METHODS OF TREATING PROSTATE CANCER WITH GnRH ANTAGONIST
AssigneeFerring B.V.
InventorsTine Kold Olesen, Bo-Eric Persson, Per Cantor, Egbert A. van der Meulen, Jens-Kristian Slott Jensen
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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.
Claims33
1-89. (canceled)
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 subcutaneously;
- and
- administering a maintenance dose of 60-160 mg of degarelix to the subject once every 20-36 days thereafter for 364 days, wherein the maintenance dose results in a testosterone suppression below 0.5 ng/mL;
- wherein the testosterone suppression remains below 0.5 ng/mL to day 364 of treatment.
The method of claim 1, wherein the maintenance dose is administered at a concentration of 20 mg/mL.
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 subcutaneously;
- and
- administering a maintenance dose of 60-160 mg of degarelix to the subject once every 28 days thereafter for 364 days, wherein the maintenance dose results in a testosterone suppression below 0.5 ng/mL;
- wherein the testosterone suppression is less than or equal to 0.5 ng/mL from day 28 to day 364 of treatment.
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, the method comprising:
- administering an initial dose of 240 mg of degarelix to the subject, wherein the initial dose is administered subcutaneously;
- and
- administering a maintenance dose of 80 mg of degarelix to the subject every 28 days thereafter, wherein the maintenance dose results in a testosterone suppression below 0.5 ng/mL;
- wherein the testosterone suppression remains less than or equal to 0.5 ng/mL from day 28 to day 364 of treatment.
Dependencies are inferred from the claim text.