METHODS FOR 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 - 35 . (canceled)
36 . A method for treating a patient with metastatic prostate cancer, comprising:
administering to the patient an initial dose of degarelix of 240 mg given as two injections of 120 mg each, and
administering to the patient a maintenance dose of degarelix of 80 mg given as one injection, wherein the maintenance dose is administered approximately every 28 days after the previous dose of degarelix for a duration treatment,
wherein, after 60 days of treatment, the patient's serum alkaline phosphatase (S-ALP) level is reduced by at least 50 IU/L from a baseline level, wherein the baseline level is the patient's S-ALP level prior to treatment.
37 . The method of claim 36 , wherein, after 364 days of treatment, the patient's S-ALP level is reduced by at least 50 IU/L from the baseline level.
38 . The method of claim 36 , wherein, after 112 days of treatment, the patient's S-ALP level is reduced by at least 90 IU/L from the baseline level.
39 . The method of claim 38 , wherein, after 364 days of treatment, the patient's S-ALP level is reduced by at least 90 IU/L from the baseline level.
40 . The method of claim 36 , wherein, after 112 days of treatment, the patient's S-ALP level is reduced by at least 160 IU/L from the baseline level.
41 . The method of claim 40 , wherein, after 364 days of treatment, the patient's S-ALP level is reduced by at least 160 IU/L from the baseline level.
42 . The method of claim 36 , wherein the treatment has a duration longer than 364 days.
43 . The method of claim 36 , wherein the initial dose of degarelix is given as two subcutaneous injections of 120 mg each at a concentration of 40 mg/mL.
44 . The method of claim 36 , wherein the maintenance dose of degarelix of 80 mg is given as one subcutaneous injection at a concentration of 20 mg/mL.
45 . The method of claim 36 , further comprising, prior to administering the initial dose of degarelix, identifying the patient as having metastatic stage prostate cancer.
46 . The method of claim 45 , wherein the identifying comprises identifying metastatic lesions by imaging.
47 . The method of claim 45 , wherein the identifying comprises identifying metastatic lesions by bone scan.
48 . The method of claim 45 , wherein the identifying comprises determining the patient's serum prostate-specific antigen (PSA) level.
49 . A method for treating a patient with metastatic prostate cancer, comprising:
identifying a patient with metastatic stage prostate cancer;
administering to the patient an initial dose of degarelix of 240 mg given as two injections of 120 mg each, and administering to the patient a maintenance dose of degarelix of 80 mg given as one injection, wherein the maintenance dose is administered approximately every 28 days after the previous dose of degarelix for a duration treatment,
wherein the method achieves a mean serum alkaline phosphatase (S-ALP) level that is lower than a mean S-ALP level achieved by treatment with monthly intramuscular injections of 7.5 mg leuprolide.
50 . The method of claim 49 , wherein the treatment has a duration longer than 364 days.
51 . The method of claim 49 , wherein the initial dose of degarelix is given as two subcutaneous injections of 120 mg each at a concentration of 40 mg/mL.
52 . The method of claim 49 , wherein the maintenance dose of degarelix of 80 mg is given as one subcutaneous injection at a concentration of 20 mg/mL.
53 . The method of claim 49 , further comprising, prior to administering the initial dose of degarelix, identifying the patient as having metastatic stage prostate cancer.
54 . The method of claim 53 , wherein the identifying comprises identifying metastatic lesions by imaging.
55 . The method of claim 53 , wherein the identifying comprises identifying metastatic lesions by bone scan.
56 . The method of claim 53 , wherein the identifying comprises determining the patient's serum prostate-specific antigen (PSA) level.