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NCT03474913Recruiting

Upright MRI for Prostate Cancer Screening

Feasibility and Efficacy of Upright MP - MRI for Prostate Cancer Screening

Source: ClinicalTrials.gov · Last updated 7 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
550 (estimated)
First submitted
16 Mar 2018
Start date
1 Oct 2018
Primary completion date
1 Jul 2026
Lead sponsor
Icahn School of Medicine at Mount Sinai
NCT number
NCT03474913

What you commit to

  • Study type: Observational
  • Planned participants: 550
  • From 1 Oct 2018 to the primary completion date, 1 Jul 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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)

Other illness

  • Patients who have evidence of a urinary tract infection or history of acute prostatitis within the last 3 months.
  • History of any other medical condition precluding procedures described in the protocol

Lab values

  • Patients contraindicated to undergoing the MRI procedure e.g. pacemaker, estimated GFR\<=50, automatic implantable cardiac defibrillators.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 100 years · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Icahn School of Medicine at Mount Sinai
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.