METHOD OF TREATING PROSTATE CANCER WITH GnRH ANTAGONIST

1 . A method of treating prostate cancer in a subject with a reduced likelihood of causing a testosterone spike or other side effect of a gonadotrophin releasing hormone (GnRH) agonist therapy, comprising:

administering an initial dose of about 240 mg of degarelix to the subject; and

administering a maintenance dose of about 80 mg of degarelix to the subject once every approximately 28 days thereafter,

thereby treating prostate cancer in the subject with a reduced likelihood of causing a testosterone spike or other GnRH agonist side effect.

2 . A method of treating prostate cancer in a subject with a reduced likelihood of causing a testosterone spike or other gonadotrophin releasing hormone (GnRH) agonist side-effect comprising:

administering an initial dose of 160-320 mg of degarelix to the subject; and

administering a maintenance dose of 60-160 mg of degarelix to the subject once every 20-36 days thereafter,

thereby treating prostate cancer in the subject with a reduced likelihood of causing a testosterone spike or other GnRH agonist side effect.

3 . The method of claim 1 or 2 , wherein the maintenance dose is administered monthly.

4 . The method of claim 1 or 2 , wherein the treated subject has a decreased likelihood of developing or experiencing an undesirable side effect during treatment compared to treatment with the gonadotrophin releasing hormone (GnRH) agonist leuprolide.

5 . The method of claim 1 or 2 , wherein the treated subject has a decreased likelihood of developing or experiencing a cardiovascular side effect during treatment compared to treatment with the gonadotrophin releasing hormone (GnRH) agonist leuprolide.

6 . The method of claim 5 , wherein the treated subject has a decreased likelihood of myocardial infarction during treatment.

7 . The method of claim 5 , wherein the treated subject has a decreased likelihood of developing chest pain during treatment.

8 . The method of claim 5 , wherein the treated subject has a decreased likelihood of developing a cardiac murmur during treatment.

9 . The method of claim 5 , wherein the treated subject has a decreased likelihood of developing a vascular side effect during treatment.

10 . The method of claim 9 , wherein the treated subject has a decreased likelihood of developing deep vein thrombosis (DVT) during treatment.

11 . The method of claim 1 or 2 , wherein the treated subject has a decreased likelihood of developing a side effect selected from the group consisting of a cardiac arrhythmia, a coronary artery disorder, and a cardiac disorder.

12 . The method of claim 11 , wherein the treated subject has a body mass index (BMI) of less than 30 kg/m 2 .

13 . The method of claim 11 , wherein the treated subject has a body mass index (BMI) of less than 25 kg/m 2 .

14 . The method of claim 11 , wherein the treated subject has a cholesterol level of greater than or equal to 4 mmol/L (155 mg/dL).

15 . The method of claim 1 , wherein the subject is at risk for cardiovascular disease.

16 . The method of claim 1 , further comprising the step of identifying a prostate cancer subject who is also at risk for cardiovascular disease for treatment by the method.

17 . The method of claim 1 or 2 , wherein the treated subject has a decreased likelihood of developing or experiencing an increase in arthralgia and/or musculoskeletal stiffness during treatment compared to treatment with the gonadotrophin releasing hormone (GnRH) agonist leuprolide.

18 . The method of claim 17 , wherein the treated subject has locally advanced prostate cancer.

19 . The method of claim 17 , wherein the treated subject is less than 65 years old.

20 . The method of claim 1 or 2 , wherein the treated subject has a decreased likelihood of developing a musculoskeletal disorder and/or a connective tissue disorder during treatment compared to treatment with the gonadotrophin releasing hormone (GnRH) agonist leuprolide.

21 . The method of claim 20 , wherein the musculoskeletal disorder and/or a connective tissue disorder is arthralgia.

22 . The method of claim 20 , wherein the musculoskeletal disorder and/or a connective tissue disorder is musculoskeletal stiffness.

23 . The method of claim 1 or 2 , wherein the treated subject has a decreased likelihood of developing noninfective cystitis during treatment compared to treatment with the gonadotrophin releasing hormone (GnRH) agonist leuprolide.

24 . The method of claim 1 or 2 , wherein the treated subject has a decreased likelihood of developing a urinary or renal system disorder compared to treatment with the gonadotrophin releasing hormone (GnRH) agonist leuprolide.

25 . The method of claim 24 , wherein the urinary or renal system disorder is a urinary tract infection.

26 . The method of claim 25 , wherein the treated subject has locally advanced prostate cancer.

27 . The method of claim 24 , wherein the urinary or renal system disorder is an increase in urinary retention.

28 . The method of claim 24 , wherein the urinary or renal system disorder is a noninfective cystitis.

29 . The method of claim 1 , wherein the treated subject has at least about a 95% likelihood of maintaining a therapeutically low serum testosterone level of less than or equal to 0.5 ng/mL by day 28 of treatment.

