Fusion or Cognitive Ultrasound-guided Biopsy to Detect Prostate Cancer

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• Men undergoing prostate biopsy (either transrectal or transperineal) for suspected prostate cancer as part of their regular medical care
• Must be eligible to undergo both prostate biopsy procedure (cognitive or fusion)
• Men undergoing their first prostate biopsy procedure or with no previous prostate biopsy within 3 years
• Pre-biopsy mp-MRI of prostate with one or more lesions classified as PIRADS 3-5
• Largest dimension of any lesion on mp-MRI to be ≤ 2 cm
• Prostate-specific antigen level ≤ 20 ng/mL and/or abnormal digital rectal examination

🚫 You may not be able to join if…

• mp-MRI detected lesions that are > 2 cm
• History of prostate biopsy within 3 years
• Previous diagnosis of prostate cancer
• Contraindications to prostate biopsy (eg, fever, evidence of genito-urinary infection, excessive co-morbidities as per treating physician)

Where this trial is running

• Lahey Clinic, Inc, Burlington, Massachusetts, United States
• Albany Medical Center, Albany, New York, United States
• Pennsylvania State University, Hershey, Pennsylvania, United States
• Manitoba Prostate Centre, CancerCare Manitoba, Winnipeg, Manitoba, Canada

Who to contact

Badar M Mian, MD · 5182623296 · mianb@amc.edu

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06517901.