Status:
UNKNOWN
Decision Impact Trial of the ExoDx Prostate (IntelliScore)
Lead Sponsor:
Exosome Diagnostics, Inc.
Collaborating Sponsors:
CareFirst BlueCross BlueShield
Chesapeake Urology Research Associates
Conditions:
Cancer of the Prostate
Eligibility:
MALE
50+ years
Phase:
NA
Brief Summary
The purpose of this research study is to investigate the utility of a validated urine test which predicts the likelihood of high grade prostate cancer on an initial prostate biopsy.
Detailed Description
Primary Objective(s) 1. Evaluate performance of the ExoDx Prostate(IntelliScore) (EPI) to reduce the number of initial prostate biopsies by greater than or equal to 15% for men with an elevated Prost...
Eligibility Criteria
Inclusion
- 50 years of age
- Clinical suspicion for prostate cancer
- Elevated Prostate-specific antigen between: 2.0 - 10 ng/ mL
- No clinical history of a prior negative biopsy
Exclusion
- History of prior prostate biopsy.
- Use of medications or hormones that are known to affect serum Prostate-specific antigen levels within 3-6 months of study enrollment.
- 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 (Benign Prostatic Hyperplasia) or lower urinary track symptoms within 6 months of study enrollment.
- Known hepatitis (all types) and/or HIV documented in patient's medical record.
- Patients with history of concurrent renal/bladder tumors.
Key Trial Info
Start Date :
July 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 29 2023
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT03235687
Start Date
July 19 2017
End Date
September 29 2023
Last Update
May 6 2022
Active Locations (1)
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1
Chesapeake Urology Research Associates
Towson, Maryland, United States, 21204