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Trial record 22 of 121 for:    prostate cancer AND prostate cancer screening | ( Map: United States )

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 : March 25, 2019
Sponsor:
Collaborator:
The Fonar Corporation
Information provided by (Responsible Party):
Ashutosh Kumar Tewari, Icahn School of Medicine at Mount Sinai

Brief Summary:
This is a clinical trial to test the efficacy of an upright MRI 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. The target population is men who are at risk for prostate cancer, as determined by the urologist. Patients will be asked to take the Indomitable Magnetic Resonance Imaging Scanner, magnetic resonance imaging using 0.6 T strength, as well as a standard of care closed 3T MRI. The patient will then be given a series of questionnaires to assess their comfort level during both MRI's.

Condition or disease Intervention/treatment Phase
Prostate Cancer Elevated PSA Malignant Neoplasm of Prostate Device: Upright MRI Device: standard MRI Not Applicable

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 also cause life-threatening sepsis.

Also, 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 : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Patients will have both a standard MRI and an Upright MRI to image potential prostate lesions. The order of the MRIs will be random, and the second will be done within two weeks of the first.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Efficacy of Upright MRI for Prostate Cancer Screening
Actual Study Start Date : March 8, 2018
Estimated Primary Completion Date : March 8, 2023
Estimated Study Completion Date : March 8, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Active Comparator: Upright MRI first, Standard MRI second
People randomized to have the upright MRI first and the standard MRI second
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

Active Comparator: Standard MRI first, Upright MRI second
People randomized to have the standard MRI first and the Upright MRI second
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) is a protein produced by the prostate gland.


Secondary Outcome Measures :
  1. Epstein's criteria [ Time Frame: 5 years ]
    The updated Epstein's criteria for clinically significant cancer which is PSA density < 0.15 ng/ml per gram, Gleason score<= 6, fewer than 3 positive cores, and <50% of cancer involvement in any core.

  2. Change in Magnetic Resonance Imaging- Anxiety Questionnaire [ Time Frame: baseline and 2 years ]
    One of three patient reported outcome questionnaires. The Magnetic Resonance Imaging- Anxiety Questionnaire is given after both MRIs, and is scored from 15-60, with 15 meaning the lowest anxiety and 60 meaning highest anxiety. This scale is given at baseline and after both MRIs.

  3. Change in National Comprehensive Cancer Network Distress Thermometer [ Time Frame: baseline and 2 years ]
    The National Comprehensive Cancer Network Distress Thermometer is a scale from 0 to 10, with 0 meaning no distress and 10 meaning the most distress. This scale is given at baseline and after both MRIs.

  4. Change in Claustrophobia 36 [ Time Frame: baseline and 2 years ]
    One of three patient reported outcome questionnaires. The Claustrophobia 36 item questionnaire is on a scale from 36-180, with 36 indicating the lowest level of anxiety and 180 the highest level of anxiety. This scale is given at baseline and after both MRIs.

  5. Final histology of the radical prostatectomy specimen [ Time Frame: 5 years ]
    The final histology of the radical prostatectomy (RP) specimen. Threshold PSA density >0.15ng/mL will be used.

  6. Number of correct identification of side of prostate unaffected [ Time Frame: 5 years ]
    Upright MRI's ability to correctly identify side of prostate unaffected in men with pathological T2a and T2b disease.



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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
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: Julia Wagner, MPH 212-659-8307 julia.wagner@mountsinai.org
Contact: Ash Tewari, MD 212-659-8307 ash.tewari@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     History of Changes
Other Study ID Numbers: GCO 17-2776
First Posted: March 23, 2018    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
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
Device Product Not Approved or Cleared by U.S. FDA: No
Keywords provided by Ashutosh Kumar Tewari, Icahn School of Medicine at Mount Sinai:
Prostate Cancer
Magnetic Resonance Imaging
case cross over
diagnostic
clinical trial
prostate imaging
PSA
Additional relevant MeSH terms:
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Prostatic Neoplasms
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases