Clinical trial NCT06360523: To Evaluate an MRI-based Optimized Prostate Cancer Diagnostic Pathway Powered by Artificial Intelligence
Official title: ProstateAI - A Prospective Paired Validating Cohort Study to Evaluate an MRI-based Optimized Prostate Cancer Diagnostic Pathway Powered by Artificial Intelligence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 368
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Prostate Cancer detection rate of ISUP grade group ≥2
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
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 CHIU, FRCS, PhD
role: PRINCIPAL_INVESTIGATOR
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