ExoDx Prostate Evaluation in Active Surveillance Patient Population

Exosome Diagnostics

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Diagnostic Test: ExoDx Prostate

Study type: Observational

Funder types: Industry

Identifiers

NCT05572099

ECT2022-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 750 estimated patients

Sex: Male

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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