Team Project

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

PASS Ref Set App: GHI collaboration

No coordinating investigator defined.

No design specified.
Prostate and Urologic Cancers Research Group

Validate a panel of tissue-based biomarkers to determine the presence of or progression to clinically relevant prostate cancer at the time of diagnosis. Utilize a novel, biopsy based multi-gene quantitative RT-PCR assay developed by Genomic Health, Oncotype DX Prostate Cancer Assay, which discriminates aggressive from indolent cancer on multivariate modeling of PCa patients.

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.

No datasets are currently associated with this protocol.

Version 5.1.0