Claims for Patent: 12,533,387

Summary for Patent: 12,533,387

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):	Tine Kold OLESEN, Bo-Eric Persson, Per CANTOR, Egbert A. van der MEULEN, Jens-Kristian Slott JENSEN
Assignee:	Ferring BV
Application Number:	US17/199,733
Patent Claims:	1. A method of treating advanced stage prostate cancer in a human subject with a decreased likelihood of developing arthralgia during treatment as compared to treatment with a gonadotrophin releasing hormone (GnRH) agonist, comprising: administering an initial dose of 240 mg of degarelix to the subject as two subcutaneous injections of 120 mg each at a concentration of 40 mg/mL on the same day, and administering a maintenance dose of 80 mg of degarelix at a concentration of 20 mg/mL to the subject as one subcutaneous injection, wherein the maintenance dose is administered approximately every 28 days after the previous dose of degarelix for a duration of treatment, wherein the treated subject has a decreased likelihood of developing arthralgia during treatment compared to treatment with a GnRH agonist. 2. A method of treating advanced stage prostate cancer in a human subject and achieving an at least 50% decrease in serum prostate specific antigen (PSA) level by about day 14 of treatment, comprising: administering an initial dose of 240 mg of degarelix to the subject as two subcutaneous injections of 120 mg each at a concentration of 40 mg/mL on the same day, and administering a maintenance dose of 80 mg of degarelix at a concentration of 20 mg/mL to the subject as one subcutaneous injection, wherein the maintenance dose is administered approximately every 28 days after the previous dose of degarelix for a duration of treatment, wherein the treated subject has at least a 50% decrease in serum PSA level by about day 14 of treatment. 3. The method of claim 1, wherein the subject is less than 65 years old. 4. The method of claim 1, wherein the GnRH agonist is leuprolide. 5. The method of claim 1, wherein the subject has a body mass index of less than 30 kg/m2. 6. The method of claim 2, wherein the treated subject has at least a 60% decrease in serum PSA level by day 28 of treatment. 7. The method of claim 2, wherein the treated subject has at least a 75% decrease in serum PSA level by day 28 of treatment. 8. The method of claim 1, wherein the treatment with a GnRH agonist is treatment with monthly intramuscular injections of 7.5 mg leuprolide. 9. The method of claim 1, wherein the subject has locally advanced prostate cancer. 10. The method of claim 1, wherein the subject has metastatic prostate cancer. 11. The method of claim 2, wherein the treated subject has at least a 50% decrease in serum PSA level by day 14 of treatment. 12. The method of claim 2, wherein the treated subject has at least a 60% decrease in serum PSA level by about day 28 of treatment. 13. The method of claim 2, wherein the treated subject has at least a 75% decrease in serum PSA level by about day 28 of treatment. 14. The method of claim 2, wherein the subject has locally advanced prostate cancer. 15. The method of claim 2, wherein the subject has metastatic prostate cancer. 16. A method of treating advanced stage prostate cancer in a human subject with a decreased likelihood of urinary tract infection during treatment as compared to treatment with a gonadotrophin releasing hormone (GnRH) agonist, comprising: administering an initial dose of 240 mg of degarelix at a concentration of 40 mg/mL to the subject as two subcutaneous injections of 120 mg each on the same day, and administering a maintenance dose of 80 mg of degarelix at a concentration of 20 mg/mL to the subject as one subcutaneous injection, wherein the maintenance dose is administered approximately every 28 days after the previous dose of degarelix for a duration of treatment, wherein the treated subject has a decreased likelihood of urinary tract infection during treatment compared to treatment with a GnRH agonist. 17. The method of claim 16, wherein the subject has locally advanced prostate cancer. 18. The method of claim 16, wherein the subject is less than 65 years old. 19. The method of claim 16, wherein the GnRH agonist is leuprolide. 20. The method of claim 16, wherein the treatment with a GnRH agonist is treatment with monthly intramuscular injections of 7.5 mg leuprolide. 21. The method of claim 2, wherein the subject is less than 65 years old. 22. The method of claim 2, wherein the GnRH agonist is leuprolide. 23. The method of claim 2, wherein the treatment with a GnRH agonist is treatment with monthly intramuscular injections of 7.5 mg leuprolide. 24. The method of claim 16, wherein the subject has metastatic prostate cancer.