ExoDx Prostate Evaluation in Active Surveillance Patient Population

N/AUnknownNCT05572099

Exosome Diagnostics, Inc.750 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

750

Conditions

Prostate Cancer

Interventions

ExoDx ProstateDIAGNOSTIC_TEST

Observational only.

Eligibility

Sex: MALEMin age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Chesapeake Urology

Towson, Maryland, United States

RECRUITING

Outcomes

Primary Outcomes

Develop and evaluate risk-based scoring using the ExoDx Prostate test.

Time frame: 1yr after last enrolled patient

Central Contacts

Sonia Kumar, PhD

CONTACT

6175880500 Sonia.Kumar@bio-techne.com

Data from ClinicalTrials.gov

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