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.
Primary Feasibility Objective: 1\. Assess the acceptance rate of randomization and biopsy recommendations based on study protocol and AI algorithm results by the patients. This will be assessed in the first 10 patients who enroll during the phase I feasibility segment. Primary Efficacy Objective: 1\. Evaluate the 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. This will be evaluated in all 25 patients per arm (50 patients). Secondary Objectives (These objectives will be satisfied using endpoint data from all 50 subjects (25/arm) enrolled): 1. Evaluate benign and clinically non-significant PCa rates (GS \<7) in patients who underwent AI-algorithm informed (the intervention arm) versus contemporary (the control arm) prostate biopsies. 2. Evaluate the specificity and sensitivity of AI algorithm-informed biopsy (AI-targeted and perilesional prostate biopsy) versus contemporary biopsy in detection of csPCa. 3. Obtain and evaluate adverse events (AEs), urinary function (IPSS), sexual function (IIEF) quality of life (QOL) \[ SF-12 and TMI scores\] and decision regret (DRS) measures on subjects that underwent contemporary biopsy versus AI Algorithm-informed biopsy. Exploratory Objective: 1\. Collect data via genomic and transcriptomic approaches (Whole exome sequencing + Targeted RNA sequencing OR single cell RNA sequencing) in patients whose standard contemporary biopsy, perilesional biopsy and AI-targeted biopsy revealed csPCa, and compare collected data on all endpoints for differences among perilesional biopsy, AI-targeted biopsy and contemporary standard biopsy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
50
Artificial 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.
Time frame: 4 months
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.
Time frame: 4 months
Percentage of benign and clinically non-significant PCa detected in patients who underwent AI Algorithm-informed or contemporary prostate biopsies.
Time frame: 4 months
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
Time frame: 4 months
Evaluation of adverse events on subjects that underwent contemporary biopsy versus AI Algorithm-informed biopsy graded by CTCAE v5.0
Time frame: 4 months
Evaluation of urinary function (IPSS) on subjects that underwent contemporary biopsy versus AI Algorithm-informed biopsy
Time frame: 4 months
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Evaluation of sexual function (Form IIEF) on subjects that underwent contemporary biopsy versus AI Algorithm-informed biopsy
Time frame: 4 months
Evaluation of quality of life using Form TMI and Form SF12 scores on subjects that underwent contemporary biopsy versus AI Algorithm-informed biopsy
Time frame: 4 months
Evaluation of decision regret using the Decision Regret Scale (Form DRS) to measure on subjects that underwent contemporary biopsy versus AI Algorithm-informed biopsy
Time frame: 4 months