Feasibility and Efficacy of Upright MP - MRI for Prostate Cancer Screening
Icahn School of Medicine at Mount Sinai
Summary
This is an investigator initiated study to test the efficacy of an upright MRI (Magnetic Resonance Imaging) for the screening of prostate cancer. The purpose of this study is to compare Upright MRI as a technique to PSA (Prostate Specific Antigen) and current MRI imaging. It will take place at Mount Sinai Hospital, and last for a total of about 5 years. Eligible patients will be determined by the urologist. The target population is men who are at risk for prostate cancer, as determined by the urologist. Diagnostic criteria will include elevated PSA and an abnormal digital rectal exam (DRE). After patients are screened and determined eligible, they will be asked to have a seated MRI using the Indomitable Magnetic Resonance Imaging Scanner, Ex vivo magnetic resonance imaging using 0.6 T strength, as well as a standard of care closed 3T MRI. After each scan, the patient will be given a series of questionnaires to assess their comfort level during the scan. Patients will be followed every 6 months after completion of (or early withdrawal from) study enrollment until 5 years.
Description
Prostate cancer (PCa) is the second most common cancer among men in the United States, with over 180,000 new cases diagnosed in 2016. This commonality implies that set standards need to be set and devise effective tools to screen and diagnose prostate cancer. Today, prostate specific antigen (PSA) test is the most widely adopted screening method for PCa. Since its introduction in 1979, it has helped in earlier diagnosis of PCa and has had a marked shift on the stage at which PCa is identified. PSA, although popular as a screening tool, has several shortcomings. It is organ-specific rather than…
Eligibility
- Age range
- 18–100 years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Men at risk of prostate cancer and have been advised to have a prostate MRI. * Age ≥ 18 years. * Fit for undergoing all study protocol procedures which includes an ultrasound guided biopsy. * Able to tolerate general or spinal anesthesia. * Ability to understand and the willingness to sign a written informed consent and to comply with the protocol. Exclusion Criteria: * Patients who have been treated using 5- alpha-reductase inhibitors at the time of study enrollment or 6 months prior to enrollment. * Patients with previous history of prostate biopsy, prostate surgery…
Interventions
- DeviceUpright MRI
Indomitable Magnetic Resonance Imaging Scanner, magnetic resonance imaging using 0.6 T strength
- DeviceStandard MRI
standard of care closed 3T MRI
Location
- Icahn School of Medicine at Mount SinaiNew York, New York