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NCT05572099 Clinical Trial

ExoDx Prostate Evaluation in Active Surveillance Patient Population

Prostate Cancer Clinical Trial

Official title:
ExoDx Prostate Evaluation in Active Surveillance Patient Population

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05572099
Other study ID # ECT2022-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2022
Est. completion date October 2023

Study information
Verified date October 2022
Source Exosome Diagnostics, Inc.
Contact Sonia Kumar, PhD
Phone 6175880500
Email Sonia.Kumar@bio-techne.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 750
Est. completion date October 2023
Est. primary completion date October 2023
Accepts healthy volunteers
Gender Male
Age group 45 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• ExoDx Prostate
Observational only.

Locations
Country Name City State
United States Chesapeake Urology Towson Maryland

Sponsors (1)
Lead Sponsor Collaborator
Exosome Diagnostics, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Develop and evaluate risk-based scoring using the ExoDx Prostate test. 1yr after last enrolled patient
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