AI Algorithm-Informed Biopsy for Prostate Cancer Detection
This study is investigating a new way to detect prostate cancer using an artificial intelligence (AI) system called the Bi-parametric MRI-based cascaded deep-learning AI algorithm (DEVICE). This AI system helps doctors decide where to take biopsies (tissue samples) from the prostate, especially for men who have unclear or low-risk findings on their prostate MRI (magnetic resonance imaging) scans. The study aims to see if using this AI system improves the detection of clinically significant prostate cancer (csPCa), which is cancer that needs treatment. You might be eligible if you are a man aged 40 or older, have had a recent prostate MRI, and have certain MRI findings and elevated PSA (prostate-specific antigen) levels. The researchers will compare the AI-guided biopsy approach to the standard biopsy method to see which is better at finding cancer.
- Study design
- This interventional study plans to enroll 50 men. Participants will be randomly assigned to either the AI-informed biopsy group or the standard biopsy group.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcomes of the study, including acceptance rates and cancer detection rates, will be measured at 4 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
AI Algorithm-Informed Biopsy for Prostate Cancer Detection With Indeterminate and Low-Risk Prostate MRI Lesions
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Ahmet M Aydin, MD · PRINCIPAL_INVESTIGATOR · University of Arkansas
Who to contact
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What this trial measures
- Acceptance rate of randomization and biopsy recommendations based on study protocol and AI algorithm results by the patients4 months
Number and percent of the first 10 enrolled and randomized subjects who agree to undergo the prostate biopsy procedure to which they were randomized and accept the biopsy recommendations based on study protocol and AI algorithm results.
- Per-patient and per-lesion csPCa detection rates of AI algorithm-informed biopsy (the intervention arm) versus contemporary biopsy (the control arm) in patients randomly allocated 1:1 to each arm4 months
The percent of csPCa detected per-patient and per-lesion in the biopsy cores obtained from each study arm. We expect at least 42% for the csPCa detection rate on the AI algorithm-informed-biopsy arm, which would be a 27% increase relative to the current csPCa detection rate (15%) expected on the contemporary prostate-biopsy arm.