NCT02250313

PASCUAL (Prostate Assay Specific Clinical Utility at Launch) Study

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 600 (actual)
• Sponsor: MDx Health · Industry
• Sex: Male
• Age: 40 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The main hypothesis of this study is to demonstrate that the use of the ConfirmMDx for Prostate Cancer test in previously biopsied patients improves urologists' patient management by reducing unnecessary repeat biopsies, attendant procedure costs, and potential adverse events in men being considered for a repeat procedure.

Detailed description

The results of the study will reveal the clinical utility of this test by analyzing the physicians' use of negative or positive assays compared to patients managed using SOC methods without assay findings. The repeat biopsy rate at 12 months from study entry will be used for the primary endpoint analysis. All patients will be followed for 24 months from the date of the previous negative biopsy to evaluate an extended period of observation to track repeat biopsies and cancer detection. The primary objective of this study is to demonstrate a lower repeat biopsy rate by using the negative results of ConfirmMDx for Prostate Cancer in practice rather than current SOC. All patients will have the tissue from their previous negative biopsy tested with the assay. Only data from Cases (informed of ConfirmMDx assay results) and Controls (blinded of the ConfirmMDx assay result) patients with negative test results will be used for the primary objective.

Conditions

• Prostate Cancer

Timeline

• Start date: 2014-09-01
• Primary completion: 2018-07-01
• Completion: 2018-07-01
• First posted: 2014-09-26
• Last updated: 2018-07-26

Locations

15 sites across 1 country: United States