Use of AI algorithm for PCa detection is feasible, and AI-informed biopsies (AI-targeted and perilesional biopsy) improves csPCa detection in patients with indeterminate MRI lesions and in patients with low-risk MRI lesions and high-risk clinical features.
40 years of age or older.
A recent pMRI performed within last 12 weeks
Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.
Any patient with PIRADS 3 lesions per pMRI, AND elevated PSA ("=> 3.0 ng/ml" for patients between 40 and 75 years old, and "=> 4.0 ng/ml" for the patients older than 75 years).
Patients younger than 18 years old.
Any patient with PIRADS 4-5 lesion per pMRI.
Any patient with known csPCa (GS ≥7 (3+4)) per biopsy.
Any patient with PCa and managed with active surveillance, surgery or radiation.
Parallel
Bi-parametric MRI-based cascaded deep-learning AI algorithm
DeviceArtificial intelligence system used in medical imaging, primarily for the automated detection and classification of lesions (such as prostate cancer) using only specific types of magnetic resonance imaging (MRI) data.
Acceptance rate of randomization and biopsy recommendations based on study protocol and AI algorithm results by the patients
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 arm
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.
Percentage of benign and clinically non-significant PCa detected in patients who underwent AI Algorithm-informed or contemporary prostate biopsies.
Percentage of true positive, false positive, true negative and false negative findings for csPCa in all patients who enrolled in both study arms.versus contemporary biopsy in detection of csPCa
Evaluation of adverse events on subjects that underwent contemporary biopsy versus AI Algorithm-informed biopsy graded by CTCAE v5.0
Evaluation of urinary function (IPSS) on subjects that underwent contemporary biopsy versus AI Algorithm-informed biopsy
Expression levels and/or expression profiles of genomic and transcriptomic signatures in csPCa diagnosed from perilesional biopsy, AI-targeted biopsy and contemporary standard biopsy
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