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

N/ACompletedNCT04720599

Exosome Diagnostics, Inc.120 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

Urologic Cancer

Interventions

ExoDx Prostate(IntelliScore)DIAGNOSTIC_TEST

The ExoDx Prostate test result supports the biopsy decision process by stratifying patients based on risk for high grade prostate cancer

Eligibility

Sex: MALEMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (3)

Chesapeake Urology Research Associates

Baltimore, Maryland, United States

New Jersey Urology

Voorhees Township, New Jersey, United States

Klinikum der Universität München

München, Germany

Outcomes

Primary Outcomes

Correlation of the ExoDx Prostate test results with the outcome of prostate biopsies in an initial biopsy patient cohort.

Time frame: 1 year

Data from ClinicalTrials.gov

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