Using Biparametric MRI to Screen for Prostate Cancer in High-Risk Individuals
Utility of Biparametric MRI (Magnetic Resonance Imaging) as a Screening Tool for Prostate Cancer in a High-Risk Cohort
This study is testing if using a special type of MRI along with blood tests can help find prostate cancer earlier in men aged 40-55 who are at high risk.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 40 Years to 55 Years |
| Sex | Male |
| Sponsor | Northwell Health Academic / other |
| Locations | 1 site (Lake Success, New York) |
| Trial ID | NCT05384535 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are men aged 40-55 with a PSA level between 1.0 and 2.5 ng/mL who are at high risk for prostate cancer due to ethnicity or family history.
Not a fit: Patients with prior prostate biopsies, surgeries, or those with conditions that contraindicate MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance early detection of prostate cancer in high-risk populations, potentially leading to better patient outcomes.
How similar studies have performed: Other studies have shown promise in using advanced imaging techniques for prostate cancer detection, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lake Success, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.