Recruiting

Biparametric MRI

Sponsor:

Northwell Health

Code:

NCT05384535

Conditions

Prostate Cancer

Magnetic Resonance Imaging

Population at Risk

Eligibility Criteria

Sex: Male

Age: 40 - 55

Healthy Volunteers: Not accepted

Interventions

Bi-parametric MRI

Study Details

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

Study ID

NCT05384535

Start date

Aug 15, 2022

Status verified date

Nov, 2025

Completion date

Oct 31, 2028

Anticipated

Primary completion date

Oct 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 40 - 55

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Bi-parametric Screening MRI

Bi-parametric MRI to be administered to High Risk males

Interventions

Bi-parametric MRI

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 outcome measure

  • Proportion of suspicious lesions on MRI in men with PSA less than 2.5 ng/ml [ Time Frame: 3 months ]

Central Contacts and Locations

Locations

Cynthia Knauer

Recruiting

Lake Success, New York, United States, 11042

Contacts

Principal Investigator:

Ardeshir Rastinehad, DO

More Information

Sponsor

Northwell Health

Last update posted

Nov 24, 2025

Last verified

Nov, 2025

Keywords

  • Prostate Cancer
  • Screening
  • Magnetic Resonance Imaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2025-11-24.