Abbreviated Name

PCA3 Ref Set App-T2 ERG-Sanda (2014)

Lead Investigator

— Emory University

Coordinating Investigator

Zheng, Yingye — Fred Hutchinson Cancer Center

Involved Investigators

• Groskopf, Jack — Hologic Gen-Probe Incorporated
• Chan, Daniel — Johns Hopkins Medical Institutions
• — Emory University
• Zheng, Yingye — Fred Hutchinson Cancer Center

Abstract

No abstract availalbe.

Aims

Primary Specific Aims Aim 1:   To validate the performance of urinary T2:erg in a multiplex model in combination with PCA3 predicting the diagnosis of histologically clinically significant prostate cancer among men without prior evidence of prostate cancer Secondary Aims Aim 1:   To evaluate the sensitivity, specificity, PPV, NPV and absolute risk prediction by T2:erg/PCA3 combined and multiplexed with other biomarkers and clinical variables in the detection of histologically clinically significant prostate cancer Aim 2:    To validate the performance of urinary T2:erg in a multiplex model in combination with PCA3 predicting the diagnosis of ANY prostate cancer Aim 3:    To investigate whether the multiplex model performance is improved by addition of % free PSA, PSAV, -2proPSA, and other markers in development Aim 4:   To evaluate the correlation between urinary and tissue based T2:erg and prostate biopsy tumor grade

Analytic Method

Transcription mediated amplification based assay

Outcome

We hypothesize that combining T2:erg (T2:erg) fusion and PCA3 detection in urine collected after digital rectal exam can improve the specificity of identifying clinically significant prostate cancer presence over the standard PSA and DRE. To address this hypothesis we propose to validate the performance of the urinary T2:erg in a multiplex model predicting the diagnosis of clinically significant prostate cancer on subsequent prostate biopsy using post-DRE pre biopsy urine specimens from a cohort of 900 men on the EDRN’s PCA3 trial.

Publications

• No publications available at this time for this protocol.

Biomarkers

• PCA3
• TMPRSS2:ERG

Data Collections

• No data collections available at this time for this protocol.

Start Date

Jun 14 2013

Finish Date

Jul 4 2016

Protocol ID

376

Protocol Type

Reference Set

Fields of Research

• Genomics

Collaborative Group

Prostate and Urologic Cancers Research Group

Cancer Types

• Malignant neoplasm of prostate

Phased Status

2