Decision Impact Study to Measure the Influence of DECIPHER on Treatment Recommendations for Radiation Oncologists (DECIDE3)

February 26, 2016 updated by: GenomeDx Biosciences Corp

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Physicians:

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.

Patients:

Patients diagnosed with localized prostate cancer that received radical prostatectomy as the first line treatment.

De-identified patient cases were selected from an independent clinical validation study of patients with adverse pathology features treated between 2000 and 2006. (Karnes et al., 2013)

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Radiation Oncologists

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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months
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.
12 months
Confidence in treatment
Time Frame: 12 months
Changes in Radiation Oncologist's expressed level of confidence in the treatment recommendation
12 months
Utility of Decipher test
Time Frame: 12 months
Radiation Oncologist's perception regarding the utility of the Decipher test
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GenomeDx Biosciences Corp

Collaborators

Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

January 10, 2014

First Submitted That Met QC Criteria

January 10, 2014

First Posted (Estimate)

January 14, 2014

Study Record Updates

Last Update Posted (Estimate)

February 29, 2016

Last Update Submitted That Met QC Criteria

February 26, 2016

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CU001.B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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