NCT04357717

ExoDx Prostate Evaluation in Prior Negative Prostate Biopsy Setting

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 150 (actual)
• Sponsor: Exosome Diagnostics, Inc. · Industry
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

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

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): 1. Evaluate the clinical performance of the ExoDx Prostate test at the cut-point of 15.6 defined for the initial biopsy patient cohort. 2. Associate ExoDx Prostate test results with other ancillary studies including the use of radiographic imaging (e.g. multiparametric MRI). 3. 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. 4. Evaluate ExoDx Prostate with and without inclusion of standard of care parameters such as PSA, ethnicity, DRE, age and family history.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	ExoDx Prostate	Urine-based biomarker tool to support decision to biopsy in patients with PSA between 2-10ng/ml

Timeline

• Start date: 2020-03-15
• Primary completion: 2021-09-01
• Completion: 2021-09-01
• First posted: 2020-04-22
• Last updated: 2022-03-31

Locations

2 sites across 1 country: United States