Prospective Clinical Utility Study to Assess the Impact of Decipher on Treatment Decisions After Surgery (PRO-IMPACT)

February 24, 2017 updated by: GenomeDx Biosciences Corp

PROspective Study of the IMPACT of Decipher™ Prostate Cancer Classifier on Physician and Patient Treatment Consideration and Decisions Following Radical Prostatectomy [PRO-IMPACT]

The influence of Decipher test on urologist and patient treatment plan choices immediately post RP and at the time of PSA rise or BCR

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This prospectively decision impact study will evaluate physicians and patient treatment plan choices before and after reviewing Decipher results for eligible patient cases. The clinical utility of Decipher will be evaluated for patients meeting the inclusion criteria at two time-points post-RP:

  1. In the adjuvant setting: within 12 months after surgery (in the absence of detectable PSA rise of BCR)
  2. In the salvage setting: post-RP with evidence of PSA rise or BCR (defined as PSA detectable and rising on 2 or more subsequent determinations)

A total of 150 patient cases, in each arm, will be prospectively selected from clinical sites. The study as a whole will enroll 300 patient cases.

As a condition of participation in the study, each clinical site must agree to provide a minimum of 10 patient cases.

Study Type

Interventional

Enrollment (Actual)

286

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99503
        • Alaska Urology Institute Alaska Clinical Research Center
    • California
      • Los Angeles,, California, United States, 90048
        • Cedars-Sinai Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado, Denver Medical Campus
      • Denver, Colorado, United States, 80211
        • The Urology Center of Colorado
    • Florida
      • Hialeah, Florida, United States, 33016
        • Urological Research Network
      • Lakeland, Florida, United States, 33805
        • Lakeland Regional Health Systems
      • Miami, Florida, United States, 33101
        • University of Miami Miller School of Medicine
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Spectrum Health Medical Group
    • New Jersey
      • Voorhees, New Jersey, United States, 08043
        • Delaware Valley Urology, LLC
    • North Carolina
      • Gastonia, North Carolina, United States, 28054
        • Carolina Urology Partners
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17604
        • Lancaster Urology
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
    • Texas
      • Dallas, Texas, United States, 753910-9110
        • UT Southwestern Medical Center
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Hospital
    • Vermont
      • Burlington, Vermont, United States, 05401
        • University of Vermont Medical Center
    • Virginia
      • Richmond, Virginia, United States, 23235
        • Virginia Urology
    • Washington
      • Seattle, Washington, United States
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Pathological T3 stage of disease (i.e., EPE or SVI), or
  2. Positive surgical margins, or
  3. Detectable PSA, defined as PSA detectable and rising on 2 or more subsequent determinations

Exclusion Criteria:

  1. For adjuvant setting patients: Metastatic Disease (M+) prior to surgery
  2. For salvage setting patients: Metastatic Disease at PSA rise
  3. Failure of PSA to nadir after surgery
  4. Received any neo-adjuvant prostate cancer treatment before radical prostatectomy
  5. Received any adjuvant chemotherapy
  6. Required patient clinical data is not available for evaluation of eligibility criteria
  7. For adjuvant setting patients, any treatment received after surgery
  8. For salvage setting patients, lack of documented treatment or management recommendation on file
  9. Tissue specimen is inadequate for sampling and analysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Salvage setting
The clinical utility of Decipher will be evaluated for patients meeting the inclusion criteria in the salvage setting: post-RP with evidence of PSA rise or BCR (defined as PSA detectable and rising on 2 or more subsequent determinations)
Other: Decipher
OTHER: Adjuvant setting
The clinical utility of Decipher will be evaluated for patients in the adjuvant setting: within 12 months after surgery (in the absence of detectable PSA rise of BCR)
Other: Decipher

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants for which the Decipher test changes the urologist's and patient's treatment plan choices
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure the number of participants for which treatment was Increased or decreased in the intensity.
Time Frame: 3 months
This outcome will compare recommended treatment pre-Decipher to recommended treatment post-Decipher
3 months
The number of different treatment plans most influenced by Decipher as a measure of clinical utility
Time Frame: 12 months
12 months
Comparison of type of treatment plans between high risk and low risk patients
Time Frame: 6 months
How many treatment plans are similar for those considered at high versus low risk by Decipher test
6 months
Account for the number of specific treatment assignments that correlated with a change in treatment recommendation
Time Frame: 12 months
12 months
Frequency of follow visits as a measure of reproducibility
Time Frame: 12 months
The extent to which the Decipher test results influence urologist recommendations on frequency of follow-up for patients
12 months
Measure the urologist's and patient's Level of confidence in their selected treatment plan through the use of a share decision making tool
Time Frame: 3 months
3 months
Assess the number of physicians that assigned the same treatment treatment recommendations for patient of the same pathological profile as a measure of concordance
Time Frame: 12 months
12 months
A measure of the patient's quality of life (QOL) as a measure of Decipher's clinical utility for patients
Time Frame: 12 months
The extent to which the Decipher test results affect patient comfort level with treatment decisions as based on QOL and treatment regret tools
12 months
Evaluate number of participants which show coherence to treatment decisions
Time Frame: 12 months
For how many cases was the original selected treatment for a patient actually executed upon
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GenomeDx Biosciences Corp

Collaborators

Society of Urologic Oncology (SUO)

Investigators

  • Principal Investigator: Daniel W Lin, MD, The Society of Urologic Oncology (SUO)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (ACTUAL)

February 1, 2017

Study Completion (ACTUAL)

February 1, 2017

Study Registration Dates

First Submitted

February 18, 2014

First Submitted That Met QC Criteria

March 4, 2014

First Posted (ESTIMATE)

March 6, 2014

Study Record Updates

Last Update Posted (ACTUAL)

February 27, 2017

Last Update Submitted That Met QC Criteria

February 24, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CU 004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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