IP Library Granted Patent US 7,015,253
Granted Patent B2
US 7,015,253 · App. 10/193,716 · Granted Mar 21, 2006

Regimen for treating prostate tissue and surgical kit for use in the regimen

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Quick Facts
Patent No.
US 7,015,253
App. No.
10/193,716
Granted
Mar 21, 2006
Kind
B2
Abstract

The present invention provides treatment regimens for treating diseased prostate tissue, including the steps of chemically ablating prostate tissue and coadministering an antiandrogen. In some embodiments, prostate tissue is chemically ablated by injection of ethanol, or an injectable gel comprising ethanol, into prostate tissue. Steroidal and non-steroidal antiandrogens are suitable antiandrogens. One suitable non-steroidal antiandrogen is bicalutamide. The treatment regimen is suitable for treatment of prostate tissue diseases including benign prostatic hyperplasia and prostatic carcinoma. The invention further provides a treatment regimen for treating benign prostatic hyperplasia, including the steps of damaging prostate tissue and coadministering an antiandrogen. Also provided by the present invention is a kit for treating a human male, including a means for necrosing prostate tissue, an antiandrogen drug, and a means for administering the antiandrogen drug. A kit including a first surgical device for delivering a chemoablation fluid to prostate tissue transurethrally, an antiandrogen drug such as bicalutamide, and a second surgical device for administering the antiandrogen drug, is further provided.

Claims (49)

1. A treatment regimen for treating benign prostatic hyperplasia comprising:

a) necrosing hyperplastic prostate tissue sufficiently to elicit a reparative process, wherein necrosing prostate tissue includes surgically damaging a portion of prostate tissue by injecting ethanol into the portion of prostate tissue; and

b) coadministering a therapeutically effective amount of an antiandrogen;

such that steps a) and b) are sufficient to reduce the size of the prostate relative to its size prior to treatment.

2. The treatment regimen of claim 1 wherein surgically damaging the prostate tissue further includes heating the portion of prostate tissue.

3. The treatment regimen of claim 1 wherein surgically damaging the prostate tissue further includes cryoablating the portion of prostate tissue.

4. The treatment regimen of claim 1 wherein surgically damaging the prostate tissue futher includes irradiating the portion of prostate tissue with electromagnetic radiation.

5. The treatment regimen of claim 1 wherein surgically damaging the prostate tissue further includes irradiating the portion of prostate tissue with nuclear radiation.

6. The treatment regimen of claim 1 wherein surgically damaging the prostate tissue futher includes electrically vaporizing the portion of prostate tissue.

7. The treatment regimen of claim 1 wherein necrosing prostate tissue further includes chemically ablating a portion of prostate tissue.

8. The treatment regimen of claim 1 wherein ethanol is injected transurethrally.

9. The treatment regimen of claim 1 wherein ethanol is injected in the form of an injectable gel.

10. The treatment regimen of claim 1 wherein necrosing prostate tissue further includes medicinally damaging a portion of prostate tissue.

11. The treatment regimen of claim 1 wherein coadministering an antiandrogen includes administering a non-steroidal antiandrogen.

12. The treatment regimen of claim 11 wherein the non-steroidal antiandrogen is selected from the group consisting of flutamide, nilutamide and bicalutamide.

13. The treatment regimen of claim 11 wherein the non-steroidal antiandrogen comprises bicalutamide.

14. The treatment regimen of claim 1 wherein coadministering an antiandrogen includes administering a steroidal antiandrogen.

15. The treatment regimen of claim 14 wherein the steroidal antiandrogen is selected from the group consisting of cyproterone acetate, megestrol acetate, medroxyprogesterone acetate, chlormadinone acetate, and WIN 49596.

16. The treatment regimen of claim 1 wherein coadministering an antiandrogen occurs after necrosing the prostate tissue.

17. The treatment regimen of claim 1 wherein at least part of the step of coadministering an antiandrogen occurs prior to necrosing the prostate tissue.

18. The treatment regimen of claim 1 wherein at least part of the step of coadministering an antiandrogen occurs substantially during the step of necrosing the prostate tissue.

19. The treatment regimen of claim 1 wherein coadministering an antiandrogen further includes administering a luteinizing hormone-releasing hormone analog.

