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

NCT05384535 | Recruiting FDA Device

• 1 other identifier: 21-1380
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Magnetic Resonance Imaging; Population at Risk

Keywords

Prostate Cancer; Screening; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• Proportion of suspicious lesions on MRI in men with PSA less than 2.5 ng/ml

  To determine the incidence of positive mpMRI prostate in a high-risk cohort of men as a screening tool for prostate cancer.

  3 months

Secondary Outcomes (3)

• Prostate cancer detection rate using 3T bpMRI in patients with high risk and suspicious lesions on bpMRI

  3 months

• Association of whether findings on bpMRI and serum PSA (i.e. PSA density) are associated with future diagnosis of prostate cancer.

  5 years

• To correlate bpMRI findings with future changes in PSA

  5 years

Study Arms (1)

Bi-parametric Screening MRI

EXPERIMENTAL

Bi-parametric MRI to be administered to High Risk males

Diagnostic Test: Bi-parametric MRI

Interventions

Bi-parametric MRI DIAGNOSTIC_TEST

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

Bi-parametric Screening MRI

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Cynthia Knauer

Lake Success, New York, 11042, United States

RECRUITING

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Related Links

• Guidance for Industry and FDA Staff: Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices
• Medical Device Regulation and Overview General and Special Controls
• How to Market Your Device
• How to market Your Device (2)
• Accessing Data
• Post Market Regulation Requirements

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Ardeshir Rastinehad, DO

  Northwell Health

  PRINCIPAL INVESTIGATOR

• Manish Vira, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cynthia Knauer, RN

CONTACT

516-734-8500; urologyresearch@northwell.edu

Monica Johnson

CONTACT

516-734-8500; urologyresearch@northwell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 20, 2022
• Study Start: August 15, 2022
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2028
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)