# US 2014/0155293 A1 · Identification of biomarkers for detecting prostate cancer

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- Number: US 2014/0155293 A1
- Document ID: US20140155293A1
- Status: Published application
- Kind: A1
- Application number: 13/950,823
- Filed: 2013-07-25
- Published: 2014-06-05
- Earliest claimed: 2002-04-26
- Assignees: The Johns Hopkins University
- Applicants: The Johns Hopkins University
- Inventors: Daniel W. Chan; Jinong Li; Zhen Zhang
- Web page: https://patentgrep.com/patent/US20140155293A1

## CPC

- G01N 33/6893: {related to diseases not provided for elsewhere}
- G01N 33/57525: of the liver or pancreas
- G01N 33/57555: of the prostate
- G01N 33/57585: {involving compounds identifiable in body fluids}
- G01N 33/6848: {Methods of protein analysis involving mass spectrometry}
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

The present invention relates to a method of qualifying prostate cancer status in a subject comprising: (a) measuring at least one of the disclosed biomarkers in a sample from the subject and (b) correlating the measurement with prostate cancer status. The invention further relates to kits for qualifying prostate cancer status in a subject.

## Claims

### Claim 1

A method of qualifying prostate cancer status in a subject comprising:
(a) measuring at least one biomarker in a sample from the subject, wherein the biomarker is selected from the group consisting of
Marker I: having a molecular weight of about 7.808 kD
Marker II: having a molecular weight of about 14.576 kD
Marker III: having a molecular weight of about 2.062 kD
Marker IV: having a molecular weight of about 7.974 kD
Marker V: having a molecular weight of about 6.677 kD
Marker VI: having a molecular weight of about 3.936 kD
Marker VII: having a molecular weight of about 60.958 kD
Marker VIII: having a molecular weight of about 5.149 kD
Marker IX: having a molecular weight of about 5.861 kD
Marker X: having a molecular weight of about 28.098 kD
Marker XI: having a molecular weight of about 2.996 kD
Marker XII: having a molecular weight of about 24.346 kD
Marker XIII: having a molecular weight of about 6.722 kD
Marker XIV: having a molecular weight of about 5.999 kD
Marker XV: having a molecular weight of about 6.158 kD
Marker XVI: having a molecular weight of about 55.785 kD
Marker XVII: having a molecular weight of about 2.540 kD
Marker XVIII: having a molecular weight of about 8.019 kD
Marker XIX: having a molecular weight of about 4.658 kD
Marker XX: having a molecular weight of about 14.703 kD
Marker XXI: having a molecular weight of about 2.68 kD
Marker XXII: having a molecular weight of about 3.16 kD
Marker XXIII: having a molecular weight of about 10.3 kD
Marker XXIV: having a molecular weight of about 10.8 kD
Marker XXV: having a molecular weight of about 12.7 kD
Marker XXVI: having a molecular weight of about 17.9 kD
Marker XXVII: having a molecular weight of about 2.79 kD
Marker XXVIII: having a molecular weight of about 3.32 kD
Marker XXIX: having a molecular weight of about 4.29 kD
Marker XXX: having a molecular weight of about 15.9 kD
Marker XXXI: having a molecular weight of about 16.1 kD
Marker XXXII: having a molecular weight of about 16.3 kD, and
combinations thereof, and
(b) correlating the measurement with prostate cancer status.

### Claim 2 (depends on 1)

The method of claim 1 further comprising:
(c) managing subject treatment based on the status.

### Claim 3 (depends on 2)

The method of claim 2, wherein managing subject treatment is selected from ordering more tests, performing surgery, and taking no further action.

### Claim 4 (depends on 2)

The method of claim 2 further comprising:
(d) measuring the at least one biomarker after subject management.

### Claim 5 (depends on 1)

The method of claim 1 wherein the prostate cancer status is selected from the group consisting of the subject's risk of cancer, the presence or absence of disease, the type of disease, the stage of disease and the effectiveness of treatment of disease.

