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
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|Condition or disease||Intervention/treatment|
|Cancer of Prostate||Diagnostic Test: ExoDx Prostate Intelliscore|
- 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|
|Actual Enrollment :||532 participants|
|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|
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).
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
- 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
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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|
- 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
- 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.
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
|Study Director:||Roger Tun||Exosome Diagnostics, Inc.|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Exosome Diagnostics, Inc.|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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