Early Detection Research Network

PCA3 Reference Set Application: T2-Erg-Martin Sanda-Emory (2014)

PCA3 Ref Set App-T2 ERG-Sanda (2014)
376
Sanda, MartinEmory University
Feng, ZidingFred Hutchinson Cancer Research Center
T2-erg, PCA3
No design specified.
Genomics
Prostate and Urologic Cancers Research Group
2

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.

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
Transcription mediated amplification based assay

No datasets are currently associated with this protocol.


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