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

GenomeDx Biosciences

Status: Completed

Conditions: Prostate Cancer

Treatments: Other: DECIPHER Questionnaire

Study type: Observational

Funder types: Industry

Identifiers

NCT02020876

CU001

Details and patient eligibility

About

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

Full 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)

Enrollment: 21 patients

Sex: Male

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

21 participants in 1 patient group

Practicing urologic surgeons

Description:

Performing at least 60 radical prostate surgeries annually

Treatment:

Other: DECIPHER Questionnaire