ExoDx Prostate Evaluation in Prior Negative Prostate Biopsy Setting

Study Overview
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Brief Summary
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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.

Detailed Description
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Primary Endpoint: Evaluate the correlation of the ExoDx Prostate test results with the outcome of prostate biopsies in a prior negative repeat biopsy patient cohort. Secondary Endpoints (exploratory): Evaluate the clinical performance of the ExoDx Prostate test at the cut-point of 15.6 defined for the initial biopsy patient cohort. Associate ExoDx Prostate test results with other ancillary studies including the use of radiographic imaging (e.g. multiparametric MRI). Evaluate the correlation of ExoDx Prostate as a function of risk. It is known that a higher ExoDx Prostate score correlates to a higher risk of finding prostate cancer, including HGPC, upon biopsy. Evaluate ExoDx Prostate with and without inclusion of standard of care parameters such as PSA, ethnicity, DRE, age and family history.

Official Title
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Clinical Evaluation of ExoDx™ Prostate (IntelliScore) in Men With Prior Negative Prostate Biopsy Presenting for a Repeat Biopsy

Conditions
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Prostate Cancer

Intervention / Treatment
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* Diagnostic Test: ExoDx Prostate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: ExoDx Prostate|Urine-based biomarker tool to support decision to biopsy in patients with PSA between 2-10ng/ml|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of the ExoDx Prostate test results with the outcome of prostate biopsies in a prior negative repeat biopsy patient cohort. |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exosome, ExoDx Prostate