Not Yet RecruitingNot Applicable

AI Algorithm-Informed Biopsy for Prostate Cancer Detection With Indeterminate and Low-Risk Prostate MRI Lesions

50 participantsStarted 2026-05

Plain-language summary

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.

Who can participate

Age range40 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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,

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.
✕. 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.

What they're measuring

Acceptance rate of randomization and biopsy recommendations based on study protocol and AI algorithm results by the patients

Timeframe: 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

Timeframe: 4 months

Trial details

NCT IDNCT07231627

SponsorUniversity of Arkansas

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-01

Contact for this trial

Aaron Holley

5016868274 JAHolley@uams.edu

View on ClinicalTrials.gov More Prostate Cancer trials

Who can participate

Age range40 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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,

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.
✕. 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.

What they're measuring

Acceptance rate of randomization and biopsy recommendations based on study protocol and AI algorithm results by the patients

Timeframe: 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

Timeframe: 4 months