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Clinical trial Recruiting at 1 site Interventional Ages 40 and up Men only

AI-guided biopsy approach for detecting prostate cancer with indeterminate or low-risk MRI findings

Official title: A Prospective Randomized Phase I/II Study of Artificial Intelligence Algorithm-Informed Biopsy for Detection of Prostate Cancer in Patients With Indeterminate and Low-risk Prostate MRI Lesions

Run by University of Arkansas · NCT07231627 · Data updated 2026-11-12

We test if an AI-informed biopsy approach helps find significant prostate cancer in men with indeterminate or low-risk MRI results and elevated PSA.

Quick facts

Study typeInterventional
Ages40 Years and up
SexMen only
Enrollment50 (estimated)
SponsorUniversity of Arkansas
Academic / other
Drugs / interventionsradiation
Locations1 site (Little Rock, Arkansas)
StatusRecruiting
StartedJune 19, 2026
Main results expectedJanuary 2028
Study endsJanuary 2029
Registry record updatedAugust 19, 2026
Trial IDNCT07231627 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Men 40 years or older with recent MRI showing PIRADS 3 lesions or PIRADS 1-2 lesions plus elevated PSA and at least one risk factor (e.g., high PSA density, suspicious DRE, high-risk biomarkers, or favorable family/genetic risk).

Probably not a fit

Patients with MRI findings or risk profiles unlikely to yield csPCa or who do not undergo biopsy may not benefit from this approach.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional feasibility study evaluates an AI-driven, MRI-based, cascaded deep-learning algorithm to guide biopsy in men with prostate cancer risk and specific MRI findings. Participants are randomized 1:1 to receive AI-informed biopsy versus standard contemporary biopsy, with primary goals including csPCa detection per patient and per lesion. Secondary aims track biopsy accuracy, adverse events, urinary and sexual function, and quality of life, using a broad set of patient-reported outcomes. Exploratory analyses will collect genomic and transcriptomic data from tumor samples. The study is conducted at the University of Arkansas for Medical Sciences and is led by the University of Arkansas.

Why it matters

Potential benefit: If successful, AI-guided biopsies could improve detection of clinically significant prostate cancer while potentially reducing unnecessary procedures.

How similar studies have gone: Prior research suggests AI-guided biopsy has potential to improve csPCa detection, but this exact randomized feasibility design is novel for this imaging/biopsy context.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. 40 years of age or older.
2. A recent pMRI performed within last 12 weeks
3. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.
4. 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).
5. 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:

   1. High PSA density (0.15 ng/ml/g or higher),
   2. suspicious DRE,
   3. a positive/high-risk blood or urine biomarker test,
   4. high-risk ancestry (Black/African American),
   5. those with germline mutations that increase the risk for prostate cancer,
   6. significant personal medical history,
   7. significant family history,
   8. 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:

1. Patients younger than 18 years old.
2. Any patient with PIRADS 4-5 lesion per pMRI.
3. Any patient with known csPCa (GS ≥7 (3+4)) per biopsy.
4. 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).
5. Medically unfit for anesthesia.
6. Any history of allergic reactions attributed to contrast agents, or other compounds of similar chemical compositions.
7. Any medical history preventing pMRI or prostate biopsy.
8. Any medical condition distorting quality of pMRI such as artificial hip prosthesis, and excessive rectal gas.
9. 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 it's running

  • University of Arkansas for Medical Sciences
    Little Rock, Arkansas, United States     Recruiting

Study contacts

  • Principal investigator: Ahmet M Aydin, MD — University of Arkansas
  • Study coordinator: Aaron Holley
  • Email: JAHolley@uams.edu
  • Phone: 5016868274

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.