Clinical Evaluation of ExoDx Prostate(IntelliScore) in Men Presenting for Initial Prostate Biopsy

Exosome Diagnostics

Status: Completed

Conditions: Urologic Cancer

Treatments: Diagnostic Test: ExoDx Prostate(IntelliScore)

Study type: Observational

Funder types: Industry

Identifiers

NCT04720599

ECT2020-002

Details and patient eligibility

About

The study described here is being conducted to prospectively confirm the performance of the ExoDx Prostate gene expression assay in patients presenting for an initial prostate biopsy and support of CE-marking the test for a European Union Launch.

Enrollment: 120 patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical suspicion for prostate cancer
• Elevated Prostate-specific Antigen between 2.0-10 ng/ mL
• Scheduled for a initial prostate biopsy

Exclusion criteria

• Clinical symptoms of urinary tract infection (including prostatitis) at the time of enrollment.
• History of prostate cancer.
• History of invasive treatments for benign prostatic hypertrophy (BPH) or lower urinary track symptoms within 6 months of study enrollment.
• Known hepatitis status (all types) and/or HIV documented in patient's medical record.
• Patients with history of concurrent renal/bladder tumors.
• Prior MRI used in the decision to biopsy