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Diagnostic Test

Biparametric MRI Screening for Prostate Cancer

N/A
Recruiting
Led By Ardeshir Rastinehad, DO
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Must not have
Participants that experience claustrophobia, anxiety and/or vertigo when moved inside the scanner
The participant cannot tolerate lying flat for the study duration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether using MRI to screen for prostate cancer in addition to the PSA test will improve the accuracy of prostate cancer screening.

Who is the study for?
This trial is for men at high risk of prostate cancer, which includes Black men or those with a family history (father, brother) or specific genetic mutations (BRCA 1/2, HOX B13). Participants should have PSA levels between 1.0 and 2.5 ng/dL and be able to consent. Men who've had recent UTIs, prostatitis, prostate surgery/biopsy, take certain medications for enlarged prostate, or can't undergo MRI are excluded.
What is being tested?
The study tests if biparametric MRI as a screening tool alongside PSA testing improves detection of prostate cancer in high-risk individuals. It aims to see whether this method can better identify patients who may need further investigation compared to current screening protocols.
What are the potential side effects?
While the biparametric MRI itself doesn't involve medication and thus has no direct side effects like drugs do, participants might experience discomfort from lying still during the scan or anxiety due to claustrophobia inside the scanner.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I feel claustrophobic, anxious, or dizzy in tight spaces like a scanner.
Select...
I cannot lie flat for long periods.
Select...
I have had a biopsy or surgery on my prostate before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of suspicious lesions on MRI in men with PSA less than 2.5 ng/ml
Secondary study objectives
Association of whether findings on bpMRI and serum PSA (i.e. PSA density) are associated with future diagnosis of prostate cancer.
Prostate cancer detection rate using 3T bpMRI in patients with high risk and suspicious lesions on bpMRI
To correlate bpMRI findings with future changes in PSA

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Bi-parametric Screening MRIExperimental Treatment1 Intervention
Bi-parametric MRI to be administered to High Risk males

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor
474 Previous Clinical Trials
469,060 Total Patients Enrolled
Ardeshir Rastinehad, DOPrincipal InvestigatorNorthwell Health
3 Previous Clinical Trials
2,306 Total Patients Enrolled
Manish Vira, MDPrincipal InvestigatorNorthwell Health
1 Previous Clinical Trials
107 Total Patients Enrolled

Media Library

Bi-parametric MRI (Diagnostic Test) Clinical Trial Eligibility Overview. Trial Name: NCT05384535 — N/A
Population at Risk Research Study Groups: Bi-parametric Screening MRI
Population at Risk Clinical Trial 2023: Bi-parametric MRI Highlights & Side Effects. Trial Name: NCT05384535 — N/A
Bi-parametric MRI (Diagnostic Test) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05384535 — N/A
~26 spots leftby Oct 2025
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