Health TrialsbyHealthPanel

Utility of Biparametric MRI (Magnetic Resonance Imaging) as a Screening Tool for Prostate Cancer in a High-Risk Cohort

ConditionsProstate CancerMagnetic Resonance ImagingPopulation at Risk
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age40-55
SponsorNorthwell Health

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Nodularity or firmness of prostate on exam

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.

Patient has a history of UTI or prostatitis in the preceding 6 months, as this can significantly alter PSA levels.

Trial design

Design model

Single group

Treatments tested in this trial

  • Bi-parametric MRI

    Diagnostic test

    When used for the evaluation of prostate cancer, MRI typically involves multiple sequences and typically includes typical T1 and T2 phases with the addition of diffusion weighted imaging and dynamic contrast enhanced imaging. In this study, we have decided to omit dynamic contrast enhanced imaging due to its decreased diagnostic yield relative to T2 and DWI and associated increased risk of contrast agents, this is a common approach for prostate cancer screening and is referred to as a bi-parametric MRI

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Bi-parametric Screening MRIExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of suspicious lesions on MRI in men with PSA less than 2.5 ng/ml

To determine the incidence of positive mpMRI prostate in a high-risk cohort of men as a screening tool for prostate cancer.

Time frame
3 months

Secondary outcomes

1

Prostate cancer detection rate using 3T bpMRI in patients with high risk and suspicious lesions on bpMRI

Proportion of men with suspicious lesion found to have cancer on biopsy, this is the PPV based on the prevalence of this population.

Time frame
3 months
2

Association of whether findings on bpMRI and serum PSA (i.e. PSA density) are associated with future diagnosis of prostate cancer.

Proportion diagnosed with prostate cancer over 5 year follow-up among patients who were not diagnosed with prostate cancer based on findings of initial mpMRI (i.e. mend who either did not have any suspicious lesions or had suspicious lesions but were negative for cancer on biopsy)

Time frame
5 years
3

To correlate bpMRI findings with future changes in PSA

PSA density will be measured every year for five years

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwell Health

Lead sponsor

Source ClinicalTrials.gov
Apply now