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 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 the patient has a decreased likelihood of prostate-specific antigen failure (PSA failure) compared to treatment with a gonadotrophin releasing hormone (GnRH) agonist.
37 . The method of claim 36 , wherein the patient has an increased probability of completing a 364 day duration of treatment without PSA failure compared to treatment with a gonadotrophin releasing hormone (GnRH) agonist.
38 . The method of claim 36 , wherein the treatment duration is longer than 364 days.
39 . The method of claim 36 , wherein the patient's prostate cancer is at a stage selected from localized prostate cancer, locally advanced prostate cancer, metastatic prostate cancer, and non-classifiable prostate cancer.
40 . The method of claim 36 , wherein the patient has locally advanced prostate cancer.
41 . The method of claim 36 , wherein the patient has metastatic prostate cancer.
42 . The method of claim 41 , further comprising, prior to administering the initial dose of degarelix, identifying the patient as having metastatic stage prostate cancer.
43 . The method of claim 43 , wherein the identifying comprises identifying metastatic lesions by imaging.
44 . The method of claim 43 , wherein the identifying comprises identifying metastatic lesions by bone scan.
45 . The method of claim 43 , wherein the identifying comprises determining the patient's serum prostate-specific antigen (PSA) level.
46 . The method of claim 36 , wherein the patient has a serum PSA level >50 ng/ml prior to treatment.
47 . The method of claim 36 , wherein the patient has a serum PSA level of 20-50 ng/ml prior to treatment.
48 . The method of claim 36 , wherein PSA failure is defined as an increase in serum PSA level of 50% and 5 ng/mL compared with nadir, measured on two consecutive occasions at least two weeks apart.
49 . 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.
50 . 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.
51 . The method of claim 36 , wherein the treatment with a GnRH agonist is treatment with monthly intramuscular injections of 7.5 mg leuprolide.