ExoDx Prostate Evaluation in Prior Negative Prostate Biopsy Setting

About this trial

Last updated 4 years ago

Study ID

ECT2018-001

Status

Terminated

Type

Observational

Placebo

Accepting

50+ Years

Male

Trial Timing

Ended 5 years ago

What is this trial about?

The study is designed to confirm the performance of the ExoDx Prostate test in prior negative biopsy patients now presenting for a repeat prostate biopsy. Note: ExoDx Prostate test results are collected for correlation to biopsy results and are not disclosed to the physician or study subject.

What are the participation requirements?

Inclusion Criteria

* 50+ years of age

* Clinical suspicion for prostate cancer

* Elevated Prostate-specific Antigen between 2.0-10 ng/ mL

* At least one (1) prior negative prostate biopsy

Exclusion Criteria

* Use of medications or hormones that are known to affect serum PSA levels within 3-6 months of study enrollment including 5-alpha-reductase inhibitors used in the treatment of an enlarged prostate gland (benign prostatic hyperplasia). Drugs in this class are finasteride (Proscar, Propecia) and dutasteride (Avodart).

* 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.

* No known hepatitis status (all types) and/or HIV documented in patient's medical record.

* Patients with history of concurrent renal/bladder tumors.