Prospective Clinical Utility Study to Assess the Impact of Decipher on Treatment Decisions After Surgery
- Conditions
- Prostate Cancer
- Interventions
- Other: Decipher
- Registration Number
- NCT02080689
- Lead Sponsor
- GenomeDx Biosciences Corp
- 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:
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 286
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Adjuvant setting Decipher 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) Salvage setting Decipher 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)
- Primary Outcome Measures
Name Time Method Number of participants for which the Decipher test changes the urologist's and patient's treatment plan choices 3 months
- Secondary Outcome Measures
Name Time Method 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
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 The number of different treatment plans most influenced by Decipher as a measure of clinical utility 12 months 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
Account for the number of specific treatment assignments that correlated with a change in treatment recommendation 12 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 12 months 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
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
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
Trial Locations
- Locations (19)
Cedars-Sinai Medical Center
🇺🇸Los Angeles,, California, United States
Lakeland Regional Health Systems
🇺🇸Lakeland, Florida, United States
Carolina Urology Partners
🇺🇸Gastonia, North Carolina, United States
Lancaster Urology
🇺🇸Lancaster, Pennsylvania, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Alaska Urology Institute Alaska Clinical Research Center
🇺🇸Anchorage, Alaska, United States
Urological Research Network
🇺🇸Hialeah, Florida, United States
University of Miami Miller School of Medicine
🇺🇸Miami, Florida, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Delaware Valley Urology, LLC
🇺🇸Voorhees, New Jersey, United States
Spectrum Health Medical Group
🇺🇸Grand Rapids, Michigan, United States
University of Vermont Medical Center
🇺🇸Burlington, Vermont, United States
University of Washington
🇺🇸Seattle, Washington, United States
University of Colorado, Denver Medical Campus
🇺🇸Aurora, Colorado, United States
The Urology Center of Colorado
🇺🇸Denver, Colorado, United States
Huntsman Cancer Hospital
🇺🇸Salt Lake City, Utah, United States
Virginia Urology
🇺🇸Richmond, Virginia, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States