Method of treating prostate cancer with GnRH antagonist

Patent metadata

Field	Value
Publication number	US-9579359-B2
Application number	US-201314139922-A
Country	US
Kind code	B2
Filing date	Dec 24, 2013
Priority date	Feb 11, 2008
Publication date	Feb 28, 2017
Grant date	Feb 28, 2017

Abstract

The invention provides methods and dosing regimens for safely and effectively treating androgen-dependent prostate cancer with a gonadotrophin releasing hormone (GnRH) antagonist without causing a testosterone spike and/or other side effect of GnRH agonist therapy such as a urinary tract infection, or an arthralgia-related or cardiovascular side effect.

First claim

The invention claimed is:

1. A method of treating prostate cancer in a subject with a reduced likelihood of causing a testosterone spike or other gonadotrophin releasing hormone (GnRH) agonist side-effect comprising:
administering an initial dose of 160-320 mg of degarelix to the subject, wherein the initial dose is administered as two subcutaneous injections; and
administering a maintenance dose of 60-160 mg of degarelix to the subject once every 20-36 days thereafter, wherein the maintenance dose results in a testosterone suppression below 0.5 ng/mL;
thereby treating prostate cancer in the subject with a reduced likelihood of causing a testosterone spike or other GnRH agonist side effect.

2. The method of claim 1 , wherein the maintenance dose is administered monthly.

3. The method of claim 1 , wherein the treated subject has a decreased likelihood of developing or experiencing an undesirable side effect during treatment compared to treatment with the gonadotrophin releasing hormone (GnRH) agonist leuprolide.

4. The method of claim 1 , wherein the treated subject has at least about a 30% decrease in prostate specific antigen (PSA) by day 14 of treatment.

5. The method of claim 1 , wherein the treated subject has at least about a 60% decrease in prostate specific antigen (PSA) by day 28 of treatment.

6. The method of claim 1 , wherein the treated subject has at least about an 80% likelihood of maintaining a low prostate specific antigen (PSA) level of less than about 5 ng/mL during treatment.

7. The method of claim 1 , wherein the treated subject has locally advanced prostate cancer and has at least about a 40% decrease in PSA by day 14 of treatment.

8. The method of claim 1 , wherein the subject has a body mass index of less than 30 kg/m 2 .

9. The method of claim 1 , wherein the initial dose is administered at a concentration ranging from 5 mg/mL to 40 mg/mL.

10. The method of claim 9 , wherein the initial dose is administered at a concentration of 40 mg/mL.

11. The method of claim 1 , wherein the maintenance dose is administered as a single injection.

12. The method of claim 1 , wherein the maintenance dose is administered at a concentration ranging from 5 mg/mL to 40 mg/mL of degarelix.

13. The method of claim 12 , wherein the maintenance dose is administered at a concentration of 20 mg/mL of degarelix.

Assignees

• Ferring Bv

Inventors

• Olesen Tine Kold
• Persson Bo-Eric
• Cantor Per
• Van Der Meulen Egbert A
• Jensen Jens-Kristian Slott

Classifications

• A61K38/09 Primary

  Luteinising hormone-releasing hormone [LHRH] {, i.e. Gonadotropin-releasing hormone [GnRH]}; Related peptides · CPC title

• A61K38/08

  Peptides having 5 to 11 amino acids {(A61K38/043 - A61K38/046 take precedence)} · CPC title

• A61K9/0019

  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) · CPC title

• A61P35/00

  Antineoplastic agents · CPC title

• A61P35/04

  specific for metastasis · CPC title