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
Trial ID: NCT07231627
Status: NOT_YET_RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2026-05
Completion date: 2029-01
Sponsor: University of Arkansas
Conditions: Prostate Cancer
Interventions: Bi-parametric MRI-based cascaded deep-learning AI algorithm
Locations: University of Arkansas for Medical Sciences
Countries: United States
Enrollment: 50
Age range: 40 Years - None
Sex: MALE

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.

Eligibility 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.

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