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

Prostate Cancer Clinical Trial

— DECIDE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02020876
• Other study ID #: CU001
• Status: Completed
• Phase: N/A
• First received: December 18, 2013
• Last updated: December 19, 2013
• Start date: August 2012
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: GenomeDx Biosciences Corp
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	GenomeDx Bioscience Inc.	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
GenomeDx Biosciences Corp

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 stud — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No