30 . The method of claim 29 , wherein the treated subject has at least about a 95% likelihood of maintaining a therapeutically low serum testosterone level of less than or equal to 0.5 ng/mL from day 28 through day 364 of treatment.

31 . The method of claim 1 , wherein the treated subject has at least about a 30% decrease in prostate specific antigen (PSA) by day 14 of treatment.

32 . The method of claim 31 , wherein the treated subject has at least about a 50% decrease in prostate specific antigen (PSA) by day 14 of treatment.

33 . The method of claim 1 , wherein the treated subject has at least about a 60% decrease in prostate specific antigen (PSA) by day 28 of treatment.

34 . The method of claim 33 , wherein the treated subject has at least about a 75% decrease in prostate specific antigen (PSA) by day 28 of treatment.

35 . The method of claim 1 , wherein the treated subject has at least about an 80% likelihood of maintaining a low prostate specific antigen (PSA) level of less than about 5 ng/mL during treatment.

36 . The method of claim 35 , wherein the treated subject is at least 75 years old and has at least about a 95% likelihood of maintaining a low prostate specific antigen (PSA) level of less than about 5 ng/mL during treatment.

37 . The method of claim 1 , wherein the treated subject has locally advanced prostate cancer and has at least about a 40% decrease in PSA by day 14 of treatment.

38 . The method of claim 37 , wherein the treated subject has metastatic prostate cancer and has at least about a 60% decrease in PSA by day 14 of treatment.

39 . The method of claim 1 or 2 , wherein the subject has a body mass index of less than 30 kg/m 2 .

40 . The method of claim 39 , wherein the subject has a body mass index of less than 25 kg/m 2 .

41 . A method of treating prostate cancer in a subject at risk for a cardiovascular disease or disorder comprising administering a therapeutically effective dose of degarelix to the subject with prostate cancer who is at risk for a cardiovascular disease or disorder.

42 . The method of claim 41 , wherein the therapeutically effective dose comprises an initial starting dose of 160 to 320 mg of degarelix, and a monthly maintenance dose of 60 to 160 mg of degarelix.

43 . The method of claim 41 , wherein the therapeutically effective dose of degarelix comprises a maintenance dose of about 80 mg of degarelix once every approximately 28 days of treatment.

44 . The method of claim 43 , further comprising administering an initial dose of about 240 mg of degarelix at the start of treatment.

45 . The method of claim 43 , wherein the subject is at risk of a cardiovascular disease or disorder selected from the group consisting of cardiac murmur, atrioventricular blockage, and myocardial ischemia.

46 . The method of claim 43 , wherein the subject possesses an indicator of increased risk for cardiovascular disease.

47 . The method of claim 46 , wherein the indicator of increased risk for cardiovascular disease is selected from the group consisting of high blood pressure, high low-density lipoprotein cholesterol, low high-density lipoprotein cholesterol, high serum glucose and habitual smoking.

48 . The method of claim 47 , wherein the subject has high blood pressure of greater than or equal to 130 over 85 mm Hg.

49 . The method of claim 47 , wherein the subject smokes cigarettes daily.

50 . The method of claim 47 , wherein the subject has an elevated level of low-density lipoprotein cholesterol of greater than or equal to about 160 mg/dl.

51 . The method of claim 47 , wherein the subject has a low level of high-density lipoprotein cholesterol of less than 35 mg/dl.

52 . The method of claim 47 , wherein the subject has an elevated fasting glucose level of greater than about 120 mg/dL.

53 . The method of claim 46 , wherein the indicator of increased risk for cardiovascular disease is selected from the group consisting of high serum C-reactive protein (CRP), high serum homocysteine, high serum fibrinogen, and high serum lipoprotein(a) (Lp(a)).

54 . The method of claim 53 , wherein the subject has an elevated level of C-reactive protein of greater than 3 mg/dL.

55 . The method of claim 53 , wherein the subject has an elevated level of serum homocysteine of greater than 30 μmol/L.

56 . The method of claim 53 , wherein the subject has an elevated level of serum fibrinogen of greater than 7.0 g/L.

57 . The method of claim 53 , wherein the subject has an elevated level of serum Lp(a) of greater than 30 mg/dL.

58 . The method of claim 41 , wherein the subject has a body mass index of less than 30 kg/m 2 .

59 . The method of claim 58 , wherein the subject has a body mass index of less than 25 kg/m 2 .

60 . The method of claim 41 , wherein the treated subject has a decreased likelihood, compared to treatment with the gonadotrophin releasing hormone (GnRH) agonist leuprolide, of developing a side effect selected from the group consisting of a cardiac arrhythmia, a coronary artery disorder, and a cardiac disorder.

61 . The method of claim 60 , wherein the treated subject has a body mass index (BMI) of less than 30 kg/m 2 .

62 . The method of claim 60 , wherein the treated subject has a body mass index (BMI) of less than 25 kg/m 2 .

