Clinical Evaluation of the 'ExoDx Prostate IntelliScore' (EPI)

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ClinicalTrials.gov Identifier: NCT03031418

Recruitment Status : Completed

First Posted : January 25, 2017

Last Update Posted : December 29, 2020

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Exosome Diagnostics, Inc.

Study Description

Brief Summary:

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).

Condition or disease	Intervention/treatment
Cancer of Prostate	Diagnostic Test: ExoDx Prostate Intelliscore

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 Design

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Study Type :	Observational
Actual Enrollment :	532 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Clinical Evaluation of the 'ExoDx Prostate IntelliScore' in Men Presenting for Initial Biopsy; Additional Confirmation Study Including Impact on Decision-making and Health Economics.
Actual Study Start Date :	September 1, 2016
Actual Primary Completion Date :	September 1, 2018
Actual Study Completion Date :	September 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Prostate cancer

MedlinePlus related topics: Biopsy Prostate Cancer

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
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).
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.	Diagnostic Test: 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 Name: EPI

Group/Cohort

Intervention/treatment

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).

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.

Diagnostic Test: 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 Name: EPI

Outcome Measures

Primary Outcome Measures :

Confirm performance of the ExoDx Prostate IntelliScore [ Time Frame: 6 months ]
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).

Biospecimen Retention: Samples Without DNA

Random first catch urine sample > 20mL

Eligibility Criteria

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Ages Eligible for Study:	50 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	Male
Gender Based Eligibility:	Yes
Gender Eligibility Description:	Must be male to screen for prostate cancer
Accepts Healthy Volunteers:	Yes
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.

Criteria

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.

Contacts and Locations

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): NCT03031418

Locations

Show 18 study locations

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United States, Florida
21st Century Oncology
Fort Myers, Florida, United States, 33907
Mount Sinai Medical Center of Florida
Miami, Florida, United States, 33140
United States, Georgia
Southeastern Urology Associates
Macon, Georgia, United States, 31217
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Walter Reed National Military Medical CPDR
Bethesda, Maryland, United States, 20889
United States, Michigan
Comprehensive Urology
Royal Oak, Michigan, United States, 48073
United States, Montana
Five Valley Urology
Missoula, Montana, United States, 59808
United States, New Jersey
Premier Urology Group
Edison, New Jersey, United States, 08837
Urologic Research and Consulting LLC
Englewood, New Jersey, United States, 07631
Delaware Valley Urology
Voorhees, New Jersey, United States, 08043
United States, New York
Manhattan Medical Research
New York, New York, United States, 10016
NYU Urology Associates
New York, New York, United States, 10016
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Columbia University Medical Center
New York, New York, United States, 10032
United States, North Carolina
Associated Urologists of North Carolina
Raleigh, North Carolina, United States, 27612
United States, South Carolina
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
United States, Texas
UT Health Science Center
San Antonio, Texas, United States, 78229
United States, Virginia
Urology of Virginia
Virginia Beach, Virginia, United States, 23462

Sponsors and Collaborators

Exosome Diagnostics, Inc.

Investigators

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Study Director:	Roger Tun	Exosome Diagnostics, Inc.

More Information

Publications of Results:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	Exosome Diagnostics, Inc.
ClinicalTrials.gov Identifier:	NCT03031418
Other Study ID Numbers:	ECT2016-001
First Posted:	January 25, 2017 Key Record Dates
Last Update Posted:	December 29, 2020
Last Verified:	December 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:	No

Additional relevant MeSH terms:

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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms	Genital Diseases, Male Genital Diseases Urogenital Diseases Prostatic Diseases Male Urogenital Diseases

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