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

Completed · Not applicable

Conditions studied: Prostate Cancer

In brief

The influence of Decipher test on urologist and patient treatment plan choices immediately post RP and at the time of PSA rise or BCR

Key facts

Study ID

NCT02080689

Run by

GenomeDx Biosciences Corp

People needed

286

Starts

2014-05-01

Expected to finish

2017-02-01

Last updated by the study team

2017-02-27

Who can join

Age: any. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Carolina Urology Partners — Gastonia, North Carolina, United States
• Lancaster Urology — Lancaster, Pennsylvania, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• UT Southwestern Medical Center — Dallas, Texas, United States
• Huntsman Cancer Hospital — Salt Lake City, Utah, United States
• University of Vermont Medical Center — Burlington, Vermont, United States
• Virginia Urology — Richmond, Virginia, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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