Study In Urology Practices Looking At Impact Of OncotypeDX GPS Test On Men Choosing And Remaining On Active Surveillance
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|ClinicalTrials.gov Identifier: NCT03502213|
Recruitment Status : Completed
First Posted : April 18, 2018
Last Update Posted : April 23, 2021
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||489 participants|
|Official Title:||A Prospective Multi-center Observational Trial to Assess Persistence on Active Surveillance When Using the OncotypeDX® Prostate Cancer Assay|
|Actual Study Start Date :||July 1, 2014|
|Actual Primary Completion Date :||June 30, 2018|
|Actual Study Completion Date :||June 30, 2018|
- Rate of persistence on Active Surveillance at 1 and 2 years after receiving the OncotypeDX Genomic Prostate Score (GPS) [ Time Frame: The analysis will estimate the absolute magnitude of the rates of persistence at these two time points (1 and 2 years after receiving GPS) ]The analysis will estimate the absolute magnitude of the rates of persistence at these two time points, and the change between the two rates. The rate of persistence, at the particular timepoint, will be calculated as the proportion of patients who remain on Active Surveillance as of the doctor visit at the time. The rate of persistence will range from 0% to 100%, with 100% indicating all evaluable patients stay on Active Surveillance at the particular timepoint, and 0% indicating no evaluable patient on Active Surveillance.
Biospecimen Retention: Samples With DNA