Details for Patent: 9,877,999

Title:	Methods for treating metastatic stage prostate cancer
Abstract:	The invention provides methods and dosing regimens for eating metastatic stage prostate cancer in a subject using degarelix, as well as related methods of using degarelix in a subject identified as having metastatic stage prostate cancer, and methods of using degarelix to prevent or delay the progression of locally advanced prostate cancer.
Inventor(s):	Persson; Bo-Eric (Saint-Prex, CH)
Assignee:	Ferring International Center SA (Saint-Prex, CH)
Filing Date:	Aug 08, 2014
Application Number:	14/454,825
Claims:	1. A method for treating a subject with metastatic stage prostate cancer having a serum alkaline phosphatase (S-ALP) level above a normal range for S-ALP prior to treatment, the method comprising: identifying a subject with metastatic stage prostate cancer having a S-ALP level above the normal range for S-ALP; reducing the subject's S-ALP level by administering an initial dose of degarelix ranging from about 160 mg to about 320 mg to the subject; and administering at least one maintenance dose of degarelix ranging from about 60 mg to 160 mg to the subject, wherein the at least one maintenance dose is administered approximately 20 to 36 days after the previous dose of degarelix for a duration of treatment ranging from 20 days to 450 days. 2. The method of claim 1, wherein the initial dose of degarelix is about 240 mg, and the at least one maintenance dose of degarelix is about 80 mg administered to the subject approximately 28 days after the previous dose of degarelix. 3. The method of claim 1, wherein the subject to be treated is further identified by having a hemoglobin (Hb) level of 130 g/L or less. 4. The method of claim 1, wherein the subject to be treated is further identified by having a prostate-specific antigen (PSA) level greater than or equal to 50 ng/mL. 5. The method of claim 4, wherein the treated subject's S-ALP level is reduced by at least 60 IU/L between day 112 and day 364 of treatment. 6. The method of claim 1, wherein the treated subject's S-ALP level is reduced by at least 50 IU/L between day 60 and day 364 of treatment. 7. The method of claim 1, wherein the treated subject's S-ALP level is reduced by at least 50 IU/L between day 364 and day 450 of treatment. 8. The method of claim 1, wherein the treated subject's S-ALP level is reduced by at least 90 IU/L between day 112 and day 364 of treatment. 9. The method of claim 1, wherein the treated subject's S-ALP level is reduced by at least 160 IU/L between day 112 and day 364 of treatment. 10. The method of claim 1, further comprising achieving at least a 95% likelihood of having a therapeutically low serum testosterone level of less than or equal to 0.5 ng/mL by day 28 of treatment in the subject. 11. The method of claim 1, further comprising maintaining at least a 95% likelihood of a therapeutically low serum testosterone level of less than or equal to 0.5 ng/mL from day 28 to day 365 of treatment in the subject. 12. The method of claim 4, wherein the treated subject having a S-ALP level above the normal range prior to treatment has at least a 60% decrease in the level of prostate-specific antigen (PSA) by day 14 of treatment. 13. The method of claim 12, wherein the treated subject having a S-ALP level above the normal range prior to treatment has at least a 75% decrease in the level of prostate-specific antigen (PSA) by day 28 of treatment. 14. The method of claim 4, wherein the treated subject having a S-ALP level above the normal range prior to treatment has at least an 80% likelihood of maintaining a prostate-specific antigen (PSA) level of less than 5 ng/mL during treatment. 15. A method of treating a subject with metastatic prostate cancer having a serum alkaline phosphatase (S-ALP) level above a normal range for S-ALP prior to treatment, the method comprising: testing the prostate-specific antigen (S-ALP) and a prostate specific antigen (PSA) of a potential subject; selecting the potential subject for treatment if the subject's S-ALP is above the normal range for S-ALP and the PSA level is greater than or equal to 50 ng/mL; administering an initial dose of degarelix ranging from about 160 mg to about 320 mg to the subject; and administering at least one maintenance dose of degarelix ranging from about 60 mg to 160 mg to the subject, wherein the at least one maintenance dose is administered approximately 20 to 36 days after the previous dose of degarelix for a duration of treatment ranging from 20 days to 450 days; and further wherein the S-ALP level is reduced for the duration of treatment. 16. The method of claim 15, wherein the treated subject's S-ALP level is reduced by at least 60 IU/L from the baseline level between day 112 and day 364 of treatment. 17. A method of using degarelix for the treatment of metastatic stage prostate cancer in a subject having a serum alkaline phosphatase (S-ALP) level above a normal range for S-ALP prior to treatment comprising: identifying a subject with metastatic stage prostate cancer having a S-ALP level above a normal range for S-ALP; reducing the subject's S-ALP level by administering an initial dose of degarelix of about 240 mg to the subject; and administering a maintenance dose of degarelix of about 80 mg to the subject once every 20 to 36 days thereafter. 18. The method of claim 17, wherein the subject with metastatic stage prostate cancer is further identified by having a hemoglobin (Hb) level of 130 g/L or less. 19. The method of claim 17, wherein the subject with metastatic stage prostate cancer is further identified by having a prostate-specific antigen (PSA) level of greater than or equal to 50 ng/mL. 20. A method of using degarelix to prevent or delay the progression of localized or locally advanced prostate cancer to metastatic stage prostate cancer in a subject having a serum alkaline phosphatase (S-ALP) level above a normal range for S-ALP prior to treatment comprising: identifying a subject with localized or locally advanced prostate cancer having a S-ALP range above the normal range for S-ALP; reducing the subject's S-ALP level by administering an initial dose of degarelix ranging from about 160 mg to about 320 mg to the subject; and administering at least one maintenance dose of degarelix ranging from about 60 mg to 160 mg to the subject, wherein the at least one maintenance dose is administered approximately 20 to 36 days after the previous dose of degarelix for a duration of treatment ranging from 20 days to 450 days. 21. The method of claim 20, wherein the subject with localized or locally advanced prostate cancer is further identified by having a prostate-specific antigen (PSA) level of 10-50 ng/mL. 22. The method of claim 20, wherein the subject with localized or locally advanced prostate cancer is further identified by having a prostate-specific antigen (PSA) level of 20-50 ng/mL. 23. The method of claim 20, wherein the subject has a serum alkaline phosphatase (S-ALP) level of between 44 and 147 IU/L. 24. A method of treating metastatic stage prostate cancer in a subject having a serum alkaline phosphatase (S-ALP) level above a normal range for S-ALP prior to treatment comprising: identifying a subject with metastatic stage prostate cancer having a S-ALP range above the normal range for S-ALP; reducing the subject's S-ALP level by administering an initial dose of degarelix of 240 mg to the subject; and administering a maintenance dose of degarelix of 80 mg to the subject once every 28 days.