Methods for treating metastatic stage prostate cancer

Abstract

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 of treating prostate cancer in a subject in need thereof, the method comprising:
 testing the prostate specific antigen (PSA) of a potential subject;   selecting the potential subject for treatment if the subject's 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. 
     
     
         37 . The method of  claim 36 , 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 initial dose of degarelix. 
     
     
         38 . The method of  claim 36 , wherein the subject has at least a 60% decrease in the level of PSA by day 14 of treatment. 
     
     
         39 . The method of  claim 38 , wherein the subject has at least a 75% decrease in the level of PSA by day 28 of treatment. 
     
     
         40 . The method of  claim 36 , wherein the subject has at least an 80% likelihood of maintaining a PSA level of less than 5 ng/mL during treatment. 
     
     
         41 . The method of  claim 40 , wherein the duration of treatment ranges from 20 days to 450 days. 
     
     
         42 . The method of  claim 36 , wherein the selected subject has a hemoglobin (Hb) level of 130 g/L or less. 
     
     
         43 . The method of  36 , 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. 
     
     
         44 . The method of  claim 36 , 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 from day 28 to day 365 of treatment.