Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-03-08 @ 12:02 AM
Study NCT ID:
NCT03031418
Status:
COMPLETED
Last Update Posted:
2020-12-29
First Post:
2017-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of the 'ExoDx Prostate IntelliScore' (EPI)
Sponsor:
Exosome Diagnostics, Inc.
Organization:
Study Overview
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.
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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.
* 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: