Status:
RECRUITING
Utility of Biparametric MRI (Magnetic Resonance Imaging) as a Screening Tool for Prostate Cancer in a High-Risk Cohort
Lead Sponsor:
Northwell Health
Conditions:
Prostate Cancer
Magnetic Resonance Imaging
Eligibility:
MALE
40-55 years
Phase:
NA
Brief Summary
To determine whether using bpMRI in subjects who are at high risk of developing prostate cancer in conjunction with PSA will improve prostate cancer screening protocols.
Detailed Description
The Investigators propose a pilot study which utilizes bpMRI in conjunction with PSA in the early detection of clinically significant prostate cancer in a high-risk group. Our study would focus on the...
Eligibility Criteria
Inclusion
- PSA between 1.0 and 2.5 ng/dL
- High risk for prostate cancer, i.e. Black or they have a first degree relative with history of prostate cancer (father, brother) or specific genetic syndromes i.e. BRCA 1/2, HOX B13, Lynch syndrome, ATM, CHEK2
- Patient is willing to participated in prostate cancer screening
- Patient is capable of giving informed consent
Exclusion
- Nodularity or firmness of prostate on exam
- Patient has undergone a prior biopsy or prostate surgery
- Patient is taking 5-alpha reductase inhibitors to manage benign prostatic hyperplasia, as this can significantly alter PSA levels.
- Patient has a history of UTI or prostatitis in the preceding 6 months, as this can significantly alter PSA levels.
- Patient has a contraindication to MRI, these include but are not limited to pacemakers, neurostimulator devices, metal cardiac valves, certain tattoos, or foreign bodies
- Participants that experience claustrophobia, anxiety and/or vertigo when moved inside the scanner
- The participant cannot tolerate lying flat for the study duration
Key Trial Info
Start Date :
August 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05384535
Start Date
August 15 2022
End Date
October 31 2028
Last Update
November 24 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cynthia Knauer
Lake Success, New York, United States, 11042