Upright MRI for Prostate Cancer Screening

Recruiting

• Conditions: Elevated PSA; Elevated Prostate Specific Antigen; Prostate Cancer
• Interventions: Device: Upright MRI; Device: Standard MRI

• Registration Number: NCT03474913
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-03-16
• Study First Submitted QC: 2018-03-16
• Study First Posted: 2018-03-23
• Study Start: 2018-10-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-24
• Last Update Posted: 2024-10-28
• Primary Completion: 2026-07-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 550

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Standard MRI first	Upright MRI	Patients will have a standard of care MRI, then consent to study participation and have an upright MRI.
MRIs in random order	Standard MRI	Patients will consent to participate in the study, then do two MRIs in random order.
MRIs in random order	Upright MRI	Patients will consent to participate in the study, then do two MRIs in random order.

Primary Outcome Measures

Name	Time	Method
PSA levels	5 years	Prostate-specific Antigen (PSA) levels

Secondary Outcome Measures

Name	Time	Method
Diagnostic Yield of MRI and PSA Density	5 years	To compare the diagnostic yield of using MP-MRI with thresholds PSA density used for detecting prostate cancer.
Number of Correctly Identified side	5 years	Number of correctly identified side of prostate unaffected in men with pathological disease
Upright MRI compared to Standard MRI	5 years	To compare performance characteristics of Upright MP-MRI versus 3T MP-MRI in detecting clinically significant PCa and PCa in general.
Claustrophobic Questionnaire (CLQ)	5 years	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.
Magnetic Resonance Imaging-Anxiety Questionnaire (MRI-AQ)	5 years	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.
NCCN Distress Thermometer	5 years	NCCN Distress Thermometer is a visual scale - full scale from 0-10, higher score indicating higher level of distress

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States