NCT05384535 Utility of Biparametric MRI (Magnetic Resonance Imaging) as a Screening Tool for Prostate Cancer in a High-Risk Cohort
| NCT ID | NCT05384535 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Northwell Health |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-08-15 |
| Primary Completion | 2027-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2022-08-15 with a primary completion date of 2027-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Ardeshir Rastinehad, DO
PRINCIPAL INVESTIGATOR
Northwell Health
Frequently Asked Questions
Who can join the NCT05384535 clinical trial?
This trial is open to male participants only, aged 40 Years or older, up to 55 Years, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05384535 currently recruiting?
Yes, NCT05384535 is actively recruiting participants. Contact the research team at urologyresearch@northwell.edu for enrollment information.
Where is the NCT05384535 trial being conducted?
This trial is being conducted at Lake Success, United States.
Who is sponsoring the NCT05384535 clinical trial?
NCT05384535 is sponsored by Northwell Health. The principal investigator is Ardeshir Rastinehad, DO at Northwell Health. The trial plans to enroll 100 participants.
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