NCT02034812

Decision Impact Study to Measure the Influence of DECIPHER on Treatment Recommendations for Radiation Oncologists

GenomeDx Decipher Test for Metastatic Disease Prognosis in Prostate Cancer for Patients With Adverse Pathology Post Radical Prostatectomy: Does it Impact Radiation Oncologist' Treatment Recommendations?

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 25 (actual)
• Sponsor: GenomeDx Biosciences Corp · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

This clinical utility study is based on a review of real but de-identified and randomized patient cases and aims to evaluate radiation oncologist's treatment recommendations before and after reviewing the results provided by the Decipher test. The primary intent is to help guide development and design of future clinical utility studies for Decipher.

Detailed description

Patient cases were selected using existing data generated from patient specimens collected in a separate IRB approved protocol, in which pathological specimens were tested to generate a test result for comparison to outcomes. Those test results are presented in this study, but not the individual patient outcomes. Physicians participating in this current study did not provide care for any of the subjects in the previous study. Cases are presented to physicians in a randomized order and in a form that prevents the patients from being identified, directly or indirectly. High risk patient cases were selected to reflect a range of clinicopathological variables and were further stratified based on the Decipher predicted probability of developing metastasis 5 years after RP and 3 years after BCR (as shown in the table below). High (low) Decipher (GC) risk was defined as a 5- or 3-year predicted probability of metastasis greater (less) than 6% for the adjuvant setting and greater (less) than 18% for the salvage setting.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
OTHER	Decipher Questionnaire	Pathological data from 12 de-identified patient cases will be reviewed by at least 25 Radiation Oncologists before and after exposure to the Decipher test results. Given the number of patient cases, reviewed by each participant, this allows for assessment of decision making based on 300 patient case reviews at each time point, immediately following RP and at the time of PSA rise.

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2014-01-14
• Last updated: 2016-02-29

Locations

1 site across 1 country: United States