Method for Using Gene Expression to Determine Prognosis of Prostate Cancer

Abstract

Molecular assays that involve measurement of expression levels of prognostic biomarkers, or co-expressed biomarkers, from a biological sample obtained from a prostate cancer patient, and analysis of the measured expression levels to provide information concerning the likely prognosis for said patient, and likelihood that said patient will have a recurrence of prostate cancer, or to classify the tumor by likelihood of clinical outcome or TMPRSS2 fusion status, are provided herein.

1 .- 20 . (canceled) 
     
     
         21 . A method of analyzing the expression of RNA transcripts of genes in a human prostate cancer patient, comprising:
 obtaining a prostate tumor tissue sample from a human prostate cancer patient;   extracting RNA from the tissue sample;   reverse transcribing RNA transcripts of a group of genes comprising each of: BGN, COL1A1, SFRP4, FLNC, GSN, GSTM2, TPM2, AZGP1, KLK2, FAM13C, SRD5A2, and TPX2, and at least one reference gene, to produce cDNAs from the RNA transcripts, wherein a reference gene is a gene that does not exhibit a significantly different RNA expression level in cancerous prostate tissue compared to non-cancerous prostate tissue; and   amplifying the cDNAs to produce amplicons from the cDNAs for determination of expression levels of the RNA transcripts.   
     
     
         22 . The method of  claim 21 , wherein the at least one reference gene consists of from 1 to 6 reference genes. 
     
     
         23 . The method of  claim 21 , wherein the at least one reference gene comprises one or more of AAMP, ARF1, ATP5E, CLTC, EEF1A1, GPS1, GPX1, and PGK1. 
     
     
         24 . The method of  claim 21 , wherein the at least one reference gene is selected from the group consisting of AAMP, ARF1, ATP5E, CLTC, EEF1A1, GPS1, GPX1, and PGK1. 
     
     
         25 . The method of  claim 21 , wherein the tissue sample has a positive TMPRSS2 fusion status. 
     
     
         26 . The method of  claim 21 , wherein the tissue sample has a negative TMPRSS2 fusion status. 
     
     
         27 . The method of  claim 21 , wherein the patient has early-stage prostate cancer. 
     
     
         28 . The method of  claim 21 , wherein the tissue sample comprises prostate tumor tissue with the primary Gleason pattern for the patient's prostate tumor. 
     
     
         29 . The method of  claim 21 , wherein the tissue sample comprises prostate tumor tissue with the highest Gleason pattern for the patient's prostate tumor. 
     
     
         30 . The method of  claim 21 , wherein the tissue sample comprises non-tumor prostate tissue. 
     
     
         31 . The method of  claim 21 , wherein the patient is receiving active surveillance treatment.