RecruitingNCT05443412

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

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

Sponsor

Chinese University of Hong Kong

Enrollment

510 participants

Start Date

Aug 1, 2023

Study Type

OBSERVATIONAL

Conditions

Prostate Cancer

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)

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether using artificial intelligence (AI) to analyze MRI scans and PSA test results can help doctors better decide who needs a prostate biopsy, reducing unnecessary procedures. **You may be eligible if...** - You are a man aged 18 or older - Your doctor suspects you may have prostate cancer - Your PSA (prostate-specific antigen) level is between 4 and 20 ng/mL - Your digital rectal exam shows the cancer appears localized to the prostate - You have not had a prior prostate biopsy **You may NOT be eligible if...** - You have a prior history of prostate cancer - You cannot have an MRI (e.g., you have a pacemaker or severe claustrophobia) - You cannot safely undergo a prostate biopsy (e.g., you have a blood clotting problem or active urinary infection) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTDiagnostic test for prostate cancer

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.