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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Decipher
Sponsored by
GenomeDx Biosciences Corp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Alaska Urology Institute Alaska Clinical Research Center
  • Cedars-Sinai Medical Center
  • University of Colorado, Denver Medical Campus
  • The Urology Center of Colorado
  • Urological Research Network
  • Lakeland Regional Health Systems
  • University of Miami Miller School of Medicine
  • Brigham and Women's Hospital
  • Spectrum Health Medical Group
  • Delaware Valley Urology, LLC
  • Carolina Urology Partners
  • Lancaster Urology
  • Thomas Jefferson University
  • Fox Chase Cancer Center
  • UT Southwestern Medical Center
  • Huntsman Cancer Hospital
  • University of Vermont Medical Center
  • Virginia Urology
  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Salvage setting

Adjuvant setting

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

Number of participants for which the Decipher test changes the urologist's and patient's treatment plan choices

Secondary Outcome Measures

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

Full Information

First Posted
February 18, 2014
Last Updated
February 24, 2017
Sponsor
GenomeDx Biosciences Corp
Collaborators
Society of Urologic Oncology (SUO)
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1. Study Identification

Unique Protocol Identification Number
NCT02080689
Brief Title
Prospective Clinical Utility Study to Assess the Impact of Decipher on Treatment Decisions After Surgery
Acronym
PRO-IMPACT
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 Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
February 1, 2017 (Actual)
Study Completion Date
February 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GenomeDx Biosciences Corp
Collaborators
Society of Urologic Oncology (SUO)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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: In the adjuvant setting: within 12 months after surgery (in the absence of detectable PSA rise of BCR) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
286 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Salvage setting
Arm Type
Other
Arm Description
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)
Arm Title
Adjuvant setting
Arm Type
Other
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Decipher
Primary Outcome Measure Information:
Title
Number of participants for which the Decipher test changes the urologist's and patient's treatment plan choices
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Measure the number of participants for which treatment was Increased or decreased in the intensity.
Description
This outcome will compare recommended treatment pre-Decipher to recommended treatment post-Decipher
Time Frame
3 months
Title
The number of different treatment plans most influenced by Decipher as a measure of clinical utility
Time Frame
12 months
Title
Comparison of type of treatment plans between high risk and low risk patients
Description
How many treatment plans are similar for those considered at high versus low risk by Decipher test
Time Frame
6 months
Title
Account for the number of specific treatment assignments that correlated with a change in treatment recommendation
Time Frame
12 months
Title
Frequency of follow visits as a measure of reproducibility
Description
The extent to which the Decipher test results influence urologist recommendations on frequency of follow-up for patients
Time Frame
12 months
Title
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
Title
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
Title
A measure of the patient's quality of life (QOL) as a measure of Decipher's clinical utility for patients
Description
The extent to which the Decipher test results affect patient comfort level with treatment decisions as based on QOL and treatment regret tools
Time Frame
12 months
Title
Evaluate number of participants which show coherence to treatment decisions
Description
For how many cases was the original selected treatment for a patient actually executed upon
Time Frame
12 months

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pathological T3 stage of disease (i.e., EPE or SVI), or Positive surgical margins, or Detectable PSA, defined as PSA detectable and rising on 2 or more subsequent determinations Exclusion Criteria: For adjuvant setting patients: Metastatic Disease (M+) prior to surgery For salvage setting patients: Metastatic Disease at PSA rise Failure of PSA to nadir after surgery Received any neo-adjuvant prostate cancer treatment before radical prostatectomy Received any adjuvant chemotherapy Required patient clinical data is not available for evaluation of eligibility criteria For adjuvant setting patients, any treatment received after surgery For salvage setting patients, lack of documented treatment or management recommendation on file Tissue specimen is inadequate for sampling and analysis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel W Lin, MD
Organizational Affiliation
The Society of Urologic Oncology (SUO)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John L Gore, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alaska Urology Institute Alaska Clinical Research Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99503
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles,
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of Colorado, Denver Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
The Urology Center of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80211
Country
United States
Facility Name
Urological Research Network
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Lakeland Regional Health Systems
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33101
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Spectrum Health Medical Group
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
Delaware Valley Urology, LLC
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Carolina Urology Partners
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
Country
United States
Facility Name
Lancaster Urology
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
753910-9110
Country
United States
Facility Name
Huntsman Cancer Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
University of Vermont Medical Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Virginia Urology
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
Country
United States

12. IPD Sharing Statement

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Links:
URL
http://suonet.org/default.aspx
Description
The Society of Urologic Oncology (SUO)

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Prospective Clinical Utility Study to Assess the Impact of Decipher on Treatment Decisions After Surgery

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