Clinical Evaluation of ExoDx Prostate(IntelliScore) in Men Presenting for Initial Prostate Biopsy
Completed
- Conditions
- Urologic Cancer
- Registration Number
- NCT04720599
- Lead Sponsor
- Exosome Diagnostics, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 120
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Correlation of the ExoDx Prostate test results with the outcome of prostate biopsies in an initial biopsy patient cohort. 1 year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Chesapeake Urology Research Associates
🇺🇸Baltimore, Maryland, United States
New Jersey Urology
🇺🇸Voorhees, New Jersey, United States
Klinikum der Universität München
🇩🇪München, Germany