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ExoDx Prostate Evaluation in Active Surveillance Patient Population

Recruiting
Conditions
Prostate Cancer
Registration Number
NCT05572099
Lead Sponsor
Exosome Diagnostics, Inc.
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
Male
Target Recruitment
750
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

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Develop and evaluate risk-based scoring using the ExoDx Prostate test.1yr after last enrolled patient
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Chesapeake Urology

🇺🇸

Towson, Maryland, United States

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