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

Completed

Conditions studied: Urologic Cancer

In brief

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.

Key facts

Study ID

NCT04720599

Run by

Exosome Diagnostics, Inc.

People needed

120

Starts

2020-06-01

Expected to finish

2021-06-01

Last updated by the study team

2021-09-30

Who can join

Age: 50 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Chesapeake Urology Research Associates — Baltimore, Maryland, United States
• New Jersey Urology — Voorhees Township, New Jersey, United States
• Klinikum der Universität München — München, Germany

Full record on ClinicalTrials.gov

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