Fusion or Cognitive Ultrasound-guided Biopsy to Detect Prostate Cancer

Recruiting

MRI-targeted Fusion or Cognitive Ultrasound-guided Biopsy to Detect Prostate Cancer

Who can join

Ages 18 and older · Men

Full eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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)

About the study

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.

What is being tested

Software fusion prostate biopsy (procedure)
Cognitive fusion prostate biopsy (procedure)

Sponsor: Albany Medical College · Participants: 1,306 · Started: Apr 18, 2025

Contact the study team

Badar M Mian, MD · Phone: 5182623296

Official record on ClinicalTrials.gov — NCT06517901

Locations in the U.S.

Massachusetts	Lahey Clinic, Inc, Burlington
New York	Albany Medical Center, Albany
Pennsylvania	Pennsylvania State University, Hershey (Not yet recruiting)

Conditions

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.