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

Sponsor
GenomeDx Biosciences Corp (Industry)
Overall Status
Completed
CT.gov ID
NCT02080689
Collaborator
Society of Urologic Oncology (SUO) (Other)
286
Enrollment
19
Locations
2
Arms
33.1
Duration (Months)
15.1
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Other: Decipher
 N/A

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

Study Type:
Interventional
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 1, 2014
Actual Primary Completion Date :
Feb 1, 2017
Actual Study Completion Date :
Feb 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Number of participants for which the Decipher test changes the urologist's and patient's treatment plan choices [3 months]

Secondary Outcome Measures

  1. Measure the number of participants for which treatment was Increased or decreased in the intensity. [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 [12 months]

  3. Comparison of type of treatment plans between high risk and low risk patients [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 [12 months]

  5. Frequency of follow visits as a measure of reproducibility [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 [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 [12 months]

  8. A measure of the patient's quality of life (QOL) as a measure of Decipher's clinical utility for patients [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 [12 months]

    For how many cases was the original selected treatment for a patient actually executed upon

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Locations

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

Sponsors and Collaborators

  • GenomeDx Biosciences Corp
  • Society of Urologic Oncology (SUO)

Investigators

  • Principal Investigator: Daniel W Lin, MD, The Society of Urologic Oncology (SUO)
  • Principal Investigator: John L Gore, MD, University of Washington

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
GenomeDx Biosciences Corp
ClinicalTrials.gov Identifier:
NCT02080689
Other Study ID Numbers:
  • CU 004
First Posted:
Mar 6, 2014
Last Update Posted:
Feb 27, 2017
Last Verified:
Feb 1, 2017
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Feb 27, 2017