Status:
RECRUITING
Upright MRI for Prostate Cancer Screening
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
The Fonar Corporation
Conditions:
Prostate Cancer
Elevated PSA
Eligibility:
MALE
18-100 years
Brief 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...
Detailed 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 dev...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
550 Patients enrolled
Trial Details
Trial ID
NCT03474913
Start Date
October 1 2018
End Date
July 1 2026
Last Update
January 7 2026
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029