Upright MRI for Prostate Cancer Screening

NCT03474913 | Recruiting FDA Device

• 1 other identifier: GCO 17-2776
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 1

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

Elevated Prostate Specific Antigen; Prostate Cancer; Elevated PSA

Keywords

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

Outcome Measures

Primary Outcomes (1)

• PSA levels

  Prostate-specific Antigen (PSA) levels

  5 years

Secondary Outcomes (6)

• Upright MRI compared to Standard MRI

  5 years

• Claustrophobic Questionnaire (CLQ)

  5 years

• NCCN Distress Thermometer

  5 years

• Magnetic Resonance Imaging-Anxiety Questionnaire (MRI-AQ)

  5 years

• Diagnostic Yield of MRI and PSA Density

  5 years

Study Arms (2)

Standard MRI first

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

Device: Upright MRI

MRIs in random order

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

Device: Upright MRI; Device: Standard MRI

Interventions

Upright MRI DEVICE

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

MRIs in random order; Standard MRI first

Standard MRI DEVICE

standard of care closed 3T MRI

MRIs in random order

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Women do not have prostates and this is a study of prostate health
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men at risk for prostate cancer

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• The Fonar Corporation: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Prostate Biopsy Cores and/or Punch Cores from Radical Prostatectomy Specimen

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms; Disease

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ash Tewari, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Monali Fatterpekar, Ph.D.

CONTACT

(212) 241-0751; monali.fatterpekar@mountsinai.org

Cristina Pasat-Karasik

CONTACT

347-466-2783; Cristina.Pasat-karasik@mountsinai.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 16, 2018
• First Posted: March 23, 2018
• Study Start: October 1, 2018
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

US (1)