An observational study in Cancer of Prostate, sponsored by Exosome Diagnostics, Inc.. Completed at 18 sites in United States. Open to male participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-29.
Sponsored by Exosome Diagnostics, Inc. · Observational
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).
Primary Objective(s)
Secondary and Exploratory Objectives
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 532 is above the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Exosome Diagnostics, Inc. is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
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Male, 50+ years of age with a clinical suspicion for prostate cancer based in part on an elevated Prostate-specific antigen (limit range: 2.0 - 10 ng/ mL), and or suspicious DRE, without the clinical history of a prior negative biopsy.
Exclusion Criteria:
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.
Also known as: EPI
Confirm performance of the ExoDx Prostate IntelliScore
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).
Time frame: 6 months
Plan to share: Undecided
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Exosome Diagnostics, Inc.