Prostate Cancer
Conditions
Brief summary
The goal of this observational study is to test whether the ExoDx Prostate test add value in biopsy decision making to patients with prostate cancer on an active surveillance regimen.
Detailed description
The current trial seeks to evaluate the role of the ExoDx Prostate test in men with low and favorable intermediate prostate cancer undergoing an active surveillance regimen.
Interventions
DIAGNOSTIC_TESTExoDx Prostate
Observational only.
Sponsors
Exosome Diagnostics, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
45 Years to No maximum
Inclusion criteria
* Male, 45+ years of age diagnosed with low-grade or favorable-intermediate prostate cancer and on an active surveillance regimen
Exclusion criteria
* Clinical symptoms of urinary tract infection at time of enrollment. * History of invasive treatment for benign prostatic hypertrophy with in 6 months of enrollment. * Known hepatitis or HIV * History of concurrent renal/bladder tumors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Develop and evaluate risk-based scoring using the ExoDx Prostate test. | 1yr after last enrolled patient |
Countries
United States
Contacts
Primary ContactSonia Kumar, PhD
Outcome results
None listed