NCT05384535

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Northwell Health · Academic / Other
• Sex: Male
• Age: 40 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The Investigators propose a pilot study which utilizes bpMRI in conjunction with PSA in the early detection of clinically significant prostate cancer in a high-risk group. Our study would focus on these high-risk subjects between the ages of 40-55 with a normal PSA ranging from ≥1.0 to \<2.5 ng/mL. bpMRI would be obtained in this group of subjects. If any suspicious lesions are found, the recommendation is to undergo MRI/US fusion biopsy. Subjects with negative bpMRI will be followed every year with serum PSA. Subjects with a positive bpMRI will have a prostate fusion and systematic biopsy performed. Those with a benign biopsy will be followed every year with serum PSA. Those who have a biopsy positive for cancer will be managed and followed according to the standard of care. All subjects will be followed for 5 years. Our hypothesis is that bpMRI in conjunction with above average PSA in a high-risk group will increase detection of clinically relevant prostate cancer and provide a useful addition to PSA screening.

Conditions

• Prostate Cancer
• Magnetic Resonance Imaging
• Population at Risk

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Bi-parametric MRI	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

Timeline

• Start date: 2022-08-15
• Primary completion: 2027-10-31
• Completion: 2028-10-31
• First posted: 2022-05-20
• Last updated: 2025-11-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study