About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 or treatment for prostate cancer (interventions for benign prostatic hyperplasia/bladder outflow obstruction is acceptable)
Patients who have evidence of a urinary tract infection or history of acute prostatitis within the last 3 months.
Patients contraindicated to undergoing the MRI procedure e.g. pacemaker, estimated GFR<=50, automatic implantable cardiac defibrillators.
Trial population
Men at risk for prostate cancer
Trial design
Case-only
Prospective
Treatments tested in this trial
Upright MRI
DeviceIndomitable Magnetic Resonance Imaging Scanner, magnetic resonance imaging using 0.6 T strength
Standard MRI
Devicestandard of care closed 3T MRI
Treatment groups
Trial outcomes
Primary outcomes
PSA levels
Prostate-specific Antigen (PSA) levels
Secondary outcomes
Upright MRI compared to Standard MRI
To compare performance characteristics of Upright MP-MRI versus 3T MP-MRI in detecting clinically significant PCa and PCa in general.
Claustrophobic Questionnaire (CLQ)
Claustrophobic Questionnaire (CLQ) is a 46 item instrument, each item score on a likert scale from 1-5, full scale from 36 to 180, with higher score indicating more anxiety.
NCCN Distress Thermometer
NCCN Distress Thermometer is a visual scale - full scale from 0-10, higher score indicating higher level of distress
Magnetic Resonance Imaging-Anxiety Questionnaire (MRI-AQ)
Magnetic Resonance Imaging-Anxiety Questionnaire (MRI-AQ) is a 15 item instrument, each item score on a likert scale from 1 to 4, full scale range from 15 to 66, with higher score indicating higher degree of anxiety.
Sponsors and contacts
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Icahn School of Medicine at Mount Sinai
Lead sponsor
The Fonar Corporation
Collaborator