63 . The method of claim 60 , wherein the treated subject has a cholesterol level of greater than or equal to 4 mmol/L (155 mg/dL).

64 . A method of treating prostate cancer in a subject at risk for a cardiovascular disease or disorder comprising:

identifying a suitable subject with prostate cancer and at risk for a cardiovascular disease or disorder;

administering an initial dose of about 240 mg of degarelix to the subject; and

administering a maintenance dose of about 80 mg of degarelix to the subject once every approximately 28 days thereafter,

thereby treating prostate cancer in the subject at risk for a cardiovascular disease or disorder.

65 . The method of claim 64 , wherein the maintenance dose is administered monthly.

66 . A method of treating prostate cancer in a subject at risk for a cardiovascular disease or disorder comprising:

identifying a suitable subject with prostate cancer and at risk for a cardiovascular disease or disorder;

administering an initial dose of 160-320 mg of degarelix to the subject; and

administering a maintenance dose of 60-160 mg of degarelix to the subject once every 20-36 days thereafter,

thereby treating prostate cancer in the subject with a reduced likelihood of causing a testosterone spike or other GnRH agonist side-effect.

67 . The method of claim 64 or 66 , wherein the subject has a body mass index of less than 30 kg/m 2 .

68 . The method of claim 67 , wherein the subject has a body mass index of less than 25 kg/m 2 .

69 . The method of claim 64 or 66 , wherein the subject is at risk of a cardiovascular disease or disorder selected from the group consisting of cardiac murmur, atrioventricular blockage, and myocardial ischemia.

70 . The method of claim 64 or 66 , wherein the subject possesses an indicator of increased risk for cardiovascular disease.

71 . The method of claim 70 , wherein the indicator of increased risk for cardiovascular disease is selected from the group consisting of high blood pressure, high low-density lipoprotein cholesterol, low high-density lipoprotein cholesterol, high serum glucose and habitual smoking.

72 . The method of claim 71 , wherein the subject has high blood pressure of greater than or equal to 130 over 85 mm Hg.

73 . The method of claim 71 , wherein the subject smokes cigarettes daily.

74 . The method of claim 71 , wherein the subject has an elevated level of low-density lipoprotein cholesterol of greater than or equal to about 160 mg/dl.

75 . The method of claim 70 , wherein the subject has a low level of high-density lipoprotein cholesterol of less than 35 mg/dl.

76 . The method of claim 70 , wherein the subject has an elevated fasting glucose level of greater than about 120 mg/dL.

77 . The method of claim 70 , wherein the indicator of increased risk for cardiovascular disease is selected from the group consisting of high serum C-reactive protein (CRP), high serum homocysteine, high serum fibrinogen, and high serum lipoprotein(a) (Lp(a)).

78 . The method of claim 77 , wherein the subject has an elevated level of C-reactive protein of greater than 3 mg/dL.

79 . The method of claim 77 , wherein the subject has an elevated level of serum homocysteine of greater than 30 μmol/L.

80 . The method of claim 77 , wherein the subject has an elevated level of serum fibrinogen of greater than 7.0 g/L.

81 . The method of claim 77 , wherein the subject has an elevated level of serum Lp(a) of greater than 30 mg/dL.

82 . The method of claim 64 or 66 , wherein the treated subject has a decreased likelihood, compared to treatment with the gonadotrophin releasing hormone (GnRH) agonist leuprolide, of developing a side effect selected from the group consisting of a cardiac arrhythmia, a coronary artery disorder, and a cardiac disorder.

83 . The method of claim 82 , wherein the treated subject has a body mass index (BMI) of less than 30 kg/m 2 .

84 . The method of claim 82 , wherein the treated subject has a body mass index (BMI) of less than 25 kg/m 2 .

85 . The method of claim 82 , wherein the treated subject has a cholesterol level of greater than or equal to 4 mmol/L (155 mg/dL).

86 . A method of treating prostate cancer in a preferred subject comprising:

identifying a subject with prostate cancer having a body mass index of less than about 25 kg/m 2 ;

administering an initial dose of 160-320 mg of degarelix to the subject; and

administering a maintenance dose of 60-160 mg of degarelix to the subject once every 20-36 days thereafter,

thereby treating prostate cancer in the preferred subject.

87 . The method of claim 86 , wherein the treated subject has a decreased likelihood, compared to treatment with the gonadotrophin releasing hormone (GnRH) agonist leuprolide, of developing a side effect selected from the group consisting of a cardiac arrhythmia, a coronary artery disorder, and a cardiac disorder.

88 . The method of claim 86 , wherein the initial dose of degarelix is about 240 mg, and the maintenance dose of degarelix is about 80 mg administered monthly.

89 . The method of claim 86 , wherein the preferred subject has a cholesterol level of greater than or equal to 4 mmol/L (155 mg/dL).