Decision Impact Study to Measure the Influence of DECIPHER on Treatment Recommendations for Radiation Oncologists (DECIDE3)
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|ClinicalTrials.gov Identifier: NCT02034812|
Recruitment Status : Completed
First Posted : January 14, 2014
Last Update Posted : February 29, 2016
|Condition or disease||Intervention/treatment|
|Prostate Cancer||Other: Decipher Questionnaire|
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.
|Study Type :||Observational|
|Actual Enrollment :||25 participants|
|Official Title:||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?|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
Radiation oncologists targeted for recruitment into the study must meet the following criteria:
Each participant is asked to complete a questionnaire to assess the impact of Decipher on physicians' treatment recommendation. All participants use the same data collection instrument. Each participant's opinion is collected based on a random selection of cases.
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.
- Change in treatment recommendation [ Time Frame: 12 months ]Change in treatment recommendation from pre- to post-Decipher report, defined as any change in treatment recommendation.
- Specific change in treatment recommendation [ Time Frame: 12 months ]1. Change in treatment recommendation from pre- to post-Decipher report defined as any of the following: Observation to Any treatment Any treatment to Observation
- Measure of Intensity of treatment [ Time Frame: 12 months ]Change in treatment recommendation from pre- to post-Decipher report involving an increase or decrease in intensity.
- Confidence in treatment [ Time Frame: 12 months ]Changes in Radiation Oncologist's expressed level of confidence in the treatment recommendation
- Utility of Decipher test [ Time Frame: 12 months ]Radiation Oncologist's perception regarding the utility of the Decipher test
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02034812
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Paul L. Nguyen, MD||Dana-Farber Cancer Institute|