Claims for Patent: 10,729,739

Summary for Patent: 10,729,739

Title:	Methods of treating prostate cancer with GnRH antagonist
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.
Inventor(s):	Olesen; Tine Kold (New York, NY), Persson; Bo-Eric (St. Prex, CH), Cantor; Per (Charlottenlund, DK), van der Meulen; Egbert A (Dalby, SE), Jensen; Jens-Kristian Slott (Bagsvaerd, DK)
Assignee:	Ferring B.V. (Hoofddorp, NL)
Application Number:	15/405,552
Patent Claims:	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 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, and wherein the initial dose is administered as two subcutaneous injections. 2. The method of claim 1, wherein the maintenance dose is administered monthly. 3. The method of claim 1, wherein the subject has a decreased likelihood of developing or experiencing an undesirable side effect during treatment compared to treatment with gonadotrophin releasing hormone (GnRH) agonist leuprolide. 4. The method of claim 1, wherein the 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 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 subject has at least about at 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 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.sup.2. 9. The method of claim 1, wherein the initial dose is administered at a concentration ranging from 5 mg/mL to 40 mg/m L. 10. The method of claim 1, wherein the initial dose is administered at a concentration of 40 mg/m L. 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. 13. The method of claim 1, wherein the maintenance dose is administered at a concentration of 20 mg/mL. 14. 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, and wherein the initial dose is administered as two subcutaneous injections. 15. The method of claim 14, wherein the maintenance dose is administered monthly. 16. The method of claim 14, wherein the subject has a decreased likelihood of developing or experiencing an undesirable side effect during treatment compared to treatment with gonadotrophin releasing hormone (GnRH) agonist leuprolide. 17. The method of claim 14, wherein the subject has at least about a 30% decrease in prostate specific antigen (PSA) by day 14 of treatment. 18. The method of claim 14, wherein the subject has at least about a 60% decrease in prostate specific antigen (PSA) by day 28 of treatment. 19. The method of claim 14, wherein the subject has at least about a 80% likelihood of maintaining a low prostate specific antigen (PSA) level of less than about 5 ng/mL during treatment. 20. The method of claim 14, wherein the subject has locally advanced prostate cancer and has at least about a 40% decrease in PSA by day 14 of treatment. 21. The method of claim 14, wherein the subject has a body mass index of less than 30 kg/m.sup.2. 22. The method of claim 14, wherein the initial dose is administered at a concentration ranging from 5 mg/mL to 40 mg/m L. 23. The method of claim 14, wherein the initial dose is administered at a concentration of 40 mg/mL. 24. The method of claim 14, wherein the maintenance dose is administered as a single injection. 25. The method of claim 14, wherein the maintenance dose is administered at a concentration ranging from 5 mg/mL to 40 mg/m L. 26. The method of claim 14, wherein the maintenance dose is administered at a concentration of 20 mg/mL. 27. 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, and wherein the initial dose is administered as two subcutaneous injections. 28. The method of claim 27, wherein the maintenance dose is administered monthly. 29. The method of claim 27, wherein the maintenance dose is administered as a single injection.