Upright MRI for prostate cancer screening
Feasibility and Efficacy of Upright MP - MRI for Prostate Cancer Screening
Icahn School of Medicine at Mount Sinai · NCT03474913
This study is testing if an upright MRI can be a better way to screen for prostate cancer in men at risk compared to the usual PSA test and standard MRI.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 550 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | Male |
| Sponsor | Icahn School of Medicine at Mount Sinai (other) |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT03474913 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of upright MRI as a screening tool for prostate cancer compared to the traditional PSA test and standard MRI imaging. Conducted at Mount Sinai Hospital, it aims to enroll men at risk for prostate cancer, particularly those with elevated PSA levels or abnormal digital rectal exams. Participants will undergo both upright MRI and standard closed MRI scans, followed by questionnaires to assess their comfort during the procedures. The study will last approximately five years and is designed to improve prostate cancer diagnostic accuracy.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 and older who are at risk for prostate cancer and have been advised to undergo a prostate MRI.
Not a fit: Patients who have previously undergone prostate biopsy or surgery, or those with contraindications to MRI, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate prostate cancer screenings and reduce unnecessary biopsies and treatments.
How similar studies have performed: While the use of upright MRI for prostate cancer screening is a novel approach, other imaging techniques have shown promise in improving diagnostic accuracy.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Ash Tewari, MD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Monali Fatterpekar, Ph.D.
- Email: monali.fatterpekar@mountsinai.org
- Phone: (212) 241-0751
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Cancer, Elevated PSA, Elevated Prostate Specific Antigen, Prostate Cancer Diagnosis, Imaging, Magnetic Resonance Imaging, Cancer, Diagnostic