Decision Impact Study to Measure the Influence of DECIPHER on Treatment Recommendations (DECIDE)

GenomeDx Decipher Test for Metastatic Disease in Prostate Cancer for Patients With Adverse Pathology Post Radical Prostatectomy: Does it Impact Physician Decision Making?

This clinical utility study pilot is based on a review of real but de-identified and randomized patient cases and aims to evaluate Urologists' treatment recommendations before and after reviewing the results provided by the Decipher test. This is a pilot study and the primary intent is to help guide development and design of future clinical utility studies for Decipher

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Other: DECIPHER Questionnaire

Detailed Description

The primary and secondary objectives will be assessed in retrospectively selected prostate cancer patients treated with radical prostatectomy with one or more adverse pathological features (APFs)

• Study Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92121
      • GenomeDx Bioscience Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

This is an exploratory study utilizing archived tumor specimens and demographic and pathologic characteristics derived from the patient's medical charts. The study participants are the urologists who review the selected case files.

Description

Criteria (Participant enrollment)

Inclusion Criteria Study participants:

1. Practicing board-certified urologic surgeons
2. Performing at least 40 radical prostate surgeries annually

Exclusion Criteria Study Participants:

(1) Did not meet the inclusion criteria

Criteria (Case selection)

Inclusion Criteria Case File:

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 (= Extraprostatic extension) or T3B (=Seminal vesicle invasion); Positive surgical margins Gleason grade upgrade from biopsy to surgery

Exclusion Criteria Case File:

Metastatic disease (M+) prior to surgery Received any neo-adjuvant prostate cancer treatment with radical prostatectomy (radiation, hormone, chemotherapy)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Practicing urologic surgeons; Performing at least 60 radical prostate surgeries annually	Other: DECIPHER Questionnaire; Participants are 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 opinion is collected based on a random selection of cases.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in treatment recommendation	To determine the extent to which the use of the Decipher test influences treatment recommendations by physicians post radical prostatectomy (RP). This decision impact study aims to evaluate Urologists' treatment recommendations before and after reviewing the results provided by the Decipher test.	1.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urologist's perception regarding the utility of the Decipher	Changes in Urologists expressed level of confidence in the treatment recommendation as measured by the response to item 4a in the eCRF survey.; Urologist's perception regarding the utility of the Decipher test as measured by the responses to question 4b and 38b and 38c in the eCRF survey.; Agreement in treatment recommendation	1.5 years

Collaborators and Investigators

• Sponsor: GenomeDx Biosciences Corp
• Investigators: Principal Investigator: Elai Davicioni, pHd, GenomeDx Biosciences Inc.; Principal Investigator: Badani Ketan, MD, Department of Urology, Columbia University, New York, NY USA

Publications and helpful links

General Publications

• Badani K, Thompson DJ, Buerki C, Davicioni E, Garrison J, Ghadessi M, Mitra AP, Wood PJ, Hornberger J. Impact of a genomic classifier of metastatic risk on postoperative treatment recommendations for prostate cancer patients: a report from the DECIDE study group. Oncotarget. 2013 Apr;4(4):600-9. doi: 10.18632/oncotarget.918.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: December 18, 2013
• First Submitted That Met QC Criteria: December 19, 2013
• First Posted (Estimate): December 25, 2013

Study Record Updates

• Last Update Posted (Estimate): December 25, 2013
• Last Update Submitted That Met QC Criteria: December 19, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: CU001