# US 11,078,542 B2 · Genetic signatures to predict prostate cancer metastasis and identify tumor aggressiveness

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- Number: US 11,078,542 B2
- Document ID: US11078542B2
- Status: Granted
- Kind: B2
- Application number: 15/977,249
- Filed: 2018-05-11
- Published: 2019-01-17
- Granted: 2021-08-03
- Earliest claimed: 2017-05-12
- Assignees: Decipher Biosciences, Inc.
- Applicants: Decipher Biosciences, Inc.
- Inventors: Elai Davicioni; Nicholas Erho; Hussam Al-Deen Ashab; Mohammed Alshalalfa
- Web page: https://patentgrep.com/patent/US11078542B2

## CPC

- C12Q 1/6886: for cancer (immunoassay for cancer G01N33/575)
- G01N 33/57555: of the prostate
- C12Q 2600/112: Disease subtyping, staging or classification
- C12Q 2600/118: Prognosis of disease development
- C12Q 2600/158: Expression markers
- G01N 2800/52: Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- 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 methods, systems and kits for the diagnosis, prognosis and the determination of cancer progression of prostate cancer in a subject. The invention also provides clinically useful genomic classifiers for predicting prostate cancer metastasis and identifying tumor aggressiveness. The methods, systems and kits can provide expression-based analysis of biomarkers for purposes of predicting metastatic disease and lethal prostate cancer in a subject. Further disclosed herein, in certain instances, are probe sets for use in predicting prostate cancer metastasis in a subject. Classifiers for predicting prostate cancer metastasis are provided. Methods of treating cancer based on tumor aggressiveness are also provided. The methods and classifiers of the present invention are also useful for predicting early prostate cancer metastasis.

## Claims

### Claim 1

A method for treating prostate cancer in a subject comprising:
a) obtaining or having obtained an expression level in the sample from the subject with prostate cancer for a plurality of targets comprising SMC4, PABPC1, TRIQK, TIPARP, and AZGP1;
b) subtyping the prostate cancer as metastatic based at least on the expression level of the plurality of targets; and
c) administering a treatment selected from adjuvant chemotherapy, systemic radiation therapy, and/or anti-androgen therapy to the subject when the subtyping of step b) indicates that the prostate cancer is metastatic.

### Claim 2 (depends on 1)

The method of claim 1, wherein the plurality of targets comprise DNA and/or RNA.

### Claim 3 (depends on 1)

The method of claim 1, wherein the biological sample is a urine sample, a blood sample or a prostate tumor sample.