### Claim 6

A method for differentiating between a diagnosis of prostate cancer and non-prostate cancer comprising:
(a) detecting in a subject sample an amount of at least one biomarker selected from the group consisting of:
Marker I: having a molecular weight of about 7.808 kD
Marker II: having a molecular weight of about 14.576 kD
Marker III: having a molecular weight of about 2.061 kD
Marker IV: having a molecular weight of about 7.973 kD
Marker V: having a molecular weight of about 6.677 kD and
Marker VI: having a molecular weight of about 3.935 kD; and
(b) correlating the amount with a diagnosis of prostate cancer or non-prostate cancer.

### Claim 7

A method for differentiating between a diagnosis of prostate cancer and benign prostate hyperplasia comprising:
(a) detecting in a subject sample an amount of at least one biomarker selected from the group consisting of:
Marker VII: having a molecular weight of about 60.958 kD
Marker VIII: having a molecular weight of about 5.148 kD
Marker IX: having a molecular weight of about 5.860 kD
Marker X: having a molecular weight of about 28.097 kD
Marker XI: having a molecular weight of about 2.996 kD
Marker XII: having a molecular weight of about 24.346 kD
Marker XIII: having a molecular weight of about 6.722 kD
Marker XIV: having a molecular weight of about 5.999 kD
Marker XV: having a molecular weight of about 6.159 kD
Marker XVI: having a molecular weight of about 55.785 kD
(b) correlating the amount with a diagnosis of prostate cancer or benign prostate hyperplasia.

### Claim 8

A method for differentiating between a diagnosis of prostate cancer and benign prostate hyperplasia comprising:
(a) detecting in a subject sample an amount of at least one biomarker selected from the group consisting of:
Marker XXI: having a molecular weight of about 2.68 kD
Marker XXII: having a molecular weight of about 3.16 kD
Marker XXIII: having a molecular weight of about 10.3 kD
Marker XXIV: having a molecular weight of about 10.8 kD
Marker XXV: having a molecular weight of about 12.7 kD, and
Marker XXV having a molecular weight of about 17.9 kD.
(b) correlating the amount with a diagnosis of prostate cancer or benign prostate hyperplasia.

### Claim 9

A method for differentiating between a diagnosis of organ defined prostate cancer and non-organ-defined prostate cancer comprising:
(a) detecting in a subject sample an amount of at least one biomarker selected from the group consisting of:
Marker XVII: having a molecular weight of about 2.540 kD
Marker XVII having a molecular weight of about 8.018 kD
Marker XIX: having a molecular weight of about 4.658 kD,
and
Marker XX: having a molecular weight of about 14.703 kD; and
(b) correlating the amount with a diagnosis of organ-defined prostate cancer or non-organ-defined prostate cancer.

### Claim 10

A method for differentiating between a diagnosis of organ defined prostate cancer and non-organ-defined prostate cancer comprising:
(a) detecting in a subject sample an amount of at least one biomarker selected from the group consisting of:
Marker XXVII: having a molecular weight of about 2.79 kD
Marker XXVIII: having a molecular weight of about 3.32 kD
Marker XXIX: having a molecular weight of about 4.29 kD
Marker XXX: having a molecular weight of about 15.9 kD
Marker XXXI: having a molecular weight of about 16.1 kD, and
Marker XXXII: having a molecular weight of about 16.3 kD.
(b) correlating the amount with a diagnosis of organ-defined prostate cancer or non-organ-defined prostate cancer.

### Claim 11 (depends on 1)

The method of claim 1 wherein the marker is detected by mass spectrometry.

### Claim 12 (depends on 1)

The method of claim 1 wherein the marker is detected by capturing the marker on a biochip having an affinity surface and detecting the captured marker by SELDI.

### Claim at position 13

13-29. (canceled)

### Claim 30

A kit for aiding the diagnosis of cancer, comprising:
an adsorbent attached to a substrate, wherein the adsorbent retains one or more biomarkers selected from:
Marker I: having a molecular weight of about 7.808 kD
Marker II: having a molecular weight of about 14.576 kD
Marker III: having a molecular weight of about 2.062 kD
Marker IV: having a molecular weight of about 7.974 kD
Marker V: having a molecular weight of about 6.677 kD
Marker VI: having a molecular weight of about 3.936 kD
Marker VII: having a molecular weight of about 60.958 kD
Marker VIII: having a molecular weight of about 5.149 kD
Marker IX: having a molecular weight of about 5.861 kD
Marker X: having a molecular weight of about 28.098 kD
Marker XI: having a molecular weight of about 2.996 kD
Marker XII: having a molecular weight of about 24.346 kD
Marker XIII: having a molecular weight of about 6.722 kD
Marker XIV: having a molecular weight of about 5.999 kD
Marker XV: having a molecular weight of about 6.159 kD
Marker XVI: having a molecular weight of about 55.784 kD
Marker XVII: having a molecular weight of about 2.540 kD
Marker XVIII: having a molecular weight of about 8.019 kD
Marker XIX: having a molecular weight of about 4.658 kD
Marker XX: having a molecular weight of about 14.703 kD
Marker XXI: having a molecular weight of about 2.68 kD
Marker XXII: having a molecular weight of about 3.16 kD
Marker XXIII: having a molecular weight of about 10.3 kD
Marker XXIV: having a molecular weight of about 10.8 kD
Marker XXV: having a molecular weight of about 12.7 kD
Marker XXVI: having a molecular weight of about 17.9 kD
Marker XXVII: having a molecular weight of about 2.79 kD
Marker XXNIII: having a molecular weight of about 3.32 kD
Marker XXIX: having a molecular weight of about 4.29 kD
Marker XXX: having a molecular weight of about 15.9 kD
Marker XXXI: having a molecular weight of about 16.1 kD, and
Marker XXXII: having a molecular weight of about 16.3 kD.

### Claim 31 (depends on 30)

The kit of claim 30, further comprising written instructions for use of the kit for detection of cancer.

### Claim at position 16

32-41. (canceled)

### Claim 42

A protein purified on a biochip selected from:
Marker I: having a molecular weight of about 7.808 kD
Marker II: having a molecular weight of about 14.576 kD
Marker III: having a molecular weight of about 2.062 kD
Marker IV: having a molecular weight of about 7.974 kD
Marker V: having a molecular weight of about 6.667 kD
Marker VI: having a molecular weight of about 3.936 kD
Marker VII: having a molecular weight of about 60.958 kD
Marker VIII: having a molecular weight of about 5.149 kD
Marker IX: having a molecular weight of about 5.861 kD
Marker X: having a molecular weight of about 28.098 kD
Marker XI: having a molecular weight of about 2.996 kD
Marker XII: having a molecular weight of about 24.346 kD
Marker XIII: having a molecular weight of about 6.722 kD
Marker XIV: having a molecular weight of about 5.999 kD
Marker XV: having a molecular weight of about 6.159 kD
Marker XVI: having a molecular weight of about 55.784 kD
Marker XVII: having a molecular weight of about 2.540 kD
Marker XVIII: having a molecular weight of about 8.019 kD
Marker XIX: having a molecular weight of about 4.658 kD
Marker XX: having a molecular weight of about 14.703 kD
Marker XXI: having a molecular weight of about 2.68 kD
Marker XXII: having a molecular weight of about 3.16 kD
Marker XXIII: having a molecular weight of about 10.3 kD
Marker XXIV: having a molecular weight of about 10.8 kD
Marker XXV: having a molecular weight of about 12.7 kD
Marker XXVI: having a molecular weight of about 17.9 kD
Marker XXVII: having a molecular weight of about 2.79 kD
Marker XXVIII: having a molecular weight of about 3.32 kD
Marker XXIX: having a molecular weight of about 4.29 kD
Marker XXX: having a molecular weight of about 15.9 kD
Marker XXXI: having a molecular weight of about 16.1 kD, and
Marker XXXII: having a molecular weight of about 16.3 Kd.

### Claim 43 (depends on 42)

The purified proteins of claim 42, comprising a composition of a combination of at least two proteins.

### Claim at position 19

44-77. (canceled)
