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
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.
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
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There are 18 Locations for this study
Anchorage Alaska, 99503, United States
Los Angeles, California, 90048, United States
Aurora Colorado, 80045, United States
Denver Colorado, 80211, United States
Hialeah Florida, 33016, United States
Lakeland Florida, 33805, United States
Miami Florida, 33101, United States
Boston Massachusetts, 02115, United States
Grand Rapids Michigan, 49546, United States
Voorhees New Jersey, 08043, United States
Gastonia North Carolina, 28054, United States
Lancaster Pennsylvania, 17604, United States
Philadelphia Pennsylvania, 19107, United States
Philadelphia Pennsylvania, 19111, United States
Dallas Texas, 75391, United States
Salt Lake City Utah, 84112, United States
Burlington Vermont, 05401, United States
Richmond Virginia, 23235, United States
Seattle Washington, , United States
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