Granted Patent
B2
US 12,533,387 · App. 17/199,733 · Granted Jan 27, 2026
Methods of treating prostate cancer with GnRH antagonist
Inventors:
Tine Kold Olesen (New York, NY); Bo-Eric Persson (St. Prex, CH); Per Cantor (Charlottenlund, DK); Egbert A. van der Meulen (Dalby, SE); Jens-Kristian Slott Jensen (Bagsvaerd, DK)
Assignee:
Ferring B.V.
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Abstract
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.
Claims (33)
1 . A method of treating advanced stage prostate cancer in a human subject with a decreased likelihood of developing arthralgia during treatment as compared to treatment with a gonadotrophin releasing hormone (GnRH) agonist, comprising:
administering an initial dose of 240 mg of degarelix to the subject as two subcutaneous injections of 120 mg each at a concentration of 40 mg/mL on the same day, and
administering a maintenance dose of 80 mg of degarelix at a concentration of 20 mg/mL to the subject as one subcutaneous injection, wherein the maintenance dose is administered approximately every 28 days after the previous dose of degarelix for a duration of treatment,
wherein the treated subject has a decreased likelihood of developing arthralgia during treatment compared to treatment with a GnRH agonist.
2 . A method of treating advanced stage prostate cancer in a human subject and achieving an at least 50% decrease in serum prostate specific antigen (PSA) level by about day 14 of treatment, comprising:
administering an initial dose of 240 mg of degarelix to the subject as two subcutaneous injections of 120 mg each at a concentration of 40 mg/mL on the same day, and
administering a maintenance dose of 80 mg of degarelix at a concentration of 20 mg/mL to the subject as one subcutaneous injection, wherein the maintenance dose is administered approximately every 28 days after the previous dose of degarelix for a duration of treatment,
wherein the treated subject has at least a 50% decrease in serum PSA level by about day 14 of treatment.
3 . The method of claim 1 , wherein the subject is less than 65 years old.
4 . The method of claim 1 , wherein the GnRH agonist is leuprolide.
5 . The method of claim 1 , wherein the subject has a body mass index of less than 30 kg/m 2 .
6 . The method of claim 2 , wherein the treated subject has at least a 60% decrease in serum PSA level by day 28 of treatment.
7 . The method of claim 2 , wherein the treated subject has at least a 75% decrease in serum PSA level by day 28 of treatment.
8 . The method of claim 1 , wherein the treatment with a GnRH agonist is treatment with monthly intramuscular injections of 7.5 mg leuprolide.
9 . The method of claim 1 , wherein the subject has locally advanced prostate cancer.
10 . The method of claim 1 , wherein the subject has metastatic prostate cancer.
11 . The method of claim 2 , wherein the treated subject has at least a 50% decrease in serum PSA level by day 14 of treatment.
12 . The method of claim 2 , wherein the treated subject has at least a 60% decrease in serum PSA level by about day 28 of treatment.
13 . The method of claim 2 , wherein the treated subject has at least a 75% decrease in serum PSA level by about day 28 of treatment.
14 . The method of claim 2 , wherein the subject has locally advanced prostate cancer.
15 . The method of claim 2 , wherein the subject has metastatic prostate cancer.
16 . A method of treating advanced stage prostate cancer in a human subject with a decreased likelihood of urinary tract infection during treatment as compared to treatment with a gonadotrophin releasing hormone (GnRH) agonist, comprising:
administering an initial dose of 240 mg of degarelix at a concentration of 40 mg/mL to the subject as two subcutaneous injections of 120 mg each on the same day, and
administering a maintenance dose of 80 mg of degarelix at a concentration of 20 mg/mL to the subject as one subcutaneous injection, wherein the maintenance dose is administered approximately every 28 days after the previous dose of degarelix for a duration of treatment,
wherein the treated subject has a decreased likelihood of urinary tract infection during treatment compared to treatment with a GnRH agonist.
17 . The method of claim 16 , wherein the subject has locally advanced prostate cancer.
18 . The method of claim 16 , wherein the subject is less than 65 years old.
19 . The method of claim 16 , wherein the GnRH agonist is leuprolide.
20 . The method of claim 16 , wherein the treatment with a GnRH agonist is treatment with monthly intramuscular injections of 7.5 mg leuprolide.
21 . The method of claim 2 , wherein the subject is less than 65 years old.
22 . The method of claim 2 , wherein the GnRH agonist is leuprolide.
23 . The method of claim 2 , wherein the treatment with a GnRH agonist is treatment with monthly intramuscular injections of 7.5 mg leuprolide.
24 . The method of claim 16 , wherein the subject has metastatic prostate cancer.
Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Jul 29, 2024
From: OLESEN, TINE KOLD; PERSSON, BO-ERIC; CANTOR, PER; VAN DER MEULEN, EGBERT A.; JENSEN, JENS-KRISTIAN SLOTT
To: FERRING B.V.
Reel/Frame 068109/0357 →
Priority Claims (1)
EP 08250703
· Feb 29, 2008
· regional
Continuity (6)
Provisional Application
61027741
· Feb 11, 2008
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