Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

* 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.

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

Decipher Questionnaire

Badani K Ketan, MD

Christine d Buerki, PhD

Vipul Patel, MD

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

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.

Multi-site Decision Impact Study for Decipher

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

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. 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. 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

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.

Changes in urologists expressed level of confidence in the treatment recommendation

Urologist's perception regarding the utility of the Decipher test

Columbia University

GenomeDx Biosciences Corp

Symptoms and General Pathology

Neoplasm Metastasis

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.

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.

Paul L. Nguyen, MD

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.

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.

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

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?

Change in treatment recommendation from pre- to post-Decipher report, defined as any change in treatment recommendation.

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

Changes in Radiation Oncologist's expressed level of confidence in the treatment recommendation

Radiation Oncologist's perception regarding the utility of the Decipher test

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Multi-site Decision Impact Study for Decipher	NCT02034825	Prostate Cancer	Decipher Questi...	-	GenomeDx Biosciences Corp
Multi-site Decision Impact Study for Decipher	NCT02034825	Prostate Cancer	Decipher Questi...	-	GenomeDx Biosciences Corp
Decision Impact Study to Measure the Influence of DECIPHER on Treatment Recommendations for Radiation Oncologists	NCT02034812	Prostate Cancer	Decipher Questi...	-	GenomeDx Biosciences Corp

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