Method of diagnosing, monitoring, staging, imaging and treating prostate cancer

• US 7,326,529 B2
• Filed: 05/08/2003
• Issued: 02/05/2008
• Est. Priority Date: 12/06/1999
• Status: Expired due to Fees

• Current Assignee: Diadexus, Inc.
• Original Assignee: Diadexus, Inc.
• Inventors: Cafferkey, Robert, Recipon, Herve, Sun, Yongming, Ali, Shujath
• Primary Examiner(s): YAEN, CHRISTOPHER H
• Application Number:
  US10/431,842
• Publication Number:
  US 20030194739A1
• Time in Patent Office: 1,734 Days
• Field of Search: None
• US Class Current: 435/6.14
• CPC Class Codes: A61K 38/00 Medicinal preparations containing peptides peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00
• CPC Class Codes: A61K 39/00 Medicinal preparations containing antigens or antibodies materials for immunoassay G01N33/53
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: C07K 14/47 from mammals
• CPC Class Codes: C07K 14/705 Receptors; Cell surface antigens; Cell surface determinants tumour specific antigens C07K14/4748

Abstract

The present invention provides new markers and methods for detecting, diagnosing, monitoring, staging, prognosticating, imaging and treating prostate cancer.

Claims

1. A method for diagnosing the presence of prostate cancer in a patient comprising:

(a) determining levels of polynucleotide comprising SEQ ID NO;

3, native protein expressed by the gene comprising polynucleotide comprising SEQ ID NO;

3, or native mRNA encoded by the gene comprising polynucleotide comprising SEQ ID NO;

3 in cells, tissues or bodily fluids in a patient; and

(b) comparing the determined levels of polynucleotide comprising SEQ ID NO;

3, native protein expressed by the gene comprising polynucleotide comprising SEQ ID NO;

3, or native mRNA encoded by the gene comprising polynucleotide comprising SEQ ID NO;

3, with levels of polynucleotide comprising SEQ ID NO;

3, native protein expressed by the gene comprising polynucleotide comprising SEQ ID NO;

3, or native mRNA encoded by the gene comprising polynucleotide comprising SEQ ID NO;

3 in cells, tissues or bodily fluids from a normal human control, wherein a change in determined levels of polynucleotide comprising SEQ ID NO;

3, native protein expressed by the gene comprising polynucleotide comprising SEQ ID NO;

3, or native mRNA encoded by the gene comprising polynucleotide comprising SEQ ID NO;

3 in said patient versus normal human control is associated with the presence of prostate cancer.

2. A method of diagnosing metastases of prostate cancer in a patient comprising:

(a) identifying a patient having prostate cancer that is not known to have metastasized;

(b) determining levels of polynucleotide comprising SEQ ID NO;

3, native protein expressed by the gene comprising polynucleotide comprising SEQ ID NO;

3, or native mRNA encoded by the gene comprising polynucleotide comprising SEQ ID NO;

3 in cells, tissues, or bodily fluid from said patient; and

(c) comparing the determined levels of polynucleotide comprising SEQ ID NO;

3, native protein expressed by the gene comprising polynucleotide comprising SEQ ID NO;

3, or native mRNA encoded by the gene comprising polynucleotide comprising SEQ ID NO;

3 with levels of polynucleotide comprising SEQ ID NO;

3, native protein expressed by the gene comprising polynucleotide comprising SEQ ID NO;

3, or native mRNA encoded by the gene comprising polynucleotide comprising SEQ ID NO;

3 in cells, tissue, or bodily fluid of a normal human control, wherein an increase in determined levels of polynucleotide comprising SEQ ID NO;

3, native protein expressed by the gene comprising polynucleotide comprising SEQ ID NO;

3, or native mRNA encoded by the gene comprising polynucleotide comprising SEQ ID NO;

3 in the patient versus the normal human control is associated with a cancer which has metastasized.

3. A method of staging prostate cancer in a patient having prostate cancer comprising:

(a) identifying a patient having prostate cancer;

(b) determining levels of polynucleotide comprising SEQ ID NO;

3, native protein expressed by the gene comprising polynucleotide comprising SEQ ID NO;

3, or native mRNA encoded by the gene comprising polynucleotide comprising SEQ ID NO;

3 in cells, tissue, or bodily fluid from said patient; and

(c) comparing determined levels of polynucleotide comprising SEQ ID NO;

3, native protein expressed by the gene comprising polynucleotide comprising SEQ ID NO;

3, or native mRNA encoded by the gene comprising polynucleotide comprising SEQ ID NO;

3 with levels of polynucleotide comprising SEQ ID NO;

3, native protein expressed by the gene comprising polynucleotide comprising SEQ ID NO;

3, or native mRNA encoded by the gene comprising polynucleotide comprising SEQ ID NO;

3 in cells, tissues, or bodily fluid of a normal human control, wherein an increase in determined levels of polynucleotide comprising SEQ ID NO;

3, native protein expressed by the gene comprising polynucleotide comprising SEQ ID NO;

3, or native mRNA encoded by the gene comprising polynucleotide comprising SEQ ID NO;

3 in said patient versus the normal human control is associated with a cancer which is progressing and a decrease in the determined levels of polynucleotide comprising SEQ ID NO;

3, native protein expressed by the gene comprising polynucleotide comprising SEQ ID NO;

3, or native mRNA encoded by the gene comprising polynucleotide comprising SEQ ID NO;

3 is associated with a cancer which is regressing or in remission.

4. A method of monitoring prostate cancer in a patient for the onset of metastasis comprising:

(a) identifying a patient having prostate that is not known to have metastasized;

(b) periodically determining levels of polynucleotide comprising SEQ ID NO;

3, native protein expressed by the gene comprising polynucleotide comprising SEQ ID NO;

3, or native mRNA encoded by the gene comprising polynucleotide comprising SEQ ID NO;

3 in cells, tissues, or bodily fluid from said patient; and

(c) comparing the periodically determined levels with levels of polynucleotide comprising SEQ ID NO;

3, native protein expressed by the gene comprising polynucleotide comprising SEQ ID NO;

3, or native mRNA encoded by the gene comprising polynucleotide comprising SEQ ID NO;

3 in cells, tissues, or bodily fluid of a normal human control, wherein an increase in any one of the periodically determined levels of polynucleotide comprising SEQ ID NO;

3, native protein expressed by the gene comprising polynucleotide comprising SEQ ID NO;

3, or native mRNA encoded by the gene comprising polynucleotide comprising SEQ ID NO;

3 in the patient versus the normal human control is associated with a cancer which has metastasized.

5. A method of monitoring a change in stage of prostate cancer in a patient comprising:

(a) identifying a patient having prostate cancer;

(b) periodically determining levels of polynucleotide comprising SEQ ID NO;

3, native protein expressed by the gene comprising polynucleotide comprising SEQ ID NO;

3, or native mRNA encoded by the gene comprising polynucleotide comprising SEQ ID NO;

3 in cells, tissues, or bodily fluid from said patient; and

(c) comparing the periodically determined levels of polynucleotide comprising SEQ ID NO;

3, native protein expressed by the gene comprising polynucleotide comprising SEQ ID NO;

3, or native mRNA encoded by the gene comprising polynucleotide comprising SEQ ID NO;

3 with levels of polynucleotide comprising SEQ ID NO;

3, native protein expressed by the gene comprising polynucleotide comprising SEQ ID NO;

3, or native mRNA encoded by the gene comprising polynucleotide comprising SEQ ID NO;

3 in cells, tissues, or bodily fluid of a normal human control, wherein an increase in any one of the periodically determined levels of polynucleotide comprising SEQ ID NO;

3, native protein expressed by the gene comprising polynucleotide comprising SEQ ID NO;

3, or native mRNA encoded by the gene comprising polynucleotide comprising SEQ ID NO;

3 in the patient versus the normal human control is associated with a cancer which is progressing in stage and a decrease is associated with a cancer which is regressing in stage or in remission.