Method of treating prostate cancer with GnRH antagonist

Patent metadata

Field	Value
Publication number	US-9415085-B2
Application number	US-201213458330-A
Country	US
Kind code	B2
Filing date	Apr 27, 2012
Priority date	Feb 11, 2008
Publication date	Aug 16, 2016
Grant date	Aug 16, 2016

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. The present disclosure also provides for methods for treating prostate cancer in a patient with a history of at least one cardiovascular event, wherein administration of degarelix to the subject decreases the likelihood of developing or experiencing an additional cardiovascular event compared to treatment with a gonadotrophin releasing hormone (GnRH) agonist.

First claim

What is claimed is:

1. A method of treating prostate cancer in a subject, comprising:
selecting a subject with a history of at least one cardiovascular event and prostate cancer;
administering degarelix to the subject, wherein administration of degarelix to the subject decreases the frequency of an additional cardiovascular event in the subject as compared to the frequency of an additional cardiovascular event upon treatment with a gonadotrophin releasing hormone (GnRH) agonist in a subject with a history of at least one cardiovascular event,
wherein the at least one cardiovascular event is chosen from myocardial infarction, ischemic heart disease, ischemic stroke, hemorrhagic stroke, and other arterial thrombotic/embolic events.

2. The method of claim 1 , wherein administering degarelix to the subject comprises administering an initial does of about 240 mg of degarelix; and administering a maintenance does of about 80 mg degarelix, once every approximately 28 days thereafter.

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

4. The method of claim 1 , wherein administering degarelix to the subject comprises administering an initial does of 160 mg to 320 mg of degarelix and administering a maintenance dose of 60 mg to 160 mg degarelix, once every 20 days to 36 days thereafter.

5. The method of claim 4 , wherein the maintenance dose is administered monthly.

6. The method of claim 1 , wherein the subject has at least one risk factor chosen from greater than 65 years of age, high alcohol consumption, abstinence from alcohol, high blood pressure, low baseline serum testosterone, and prostate cancer disease state.

7. The method of claim 6 , wherein the high blood pressure is greater than or equal to 130 over 85 mm Hg.

8. The method of claim 1 , wherein the prostate cancer disease state is chosen from localized prostate cancer, locally advanced prostate cancer, metastatic prostate cancer, and non-classifiable prostate cancer.

9. The method of claim 1 , wherein administration occurs monthly.

Assignees

• Van Der Meulen Egbert A
• Tankó László Balázs
• Ferring Bv

Inventors

• Van Der Meulen Egbert A
• Tankó László Balázs

Classifications

• A61P35/00

  Antineoplastic agents · 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

• 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

• A61P35/04

  specific for metastasis · CPC title