Using Biparametric MRI to Screen for Prostate Cancer in High-Risk Individuals

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study aims to evaluate the effectiveness of biparametric MRI (bpMRI) combined with PSA testing for the early detection of clinically significant prostate cancer in high-risk individuals aged 40-55. Participants will have a normal PSA level between 1.0 and 2.5 ng/mL and will undergo bpMRI to identify any suspicious lesions. If lesions are detected, participants will be recommended for MRI/US fusion biopsy, while those with negative results will be monitored annually with PSA tests. The study will follow participants for five years to assess the impact of bpMRI on prostate cancer detection rates.

Why it matters

Who can join: the full rules

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

Where it's running

• Cynthia Knauer
  Lake Success, New York, United States Recruiting

Study contacts

• Principal investigator: Ardeshir Rastinehad, DO — Northwell Health
• Study coordinator: Cynthia Knauer, RN
• Email: urologyresearch@northwell.edu
• Phone: 516-734-8500

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.