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

Not Applicable

Recruiting

• Conditions: Prostate Cancer; Magnetic Resonance Imaging; Population at Risk
• Interventions: Diagnostic Test: Bi-parametric MRI

• Registration Number: NCT05384535
• Lead Sponsor: Northwell Health

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 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.

Study Timeline

• Study First Submitted: 2022-05-17
• Study First Submitted QC: 2022-05-17
• Study First Posted: 2022-05-20
• Study Start: 2022-08-15
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-22
• Last Update Posted: 2023-12-26
• Primary Completion: 2025-10-31
• Study Completion: 2026-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bi-parametric Screening MRI	Bi-parametric MRI	Bi-parametric MRI to be administered to High Risk males

Primary Outcome Measures

Name	Time	Method
Proportion of suspicious lesions on MRI in men with PSA less than 2.5 ng/ml	3 months	To determine the incidence of positive mpMRI prostate in a high-risk cohort of men as a screening tool for prostate cancer.

Secondary Outcome Measures

Name	Time	Method
Prostate cancer detection rate using 3T bpMRI in patients with high risk and suspicious lesions on bpMRI	3 months	Proportion of men with suspicious lesion found to have cancer on biopsy, this is the PPV based on the prevalence of this population.
Association of whether findings on bpMRI and serum PSA (i.e. PSA density) are associated with future diagnosis of prostate cancer.	5 years	Proportion diagnosed with prostate cancer over 5 year follow-up among patients who were not diagnosed with prostate cancer based on findings of initial mpMRI (i.e. mend who either did not have any suspicious lesions or had suspicious lesions but were negative for cancer on biopsy)
To correlate bpMRI findings with future changes in PSA	5 years	PSA density will be measured every year for five years

Trial Locations

Locations (1)

Cynthia Knauer; 🇺🇸 Lake Success, New York, United States