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Fusion or Cognitive Ultrasound-guided Biopsy to Detect Prostate Cancer
Sponsor: Albany Medical College
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.
Official title: MRI-targeted Fusion or Cognitive Ultrasound-guided Biopsy to Detect Prostate Cancer
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1306
Start Date
2025-04-18
Completion Date
2027-06-30
Last Updated
2025-10-03
Healthy Volunteers
No
Conditions
Interventions
Software fusion prostate biopsy
Software fusion biopsy: Each participant in this study arm will first undergo biopsy of the MRI-detected lesion using an image fusion platform such as UroNav or similar. Three biopsy cores will be taken per lesion, with a maximum of three lesions being sampled per participant. Then systematic samples will be taken from the remainder of the prostate as per standard protocol (10-12 cores).
Cognitive fusion prostate biopsy
Cognitive fusion biopsy: Each participant in this study arm will first undergo biopsy of the MRI-detected lesion using visual estimation and/or measurements of lesion. Three biopsy cores will be taken per lesion, with a maximum of three lesions being sampled per participant. Then systematic samples will be taken from the remainder of the prostate as per standard protocol (10-12 cores).
Locations (4)
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