Method of treating metastatic stage prostate cancer
The invention provides methods and dosing regimens for treating 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.
1. A method of treating metastatic stage prostate cancer in a subject, the method comprising:
identifying a subject with metastatic stage prostate cancer comprising measuring the subject's baseline serum alkaline phosphatase (S-ALP) level; and
reducing the subject's S-ALP level with respect to the baseline level by
administering an initial dose of degarelix ranging from about 160 to about 320 mg to the subject; and
administering at least one maintenance dose of degarelix ranging from about 60 mg to about 160 mg to the subject, wherein the at least one maintenance dose is administered approximately 20 days 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 relative to the initial S-ALP level measured at the start of treatment.
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 identifying the subject comprises measuring the baseline S-ALP level in the subject of 150 IU/L or greater.
4. The method of claim 1 , wherein identifying the subject comprises measuring the baseline S-ALP level in the subject of 160 IU/L or greater.
5. The method of claim 1 , wherein identifying the subject comprises measuring the baseline S-ALP level in the subject of 200 IU/L or greater.
6. The method of claim 1 , wherein identifying the subject comprises measuring the baseline S-ALP level in the subject of 300 IU/L or greater.
7. The method of claim 1 , 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.
8. The method of claim 1 , wherein the treated subject's S-ALP level is reduced by at least 50 IU/L from the baseline level between day 60 and day 364 of treatment.
9. The method of claim 1 , wherein the treated subject's S-ALP level is reduced by at least 50 IU/L from the baseline level between day 364 and day 450 of treatment.
10. The method of claim 1 , wherein the treated subject's S-ALP level is reduced by at least 90 IU/L from the baseline level between day 112 and day 364 of treatment.
11. The method of claim 1 , wherein the treated subject's S-ALP level is reduced by at least 160 IU/L from the baseline level between day 112 and day 364 of treatment.
12. The method of claim 1 , wherein the treated subject has 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.
13. The method of claim 1 , wherein the treated subject has at least a 95% likelihood of maintaining a therapeutically low serum testosterone level of less than or equal to 0.5 ng/mL from day 28 to day 365 of treatment.
14. The method of claim 1 , comprising administering from 1 to 21 maintenance doses of degarelix to the subject, wherein each maintenance dose is administered approximately 20 days to 36 days after the previous dose of degarelix.
15. A method of treating metastatic stage prostate cancer in a subject. the method comprising:
identifying a subject with metastatic stage prostate cancer comprising measuring the subject's baseline serum alkaline phosphatase (S-ALP) level and measuring the subject's baseline prostate-specific antigen (PSA) level; and
reducing the subject's S-ALP level with respect to the baseline 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 about 160 mg to the subject approximately 20 days to 36 days after the previous dose of degarelix for a duration of treatment.
16. The method of claim 15 , wherein identifying the subject comprises measuring the baseline S-ALP level in the subject of 150 IUIL or greater.
17. The method of claim 15 , wherein identifying the subject comprises measuring the baseline S-ALP level in the subject of 160 IUIL or greater.
18. The method of claim 15 , wherein the treated subject's S-ALP level is reduced by at least 60 IUIL from the baseline level between day 112 and day 364 of treatment.