Clinical Evaluation of the 'ExoDx Prostate IntelliScore' (EPI)
Public ClinicalTrials.gov record NCT03031418. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT03031418
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 532 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 50 Years and older
- Sex
- Male
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 1, 2016 (Actual)
- Primary completion
- Sep 1, 2018 (Actual)
- Completion
- Sep 1, 2018 (Actual)
- Last update posted
- Dec 29, 2020
2016 – 2018
United States locations
- U.S. sites
- 18
- U.S. states
- 11
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 21st Century Oncology | Fort Myers | Florida | 33907 | — |
| Mount Sinai Medical Center of Florida | Miami | Florida | 33140 | — |
| Southeastern Urology Associates | Macon | Georgia | 31217 | — |
| Johns Hopkins University | Baltimore | Maryland | 21287 | — |
| Walter Reed National Military Medical CPDR | Bethesda | Maryland | 20889 | — |
| Comprehensive Urology | Royal Oak | Michigan | 48073 | — |
| Five Valley Urology | Missoula | Montana | 59808 | — |
| Premier Urology Group | Edison | New Jersey | 08837 | — |
| Urologic Research and Consulting LLC | Englewood | New Jersey | 07631 | — |
| Delaware Valley Urology | Voorhees Township | New Jersey | 08043 | — |
| Manhattan Medical Research | New York | New York | 10016 | — |
| NYU Urology Associates | New York | New York | 10016 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Associated Urologists of North Carolina | Raleigh | North Carolina | 27612 | — |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | — |
| UT Health Science Center | San Antonio | Texas | 78229 | — |
| Urology of Virginia | Virginia Beach | Virginia | 23462 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03031418, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 29, 2020 · Synced Oct 30, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03031418 live on ClinicalTrials.gov.