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NCT Number: NCT02020876

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

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

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Observational

Primary location

GenomeDx Bioscience Inc.

San Diego, California, 92121, United States

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Criteria (Participant enrollment)

Inclusion criteria

Study participants:

  • Practicing board-certified urologic surgeons
  • 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)

Treatment and study plan

Decipher Questionnaire

Other

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.

Primary outcomes

  1. Change in treatment recommendation

    Time frame: 1.5 years

    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.

Secondary outcomes

  1. Urologist's perception regarding the utility of the Decipher

    Time frame: 1.5 years

    • 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

Sponsors and collaborators

Lead sponsor

GenomeDx Biosciences Corp

Industry

Registry information

Official study title

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

Acronym: DECIDE

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 25, 2013
Registry last updated
Dec 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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