Upright MRI for Prostate Cancer Screening

NCT ID: NCT03474913

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 550 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2026-07-01

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.

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 devise effective tools to screen and diagnose prostate cancer. Today, prostate specific antigen (PSA) test is the most widely adopted screening method for PCa. Since its introduction in 1979, it has helped in earlier diagnosis of PCa and has had a marked shift on the stage at which PCa is identified. PSA, although popular as a screening tool, has several shortcomings. It is organ-specific rather than cancer-specific, which means that its values can be elevated even for non-malignant conditions . Indeed, PSA based screening has reported positive predictive value as low as 30% (PSA cutoff >4.0 ng/dL) for detecting prostate cancer and an over diagnosis rate of 50%, which leads to unnecessary biopsies and aggressive treatments of men with clinically indolent (insignificant) disease.

Current diagnostic pathway of prostate cancer requires men with elevated PSA and abnormal Digital Rectal exam to undergo a Trans Rectal Ultra Sound (TRUS) guided biopsy. TRUS is a blind-systematic biopsy, which randomly samples prostate tissue. This can lead to missing or under-diagnosing clinically significant cancer and over-diagnosing clinically insignificant disease. TRUS biopsy is itself associated with morbidity, mainly in the form of hematuria, hematospermia, pain, urinary retention and sometimes can cause life-threatening sepsis.

Many of the PSA screened detected prostate cancers detected on TRUS are clinically insignificant and even if left untreated have little to no clinical impact on an individual's remaining life. Overtreatment resulting from over diagnosis often leads to side effects like erectile dysfunction (approx. 60%) from radical therapy and urinary incontinence.

Conditions

Prostate Cancer; Elevated PSA; Elevated Prostate Specific Antigen

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Standard MRI first

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

Upright MRI

Intervention Type: DEVICE

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

MRIs in random order

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

Upright MRI

Intervention Type: DEVICE

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

Standard MRI

Intervention Type: DEVICE

standard of care closed 3T MRI

Interventions

Upright MRI

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

Intervention Type: DEVICE

Standard MRI

standard of care closed 3T MRI

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

The Fonar Corporation

UNKNOWN

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Ashutosh Kumar Tewari

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ash Tewari, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Monali Fatterpekar, Ph.D.

Role: CONTACT

monali.fatterpekar@mountsinai.org

(212) 241-0751

Cristina Pasat-Karasik

Role: CONTACT

Cristina.Pasat-karasik@mountsinai.org

347-466-2783

Other Identifiers

GCO 17-2776

Identifier Type: -

Identifier Source: org_study_id