# US 2019/0167755 A1 · Methods for treating metastatic stage prostate cancer

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 2019/0167755 A1
- Document ID: US20190167755A1
- Status: Published application
- Kind: A1
- Application number: 15/845,391
- Filed: 2017-12-18
- Published: 2019-06-06
- Earliest claimed: 2008-02-11
- Assignees: Ferring International SA
- Applicants: Ferring International SA
- Inventors: Bo-Eric PERSSON
- Web page: https://patentgrep.com/patent/US20190167755A1

## CPC

- A61K 38/09: Luteinising hormone-releasing hormone [LHRH] {, i.e. Gonadotropin-releasing hormone [GnRH]}; Related peptides
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 38/08: Peptides having 5 to 11 amino acids {(A61K38/043 - A61K38/046 take precedence)}
- A61P 35/00: Antineoplastic agents
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The invention provides methods and dosing regimens for treating metastatic stage prostate cancer in a subject using degarelix, as well as related methods of using degarelix in a subject identified as having metastatic stage prostate cancer, and methods of using degarelix to prevent or delay the progression of locally advanced prostate cancer.

## Claims

### Claim at position 1

1-35. (canceled)

### Claim 36

A method of treating prostate cancer in a subject in need thereof, the method comprising:
testing the prostate specific antigen (PSA) of a potential subject;
selecting the potential subject for treatment if the subject's PSA level is greater than or equal to 50 ng/mL;
administering an initial dose of degarelix ranging from about 160 mg to about 320 mg to the subject;
and administering at least one maintenance dose of degarelix ranging from about 60 mg to 160 mg to the subject,
wherein the at least one maintenance dose is administered approximately 20 to 36 days after the previous dose of degarelix.

### Claim 37 (depends on 36)

The method of claim 36, wherein the initial dose of degarelix is about 240 mg, and the at least one maintenance dose of degarelix is about 80 mg administered to the subject approximately 28 days after the initial dose of degarelix.

### Claim 38 (depends on 36)

The method of claim 36, wherein the subject has at least a 60% decrease in the level of PSA by day 14 of treatment.

### Claim 39 (depends on 38)

The method of claim 38, wherein the subject has at least a 75% decrease in the level of PSA by day 28 of treatment.

### Claim 40 (depends on 36)

The method of claim 36, wherein the subject has at least an 80% likelihood of maintaining a PSA level of less than 5 ng/mL during treatment.

### Claim 41 (depends on 40)

The method of claim 40, wherein the duration of treatment ranges from 20 days to 450 days.

### Claim 42 (depends on 36)

The method of claim 36, wherein the selected subject has a hemoglobin (Hb) level of 130 g/L or less.

### Claim 43

The method of 36, wherein the treated subject has at least a 95% likelihood of having a therapeutically low serum testosterone level of less than or equal to 0.5 ng/mL by day 28 of treatment.

### Claim 44 (depends on 36)

The method of claim 36, wherein the treated subject has at least a 95% likelihood of having a therapeutically low serum testosterone level of less than or equal to 0.5 ng/mL from day 28 to day 365 of treatment.