Utility of Biparametric MRI (Magnetic Resonance Imaging) as a Screening Tool for Prostate Cancer in a High-Risk Cohort
Status
RECRUITING
Phase
NA
Age
40 - 55 Years
Enrollments
100Conditions
Prostate Cancer, Magnetic Resonance Imaging, Population at RiskSummary
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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Cynthia Knauer
- 516-734-8500
- [email protected]
Principal Investigator
- Ardeshir Rastinehad, DO
Eligibility Criteria
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
Study Plan
Bi-parametric Screening MRI
EXPERIMENTAL
Bi-parametric MRI to be administered to High Risk males
DIAGNOSTIC_TEST:
Bi-parametric MRIDescription:
When used for the evaluation of prostate cancer, MRI typically involves multiple sequences and typically includes typical T1 and T2 phases with the addition of diffusion weighted imaging and dynamic contrast enhanced imaging. In this study, we have decided to omit dynamic contrast enhanced imaging due to its decreased diagnostic yield relative to T2 and DWI and associated increased risk of contrast agents, this is a common approach for prostate cancer screening and is referred to as a bi-parametric MRI
Outcome Measures
Primary Outcome Measures
Proportion of suspicious lesions on MRI in men with PSA less than 2.5 ng/ml
Secondary Outcome Measures
Prostate cancer detection rate using 3T bpMRI in patients with high risk and suspicious lesions on bpMRI
Association of whether findings on bpMRI and serum PSA (i.e. PSA density) are associated with future diagnosis of prostate cancer.
To correlate bpMRI findings with future changes in PSA
Timeline
Last Updated
December 26, 2023Start Date
May 20, 2022Today
February 5, 2025Completion Date ( Estimated )
October 31, 2026
Sponsors of this trial
Lead Sponsor
Northwell Health
RECRUITING 
21 - 64 Years