Status:
TERMINATED
ExoDx Prostate Evaluation in Prior Negative Prostate Biopsy Setting
Lead Sponsor:
Exosome Diagnostics, Inc.
Conditions:
Prostate Cancer
Eligibility:
MALE
50+ years
Brief Summary
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 collec...
Detailed Description
Primary Endpoint: Evaluate the correlation of the ExoDx Prostate test results with the outcome of prostate biopsies in a prior negative repeat biopsy patient cohort. Secondary Endpoints (exploratory...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
March 15 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2021
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04357717
Start Date
March 15 2020
End Date
September 1 2021
Last Update
March 31 2022
Active Locations (2)
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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