Status:
RECRUITING
Fusion or Cognitive Ultrasound-guided Biopsy to Detect Prostate Cancer
Lead Sponsor:
Albany Medical College
Conditions:
Prostate Cancer
Diagnosis
Eligibility:
MALE
18+ years
Phase:
NA
Brief 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 MR...
Detailed Description
For prostate cancer detection, pre-biopsy multi-parametric magnetic resonance imaging (mp-MRI) followed by MRI-targeted prostate biopsy is standard of care which is supported by the guidelines from th...
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)
Key Trial Info
Start Date :
April 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
1306 Patients enrolled
Trial Details
Trial ID
NCT06517901
Start Date
April 18 2025
End Date
June 30 2027
Last Update
October 3 2025
Active Locations (4)
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1
Lahey Clinic, Inc
Burlington, Massachusetts, United States, 01805
2
Albany Medical Center
Albany, New York, United States, 12208
3
Pennsylvania State University
Hershey, Pennsylvania, United States, 17023
4
Manitoba Prostate Centre, CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3A 1M5