Clinical Evaluation of the 'ExoDx Prostate IntelliScore' (EPI)
December 28, 2020 updated by: Exosome Diagnostics, Inc.
Clinical Evaluation of the 'ExoDx Prostate IntelliScore' in Men Presenting for Initial Biopsy; Additional Confirmation Study Including Impact on Decision-making and Health Economics.
The purpose of this research study is investigate a new and validated urine test which predicts the likelihood of high grade prostate cancer on an initial prostate biopsy The current protocol has two objectives; one is to further assess and evaluate the performance of the urine test in men already scheduled for initial prostate needle biopsy (cohort (group) 1) and two, to evaluate how the results of the urine test influences the decision process for determining whether to perform a prostate biopsy (cohort (group) 2).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Primary Objective(s)
- 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.
Study Type
Observational
Enrollment (Actual)
532
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Fort Myers, Florida, United States, 33907
- 21st Century Oncology
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Miami, Florida, United States, 33140
- Mount Sinai Medical Center of Florida
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Georgia
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Macon, Georgia, United States, 31217
- Southeastern Urology Associates
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins University
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Bethesda, Maryland, United States, 20889
- Walter Reed National Military Medical CPDR
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Michigan
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Royal Oak, Michigan, United States, 48073
- Comprehensive Urology
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Montana
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Missoula, Montana, United States, 59808
- Five Valley Urology
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New Jersey
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Edison, New Jersey, United States, 08837
- Premier Urology Group
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Englewood, New Jersey, United States, 07631
- Urologic Research and Consulting LLC
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Voorhees, New Jersey, United States, 08043
- Delaware Valley Urology
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New York
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New York, New York, United States, 10032
- Columbia University Medical Center
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New York, New York, United States, 10029
- Icahn School of Medicine at Mount Sinai
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New York, New York, United States, 10016
- Manhattan Medical Research
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New York, New York, United States, 10016
- NYU Urology Associates
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North Carolina
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Raleigh, North Carolina, United States, 27612
- Associated Urologists of North Carolina
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South Carolina
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Myrtle Beach, South Carolina, United States, 29572
- Carolina Urologic Research Center
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Texas
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San Antonio, Texas, United States, 78229
- UT Health Science Center
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Virginia
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Virginia Beach, Virginia, United States, 23462
- Urology of Virginia
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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.
Eligibility Criteria
Ages Eligible for Study
46 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Probability Sample
Study Population
Male, 50+ years of age with a clinical suspicion for prostate cancer based in part on an elevated Prostate-specific antigen (limit range: 2.0 - 10 ng/ mL), and or suspicious DRE, without the clinical history of a prior negative biopsy.
Description
Inclusion Criteria:
- 50 years of age
- 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:
- History of prior prostate biopsy.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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).
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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.
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Confirm performance of the ExoDx Prostate IntelliScore
Time Frame: 6 months
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Confirm performance of the ExoDx Prostate IntelliScore utilizing a designated collection vessel for men presenting for their initial prostate biopsy with an elevated prostate-specific antigen (2-10 ng/mL).
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
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 Major Dates
Study Start (Actual)
September 1, 2016
Primary Completion (Actual)
September 1, 2018
Study Completion (Actual)
September 1, 2018
Study Registration Dates
First Submitted
January 23, 2017
First Submitted That Met QC Criteria
January 23, 2017
First Posted (Estimate)
January 25, 2017
Study Record Updates
Last Update Posted (Actual)
December 29, 2020
Last Update Submitted That Met QC Criteria
December 28, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ECT2016-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.