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

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ClinicalTrials.gov Identifier: NCT02034812
Recruitment Status : Completed
First Posted : January 14, 2014
Last Update Posted : February 29, 2016
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
GenomeDx Biosciences Corp

Study Description
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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.

Condition or disease Intervention/treatment
Prostate Cancer Other: Decipher Questionnaire

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 Design
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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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?
Study Start Date : July 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. Confidence in treatment [ Time Frame: 12 months ]
    Changes in Radiation Oncologist's expressed level of confidence in the treatment recommendation

  4. Utility of Decipher test [ Time Frame: 12 months ]
    Radiation Oncologist's perception regarding the utility of the Decipher test


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Criteria

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)

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02034812


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
GenomeDx Biosciences Corp
Brigham and Women's Hospital
Investigators
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Principal Investigator: Paul L. Nguyen, MD Dana-Farber Cancer Institute
More Information
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Publications:

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Responsible Party: GenomeDx Biosciences Corp
ClinicalTrials.gov Identifier: NCT02034812    
Other Study ID Numbers: CU001.B
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: February 29, 2016
Last Verified: September 2014
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases