# US 11,079,383 B2 · Diagnosis and monitoring treatment of prostate cancer

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- Number: US 11,079,383 B2
- Document ID: US11079383B2
- Status: Granted
- Kind: B2
- Application number: 15/682,224
- Filed: 2017-08-21
- Published: 2017-12-07
- Granted: 2021-08-03
- Earliest claimed: 2012-07-02
- Assignees: The General Hospital Corporation
- Applicants: The General Hospital Corporation
- Inventors: Daniel A. Haber; Shyamala Maheswaran; David T. Miyamoto
- Web page: https://patentgrep.com/patent/US11079383B2

## CPC

- G01N 33/57555: of the prostate
- A61K 31/167: having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
- A61K 31/496: Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
- A61K 31/58: containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin (digitoxin {A61K31/7048})
- C12Q 1/6886: for cancer (immunoassay for cancer G01N33/575)
- A61K 2039/505: {comprising antibodies}
- C12Q 2600/106: Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
- C12Q 2600/112: Disease subtyping, staging or classification
- G01N 2333/705: Assays involving receptors, cell surface antigens or cell surface determinants
- 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)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- 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

## Abstract

Provided herein are assays and methods related to determining a ratio of expression levels of PSA/PSMA or determining the expression level of PSMA in circulating tumor cells for diagnosis and/or for the purpose of monitoring treatment efficacy for prostate cancers that are likely hormone resistant.

## Claims

### Claim 1

A method for monitoring a hormone therapy for prostate cancer being administered to a patient for resistance to the therapy, the method comprising:
a) isolating circulating prostate tumor cells from a first blood sample from the patient at a first time point;
b) isolating circulating prostate tumor cells from a second blood sample from the patient at a second time point which is sequentially after the first time point;
b) measuring the levels of expression of PSA and PSMA on the surfaces of single isolated circulating prostate tumor cells from the first blood sample, and measuring the levels of expression of PSA and PSMA on the surfaces of single isolated circulating prostate tumor cells from the second blood sample;
c) providing a ratio of the measured level of expression of PSA to the measured level of expression of PSMA from the first blood sample and the second blood sample to a storage device as output stored data;
d) determining if the ratio of the levels of expression of PSA to PSMA decreases, remains the same or increases between the first blood sample and the second blood sample;
e) displaying on a display module that patient's prostate cancer is likely resistant to the therapy if the ratio increases, and displaying on a display module that patient's prostate cancer is likely sensitive to the therapy if the ratio remains the same or decreases;
wherein the first time point is before or after the patient begins treatment with the hormone therapy, and
wherein the second time point is after the patient begins treatment with the hormone therapy.

### Claim 2 (depends on 1)

The method of claim 1, wherein isolating comprises using a microfluidic capture method.

### Claim 3 (depends on 1)

The method of claim 1, wherein:
in step b, measuring comprises using a microscope;
and in step d, determining comprises comparing the output stored data using a program executed on the storage device.

### Claim 4 (depends on 1)

The method of claim 1, wherein the displaying is by using a computer monitor.

### Claim 5 (depends on 1)

The method of claim 1, further comprising transmitting the display data to the patient or physician.

### Claim 6 (depends on 1)

The method of claim 1, wherein the prostate cancer is metastatic prostate cancer.

### Claim 7 (depends on 1)

The method of claim 1, wherein the expression levels of PSA and PSMA are determined by contacting the isolated circulating tumor cells with antibody reagents specific for PSA and PSMA.

### Claim 8 (depends on 1)

The method of claim 1, wherein the expression levels of PSA and PSMA are determined by immunofluorescence staining and/or automated fluorescence microscopy.

### Claim 9 (depends on 1)

The method of claim 1, wherein said hormone therapy comprises administering to the patient leuprolide.

### Claim 10 (depends on 1)

The method of claim 1, wherein in step (b), measuring comprises using an RNA expression array or a thermal cycler.

### Claim 11 (depends on 1)

The method of claim 1, wherein the displaying is by using a printable medium or a World Wide Web browser.