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Upright MRI for Prostate Cancer Screening

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ClinicalTrials.gov Identifier: NCT03474913
Recruitment Status : Recruiting
First Posted : March 23, 2018
Last Update Posted : May 1, 2020
Sponsor:
Collaborator:
The Fonar Corporation
Information provided by (Responsible Party):
Ashutosh Kumar Tewari, Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment
Prostate Cancer Elevated PSA Elevated Prostate Specific Antigen Device: Upright MRI Device: Standard MRI

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.

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Study Type : Observational
Estimated Enrollment : 550 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Feasibility and Efficacy of Upright MP - MRI for Prostate Cancer Screening
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : August 1, 2024
Estimated Study Completion Date : August 1, 2024

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Standard MRI first
Patients will have a standard of care MRI, then consent to study participation and have an upright MRI.
Device: Upright MRI
Indomitable Magnetic Resonance Imaging Scanner, magnetic resonance imaging using 0.6 T strength

MRIs in random order
Patients will consent to participate in the study, then do two MRIs in random order.
Device: Upright MRI
Indomitable Magnetic Resonance Imaging Scanner, magnetic resonance imaging using 0.6 T strength

Device: Standard MRI
standard of care closed 3T MRI




Primary Outcome Measures :
  1. PSA levels [ Time Frame: 5 years ]
    Prostate-specific Antigen (PSA) levels


Secondary Outcome Measures :
  1. Upright MRI compared to Standard MRI [ Time Frame: 5 years ]
    To compare performance characteristics of Upright MP-MRI versus 3T MP-MRI in detecting clinically significant PCa and PCa in general.

  2. Claustrophobic Questionnaire (CLQ) [ Time Frame: 5 years ]
    Claustrophobic Questionnaire (CLQ) is a 46 item instrument, each item score on a likert scale from 1-5, full scale from 36 to 180, with higher score indicating more anxiety.

  3. NCCN Distress Thermometer [ Time Frame: 5 years ]
    NCCN Distress Thermometer is a visual scale - full scale from 0-10, higher score indicating higher level of distress

  4. Magnetic Resonance Imaging-Anxiety Questionnaire (MRI-AQ) [ Time Frame: 5 years ]
    Magnetic Resonance Imaging-Anxiety Questionnaire (MRI-AQ) is a 15 item instrument, each item score on a likert scale from 1 to 4, full scale range from 15 to 66, with higher score indicating higher degree of anxiety.

  5. Diagnostic Yield of MRI and PSA Density [ Time Frame: 5 years ]
    To compare the diagnostic yield of using MP-MRI with thresholds PSA density used for detecting prostate cancer.

  6. Number of Correctly Identified side [ Time Frame: 5 years ]
    Number of correctly identified side of prostate unaffected in men with pathological disease


Biospecimen Retention:   Samples With DNA
Prostate Biopsy Cores and/or Punch Cores from Radical Prostatectomy Specimen


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women do not have prostates and this is a study of prostate health
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Men at risk for prostate cancer
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03474913


Contacts
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Contact: Cynthia Knauer, RN, ACON 212-241-0751 cynthia.knauer@mountsinai.org
Contact: Kamala Bhatt, BA 212-659-8307 kamala.bhatt@mountsinai.org

Locations
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United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Julia Wagner, MPH    212-659-8307    julia.wagner@mountsinai.org   
Principal Investigator: Ash Tewari, MD         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
The Fonar Corporation
Investigators
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Principal Investigator: Ash Tewari, MD Icahn School of Medicine at Mount Sinai
Study Director: Cynthia Knauer, RN, ACON Icahn School of Medicine at Mount Sinai
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Responsible Party: Ashutosh Kumar Tewari, Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03474913    
Other Study ID Numbers: GCO 17-2776
First Posted: March 23, 2018    Key Record Dates
Last Update Posted: May 1, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Ashutosh Kumar Tewari, Icahn School of Medicine at Mount Sinai:
Prostate Cancer Diagnosis
Imaging
Magnetic Resonance Imaging
Cancer
Diagnostic
Malignant Neoplasm of Prostate
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases