Loading clinical trials...
Loading clinical trials...
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
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.
Age
All ages
Sex
MALE
Healthy Volunteers
No
Alaska Urology Institute Alaska Clinical Research Center
Anchorage, Alaska, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of Colorado, Denver Medical Campus
Aurora, Colorado, United States
The Urology Center of Colorado
Denver, Colorado, United States
Urological Research Network
Hialeah, Florida, United States
Lakeland Regional Health Systems
Lakeland, Florida, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Spectrum Health Medical Group
Grand Rapids, Michigan, United States
Delaware Valley Urology, LLC
Voorhees Township, New Jersey, United States
Start Date
May 1, 2014
Primary Completion Date
February 1, 2017
Completion Date
February 1, 2017
Last Updated
February 27, 2017
286
ACTUAL participants
Decipher
OTHER
Lead Sponsor
GenomeDx Biosciences Corp
Collaborators
NCT05691465
NCT06842498
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04550494