Early prostate cancer antigens (epca), polynucleotide sequences encoding them, and their use

Abstract

A novel prostate cancer marker is described that is found in cancerous and normal prostate cells of individuals that have prostate cancer but is not found in the prostate of individuals without prostate cancer. The marker also is present in normal tissue adjacent to tumor tissue in individuals having prostate cancer. The marker, however, is absent in the prostate of individuals without prostate cancer. Methods employing the novel prostate cancer marker of the invention to predict the occurrence of the prostate disease, monitor the progression of prostate cancer and effect the treatment of prostate cancer, also are described.

1 . A purified protein, comprising the amino acid sequence of SEQ ID NO: 1. 
     
     
         2 . The protein of  claim 1 , wherein said protein is found in cancerous and normal prostate cells of individuals having prostate cancer, but is not found in prostate cells of individuals without prostate cancer, wherein an individual is defined as having prostate cancer if a pathologically identified lesion is present within the prostate. 
     
     
         3 . (canceled) 
     
     
         4 . The protein of  claim 2 , wherein said protein is expressed at a higher level in prostate cells of individuals with aggressive prostate cancer than in individuals with non-aggressive prostate lesions. 
     
     
         5 . (canceled) 
     
     
         6 . (canceled) 
     
     
         7 . The protein of  claim 2 , wherein said protein has a molecular weight of about 40 kD and a pi of about 6.73. 
     
     
         8 . The protein of  claim 2 , wherein said protein further comprises an amino acid sequence selected from the group consisting of VSNTPLPGVLTK (SEQ ID NO: 7), TIGDNQK (SEQ ID NO: 2), DAYPGQIS (SEQ ID NO: 3), and DSGQGY (SEQ ID NO: 4). 
     
     
         9 . (canceled) 
     
     
         10 . The protein of  claim 2 , wherein said protein is detectable in a biological sample more than two years prior to detection of cancer based on Gleason scores. 
     
     
         11 . (canceled) 
     
     
         12 . A method of determining whether an individual will develop or already has prostate cancer, comprising determining the presence or absence of the protein of  claim 1  in a biological sample, wherein the presence of said protein indicates that said individual will develop or already has prostate cancer. 
     
     
         13 - 24 . (canceled) 
     
     
         25 . A purified polynucleotide sequence encoding the protein of  claim 1 . 
     
     
         26 . A purified polynucleotide sequence that hybridizes to the polynucleotide of  claim 25 . 
     
     
         27 . A host cell transformed with the polynucleotide sequence of  claim 25 . 
     
     
         28 . A host cell transformed with the polynucleotide sequence of  claim 26 . 
     
     
         29 . A recombinant expression vector containing the polynucleotide sequence of  claim 25 . 
     
     
         30 . A recombinant expression vector containing the polynucleotide sequence of  claims 26 . 
     
     
         31 . The recombinant expression vector of  claims 29  or  30 , wherein said vector is a virus. 
     
     
         32 . The recombinant expression vector of  claim 31 , wherein said virus is a RNA virus. 
     
     
         33 . (canceled) 
     
     
         34 . The recombinant expression vector of  claims 29  or  30 , wherein said vector is a liposome. 
     
     
         35 . (canceled) 
     
     
         36 . The recombinant expression vector of  claim 29  or  30 , wherein said vector is plasmid. 
     
     
         37 . A method for determining whether an individual will develop or already has prostate cancer from a sample containing nucleic acids, comprising
 (a) hybridizing a nucleic acid that either (i) complements a polynucleotide sequence encoding at least 5 contiguous amino acids of the protein of  claim 1  or (ii) complements a complement of a polynucleotide sequence encoding at least 5 contiguous amino acids of the protein of  claim 1 , to at least one of the nucleic acids of said sample, thereby forming a hybridization complex; and   (b) detecting said hybridization complex, wherein the presence of said hybridization complex correlates with the presence of said sequence encoding the protein of  claim 1  in said sample and indicates that said individual will develop or already has prostate cancer.   
     
     
         38 - 43 . (canceled) 
     
     
         44 . An isolated or purified antibody that specifically binds to the protein of  claim 1 . 
     
     
         45 . The isolated or purified antibody of  claim 44 , wherein said antibody is polyclonal or monoclonal. 
     
     
         46 . A method of producing the antibody of  claim 44 , wherein said antibody is capable of differentiating between cancerous prostate and normal prostate tissues, said method comprising
 (a) selecting the protein or antigenic fragment of  claim 1  as an antigen,   (b) raising an antibody against said antigen, and   (c) recovering said antibody.