Prostate Cancer Clinical Trial

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

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

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Full 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.

View Eligibility Criteria

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

Study is for people with:

Prostate Cancer

Estimated Enrollment:

286

Study ID:

NCT02080689

Recruitment Status:

Completed

Sponsor:

GenomeDx Biosciences Corp

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There are 18 Locations for this study

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Alaska Urology Institute Alaska Clinical Research Center
Anchorage Alaska, 99503, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
University of Colorado, Denver Medical Campus
Aurora Colorado, 80045, United States
The Urology Center of Colorado
Denver Colorado, 80211, United States
Urological Research Network
Hialeah Florida, 33016, United States
Lakeland Regional Health Systems
Lakeland Florida, 33805, United States
University of Miami Miller School of Medicine
Miami Florida, 33101, United States
Brigham and Women's Hospital
Boston Massachusetts, 02115, United States
Spectrum Health Medical Group
Grand Rapids Michigan, 49546, United States
Delaware Valley Urology, LLC
Voorhees New Jersey, 08043, United States
Carolina Urology Partners
Gastonia North Carolina, 28054, United States
Lancaster Urology
Lancaster Pennsylvania, 17604, United States
Thomas Jefferson University
Philadelphia Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
UT Southwestern Medical Center
Dallas Texas, 75391, United States
Huntsman Cancer Hospital
Salt Lake City Utah, 84112, United States
University of Vermont Medical Center
Burlington Vermont, 05401, United States
Virginia Urology
Richmond Virginia, 23235, United States
University of Washington
Seattle Washington, , United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

286

Study ID:

NCT02080689

Recruitment Status:

Completed

Sponsor:


GenomeDx Biosciences Corp

How clear is this clinincal trial information?

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