Clinical Evaluation of the 'ExoDx Prostate IntelliScore' (EPI)
NCT ID: NCT03031418
Last Updated: 2020-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
532 participants
OBSERVATIONAL
2016-09-01
2018-09-01
Brief Summary
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Detailed Description
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* Confirm performance of the ExoDx Prostate (IntelliScore) (EPI) utilizing a designated collection vessel for men presenting for their initial prostate biopsy with an elevated Prostate-specific antigen (2-10 ng/mL).
* Evaluate impact of the confirmed ExoDx Prostate (IntelliScore) on the decision to perform an initial prostate biopsy for men presenting with an elevated Prostate-specific antigen (2-10 ng/mL).
Secondary and Exploratory Objectives
* Assess physician satisfaction with the ExoIntelliScore Prostate report including test result presentation, graphics and interpretation.
* Assess patient satisfaction for ease of understanding test results and role on decision process to have a biopsy.
* Determine the medical economic impact of the ExoIntelliScore Prostate in the prostate biopsy decision process.
* Correlation of the ExoIntelliScore Prostate score with the actual biopsy result.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort 1
Enroll up to 500 patients to confirm performance of ExoDx Prostate IntelliScore (EPI) for men scheduled for initial biopsy. The treating physician will collect a urine sample from from a consented subject to test before their scheduled prostate biopsy (during your established clinic visit).
No interventions assigned to this group
Cohort 2
Enroll up to 500 patients to evaluate how the results of the urine test influences the decision process for determining whether to perform a prostate biopsy. The treating physician will collect a urine sample for testing and 2 weeks later discuss whether to perform a prostate biopsy with the subject knowing the results of the urine test and comparing them to the overall consensus report from Cohort 1 as well as other clinical factors the treating physician would otherwise use to determine whether they should have a prostate biopsy.
ExoDx Prostate Intelliscore
ExoDx Prostate (IntelliScore) is a non-invasive, urinary 3-gene expression validated test in which the results of the assay are adjunctive to the ordering physician's clinical judgment and work-up of the patient in the determination of whether a prostate needle biopsy is necessary. The ExoDx Prostate (IntelliScore) was clinically validated to discriminate patients with higher grade prostate cancer from those with more indolent lower grade cancer and benign disease.
Interventions
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ExoDx Prostate Intelliscore
ExoDx Prostate (IntelliScore) is a non-invasive, urinary 3-gene expression validated test in which the results of the assay are adjunctive to the ordering physician's clinical judgment and work-up of the patient in the determination of whether a prostate needle biopsy is necessary. The ExoDx Prostate (IntelliScore) was clinically validated to discriminate patients with higher grade prostate cancer from those with more indolent lower grade cancer and benign disease.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinical suspicion for prostate cancer
* Elevated Prostate-specific antigen between: 2.0 - 10 ng/ mL
* No clinical history of a prior negative biopsy
Exclusion Criteria
* Use of medications or hormones that are known to affect serum Prostate-specific antigen levels within 3-6 months of study enrollment.
* Clinical symptoms of urinary tract infection (including prostatitis) at the time of enrollment.
* History of prostate cancer.
* History of invasive treatments for benign prostatic hypertrophy (Benign Prostatic Hyperplasia) or lower urinary track symptoms within 6 months of study enrollment.
* No known hepatitis (all types) and/or HIV documented in patient's medical record.
* Patients with history of concurrent renal/bladder tumors.
50 Years
MALE
Yes
Sponsors
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Exosome Diagnostics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Roger Tun
Role: STUDY_DIRECTOR
Exosome Diagnostics, Inc.
Locations
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21st Century Oncology
Fort Myers, Florida, United States
Mount Sinai Medical Center of Florida
Miami, Florida, United States
Southeastern Urology Associates
Macon, Georgia, United States
Johns Hopkins University
Baltimore, Maryland, United States
Walter Reed National Military Medical CPDR
Bethesda, Maryland, United States
Comprehensive Urology
Royal Oak, Michigan, United States
Five Valley Urology
Missoula, Montana, United States
Premier Urology Group
Edison, New Jersey, United States
Urologic Research and Consulting LLC
Englewood, New Jersey, United States
Delaware Valley Urology
Voorhees Township, New Jersey, United States
Manhattan Medical Research
New York, New York, United States
NYU Urology Associates
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Associated Urologists of North Carolina
Raleigh, North Carolina, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
UT Health Science Center
San Antonio, Texas, United States
Urology of Virginia
Virginia Beach, Virginia, United States
Countries
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References
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Donovan MJ, Noerholm M, Bentink S, Belzer S, Skog J, O'Neill V, Cochran JS, Brown GA. A molecular signature of PCA3 and ERG exosomal RNA from non-DRE urine is predictive of initial prostate biopsy result. Prostate Cancer Prostatic Dis. 2015 Dec;18(4):370-5. doi: 10.1038/pcan.2015.40. Epub 2015 Sep 8.
Kretschmer A, Tutrone R, Alter J, Berg E, Fischer C, Kumar S, Torkler P, Tadigotla V, Donovan M, Sant G, Skog J, Noerholm M. Pre-diagnosis urine exosomal RNA (ExoDx EPI score) is associated with post-prostatectomy pathology outcome. World J Urol. 2022 Apr;40(4):983-989. doi: 10.1007/s00345-022-03937-0. Epub 2022 Jan 27.
McKiernan J, Donovan MJ, Margolis E, Partin A, Carter B, Brown G, Torkler P, Noerholm M, Skog J, Shore N, Andriole G, Thompson I, Carroll P. A Prospective Adaptive Utility Trial to Validate Performance of a Novel Urine Exosome Gene Expression Assay to Predict High-grade Prostate Cancer in Patients with Prostate-specific Antigen 2-10ng/ml at Initial Biopsy. Eur Urol. 2018 Dec;74(6):731-738. doi: 10.1016/j.eururo.2018.08.019. Epub 2018 Sep 17.
Other Identifiers
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ECT2016-001
Identifier Type: -
Identifier Source: org_study_id