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