Decision Impact Study to Measure the Influence of DECIPHER on Treatment Recommendations for Radiation Oncologists
| Status: | Completed |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | July 2013 |
| End Date: | July 2014 |
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?
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.
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.
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.
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.
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)
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