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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age40+
SponsorUniversity of Arkansas

About this trial

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

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Bi-parametric MRI-based cascaded deep-learning AI algorithm

Treatment groups

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators