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

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

Detailed Description
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The primary and secondary objectives will be assessed in retrospectively selected prostate cancer patients treated with radical prostatectomy with one or more adverse pathological features (APFs)

Official Title
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GenomeDx Decipher Test for Metastatic Disease in Prostate Cancer for Patients With Adverse Pathology Post Radical Prostatectomy: Does it Impact Physician Decision Making?

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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Criteria (Participant enrollment) Inclusion Criteria Study participants: Practicing board-certified urologic surgeons Performing at least 40 radical prostate surgeries annually Exclusion Criteria Study Participants: (1) Did not meet the inclusion criteria Criteria (Case selection) Inclusion Criteria Case File: 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 (= Extraprostatic extension) or T3B (=Seminal vesicle invasion); Positive surgical margins Gleason grade upgrade from biopsy to surgery Exclusion Criteria Case File: Metastatic disease (M+) prior to surgery Received any neo-adjuvant prostate cancer treatment with radical prostatectomy (radiation, hormone, chemotherapy)
Sexes Eligible for Study
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Male

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 |
| --- | --- |
| Practicing urologic surgeons<br>Performing at least 60 radical prostate surgeries annually | Other: DECIPHER Questionnaire<br>* Participants are 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 opinion is collected based on a random selection of cases.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in treatment recommendation | To determine the extent to which the use of the Decipher test influences treatment recommendations by physicians post radical prostatectomy (RP). This decision impact study aims to evaluate Urologists' treatment recommendations before and after reviewing the results provided by the Decipher test. | 1.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urologist's perception regarding the utility of the Decipher | Changes in Urologists expressed level of confidence in the treatment recommendation as measured by the response to item 4a in the eCRF survey. Urologist's perception regarding the utility of the Decipher test as measured by the responses to question 4b and 38b and 38c in the eCRF survey. Agreement in treatment recommendation | 1.5 years |