Clinical trial NCT03474913: Upright MRI for Prostate Cancer Screening
Official title: Feasibility and Efficacy of Upright MP - MRI for Prostate Cancer Screening
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Elevated PSA
Elevated Prostate Specific Antigen
Keywords: Prostate Cancer Diagnosis
Imaging
Magnetic Resonance Imaging
Cancer
Diagnostic
Malignant Neoplasm of Prostate
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: The Fonar Corporation
First posted: 2018-03-23
Enrollment: 550
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men at risk for prostate cancer

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.

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

Primary outcomes:
measure: PSA levels
timeFrame: 5 years
Secondary outcomes:
measure: Upright MRI compared to Standard MRI
timeFrame: 5 years
measure: Claustrophobic Questionnaire (CLQ)
timeFrame: 5 years
measure: NCCN Distress Thermometer
timeFrame: 5 years
measure: Magnetic Resonance Imaging-Anxiety Questionnaire (MRI-AQ)
timeFrame: 5 years
measure: Diagnostic Yield of MRI and PSA Density
timeFrame: 5 years
measure: Number of Correctly Identified side
timeFrame: 5 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Ash Tewari, MD
role: PRINCIPAL_INVESTIGATOR
References: