LIPID, PROTEIN, AND METABOLITE MARKERS FOR THE DIAGNOSIS AND TREATMENT OF PROSTATE CANCER
Methods for diagnosing the presence of prostate cancer in a subject are provided, such methods including the detection of levels of a variety of biomarkers diagnostic of prostate cancer. The invention also provides methods of treating prostate cancer by administering a biomarker or an agent that modulates a biomarker of prostate cancer. Compositions in the form of kits and panels of reagents for detecting the biomarkers of the invention are also provided.
1 . A method for diagnosing the presence of prostate cancer in a subject, comprising:
(a) detecting the level of a prostate cancer marker in a biological sample from the subject, wherein the prostate cancer marker comprises one or more markers selected from Tables 1-31; and
(b) comparing the level of the prostate cancer marker in the biological sample with a predetermined threshold value;
wherein the level of the prostate cancer marker above or below the predetermined threshold value indicates a diagnosis that prostate cancer is present in the subject.
2 . The method of claim 1 , wherein the subject is selected from a population of Caucasians, and wherein the prostate cancer marker comprises one or more markers selected from Tables 1, 4, 8, 11, 13, 16, 19, 22, 26, 29 and 30.
3 . The method of claim 1 , wherein the subject is selected from a population of African Americans, and wherein the prostate cancer marker comprises one or more markers selected from Tables 2, 5, 9, 12, 14, 17, 20, 23, 27 and 31.
4 . A method for diagnosing the presence of ERG-positive prostate cancer in a subject, comprising:
(a) detecting the level of an ERG-positive prostate cancer marker in a biological sample from the subject, wherein the ERG-positive prostate cancer marker comprises one or more markers selected from Tables 6, 30 and 31; and
(b) comparing the level of the ERG-positive prostate cancer marker in the biological sample with a predetermined threshold value;
wherein the level of the ERG-positive prostate cancer marker above or below the predetermined threshold value indicates a diagnosis that ERG-positive prostate cancer is present in the subject.
5 . A method for diagnosing the presence of prostate cancer in a subject with a BMI index equal or greater than 30, comprising:
(a) detecting the level of a high BMI prostate cancer marker in a biological sample from the subject, wherein the high BMI prostate cancer marker comprises one or more markers selected from Tables 7, 18 and 25; and
(b) comparing the level of the high BMI prostate cancer marker in the biological sample with a predetermined threshold value;
wherein the level of the high BMI prostate cancer marker above or below the predetermined threshold value indicates a diagnosis that prostate cancer is present in the subject.
6 . (canceled)
7 . The method of claim 1 , wherein the prostate cancer marker comprises at least two or more markers, wherein each of the two of more markers are selected from the structural lipids set forth in Tables 1-7, the signaling lipids set forth in Tables 8-12, the proteins set forth in Tables 13-18, the metabolites set forth in Tables 19-25, and the markers set forth in Tables 26-28.
8 .- 21 . (canceled)
22 . The method of claim 4 , wherein the ERG-positive prostate cancer marker comprises one or more markers with an increased level when compared to the predetermined threshold value in the subject, and/or one or more markers with a decreased level when compared to the predetermined threshold value in the subject.
23 .- 25 . (canceled)
26 . The method of claim 5 , wherein the high BMI prostate cancer marker comprises one or more markers with an increased level when compared to the predetermined threshold value in the subject, and/or one or more markers with a decreased level when compared to the predetermined threshold value in the subject.
27 . (canceled)
28 . The method of claim 1 , wherein the level of the prostate cancer marker is detected by HPLC/UV-Vis spectroscopy, enzymatic analysis, mass spectrometry, NMR, immunoassay, ELISA, or any combination thereof, or by determining the level of its corresponding mRNA in the biological sample.
29 .- 31 . (canceled)
32 . The method of claim 1 , further comprising administering a therapeutic anti-cancer treatment where the diagnosis indicates the presence of prostate cancer in the subject.
33 . The method of claim 1 , further comprising selecting a subject suspected of having or being at risk of having prostate cancer.
34 . The method of claim 1 , further comprising obtaining a biological sample from a subject suspected of having or being at risk of having prostate cancer.
35 . A method for identifying a subject as being at an increased risk for developing prostate cancer, comprising:
(a) detecting the level of a prostate cancer marker in a biological sample from the subject, wherein the prostate cancer comprises one or more markers selected from Tables 1-31; and
(b) comparing the level of the prostate cancer marker in the biological sample with a predetermined threshold value;
wherein the level of the prostate cancer marker above or below the predetermined threshold value indicates that the subject is being at an increased risk for developing prostate cancer.
36 . The method of claim 35 , wherein the subject is a Caucasian subject and wherein the one or more markers is selected from Tables 1, 4, 8, 11, 13, 16, 19, 22, 26, 29 and 30.
37 . The method of claim 35 , wherein the subject a an African American subject and wherein the one or more markers is selected from Tables 2, 5, 9, 12, 14, 17, 20, 23, 27 and 31.
38 .- 40 . (canceled)
41 . The method of claim 35 , wherein the prostate cancer marker comprises at least two or more markers, wherein each of the two of more markers are selected from the structural lipids set forth in Tables 1-7, the signaling lipids set forth in Tables 8-12, the proteins set forth in Tables 13-18, the metabolites set forth in Tables 19-25, and the markers set forth in Tables 26-28.
42 .- 61 . (canceled)
62 . The method of claim 35 , wherein the level of the prostate cancer marker is detected by HPLC/UV-Vis spectroscopy, enzymatic analysis, mass spectrometry, NMR, immunoassay, ELISA, or any combination thereof, or by determining the level of its corresponding mRNA in the biological sample.
63 . (canceled)
64 . The method of claim 35 , further comprising detecting the level of one or more additional markers of prostate cancer.
65 . The method of claim 35 , further comprising administering a therapeutic anti-cancer treatment to the subject based on the prognosis.
66 .- 91 . (canceled)