Comparing Prostate Biopsy Techniques for Cancer Detection

This study is comparing two ways to perform a prostate biopsy (a procedure to remove small tissue samples for examination) when prostate cancer is suspected based on an MRI scan. One method, called "Software fusion prostate biopsy," uses special software to combine MRI and ultrasound images to guide the biopsy. The other, "Cognitive fusion prostate biopsy," relies on a doctor's visual estimation and measurements from the MRI. The goal is to see which method is better at finding clinically significant prostate cancer (cancer that needs treatment). You might be able to join if you are a man aged 18 or older, need a prostate biopsy for suspected cancer, and have not had a biopsy in the last three years. The study aims to enroll 1306 participants.

Study design
This is an interventional study comparing two different biopsy techniques. It plans to enroll 1306 men.
What's involved
You would undergo either a software fusion or cognitive fusion prostate biopsy, where three tissue samples are taken per suspected lesion, up to a maximum of three lesions.
Compensation
Not stated in the trial record.
Follow-up
The study will measure the detection of clinically significant prostate cancer at 1 year after the biopsy.

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NCT06517901

Fusion or Cognitive Ultrasound-guided Biopsy to Detect Prostate Cancer

Recruiting
NAAges 18+InterventionalDiagnostic
Albany Medical College
~1,306 participants
Updated 2025-10-03 on ClinicalTrials.gov
What's tested:Software fusion prostate biopsyCognitive fusion prostate biopsy

At a glance

Recruiting sites
2 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Detection of clinically significant prostate cancer
Measured over 1 year
Prostate Cancer
Diagnosis
4 sites across 4 states
Massachusetts1
New York1
Pennsylvania1
Manitoba1
  • Badar M Mian, MD · STUDY_CHAIR · Albany Medical College

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Eligibility criteria

Inclusion

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

Exclusion

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)
  • Detection of clinically significant prostate cancer1 year

    Compare the overall detection of clinically significant prostate cancer following fusion vs cognitive MRI-targeted biopsy