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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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?

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: Decipher Questionnaire


Participation Criteria
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Eligibility Criteria
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Case Inclusion Criteria: Patient cases eligible for this study were treated with radical prostatectomy and have one or more adverse pathological features present defined as: Pathological Gleason score ≥ 8 or Gleason score 7 with primary pattern 4; Pathological stage T3a (= Extracapsular extension) or T3b (=Seminal vesicle invasion); Positive surgical margins Gleason grade upgrade from biopsy to surgery Detectable PSA, defined as failure of PSA to fall to undetectable, or PSA detectable and rising on 2 or more subsequent determinations Case Exclusion Criteria: Metastatic disease (M+) prior to surgery Received any neo-adjuvant prostate cancer treatment prior to radical prostatectomy (radiation, hormone, chemotherapy)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Radiation Oncologists<br>Radiation oncologists targeted for recruitment into the study must meet the following criteria: Practicing, board-certified radiation oncologists Perform consultations on at least 80 patients with prostate cancer annually 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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in treatment recommendation | Change in treatment recommendation from pre- to post-Decipher report, defined as any change in treatment recommendation. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specific change in treatment recommendation | 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 | 12 months | 
| Measure of Intensity of treatment | Change in treatment recommendation from pre- to post-Decipher report involving an increase or decrease in intensity. | 12 months | 
| Confidence in treatment | Changes in Radiation Oncologist's expressed level of confidence in the treatment recommendation | 12 months | 
| Utility of Decipher test | Radiation Oncologist's perception regarding the utility of the Decipher test | 12 months |