Upright MRI for Prostate Cancer Screening

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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer; Elevated PSA; Elevated Prostate Specific Antigen
• Intervention / Treatment: Device: Upright MRI; Device: Standard MRI

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.

• Study Type: Observational
• Enrollment (Estimated): 550

Contacts and Locations

• Study Contact: Name: Monali Fatterpekar, Ph.D.; Phone Number: (212) 241-0751; Email: monali.fatterpekar@mountsinai.org
• Study Contact Backup: Name: Cristina Pasat-Karasik; Phone Number: 347-466-2783; Email: Cristina.Pasat-karasik@mountsinai.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Icahn School of Medicine at Mount Sinai
      • Principal Investigator: Ash Tewari, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Men at risk for prostate cancer

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Standard MRI first; Patients will have a standard of care MRI, then consent to study participation and have an upright MRI.	Device: Upright MRI; 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.	Device: Upright MRI; Indomitable Magnetic Resonance Imaging Scanner, magnetic resonance imaging using 0.6 T strength; Device: Standard MRI; standard of care closed 3T MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PSA levels	Prostate-specific Antigen (PSA) levels	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Upright MRI compared to Standard MRI	To compare performance characteristics of Upright MP-MRI versus 3T MP-MRI in detecting clinically significant PCa and PCa in general.	5 years
Claustrophobic Questionnaire (CLQ)	Claustrophobic Questionnaire (CLQ) is a 46 item instrument, each item score on a likert scale from 1-5, full scale from 36 to 180, with higher score indicating more anxiety.	5 years
NCCN Distress Thermometer	NCCN Distress Thermometer is a visual scale - full scale from 0-10, higher score indicating higher level of distress	5 years
Magnetic Resonance Imaging-Anxiety Questionnaire (MRI-AQ)	Magnetic Resonance Imaging-Anxiety Questionnaire (MRI-AQ) is a 15 item instrument, each item score on a likert scale from 1 to 4, full scale range from 15 to 66, with higher score indicating higher degree of anxiety.	5 years
Diagnostic Yield of MRI and PSA Density	To compare the diagnostic yield of using MP-MRI with thresholds PSA density used for detecting prostate cancer.	5 years
Number of Correctly Identified side	Number of correctly identified side of prostate unaffected in men with pathological disease	5 years

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: The Fonar Corporation
• Investigators: Principal Investigator: Ash Tewari, MD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: March 16, 2018
• First Submitted That Met QC Criteria: March 16, 2018
• First Posted (Actual): March 23, 2018

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Cancer; Imaging; Magnetic Resonance Imaging; Diagnostic; Prostate Cancer Diagnosis; Malignant Neoplasm of Prostate
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: GCO 17-2776

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes