Biomarkers for Early Detection of Clinically Relvant Prostate Cancer: A Multi-Institutional Validation Trial - Genomic Health, Inc.

Abbreviated Name
PASS Ref Set App: GHI collaboration
Lead Investigator
Lin UW, Daniel W.University of Washington
Coordinating Investigator
No coordinating investigator
Involved Investigators


No abstract availalbe.


The Oncotype DX Prostate Assay is a clinical multi-gene RT-PCR assay that can be performed on mRNA isolated from formalin-fixed tumor tissue from prostate needle biopsies. It was developed by Genomic Health, Inc. (GHI) using the approach from GHI’s prior breast and colon cancer programs. The 17 genepanel was developed using a series of studies in a cohort of patients undergoing radical prostatectomy at Cleveland Clinic. Recently, the assay was validated in a prospectively-designed study on 395 archival needle biopsies in a cohort of men who were candidates for AS but were treated with radical prostatectomy (RP). The Oncotype DX Prostate Assay has been validated in prostate biopsy tissue to predict adverse pathology at time of radical prostatecotmy, a surrogate for aggressive disease. The assay is now commercially available and in use for men diagnosed with prostate cancer. The work proposed here will build on this growing body of evidence in support of a multi-function molecular signature in predicting disease aggressiveness. These results promise to have immediate and substantial impact on the majority of newly diagnosed PCa.

Analytic Method

No analytic method available.


  • No publications available at this time for this protocol.


Data Collections

  • No data collections available at this time for this protocol.
 Team Project
Start Date
Mar 1 2016
Finish Date
Sep 30 2018
Protocol ID
Protocol Type
Reference Set
Field of Research
Collaborative Group
Prostate and Urologic Cancers Research Group
Cancer Types
  • Malignant neoplasm of prostate
Phased Status

Associated Forms