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

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ClinicalTrials.gov Identifier: NCT03031418
Recruitment Status : Recruiting
First Posted : January 25, 2017
Last Update Posted : December 14, 2017
Sponsor:
Information provided by (Responsible Party):
Exosome Diagnostics, Inc.

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 Type : Observational
Estimated Enrollment : 1000 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
Estimated Primary Completion Date : June 1, 2018
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


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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.

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


Contacts
Contact: Roger Tun 6468434946 Roger@exosomedx.com

Locations
United States, Florida
21st Century Oncology Recruiting
Fort Myers, Florida, United States, 33907
Contact: Rachel Novella         
Mount Sinai Medical Center of Florida Recruiting
Miami, Florida, United States, 33140
Contact: Rocio Gonzalez         
United States, Georgia
Southeastern Urology Associates Recruiting
Macon, Georgia, United States, 31217
Contact: Ginger Shumate         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Elizabeth Fabian         
Walter Reed National Military Medical CPDR Recruiting
Bethesda, Maryland, United States, 20889
Contact: Judith Travis         
United States, Michigan
Comprehensive Urology Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Daniel Kim         
United States, Montana
Five Valley Urology Completed
Missoula, Montana, United States, 59808
United States, New Jersey
Premier Urology Group Recruiting
Edison, New Jersey, United States, 08837
Contact: Haleema Hameed         
Urologic Research and Consulting LLC Recruiting
Englewood, New Jersey, United States, 07631
Contact: Michael Blizzard         
Delaware Valley Urology Recruiting
Voorhees, New Jersey, United States, 08043
Contact: Renee Haney         
United States, New York
Manhattan Medical Research Recruiting
New York, New York, United States, 10016
Contact: Betsy Moclair         
NYU Urology Associates Recruiting
New York, New York, United States, 10016
Contact: Elton Llukani         
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Cynthia J Knauer         
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Bridget James         
United States, North Carolina
Associated Urologists of North Carolina Recruiting
Raleigh, North Carolina, United States, 27612
Contact: Jan Vickerson         
United States, South Carolina
Carolina Urologic Research Center Recruiting
Myrtle Beach, South Carolina, United States, 29572
Contact: Jennifer Baiden         
United States, Texas
UT Health Science Center Recruiting
San Antonio, Texas, United States, 78229
Contact: Grace Todd         
United States, Virginia
Urology of Virginia Recruiting
Virginia Beach, Virginia, United States, 23462
Contact: Laurie Jackson         
Sponsors and Collaborators
Exosome Diagnostics, Inc.
Investigators
Study Director: Roger Tun Exosome Diagnostics, Inc.

Publications of Results:
Responsible Party: Exosome Diagnostics, Inc.
ClinicalTrials.gov Identifier: NCT03031418     History of Changes
Other Study ID Numbers: ECT2016-001
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases