Materials and methods for diagnosis, prognosis and assessment of therapeutic/prophylactic treatment of prostate cancer

Patent metadata

Field	Value
Publication number	US-9617601-B2
Application number	US-201213721081-A
Country	US
Kind code	B2
Filing date	Dec 20, 2012
Priority date	Dec 30, 2011
Publication date	Apr 11, 2017
Grant date	Apr 11, 2017

Abstract

A method to detect prostate cancer comprising contacting a sample of prostate cells from the patient with a set of detectably labeled probes under hybridization conditions and determining the presence of chromosomal abnormalities in prostate tumor tissue, PIN (intra-epithelial neoplasia), histologically benign tissue and benign prostatic hyperplasia (BPH); a method to combine immunofluorescence and FISH (IF-FISH) to facilitate the assessment of chromosomal abnormalities; a set of probes; and a kit comprising the set of probes and instructions for diagnosing prostate cancer in a patient.

First claim

What is claimed is:

1. A method of detecting prostate cancer in a patient, which method comprises:
(a) contacting a sample of prostate cells from the patient with a set of detectably labeled probes comprising a locus-specific probe for MYC, a locus-specific probe for phosphatase and tensin homolog (PTEN), a centromeric probe for chromosome 8, and a centromeric probe for chromosome 7 under hybridization conditions;
(b) determining the percentage of cells from a tumor region of interest (ROI) or a benign ROI in the sample having copy number gains in MYC, chromosome 8, and chromosome 7 and copy number losses in PTEN and chromosome 7;
(c) diagnosing prostate cancer in the patient by detecting greater than 35% of cells have a MYC signal of greater than 2, greater than 33% of cells have a PTEN signal of less than 2, greater than 34% of cells have a chromosome 8 signal of greater than 2, and greater than 28% of cells have greater than 2 or less than 2 chromosome 7 signals in the sample of prostate cells; and
(d) administering treatment with, radiation, and/or hormone therapy to the patient diagnosed as having prostate cancer.

2. The method of claim 1 , wherein the sample of prostate cells is a section of the prostate of the patient.

3. The method of claim 2 , wherein the section is formalin-fixed and paraffin-embedded and placed on a microscope slide.

4. The method of claim 3 , wherein, prior to determining the presence of chromosomal gains and/or losses, the method further comprises morphologically assessing the section and identifying at least one tumor ROI, at least one benign ROI, or at least one tumor ROI and at least one benign ROI.

5. The method of claim 3 , wherein, prior to determining the presence of chromosomal gains and/or losses, the method further comprises assessing the section by immunofluorescence and identifying at least one tumor ROI.

6. The method of claim 5 , wherein assessing the section by immunofluorescence comprises contacting the section with a detectably labeled anti- α- methylacyl-CoA racemase (AMACR) antibody and detecting over-expression of AMACR, wherein over-expression of AMACR in a region of the section indicates the presence of a tumor ROI.

7. The method of claim 6 , wherein, prior to assessing the section by immunofluorescence, the method further comprises treating the section with heat-induced epitope retrieval.

8. The method of claim 1 , which comprises determining chromosomal abnormalities in a tumor ROI.

9. The method of claim 1 , which comprises determining chromosomal abnormalities in a benign ROI.

Assignees

• Abbott Molecular Inc

Inventors

• Zhang Ying
• Morrison Larry
• Pestova Ekaterina
• Sokolova Irina

Classifications

• G01N33/57555 Primary

  of the prostate · CPC title

• C12Q1/6827

  for detection of mutation or polymorphism · CPC title

• C12Q2600/158

  Expression markers · CPC title

• G01N33/48721

  Investigating individual macromolecules, e.g. by translocation through nanopores (Coulter counters in general G01N15/12; fabrication methods for nanoscale apertures B81B1/00; sequencing of nucleic acids C12Q1/68) · CPC title

• G01N2333/47

  Assays involving proteins of known structure or function as defined in the subgroups · CPC title