This study examines the performance of upright MP-MRI as a technique in screening prostate cancer compared to PSA and current MRI imaging in patients at risk of prostate cancer. PSA is the standard screening method for prostate cancer along with digital rectal exam. MRI has the potential to become a complementary screening tool to PSA. The upright MRI scanner uses a medium strength 0.6T magnet and is spacious and non-claustrophobic, unlike standard closed MRI scanners because of its unique geometric design (front and top open configuration). Patients sit upright as if sitting in a chair and can watch TV with an unobstructed view while having the scan performed. This study may potentially lead to the development of more accurate screening tools for prostate cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03474913.
Locations matching your search criteria
United States
New York
New York
Icahn School of Medicine at Mount SinaiStatus: Active
Contact: Ashutosh K. Tewari
Phone: 212-241-9955
PRIMARY OBJECTIVE:
I. To assess the feasibility of upright multi parametric magnetic resonance imaging (MP-MRI) and compare the performance of upright MP-MRI in detecting clinically significant prostate cancer compared to prostate specific antigen (PSA) levels in men undergoing prostate biopsy and/or radical prostatectomy.
SECONDARY OBJECTIVES:
I. To compare performance characteristics of upright MP-MRI versus 3 tesla (3T) MP-MRI in detecting clinically significant prostate cancer (PCa) and PCa in general.
II. To determine whether patients experienced less claustrophobia and anxiety while undergoing upright MP-MRI compared to 3T MP-MRI.
III. To compare the diagnostic yield of using MP-MRI with thresholds PSA density used for detecting prostate cancer.
IV. To determine the ability of upright MP-MRI to rule out prostate cancer by testing if upright MP-MRI correctly identified side of prostate unaffected in men with pathological T2a and T2b disease.
EXPLORATORY OBJECTIVE:
I. To evaluate the correlation between MRI imaging parameters, histopathology, and molecular determinants of prostate cancer lesions.
OUTLINE: Patients are assigned to 1 of 2 groups.
GROUP I: Patients who recently had a standard 3T MP-MRI, undergo upright MP-MRI over 45 minutes within 12 weeks of standard 3T MP-MRI.
GROUP II: Patients who have been recommended to have an MRI are randomized to 1 of 2 arms.
ARM I: Patients undergo standard 3T MP-MRI over 45 minutes and then undergo upright MP-MRI over 45 minutes within 12 weeks of standard 3T MP-MRI.
ARM II: Patients undergo upright MP-MRI over 45 minutes and then undergo standard 3T MP-MR within 12 weeks of upright MP-MR.
After completion of study, patients are followed up every 3 months, 6 months or annually for 5 years or until the time require primary treatment for prostate cancer.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationIcahn School of Medicine at Mount Sinai
Principal InvestigatorAshutosh K. Tewari
