Actively Recruiting
Fusion or Cognitive Ultrasound-guided Biopsy to Detect Prostate Cancer
Led by Albany Medical College · Updated on 2025-10-03
1306
Participants Needed
4
Research Sites
114 weeks
Total Duration
On this page
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Fusion or Cognitive Ultrasound-guided Biopsy to Detect Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men undergoing prostate biopsy (transrectal or transperineal) for suspected prostate cancer
- Eligible for both cognitive and fusion prostate biopsy procedures
- First prostate biopsy or no prostate biopsy within the past 3 years
- Pre-biopsy mp-MRI showing one or more lesions classified as PIRADS 3-5
- Largest lesion on mp-MRI is 2 cm or smaller
- Prostate-specific antigen level 20 ng/mL or less and/or abnormal digital rectal exam
You will not qualify if you...
- Lesions on mp-MRI larger than 2 cm
- Prostate biopsy within the last 3 years
- Previous diagnosis of prostate cancer
- Contraindications to prostate biopsy such as fever, genito-urinary infection, or significant co-morbidities
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Lahey Clinic, Inc
Burlington, Massachusetts, United States, 01805
Actively Recruiting
2
Albany Medical Center
Albany, New York, United States, 12208
Actively Recruiting
3
Pennsylvania State University
Hershey, Pennsylvania, United States, 17023
Not Yet Recruiting
4
Manitoba Prostate Centre, CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3A 1M5
Not Yet Recruiting
Research Team
B
Badar M Mian, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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