Utility of Biparametric MRI (Magnetic Resonance Imaging) as a Screening Tool for Prostate Cancer in a High-Risk Cohort
Recruiting · NCT05384535 · Interventional (participants receive a specific treatment) · Lead sponsor: Northwell Health
View the official record on ClinicalTrials.gov →Interventions studied
Bi-parametric MRI
What this trial is about
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.
Who can take part
Age range
40 Years to 55 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
Where it is running
1 location listed across 1 US state.
- Cynthia Knauer - Lake Success, New York, United States