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Multi-site Decision Impact Study for Decipher (ASSESS-D)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02034825
Recruitment Status : Completed
First Posted : January 14, 2014
Last Update Posted : February 29, 2016
Sponsor:
Collaborator:
Columbia University
Information provided by (Responsible Party):
GenomeDx Biosciences Corp

Brief Summary:
This prospectively designed retrospective clinical utility study will evaluate urologists' treatment recommendations before and after reviewing Decipher results for selected patient cases.

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

Detailed Description:

The clinical utility of Decipher will be evaluated at two time-points:

  1. Post RP - within 6 months after surgery
  2. PSA rise - defined as PSA detectable and rising on 2 or more subsequent determinations

Patient cases will be retrospectively selected from at least 5 sites. Participating urologists at each site will be asked to each identify a minimum of 10 to a maximum of 50 suitable cases retrospectively. The resulting cases will then be de-identified, aggregated and evenly randomly distributed among the participating urologists via a secure on-line survey platform . All study participants (ie: urologists) will be masked to the original actual treatment decision and patient outcome.

The design of this study is such that any participating urologist may or may not review a patient originating from their own clinical practice, but will not review a case they themselves identified. Patient cases will be de-identified and randomized amongst participating urologists . By the retrospective nature of this study, cases may be several years post-RP. It is not expected that that participation in this study will have any impact on actual clinical management of patients.

Participants will be asked to complete two web-based electronic Case Report Questionnaires (eCRQ):

  1. Pre-Decipher: will collect information on their recommended treatment decision and their decision confidence based on the de-identified clinical and pathological information provided for each patient case.
  2. Post-Decipher: will collect their treatment recommendation and decision confidence for each de-identified patient case in the presence of the Decipher test results.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: ASSESSing the Impact of Decipher on Practice Decision Making in Prostate Cancer After Surgery
Study Start Date : January 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Practicing urologic surgeons
  • US board-certified
  • Practicing urologic surgeons
  • Performing at least 40 radical prostate surgeries annually

Urologists will be excluded from participating in the study if:

  • They are unable to identify a the required number of eligible patient cases with available clinical data and tissue specimens;
  • They have spent less than 3 years in practice or perform less than 40 RP's per year

All participants will be asked to complete a questionnaire based on a random selection of retroactively selected cases.

Other: Decipher Questionnaire
Each participant will complete the pre and post-Decipher eCRQs for a minimum of 5 cases, and a maximum of 25 cases.




Primary Outcome Measures :
  1. Change in treatment recommendation [ Time Frame: 1.5 years ]

    Change in treatment recommendation from pre- to post-Decipher report, defined as any change in treatment recommendation. Specifically this will be defined as (pre- to post-):

    RT to ADT RT to ADT & RT RT to Observation ADT to RT ADT to ADT & RT ADT to Observation ADT & RT to RT ADT & RT to ADT ADT & RT to Observation Observation to RT Observation to ADT Observation to RT & ADT



Secondary Outcome Measures :
  1. Specific change in treatment recommendation [ Time Frame: 1.5 years ]
    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. Changes in intensity of treatment [ Time Frame: 1.5 years ]

    2. Change in treatment recommendation from pre- to post-Decipher report involving an increase or decrease in intensity defined as:

    • Increasing intensity: RT to ADT RT to ADT & RT ADT to ADT & RT Observation to any treatment

    • Decreasing intensity: Any treatment to observation ADT & RT to ADT ADT & RT to RT ADT to RT


  3. Change in treatment recommendation compared to baseline [ Time Frame: 1.5 years ]
    Changes in treatment recommendation (as described in the Primary Endpoint, and in Secondary Endpoints 1 and 2) from original, actual, treatment recommendation and post-Decipher recommendation.

  4. Confidence in treatment recommendation [ Time Frame: 1.5 years ]
    Changes in urologists expressed level of confidence in the treatment recommendation

  5. Changes in the decision conflict scale [ Time Frame: 1.5 years ]
  6. Utility of Decipher [ Time Frame: 1.5 years ]
    Urologist's perception regarding the utility of the Decipher test



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient cases will be retrospectively selected from at least 5 sites. Participating urologists at each site will be asked to each identify a minimum of 10 to a maximum of 50 suitable cases retrospectively
Criteria

Inclusion Criteria:

Patient cases eligible for this study were treated with radical prostatectomy and have one or more adverse features present as defined by AUA and NCCN guidelines:

  • Pathological T3 stage of disease (i.e., ECE or SVI)
  • Positive surgical margins, or
  • Detectable PSA, defined as PSA detectable and rising on 2 or more subsequent determinations

Exclusion Criteria:

  1. Metastatic Disease (M+) prior to surgery
  2. Failure of PSA to nadir after surgery
  3. Received any neo-adjuvant prostate cancer treatment before radical prostatectomy
  4. Received any adjuvant chemotherapy
  5. Required patient clinical data (Section 5.3) is not available for evaluation of eligibility criteria
  6. Lack of documented treatment or management recommendation on file
  7. Tissue specimen is inadequate for sampling and analysis

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): NCT02034825


Locations
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United States, California
Cedar Associates LLC
Menlo Park, California, United States, 94025
United States, Florida
Florida Hospital
Celebration, Florida, United States, 34747
United States, New York
Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
GenomeDx Biosciences Corp
Columbia University
Investigators
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Principal Investigator: Badani K Ketan, MD Columbia University
Study Director: Christine d Buerki, PhD GenomeDx Biosciences Inc.
Principal Investigator: Vipul Patel, MD AdventHealth
Publications:

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Responsible Party: GenomeDx Biosciences Corp
ClinicalTrials.gov Identifier: NCT02034825    
Other Study ID Numbers: CU003
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: February 29, 2016
Last Verified: March 2015
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases