NCT05384535Recruiting
Utility of Biparametric MRI (Magnetic Resonance Imaging) as a Screening Tool for Prostate Cancer in a High-Risk Cohort
Source: ClinicalTrials.gov · Last updated 24 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 17 May 2022
- Start date
- 15 Aug 2022
- Primary completion date
- 31 Oct 2027
- Lead sponsor
- Northwell Health
- Diseases
- Prostate cancer
- NCT number
- NCT05384535
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 15 Aug 2022 to the primary completion date, 31 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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
Other
- Nodularity or firmness of prostate on exam
- Participants that experience claustrophobia, anxiety and/or vertigo when moved inside the scanner
- The participant cannot tolerate lying flat for the study duration
Who the study is looking for
- 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
Age in the registry: 40 years to 55 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cynthia Knauer Coordinator of this site? Confirm its status | Lake Success | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.