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Last Updated: April 5, 2025

Claims for Patent: 9,884,054

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Summary for Patent: 9,884,054

Title:	Anti-androgens for the treatment of non-metastatic castrate-resistant prostate cancer
Abstract:	Described herein are methods of treating non-metastatic castrate-resistant prostate cancer with anti-androgens.
Inventor(s):	Chen; Isan (San Diego, CA)
Assignee:	ARAGON PHARMACEUTICALS, INC. (San Diego, CA)
Application Number:	14/034,460
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,884,054
Patent Claims:	1. A method of treating non-metastatic castration-resistant prostate cancer in a male human comprising administering a therapeutically effective amount of an anti-androgen to a male human in need of such treatment, wherein the anti-androgen is: 4-[7-(6-cyano-5-trifluoromethylpyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspir- o[3.4]oct-5-yl]-2-fluoro-N-methylbenzamide, or 4-[7-[4-cyano-3-(trifluoromethyl)phenyl]-8-oxo-6-thioxo-5,7-diazaspiro[3.- 4]oct-5-yl]-2-fluoro-N-methylbenzamide. 2. The method of claim 1, wherein the non-metastatic castration-resistant prostate cancer is a high risk non-metastatic castration-resistant prostate cancer. 3. The method of claim 2, wherein the male human with the high risk non-metastatic castration-resistant prostate cancer has a prostate-specific antigen doubling time (PSADT) that is less than or equal to 10 months. 4. The method of claim 1, wherein administration of the anti-androgen provides an increase in the metastasis-free survival of the male human, relative to the mean survival rate of a population of male humans, with the non-metastatic castration-resistant prostate cancer, said population having been treated with a placebo. 5. The method of claim 1 that provides an increase in the metastasis-free survival of the male human with prostate cancer, relative to the mean survival rate of a population of male humans, with prostate cancer, said population having been treated with a placebo. 6. The method of claim 1, wherein the anti-androgen is 4-[7-(6-cyano-5-trifluoromethylpyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspir- o[3.4]oct-5-yl]-2-fluoro-N-methylbenzamide. 7. The method of claim 6, wherein 4-[7-(6-cyano-5-trifluoromethylpyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspir- o[3.4]oct-5-yl]-2-fluoro-N-methylbenzamide is administered daily to the male human. 8. The method of claim 6, wherein 4-[7-(6-cyano-5-trifluoromethylpyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspir- o[3.4]oct-5-yl]-2-fluoro-N-methylbenzamide is administered orally to the male human. 9. The method of claim 6, wherein 4-[7-(6-cyano-5-trifluoromethylpyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspir- o[3.4]oct-5-yl]-2-fluoro-N-methylbenzamide is administered orally to the male human at a dose of about 30 mg per day to about 480 mg per day. 10. The method of claim 6, wherein 4-[7-(6-cyano-5-trifluoromethylpyridin-3-yl)-8-oxo-6-thioxo-5, 7-diazaspiro[3.4]oct-5-yl]-2-fluoro-N-methylbenzamide (ARN-509) is administered orally to the male human at a dose of about 180 mg per day to about 480 mg per day. 11. The method of claim 6, wherein 4-[7-(6-cyano-5-trifluoromethylpyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspir- o[3.4]oct-5-yl]-2-fluoro-N-methylbenzamide (ARN-509) is administered orally to the male human at a dose of about 30 mg per day. 12. The method of claim 6, wherein 4-[7-(6-cyano-5-trifluoromethylpyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspir- o[3.4]oct-5-yl]-2-fluoro-N-methylbenzamide (ARN-509) is administered orally to the male human at a dose of about 60 mg per day. 13. The method of claim 6, wherein 4-[7-(6-cyano-5-trifluoromethylpyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspir- o[3.4]oct-5-yl]-2-fluoro-N-methylbenzamide (ARN-509) is administered orally to the male human at a dose of about 90 mg per day. 14. The method of claim 6, wherein 4-[7-(6-cyano-5-trifluoromethylpyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspir- o[3.4]oct-5-yl]-2-fluoro-N-methylbenzamide is administered orally to the male human at a dose of about 120 mg per day. 15. The method of claim 6, wherein 4-[7-(6-cyano-5-trifluoromethylpyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspir- o[3.4]oct-5-yl]-2-fluoro-N-methylbenzamide is administered orally to the male human at a dose of about 240 mg per day. 16. The method of claim 6, wherein 4-[7-(6-cyano-5-trifluoromethylpyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspir- o[3.4]oct-5-yl]-2-fluoro-N-methylbenzamide is administered orally to the male human on a continuous daily dosage schedule. 17. A method of treating non-metastatic castration-resistant prostate cancer in a male human consisting essentially of administering a therapeutically effective amount of an anti-androgen to a male human in need of such treatment, wherein the anti-androgen is 4-[7-(6-cyano-5-trifluoromethylpyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspir- o[3.4]oct-5-yl]-2-fluoro-N-methylbenzamide, or 4-[7-[4-cyano-3-(trifluoromethyl)phenyl]-8-oxo-6-thioxo-5,7-diazaspiro[3.- 4]oct-5-yl]-2-fluoro-N-methylbenzamide. 18. The method of claim 2, wherein the anti-androgen is 4-[7-(6-cyano-5-trifluoromethylpyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspir- o[3.4]oct-5-yl]-2-fluoro-N-methylbenzamide. 19. The method of claim 3, wherein the anti-androgen is 4-[7-(6-cyano-5-trifluoromethylpyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspir- o[3.4]oct-5-yl]-2-fluoro-N-methylbenzamide.

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