NCT03502213

Study In Urology Practices Looking At Impact Of OncotypeDX GPS Test On Men Choosing And Remaining On Active Surveillance

A Prospective Multi-center Observational Trial to Assess Persistence on Active Surveillance When Using the OncotypeDX® Prostate Cancer Assay

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 489 (actual)
• Sponsor: Genomic Health®, Inc. · Industry
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

Genomic Health's OncotypeDX® Prostate Cancer Assay is a commercially available laboratory test that measures the activity of certain genes in prostate cancer. The purpose of this study is to better understand how the use of this test result impacts or affects treatment decisions for men newly diagnosed with low risk prostate cancer, their confidence in the treatment decision, and the effects and side effects of the treatment chosen on certain aspects of Quality of Life. This study will also determine what percentage of men choosing an active monitoring program as prescribed by their doctor remain on Active Surveillance and have avoided any treatment at one year after diagnosis after receiving the assay result.

Detailed description

This is a multicenter observational study that evaluates eligible patients who will submit prostate cancer diagnostic biopsy tissues for Oncotype DX Prostate Cancer Assay testing. A physician treatment recommendation will be made and the assay is ordered. The physician will review clinical data, the GPS report and discuss treatment options with the patient. At the following visit, a shared physician-patient treatment decision (immediate treatment or AS) will be made. Men selecting AS as primary treatment will be followed to assess persistence on AS. There is no required or standardized AS protocol for this study and the intensity of surveillance will be at the discretion of the investigator. Patients will not be required, but may undergo a standard TRUS guided surveillance biopsy at one year. In this study, the Oncotype DX Prostate Cancer Assay will be assessed on the diagnostic biopsy only and will not be assessed on subsequent biopsies.

Conditions

• Prostate Cancer

Timeline

• Start date: 2014-07-01
• Primary completion: 2018-06-30
• Completion: 2018-06-30
• First posted: 2018-04-18
• Last updated: 2021-04-23