Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02080689
Recruitment Status : Completed
First Posted : March 6, 2014
Last Update Posted : February 27, 2017
Sponsor:
Collaborator:
Society of Urologic Oncology (SUO)
Information provided by (Responsible Party):
GenomeDx Biosciences Corp

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The influence of Decipher test on urologist and patient treatment plan choices immediately post RP and at the time of PSA rise or BCR

Condition or disease Intervention/treatment Phase
Prostate Cancer Other: Decipher Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 286 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: PROspective Study of the IMPACT of Decipher™ Prostate Cancer Classifier on Physician and Patient Treatment Consideration and Decisions Following Radical Prostatectomy [PRO-IMPACT]
Study Start Date : May 2014
Actual Primary Completion Date : February 1, 2017
Actual Study Completion Date : February 1, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of participants for which the Decipher test changes the urologist's and patient's treatment plan choices [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. 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

  2. The number of different treatment plans most influenced by Decipher as a measure of clinical utility [ Time Frame: 12 months ]
  3. 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

  4. Account for the number of specific treatment assignments that correlated with a change in treatment recommendation [ Time Frame: 12 months ]
  5. 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

  6. 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 ]
  7. 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 ]
  8. 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

  9. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02080689


Locations
Show Show 19 study locations
Sponsors and Collaborators
GenomeDx Biosciences Corp
Society of Urologic Oncology (SUO)
Investigators
Layout table for investigator information
Principal Investigator: Daniel W Lin, MD The Society of Urologic Oncology (SUO)
Principal Investigator: John L Gore, MD University of Washington
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications:

Layout table for additonal information
Responsible Party: GenomeDx Biosciences Corp
ClinicalTrials.gov Identifier: NCT02080689    
Other Study ID Numbers: CU 004
First Posted: March 6, 2014    Key Record Dates
Last Update Posted: February 27, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases