NCT03235687

Decision Impact Trial of the ExoDx Prostate (IntelliScore)

A Prospective, Randomized Blinded, Shared Decision Impact Trial of the ExoDx Prostate (IntelliScore), EPI Test, in Men Presenting for Initial Biopsy.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Exosome Diagnostics, Inc. · Industry
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this research study is to investigate the utility of a validated urine test which predicts the likelihood of high grade prostate cancer on an initial prostate biopsy.

Detailed description

Primary Objective(s) 1. Evaluate performance of the ExoDx Prostate(IntelliScore) (EPI) to reduce the number of initial prostate biopsies by greater than or equal to 15% for men with an elevated Prostate-Specific Antigen 2-10ng/mL presenting for a biopsy in consultation with their urologist. 2. Compare performance of both the ExoDx Prostate(IntelliScore) 15.6 and 20 cut-points with respect to the biopsy decision process. 3. Assess physician satisfaction with the ExoDx Prostate(IntelliScore) report including test result presentation, graphics and interpretation. 4. Assess urologist / patient satisfaction for ease of understanding test results and role on biopsy decision process. Secondary Objectives 1. Determine the medical economic impact of the ExoDx Prostate(IntelliScore) test in the prostate biopsy decision process. 2. Correlation of the ExoDx Prostate(IntelliScore) score with the actual biopsy result by utilizing the Receiver Operating Characteristic of the Area Under Curve for discriminating high-grade (greater than or equal to Gleason Score 7, International Society of Urological Pathology 2 and 3) from low-grade (Gleason Score 6, International Society of Urological Pathology 1) and benign disease on initial prostate needle biopsy.

Conditions

• Cancer of the Prostate

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-07-19
• Primary completion: 2018-09-01
• Completion: 2023-09-29
• First posted: 2017-08-01
• Last updated: 2022-05-06

Locations

1 site across 1 country: United States