Upright MRI for Prostate Cancer Screening
Recruiting · NCT03474913 · Observational (researchers observe without assigning treatment) · Lead sponsor: Icahn School of Medicine at Mount Sinai
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 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.
- History of any other medical condition precluding procedures described in the protocol
Where it is running
1 location listed across 1 US state.
- Icahn School of Medicine at Mount Sinai - New York, New York, United States