RECRUITING

Upright MRI for Prostate Cancer Screening

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2018-10-01
Study Completion:2026-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03474913

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men at risk of prostate cancer and have been advised to have a prostate MRI.
  2. * Age ≥ 18 years.
  3. * Fit for undergoing all study protocol procedures which includes an ultrasound guided biopsy.
  4. * Able to tolerate general or spinal anesthesia.
  5. * Ability to understand and the willingness to sign a written informed consent and to comply with the protocol.
  1. * Patients who have been treated using 5- alpha-reductase inhibitors at the time of study enrollment or 6 months prior to enrollment.
  2. * Patients with previous history of prostate biopsy, prostate surgery or treatment for prostate cancer (interventions for benign prostatic hyperplasia/bladder outflow obstruction is acceptable)
  3. * Patients who have evidence of a urinary tract infection or history of acute prostatitis within the last 3 months.
  4. * Patients contraindicated to undergoing the MRI procedure e.g. pacemaker, estimated GFR\<=50, automatic implantable cardiac defibrillators.
  5. * History of any other medical condition precluding procedures described in the protocol

Contacts and Locations

Study Contact

Monali Fatterpekar, Ph.D.
CONTACT
(212) 241-0751
monali.fatterpekar@mountsinai.org
Cristina Pasat-Karasik
CONTACT
347-466-2783
Cristina.Pasat-karasik@mountsinai.org

Principal Investigator

Ash Tewari, MD
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

  • Ash Tewari, MD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-10-01
Study Completion Date2026-07-01

Study Record Updates

Study Start Date2018-10-01
Study Completion Date2026-07-01

Terms related to this study

Keywords Provided by Researchers

  • Prostate Cancer Diagnosis
  • Imaging
  • Magnetic Resonance Imaging
  • Cancer
  • Diagnostic
  • Malignant Neoplasm of Prostate

Additional Relevant MeSH Terms

  • Prostate Cancer
  • Elevated PSA
  • Elevated Prostate Specific Antigen