while biopsy urologists will be well-informed of the findings of both AI review and radiologist review and make personalized biopsy plan by combining both findings. The pathological results of MRI-ultrasound fusion biopsy (reference) will serve as the gold standard to assess the diagnostic accuracy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients recommended for prostate biopsy for diagnosis or re-assessment.
  • Men at least 18 years or over
  • Patients with prostate MRI image eligible for radiologist review and AI review.
  • Patient Informed Consent is signed.

Exclusion criteria

  • Patient contraindicated to prostate biopsy
  • Patient failed to complete the biopsy procedure

Treatment and study plan

AI modal

Diagnostic Test

The MRI image will be reviewed by radiologist and AI model(s) respectively. The urologist will combine the results of the two approaches to optimize the biopsy strategy which is expected to result in more accurate diagnosis.

Standard review

Diagnostic Test

The MRI image will be reviewed by radiologist.

Primary outcomes

  1. Prostate Cancer detection rate of ISUP grade group ≥2

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

    Assessed by AI review, Radiologist review, and Biopsy (Targeted).

Secondary outcomes

  1. Diagnosis of any grade of prostate cancer

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

    Assessed by prostate biopsy

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

ProstateAI - A Prospective Paired Validating Cohort Study to Evaluate an MRI-based Optimized Prostate Cancer Diagnostic Pathway Powered by Artificial Intelligence

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Apr 11, 2024
Registry last updated
May 6, 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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