NCT07231627 · University of Arkansas
AI Algorithm-Informed Biopsy for Prostate Cancer Detection With Indeterminate and Low-Risk Prostate MRI Lesions
What this study is about
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.
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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.
Interventions
DEVICE
Bi-parametric MRI-based cascaded deep-learning AI algorithm
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.
Primary outcome measures
Acceptance rate of randomization and biopsy recommendations based on study protocol and AI algorithm results by the patients
Time frame: 4 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 arm
Time frame: 4 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 with PIRADS 1-2 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), AND at least one of the following:
- High PSA density (0.15 ng/ml/g or higher),
- suspicious DRE,
- a positive/high-risk blood or urine biomarker test,
- high-risk ancestry (Black/African American),
- those with germline mutations that increase the risk for prostate cancer,
- significant personal medical history,
- significant family history,
- persistent and significant increase in PSA levels (persistently elevated PSA for at least 12 months with an increase of at least 100% or more within 24 months, last level confirmed twice).
Exclusion criteria
- 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. a. (Patients who never scanned with pMRI before, had GS 6 (3+3) PCa only per systematic biopsy, and currently need confirmatory prostate biopsy will be allowed to enroll in the trial).
- Medically unfit for anesthesia.
- Any history of allergic reactions attributed to contrast agents, or other compounds of similar chemical compositions.
- Any medical history preventing pMRI or prostate biopsy.
- Any medical condition distorting quality of pMRI such as artificial hip prosthesis, and excessive rectal gas.
- Any other condition that, in the opinion of the investigator, might interfere with the safe conduct of the study. Inclusion of Women and Minorities: All participants will be men without previous diagnosis for PCa. Men of all ethnic groups and races are eligible for the study. Thus, women will not be included in this study.
Where
- Little Rock, Arkansas
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 25, 2026 · Source of record for eligibility and locations