Serum levels of HER2/neu as an indicator of clinical state and prognosis of prostate cancer

• US 20060160155A1
• Filed: 12/19/2005
• Published: 07/20/2006
• Est. Priority Date: 12/17/2004
• Status: Active Grant

• Current Assignee: Siemens Healthcare Diagnostics Incorporated (Siemens AG)
• Original Assignee: Siemens Healthcare Diagnostics Incorporated (Siemens AG)
• Inventors: Taneja, Samir, Cheli, Carol D.
• Granted Patent: US 7,611,845 B2
• Time in Patent Office: Days
• US Class Current: 435/7.230
• CPC Class Codes: G01N 33/57434 of prostate

Abstract

The present invention relates to methods of diagnosing prostate cancer, predicting disease progression of prostate cancer, prognosing the stage and state of prostate cancer, and identifying appropriate treatment indication for prostate cancer patients. Methods encompass determining the levels of HER-2/neu in fluid biological samples (e.g., blood and serum) from patients.

Claims

1. A method of identifying a patient suffering from prostate cancer comprising determining levels of shed Her-2/neu protein in a blood or serum sample from the patient, wherein an increased level of shed Her-2/neu protein relative to an individual or individuals not suffering from prostate cancer indicates that the patient has prostate cancer.

2. The method of claim 1, wherein the increased level of shed Her-2/neu protein is more than 14 ng/ml.

3. The method of claim 1, wherein the level of shed Her-2/neu protein in the blood or serum of the patient is increased relative to an average level of shed Her-2/neu protein in the blood or serum of the individuals not suffering from prostate cancer.

22. The method of claim 1, wherein the increased level of shed Her-2/neu protein in the patient is at least two times the deviation from the level of shed Her-2/neu protein in the individual or individuals not suffering from prostate cancer.

23. The method of claim 1, wherein the increased level of shed Her-2/neu protein in the patient is more than two times the deviation from the level of shed Her-2/neu protein in the individual or individuals not suffering from prostate cancer.

4. A method of identifying a patient suffering from prostate cancer that has metastasized comprising determining levels of shed Her-2/neu protein in a blood or serum sample from the patient, wherein an increased level of shed Her-2/neu protein relative to an individual or individuals not suffering from metastatic prostate cancer indicates that the patient has metastatic prostate cancer.

5. The method of claim 4, wherein the individual or individuals not suffering from metastatic prostate cancer do not have prostate cancer.

6. The method of claim 4, wherein the individual or individuals not suffering from metastatic prostate cancer have prostate cancer that has not metastasized.

7. The method of claim 4, wherein the level of shed Her-2/neu protein in the blood or serum of the patient is increased relative to an average level of shed Her-2/neu protein in the blood or serum of the individuals not suffering from metastatic prostate cancer.

8. A method of identifying a patient suffering from prostate cancer that is a candidate for anti HER-2/neu treatment comprising determining levels of shed Her-2/neu protein in a blood or serum sample from the patient, wherein an increased level of shed Her-2/neu protein relative to a control indicates that the patient is a candidate for anti HER-2/neu treatment.

9. The method of claim 8, wherein the patient has androgen insensitive prostate cancer.

10. The method of claim 8, wherein the control is an individual or individuals not suffering from prostate cancer.

11. The method of claim 10, wherein the level of shed Her-2/neu protein in the blood or serum of the patient is increased relative to an average level of shed Her-2/neu protein in the blood or serum of the individuals not suffering from prostate cancer.

12. The method of claim 8, wherein the control is an individual or individuals suffering from prostate cancer that has not metastasized.

13. The method of claim 12, wherein the level of shed Her-2/neu protein in the blood or serum of the patient is increased relative to an average level of shed Her-2/neu protein in the blood or serum of the individuals suffering from prostate cancer that has not metastasized.

14. The method of claim 8, wherein the control is an individual or individuals suffering from androgen sensitive prostate cancer.

15. The method of claim 14, wherein the level of shed Her-2/neu protein in the blood or serum of the patient is increased relative to an average level of shed Her-2/neu protein in the blood or serum of the individuals suffering from androgen sensitive prostate cancer.

16. A method of identifying a patient suffering from metastatic prostate cancer with an increased risk of disease related death comprising determining levels of shed Her-2/neu protein in a blood or serum sample from the patient, wherein an increased level of shed Her-2/neu protein relative to one or more other patients suffering from metastatic prostate cancer indicates that the patient has an increased risk of disease related death.

17. The method of claim 16, wherein the patient has androgen insensitive prostate cancer.

18. The method of claim 16, wherein the level of shed Her-2/neu protein in the blood or serum of the patient is increased relative to an average level of shed Her-2/neu protein in the blood or serum of the other patients suffering from metastatic prostate cancer.

19. The method of claim 16, wherein the one or more other patients suffering from metastatic prostate cancer have androgen sensitive prostate cancer.

20. The method of claim 16, wherein the other patients suffering from metastatic prostate cancer have androgen insensitive prostate cancer.

21. The method of claim 16, wherein the increased level of shed Her-2/neu protein is at least 20 ng/ml.