Methods of treating prostate cancer with GnRH antagonist
The invention provides methods and dosing regimens for safely and effectively treating androgen-dependent prostate cancer with a gonadotrophin releasing hormone (GnRH) antagonist without causing a testosterone spike and/or other side effect of GnRH agonist therapy such as a urinary tract infection, or an arthralgia-related or cardiovascular side effect.
1. 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, wherein the initial dose is administered subcutaneously; and
administering a maintenance dose of 60-160 mg of degarelix to the subject once every 20-36 days thereafter for 364 days, wherein the maintenance dose results in a testosterone suppression below 0.5 ng/mL;
wherein the testosterone suppression remains below 0.5 ng/mL to day 364 of treatment, and wherein the initial dose is administered as two subcutaneous injections.
2. The method of claim 1 , wherein the maintenance dose is administered monthly.
3. The method of claim 1 , wherein the subject has a decreased likelihood of developing or experiencing an undesirable side effect during treatment compared to treatment with gonadotrophin releasing hormone (GnRH) agonist leuprolide.
4. The method of claim 1 , wherein the subject has at least about a 30% decrease in prostate specific antigen (PSA) by day 14 of treatment.
5. The method of claim 1 , wherein the subject has at least about a 60% decrease in prostate specific antigen (PSA) by day 28 of treatment.
6. The method of claim 1 , wherein the subject has at least about at 80% likelihood of maintaining a low prostate specific antigen (PSA) level of less than about 5 ng/mL during treatment.
7. The method of claim 1 , wherein the subject has locally advanced prostate cancer and has at least about a 40% decrease in PSA by day 14 of treatment.
8. The method of claim 1 , wherein the subject has a body mass index of less than 30 kg/m 2 .
9. The method of claim 1 , wherein the initial dose is administered at a concentration ranging from 5 mg/mL to 40 mg/m L.
10. The method of claim 1 , wherein the initial dose is administered at a concentration of 40 mg/m L.
11. The method of claim 1 , wherein the maintenance dose is administered as a single injection.
12. The method of claim 1 , wherein the maintenance dose is administered at a concentration ranging from 5 mg/mL to 40 mg/mL.
13. The method of claim 1 , wherein the maintenance dose is administered at a concentration of 20 mg/mL.
14. 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, wherein the initial dose is administered subcutaneously; and
administering a maintenance dose of 60-160 mg of degarelix to the subject once every 28 days thereafter for 364 days, wherein the maintenance dose results in a testosterone suppression below 0.5 ng/mL;
wherein the testosterone suppression is less than or equal to 0.5 ng/mL from day 28 to day 364 of treatment, and wherein the initial dose is administered as two subcutaneous injections.
15. The method of claim 14 , wherein the maintenance dose is administered monthly.
16. The method of claim 14 , wherein the subject has a decreased likelihood of developing or experiencing an undesirable side effect during treatment compared to treatment with gonadotrophin releasing hormone (GnRH) agonist leuprolide.
17. The method of claim 14 , wherein the subject has at least about a 30% decrease in prostate specific antigen (PSA) by day 14 of treatment.
18. The method of claim 14 , wherein the subject has at least about a 60% decrease in prostate specific antigen (PSA) by day 28 of treatment.
19. The method of claim 14 , wherein the subject has at least about a 80% likelihood of maintaining a low prostate specific antigen (PSA) level of less than about 5 ng/mL during treatment.
20. The method of claim 14 , wherein the subject has locally advanced prostate cancer and has at least about a 40% decrease in PSA by day 14 of treatment.
21. The method of claim 14 , wherein the subject has a body mass index of less than 30 kg/m 2 .
22. The method of claim 14 , wherein the initial dose is administered at a concentration ranging from 5 mg/mL to 40 mg/m L.
23. The method of claim 14 , wherein the initial dose is administered at a concentration of 40 mg/mL.
24. The method of claim 14 , wherein the maintenance dose is administered as a single injection.
25. The method of claim 14 , wherein the maintenance dose is administered at a concentration ranging from 5 mg/mL to 40 mg/m L.
26. The method of claim 14 , wherein the maintenance dose is administered at a concentration of 20 mg/mL.
27. 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, the method comprising:
administering an initial dose of 240 mg of degarelix to the subject, wherein the initial dose is administered subcutaneously; and
administering a maintenance dose of 80 mg of degarelix to the subject every 28 days thereafter, wherein the maintenance dose results in a testosterone suppression below 0.5 ng/mL;
wherein the testosterone suppression remains less than or equal to 0.5 ng/mL from day 28 to day 364 of treatment, and wherein the initial dose is administered as two subcutaneous injections.
28. The method of claim 27 , wherein the maintenance dose is administered monthly.
29. The method of claim 27 , wherein the maintenance dose is administered as a single injection.