Mirna biomarkers of prostate disease

Abstract

This application describes miRNAs that may be used as serum or plasma biomarkers for characterizing prostate disease in a patient. These miRNA biomarkers may be used alone or in combination with other markers for the diagnosis, prognosis, or monitoring of diseases such as prostate cancer.

1 - 22 . (canceled) 
     
     
         23 . A method for characterizing whether a prostate disease in a patient is prostate cancer or benign prostatic hyperplasia (BPH), comprising the steps of:
 a. reverse transcribing a miRNA in a serum sample;   b. amplifying the miRNA;   c. measuring the level of the miRNA;   d. detecting whether the level of the miRNA is elevated or reduced,   thereby characterizing the prostate disease in the patient as prostate cancer or BPH,   wherein the miRNA is selected from miR-1, miR-10, miR-15a, miR-15b, miR-16, miR-17-5p, miR-18a, miR-18a*, miR-19a, miR-20a, miR-20b, miR-22, miR-23a, miR-23b, miR-24, miR-25, miR-26a, miR-26b, miR-28, miR-29a, miR-29c, miR-30a-5p, miR-30b, miR-30c, miR-30d, miR-30e-3p, miR-32, miR-92, miR-93, miR-98, miR-99b, miR-103, miR-106a, miR-107, miR-122, miR-125a, miR-126, miR-130a, miR-130b, miR-132, miR-139, miR-140, miR-142-5p, miR-143, miR-145, miR-148a, miR-155, miR-181c, miR-185, miR-191, miR-192, miR-193a, miR-194, miR-195, miR-196b, miR-197, miR-199a, miR-204, miR-205, miR-206, miR-214, miR-222, miR-223, miR-224, miR-301miR-328, miR-331, miR-335, miR-339, miR-340, miR-342, miR-345, miR-361, miR-365, miR-374, miR-375, miR-422b, miR-423, miR-425, miR-483, miR-565, miR-576, miR-584, miR-638, miR-660, let-7a, let-7d, let-7f, and let-7g.   
     
     
         24 . The method of  claim 23 , wherein the stage of the prostate cancer is characterized based on the level of the miRNA. 
     
     
         25 . The method of  claim 23 , wherein the progression of the prostate cancer is characterized based on the level of the miRNA. 
     
     
         26 . The method of  claim 23 , wherein the aggressiveness of the prostate cancer is evaluated based on the level of the miRNA. 
     
     
         27 . The method of  claim 23 , wherein the amplification is by quantitative reverse transcriptase polymerase chain reaction. 
     
     
         28 . The method of  claim 23 , wherein the miRNA is expressed at an elevated level in a patient with prostate cancer. 
     
     
         29 . The method of  claim 23 , wherein the miRNA is expressed at a reduced level in a patient with prostate cancer. 
     
     
         30 . The method of  claim 23 , further comprising amplifying, measuring, and determining reduced or elevated levels of a second miRNA. 
     
     
         31 . A method for characterizing whether a prostate disease in a patient is prostate cancer or benign prostatic hyperplasia (BPH), comprising the steps of:
 a. reverse transcribing a first miRNA and a second miRNA in a serum sample;   b. amplifying the first miRNA and the second miRNA;   c. measuring the levels of the first miRNA and the second miRNA;   d. detecting whether the levels of the first miRNA and the second miRNA are elevated or reduced,   thereby characterizing the prostate disease in the patient as prostate cancer or BPH,   wherein the first and second miRNA are selected from miR-1, miR-10, miR-15a, miR-15b, miR-16, miR-17-5p, miR-18a, miR-18a*, miR-19a, miR-20a, miR-20b, miR-22, miR-23a, miR-23b, miR-24, miR-25, miR-26a, miR-26b, miR-28, miR-29a, miR-29c, miR-30a-5p, miR-30b, miR-30c, miR-30d, miR-30e-3p, miR-32, miR-92, miR-93, miR-98, miR-99b, miR-103, miR-106a, miR-107, miR-122, miR-125a, miR-126, miR-130a, miR-130b, miR-132, miR-139, miR-140, miR-142-5p, miR-143, miR-145, miR-148a, miR-155, miR-181c, miR-185, miR-191, miR-192, miR-193a, miR-194, miR-195, miR-196b, miR-197, miR-199a, miR-204, miR-205, miR-206, miR-214, miR-222, miR-223, miR-224, miR-301miR-328, miR-331, miR-335, miR-339, miR-340, miR-342, miR-345, miR-361, miR-365, miR-374, miR-375, miR-422b, miR-423, miR-425, miR-483, miR-565, miR-576, miR-584, miR-638, miR-660, let-7a, let-7d, let-7f, and let-7g.   
     
     
         32 . The method of  claim 31 , wherein the stage of the prostate cancer is characterized based on the levels of the first miRNA and the second miRNA. 
     
     
         33 . The method of  claim 31 , wherein the progression of the prostate cancer is characterized based on the levels of the first miRNA and the second miRNA. 
     
     
         34 . The method of  claim 31 , wherein the aggressiveness of the prostate cancer is evaluated based on the levels of the first miRNA and the second miRNA. 
     
     
         35 . The method of  claim 31 , wherein the amplification is by quantitative reverse transcriptase polymerase chain reaction. 
     
     
         36 . The method of  claim 31 , wherein the first miRNA is expressed at an elevated level in a patient with prostate cancer, and the second miRNA is expressed at a reduced level in a patient with prostate cancer. 
     
     
         37 . The method of  claim 31 , wherein the first and the second miRNAs are expressed at elevated levels in a patient with prostate cancer. 
     
     
         38 . The method of  claim 31 , wherein the first miRNA is expressed at a reduced level in a patient with prostate cancer, and the second miRNA is expressed at an elevated level in a patient with prostate cancer. 
     
     
         39 . The method of  claim 31 , wherein the first and the second miRNAs are expressed at reduced levels in a patient with prostate cancer.