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

February 26, 2016 updated by: GenomeDx Biosciences Corp

ASSESSing the Impact of Decipher on Practice Decision Making in Prostate Cancer After Surgery

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

50

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
    • California
      • Menlo Park, California, United States, 94025
        • Cedar Associates LLC
    • Florida
      • Celebration, Florida, United States, 34747
        • Florida Hospital
    • New York
      • New York, New York, United States, 10032
        • Columbia University

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

No

Genders Eligible for Study

Female

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

Description

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

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1.5 years
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
1.5 years
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.
1.5 years
Confidence in treatment recommendation
Time Frame: 1.5 years
Changes in urologists expressed level of confidence in the treatment recommendation
1.5 years
Changes in the decision conflict scale
Time Frame: 1.5 years
1.5 years
Utility of Decipher
Time Frame: 1.5 years
Urologist's perception regarding the utility of the Decipher test
1.5 years

Collaborators and Investigators

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

Sponsor

GenomeDx Biosciences Corp

Collaborators

Columbia University

Investigators

  • Principal Investigator: Badani K Ketan, MD, Columbia University
  • Study Director: Christine d Buerki, PhD, GenomeDx Biosciences Inc.
  • Principal Investigator: Vipul Patel, MD, AdventHealth

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

January 1, 2013

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

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

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CU003

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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