ClinConnect ClinConnect Logo
Search / Trial NCT05384535

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

Launched by NORTHWELL HEALTH · May 17, 2022

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

Prostate Cancer Screening Magnetic Resonance Imaging

ClinConnect Summary

This clinical trial is studying whether a specific type of MRI called biparametric MRI (bpMRI) can help improve screening for prostate cancer in men who are at high risk for the disease. The goal is to see if using bpMRI along with a blood test called PSA (Prostate-Specific Antigen) can make screening more effective for early detection of prostate cancer.

To participate in the trial, men must be between 14 and 88 years old, have a PSA level between 1.0 and 2.5 ng/dL, and meet certain high-risk criteria—like being Black or having a family history of prostate cancer. Participants should be willing to undergo screening and be able to give informed consent. If you decide to participate, you can expect to undergo a bpMRI scan, and the study will monitor the results to see if this approach helps identify prostate cancer earlier. It's important to note that some individuals may not be eligible if they have certain medical conditions or have had previous prostate surgery. If you're interested, please talk to your doctor about whether this trial might be right for you.

Gender

MALE

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

About Northwell Health

Northwell Health is a leading integrated health system based in New York, dedicated to advancing healthcare through innovative research and clinical trials. With a commitment to improving patient outcomes and enhancing medical knowledge, Northwell Health conducts a diverse range of clinical studies across various therapeutic areas. The organization harnesses its extensive network of hospitals, outpatient facilities, and research institutes to facilitate cutting-edge research, ensuring access to advanced treatments for patients while fostering collaboration among healthcare professionals, researchers, and industry partners. By prioritizing patient-centric approaches and leveraging state-of-the-art technology, Northwell Health aims to drive significant advancements in medical science and public health.

Locations

Lake Success, New York, United States

Patients applied

0 patients applied

Trial Officials

Ardeshir Rastinehad, DO

Principal Investigator

Northwell Health

Manish Vira, MD

Principal Investigator

Northwell Health

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Similar Trials