Patent Application

App. No. 14/208,850

Abstract

Claims (48)

1 . An assay method for selectively measuring mRNA and protein expression in a blood sample and urine sample from a subject, the method comprising:

(a) selectively measuring the expression level of a gene's mRNA from the urine sample by quantitative reverse transcription polymerase chain reaction (RT-PCR);

(b) selectively measuring the expression level of the gene's mRNA from the blood sample by quantitative RT-PCR; and

(c) selectively measuring the expression level of the gene's protein from the blood sample by immunological detection.

2 . The method of claim 1 , comprising selectively measuring the expression level of at least 3, 4, 5, 6, 7, 8, 9 or 10 genes.

3 . The method of claim 1 , comprising selectively measuring the expression level of genes selected from the group consisting of UAP1, PDLIM5, IMPDH2, HSPD1, PCA3, PSA, TMPRSS2, ERG, GAPDH, and B2M.

4 . The method of claim 3 , comprising selectively measuring the mRNA expression level of UAP1, PDLIM5, IMPDH2, PCA3, TMPRSS2 or HSPD1 in the urine sample.

5 . The method of claim 3 , comprising selectively measuring the mRNA expression level of UAP1, IMPDH2, HSPD1 or ERG in the blood sample.

6 . The method of claim 1 , comprising selectively measuring the protein expression level of PSA in the blood sample.

7 - 9 . (canceled)

10 . A method of treating a subject comprising:

(a) selecting a subject identified as at risk for a prostate cancer or an aggressive prostate cancer by a method comprising;

(i) selectively measuring mRNA and protein expression in a blood sample and urine sample from the subject in accordance with claim 1 ;

(ii) identifying the subject as at risk or not at risk for prostate cancer or aggressive prostate cancer based on the measured mRNA and protein expression levels; and

(b) administering an anti-cancer therapy to a subject identified as at risk for prostate cancer or aggressive prostate cancer.

11 . The method of claim 10 , wherein the anti-cancer therapy is a chemotherapy, a radiation therapy, a hormonal therapy, a targeted therapy, an immunotherapy or a surgical therapy.

12 . A method of selecting a subject for a diagnostic procedure comprising:

(a) selecting a subject identified as at risk for a prostate cancer or an aggressive prostate cancer by a method comprising;

(i) selectively measuring mRNA and protein expression in a blood sample and urine sample from the subject in accordance with claim 1 ;

(ii) identifying the subject as at risk or not at risk for prostate cancer or aggressive prostate cancer based on the measured mRNA and protein expression levels; and

(b) performing a diagnostic procedure on a subject identified as at risk for prostate cancer or aggressive prostate cancer.

13 . The method of claim 12 , wherein the diagnostic procedure is a biopsy.

14 - 25 . (canceled)

26 . The method of claim 1 , comprising:

(i) selectively measuring the mRNA expression level of HSPD1, IMPDH2 and PDLIM5 in the urine sample by quantitative RT-PCR and the mRNA expression level of ERG in the blood sample by quantitative RT-PCR;

(ii) selectively measuring the mRNA expression level of IMPDH2, HSPD1, PCA3, and PDLIM5 in the urine sample by quantitative RT-PCR and the mRNA expression level of ERG and PSA in the blood sample by quantitative RT-PCR; or

(iii) selectively measuring the mRNA expression level of IMPDH2, HSPD1, PCA3, and PDLIM5 in the urine sample by quantitative RT-PCR and the mRNA expression level of UAP1, ERG and PSA in the blood sample by quantitative RT-PCR.

27 . The method of claim 1 , wherein the subject has previously had a prostatectomy.

28 . The method of claim 1 , wherein the subject has or is diagnosed with an enlarged prostate or benign prostate hyperplasia (BPH).

29 - 35 . (canceled)

36 . The method of claim 1 , wherein selectively measuring the expression level of the gene's protein from the blood sample by immunological detection comprises performing an ELISA.

37 - 43 . (canceled)

44 . A method of treating a subject comprising:

(a) obtaining the expression level of at least 3 genes in a sample from the subject, said at least 3 gene selected from the group consisting of UAP1, PDLIM5, IMPDH2, HSPD1, PCA3, PSA, TMPRSS2, ERG, GAPDH, and B2M;

(b) selecting a subject having a prostate cancer or having an aggressive prostate cancer based on the expression level of said genes; and

(c) treating the selected subject with an anti-cancer therapy.

45 . The method of claim 44 , wherein the anti-cancer therapy is a chemotherapy, a radiation therapy, a hormonal therapy, a targeted therapy, an immunotherapy or a surgical therapy.

46 . The method of claim 45 , wherein the surgical therapy is a prostatectomy.

47 - 49 . (canceled)

50 . A tangible computer-readable medium comprising computer-readable code that, when executed by a computer, causes the computer to perform operations comprising:

a) receiving information corresponding to a level of expression of UAP1, PDLIM5, IMPDH2, HSPD1, PCA3, PSA, TMPRSS2, ERG, GAPDH, or B2M gene in a sample from a subject; and

b) determining a relative level of expression of one ore more of said genes compared to a reference level, wherein altered expression of one ore more of said genes compared to a reference level indicates that the subject is at risk of having prostate cancer or aggressive prostate cancer.

51 - 57 . (canceled)

58 . A method of selecting a subject for a diagnostic procedure comprising:

(a) obtaining the expression level of at least 3 genes in a sample from the subject, said at least 3 gene selected from the group consisting of UAP1, PDLIM5, IMPDH2, HSPD1, PCA3, PSA, TMPRSS2, ERG, GAPDH, and B2M;

(b) selecting a subject at risk for a prostate cancer or aggressive prostate cancer based on the expression level of said genes; and

(c) performing a diagnostic procedure on a subject identified as at risk for prostate cancer or aggressive prostate cancer.

59 . The method of claim 58 , wherein the diagnostic procedure is a biopsy.

Assignments (10)