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

Sponsor

Exosome Diagnostics, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03031418

Collaborator

(none)

532

Enrollment

Locations

Actual Duration (Months)

29.6

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

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	Phase
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

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 :

Sep 1, 2016

Actual Primary Completion Date :

Sep 1, 2018

Actual Study Completion Date :

Sep 1, 2018

Arms and Interventions

Arm	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 Names: EPI

Arm

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 Names:

EPI

Outcome Measures

Primary Outcome Measures

Confirm performance of the ExoDx Prostate IntelliScore [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	21st Century Oncology	Fort Myers	Florida	United States	33907
2	Mount Sinai Medical Center of Florida	Miami	Florida	United States	33140
3	Southeastern Urology Associates	Macon	Georgia	United States	31217
4	Johns Hopkins University	Baltimore	Maryland	United States	21287
5	Walter Reed National Military Medical CPDR	Bethesda	Maryland	United States	20889
6	Comprehensive Urology	Royal Oak	Michigan	United States	48073
7	Five Valley Urology	Missoula	Montana	United States	59808
8	Premier Urology Group	Edison	New Jersey	United States	08837
9	Urologic Research and Consulting LLC	Englewood	New Jersey	United States	07631
10	Delaware Valley Urology	Voorhees	New Jersey	United States	08043
11	Manhattan Medical Research	New York	New York	United States	10016
12	NYU Urology Associates	New York	New York	United States	10016
13	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029
14	Columbia University Medical Center	New York	New York	United States	10032
15	Associated Urologists of North Carolina	Raleigh	North Carolina	United States	27612
16	Carolina Urologic Research Center	Myrtle Beach	South Carolina	United States	29572
17	UT Health Science Center	San Antonio	Texas	United States	78229
18	Urology of Virginia	Virginia Beach	Virginia	United States	23462

Sponsors and Collaborators

Exosome Diagnostics, Inc.

Investigators

Study Director: Roger Tun, Exosome Diagnostics, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Exosome Diagnostics, Inc.

ClinicalTrials.gov Identifier:

NCT03031418

Other Study ID Numbers:

ECT2016-001

First Posted:

Jan 25, 2017

Last Update Posted:

Dec 29, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of Dec 29, 2020