Urologic Cancer
Conditions
Keywords
exosome, ExoDx Prostate
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.
Interventions
DIAGNOSTIC_TESTExoDx Prostate(IntelliScore)
The ExoDx Prostate test result supports the biopsy decision process by stratifying patients based on risk for high grade prostate cancer
Sponsors
Exosome Diagnostics, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Correlation of the ExoDx Prostate test results with the outcome of prostate biopsies in an initial biopsy patient cohort. | 1 year |
Countries
Germany, United States
Outcome results
None listed