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Trial Title:
ExoDx Prostate Evaluation in Active Surveillance Patient Population
NCT ID:
NCT05572099
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
ExoDx Prostate
Description:
Observational only.
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.
Criteria for eligibility:
Study pop:
Male, 45+ years of age diagnosed with low-grade or favorable-intermediate prostate cancer
and on an active surveillance regimen
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
Male
Gender based:
Yes
Gender description:
Have a prostate
Minimum age:
45 Years
Maximum age:
N/A
Locations:
Facility:
Name:
Chesapeake Urology
Address:
City:
Towson
Zip:
21204
Country:
United States
Status:
Recruiting
Contact:
Last name:
Emily Ayre
Start date:
October 1, 2022
Completion date:
October 2023
Lead sponsor:
Agency:
Exosome Diagnostics, Inc.
Agency class:
Industry
Source:
Exosome Diagnostics, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05572099
