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

Completed

• Conditions: Prostate Cancer
• Interventions: Other: Decipher Questionnaire

• Registration Number: NCT02034812
• Lead Sponsor: GenomeDx Biosciences Corp

Brief 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.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2014-01-10
• Study First Submitted QC: 2014-01-10
• Study First Posted: 2014-01-14
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2014-09
• Last Update Submitted: 2016-02-26
• Last Update Posted: 2016-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Radiation Oncologists	Decipher Questionnaire	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.

Primary Outcome Measures

Name	Time	Method
Change in treatment recommendation	12 months	Change in treatment recommendation from pre- to post-Decipher report, defined as any change in treatment recommendation.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States