Status:
COMPLETED
Clinical Evaluation of ExoDx Prostate(IntelliScore) in Men Presenting for Initial Prostate Biopsy
Lead Sponsor:
Exosome Diagnostics, Inc.
Conditions:
Urologic Cancer
Eligibility:
MALE
50+ years
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...
Eligibility Criteria
Inclusion
- Clinical suspicion for prostate cancer
- Elevated Prostate-specific Antigen between 2.0-10 ng/ mL
- Scheduled for a initial prostate biopsy
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04720599
Start Date
June 1 2020
End Date
June 1 2021
Last Update
September 30 2021
Active Locations (3)
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1
Chesapeake Urology Research Associates
Baltimore, Maryland, United States, 21204
2
New Jersey Urology
Voorhees Township, New Jersey, United States, 08043
3
Klinikum der Universität München
München, Germany