Recruiting

MRI

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT03474913

Conditions

Prostate Cancer

Elevated PSA

Elevated Prostate Specific Antigen

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Upright MRI

Standard MRI

Study Details

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 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.

Conditions

Prostate Cancer

Elevated PSA

Elevated Prostate Specific Antigen

Study ID

NCT03474913

Start date

Oct 1, 2018

Status verified date

Jan, 2026

Completion date

Jul 1, 2026

Anticipated

Primary completion date

Jul 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

550 participants

Anticipated

Interventions and Outcome Measures

Arms

Standard MRI first

Patients will have a standard of care MRI, then consent to study participation and have an upright MRI.

MRIs in random order

Patients will consent to participate in the study, then do two MRIs in random order.

Interventions

Upright MRI

Indomitable Magnetic Resonance Imaging Scanner, magnetic resonance imaging using 0.6 T strength

Standard MRI

standard of care closed 3T MRI

Primary outcome measure

  • PSA levels [ Time Frame: 5 years ]

Central Contacts and Locations

Locations

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Principal Investigator:

Ash Tewari, MD

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Jan 7, 2026

Last verified

Jan, 2026

Keywords

  • Prostate Cancer Diagnosis
  • Imaging
  • Magnetic Resonance Imaging
  • Cancer
  • Diagnostic
  • Malignant Neoplasm of Prostate

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-01-07.