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NCT Number: NCT05384535

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Magnetic Resonance Imaging Male Urogenital Diseases Neoplasms Neoplasms by Site Population at Risk Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Cynthia Knauer

Lake Success, New York, 11042, United States

Location status: Recruiting

Location contact

Ardeshir Rastinehad, DO

PRINCIPAL_INVESTIGATOR

Cynthia Knauer

CONTACT

[email protected]

516-734-8500

Manish Vira, MD

PRINCIPAL_INVESTIGATOR

Monica Johnson

CONTACT

[email protected]

516-734-8500

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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)

  3. To correlate bpMRI findings with future changes in PSA

    Time frame: 5 years

    PSA density will be measured every year for five years

Study contacts

Contact information is provided by the study sponsor or research team.

Cynthia Knauer, RN

CONTACT

[email protected]

516-734-8500

Monica Johnson

CONTACT

[email protected]

516-734-8500

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
May 20, 2022
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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