Multi-site Decision Impact Study for Decipher

Completed

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

• Registration Number: NCT02034825
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-01
• Study First Submitted: 2014-01-10
• Study First Submitted QC: 2014-01-10
• Study First Posted: 2014-01-14
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-03
• Last Update Submitted: 2016-02-26
• Last Update Posted: 2016-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Practicing urologic surgeons	Decipher Questionnaire	* 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.

Primary Outcome Measures

Name	Time	Method
Change in treatment recommendation	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

Name	Time	Method
Specific change in treatment recommendation	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
Changes in intensity of treatment	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
Confidence in treatment recommendation	1.5 years	Changes in urologists expressed level of confidence in the treatment recommendation
Changes in the decision conflict scale	1.5 years
Utility of Decipher	1.5 years	Urologist's perception regarding the utility of the Decipher test
Change in treatment recommendation compared to baseline	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.

Trial Locations

Locations (3)

Cedar Associates LLC; 🇺🇸 Menlo Park, California, United States

Florida Hospital; 🇺🇸 Celebration, Florida, United States

Columbia University; 🇺🇸 New York, New York, United States