Clinical Evaluation of ExoDx™ Prostate(IntelliScore) in Men Presenting for Initial Prostate Biopsy

Exosome Diagnostics, Inc.3 sites in 2 countries120 target enrollmentJune 1, 2020

ConditionsUrologic Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Urologic Cancer
Sponsor: Exosome Diagnostics, Inc.
Enrollment: 120
Locations: 3
Primary Endpoint: Correlation of the ExoDx Prostate test results with the outcome of prostate biopsies in an initial biopsy patient cohort.
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The study described here is being conducted to prospectively confirm the performance of the ExoDx Prostate gene expression assay in patients presenting for an initial prostate biopsy and support of CE-marking the test for a European Union Launch.

Registry

clinicaltrials.gov

Start Date

June 1, 2020

End Date

June 1, 2021

Last Updated

4 years ago

Study Type

Observational

Sex

Male

Investigators

Sponsor

Exosome Diagnostics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Clinical suspicion for prostate cancer
•Elevated Prostate-specific Antigen between 2.0-10 ng/ mL
•Scheduled for a initial prostate biopsy

Exclusion Criteria

•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 (BPH) or lower urinary track symptoms within 6 months of study enrollment.
•Known hepatitis status (all types) and/or HIV documented in patient's medical record.
•Patients with history of concurrent renal/bladder tumors.
•Prior MRI used in the decision to biopsy