Clinical Trial

Fusion or Cognitive Ultrasound-guided Biopsy to Detect Prostate Cancer

Study acronym: FOCUS-PC
Recruiting
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Summary
The MRI-targeted biopsy for prostate cancer detection can be performed using one of two techniques: 1. Software-based fusion of MRI and ultrasound images (software fusion) or 2. Visually estimated MRI-informed (cognitive fusion) technique To date, there is a lack of adequately powered RCTs directly comparing the cognitive vs fusion targeted biopsy. This randomized study will directly compare the detection rates of clinically significant prostate cancer following either the cognitive or the fusion targeted prostate biopsy in men with suspicious lesions noted on multi-parametric MRI (mp-MRI) of prostate.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-07-19; most recent amendment 2025-09-30.
Status change: Not Yet Recruiting → Recruiting 2025-09-30
Trial Details
NCT Number NCT06517901
Lead Sponsor Albany Medical College
Conditions Prostate Cancer, Diagnosis
Enrollment 1,306 participants
Start Date 2025-04-18
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-10-03