NCT05384535NARecruiting

Utility of Biparametric MRI (Magnetic Resonance Imaging) as a Screening Tool for Prostate Cancer in a High-Risk Cohort

Northwell Health

Start Date

8/15/2022

Completion Date

10/31/2028

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 these high-risk subjects between the ages of 40-55 with a normal PSA ranging from ≥1.0 to \<2.5 ng/mL. bpMRI would be obtained in this group of subjects. If any suspicious lesions are found, the recommendation is to undergo MRI/US fusion biopsy. Subjects with negative bpMRI will be followed every year with serum PSA. Subjects with a positive bpMRI will have a prostate fusion and systematic biopsy performed. Those with a benign biopsy will be followed every year with serum PSA. Those who have a biopsy positive for cancer will be managed and followed according to the standard of care. All subjects will be followed for 5 years. Our hypothesis is that bpMRI in conjunction with above average PSA in a high-risk group will increase detection of clinically relevant prostate cancer and provide a useful addition to PSA screening.

Eligibility Criteria

Age Range: 40 years to 55 years

Inclusion Criteria: 1. PSA between 1.0 and 2.5 ng/dL 2. 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 3. Patient is willing to participated in prostate cancer screening 4. Patient is capable of giving informed consent Exclusion Criteria: 1. Nodularity or firmness of prostate on exam 2. Patient has undergone a prior biopsy or prostate surgery 3. Patient is taking 5-alpha reductase inhibitors to manage benign prostatic hyperplasia, as this can significantly alter PSA levels. 4. Patient has a history of UTI or prostatitis in the preceding 6 months, as this can significantly alter PSA levels. 5. Patient has a contraindication to MRI, these include but are not limited to pacemakers, neurostimulator devices, metal cardiac valves, certain tattoos, or foreign bodies 6. Participants that experience claustrophobia, anxiety and/or vertigo when moved inside the scanner 7. The participant cannot tolerate lying flat for the study duration

Interventions

DIAGNOSTIC_TEST

Bi-parametric MRI

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Prostate CancerMagnetic Resonance ImagingPopulation at Risk

Locations

Cynthia Knauer

Lake Success, New York 11042

United States