Multi-site Decision Impact Study for Decipher

Completed

Conditions studied: Prostate Cancer

In brief

This prospectively designed retrospective clinical utility study will evaluate urologists' treatment recommendations before and after reviewing Decipher results for selected patient cases.

Key facts

Study ID

NCT02034825

Run by

GenomeDx Biosciences Corp

People needed

50

Starts

2013-01-01

Expected to finish

2015-01-01

Last updated by the study team

2016-02-29

Who can join

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

You may qualify if…

• Patient cases eligible for this study were treated with radical prostatectomy and have one or more adverse features present as defined by AUA and NCCN guidelines:
• Pathological T3 stage of disease (i.e., ECE or SVI)
• Positive surgical margins, or
• Detectable PSA, defined as PSA detectable and rising on 2 or more subsequent determinations

You may not qualify if…

• Metastatic Disease (M+) prior to surgery
• 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 (Section 5.3) is not available for evaluation of eligibility criteria
• Lack of documented treatment or management recommendation on file
• Tissue specimen is inadequate for sampling and analysis

Where it is running

• Cedar Associates LLC — Menlo Park, California, United States
• Florida Hospital — Celebration, Florida, United States
• Columbia University — New York, New York, United States

Full record on ClinicalTrials.gov

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