ExoDx Prostate Evaluation in Prior Negative Prostate Biopsy Setting

Stopped early

Conditions studied: Prostate Cancer

In brief

The study is designed to confirm the performance of the ExoDx Prostate test in prior negative biopsy patients now presenting for a repeat prostate biopsy. Note: ExoDx Prostate test results are collected for correlation to biopsy results and are not disclosed to the physician or study subject.

Key facts

Study ID

NCT04357717

Run by

Exosome Diagnostics, Inc.

People needed

150

Starts

2020-03-15

Expected to finish

2021-09-01

Last updated by the study team

2022-03-31

Who can join

Age: 50 and older. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 50+ years of age
• Clinical suspicion for prostate cancer
• Elevated Prostate-specific Antigen between 2.0-10 ng/ mL
• At least one (1) prior negative prostate biopsy

You may not qualify if…

• Use of medications or hormones that are known to affect serum PSA levels within 3-6 months of study enrollment including 5-alpha-reductase inhibitors used in the treatment of an enlarged prostate gland (benign prostatic hyperplasia). Drugs in this class are finasteride (Proscar, Propecia) and dutasteride (Avodart).
• 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.
• No known hepatitis status (all types) and/or HIV documented in patient's medical record.
• Patients with history of concurrent renal/bladder tumors.

Where it is running

• Chesapeake Urology Research Associates — Baltimore, Maryland, United States
• New Jersey Urology — Voorhees Township, New Jersey, United States

Full record on ClinicalTrials.gov

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