Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT03474913 |
Other study ID # |
GCO 17-2776 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
October 1, 2018 |
Est. completion date |
July 1, 2026 |
Study information
Verified date |
October 2023 |
Source |
Icahn School of Medicine at Mount Sinai |
Contact |
Monali Fatterpekar, Ph.D. |
Phone |
(212) 241-0751 |
Email |
monali.fatterpekar[@]mountsinai.org |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
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.