20. The treatment regimen of claim 19 wherein the luteinizing hormone-releasing hormone analog is selected from the group consisting of leuprolide acetate, goserelin acetate, buserelin acetate, and triptorelin pamoate.

21. The treatment regimen of claim 1 wherein coadministering an antiandrogen further includes administering a luteinizing hormone-releasing hormone antagonist.

22. The treatment regimen of claim 21 wherein the luteinizing hormone-releasing hormone antagonist is selected from the group consisting of cetrorelix and abarelix.

23. The treatment regimen of claim 1 wherein coadministering an antiandrogen further includes administering an inhibitor of 5α-reductase.

24. The treatment regimen of claim 23 wherein the inhibitor of 5α-reductase effectively inhibits Type II 5α-reductase.

25. The treatment regimen of claim 23 wherein coadministering an inhibitor of 5α-reductase includes administering a synthetic 4-azasteroid compound.

26. The treatment regimen of claim 25 wherein the 4-azasteroid compound is selected from finasteride, dutasteride and PNU 157706.

27. A treatment regimen for treating benign prostatic hyperplasia comprising:

a) damaging hyperplastic prostate tissue sufficiently to elicit a reparative process, wherein damaging prostate tissue includes chemically ablating a portion of prostate tissue by injecting ethanol into the portion of prostate tissue; and

b) coadministering a therapeutically effective amount of an antiandrogen;

such that steps a) and b) are sufficient to reduce the size of the prostate relative to its size prior to treatment.

28. The treatment regimen of claim 27 wherein damaging prostate tissue further includes surgically damaging a portion of prostate tissue.

29. The treatment regimen of claim 27 wherein ethanol is injected transurethrally.

30. The treatment regimen of claim 27 wherein ethanol is injected in the form of an injectable gel.

31. The treatment regimen of claim 27 wherein damaging prostate tissue further includes medicinally damaging a portion of prostate tissue.

32. The treatment regimen of claim 27 wherein coadministering an antiandrogen includes administering a non-steroidal antiandrogen.

33. The treatment regimen of claim 32 wherein the non-steroidal antiandrogen is selected from the group consisting of flutamide, nilutamide and bicalutamide.

34. The treatment regimen of claim 32 wherein the non-steroidal antiandrogen comprises bicalutamide.

35. The treatment regimen of claim 27 wherein coadministering an antiandrogen includes administering a steroidal antiandrogen.

36. The treatment regimen of claim 35 wherein the steroidal antiandrogen is selected from the group consisting of cyproterone acetate, megestrol acetate, medroxyprogesterone acetate, chlormadinone acetate, and WIN 49596.

37. A treatment regimen for treating benign prostatic hyperplasia comprising:

a) necrosing hyperplastic prostate tissue by injecting an effective amount of ethanol into a prostate; and

b) coadministering a therapeutically effective amount of an antiandrogen;

such that steps a) and b) are sufficient to reduce the size of the prostate relative to its size prior to treatment.

38. The treatment regimen of claim 37 wherein ethanol is injected transurethrally.

39. The treatment regimen of claim 37 wherein ethanol is injected in the form of an injectable gel.

40. The treatment regimen of claim 37 wherein the antiandrogen comprises bicalutamide.

Assignments (11)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 24, 2016
From: AMERICAN MEDICAL SYSTEMS, LLC
To: BOSTON SCIENTIFIC SCIMED, INC.
Reel/Frame 037901/0883 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 24, 2016
From: AMS RESEARCH, LLC
To: BOSTON SCIENTIFIC SCIMED, INC.
Reel/Frame 037901/0941 →
RELEASE OF SECURITY INTEREST Recorded Aug 6, 2015
From: DEUTSCHE BANK AG NEW YORK BRANCH
To: AMERICAN MEDICAL SYSTEMS, LLC; AMS RESEARCH, LLC; LASERSCOPE
Reel/Frame 036285/0146 →
GRANT OF SECURITY INTEREST IN PATENTS Recorded Mar 20, 2014
From: ENDO PHARMACEUTICALS SOLUTIONS, INC.; ENDO PHARMACEUTICALS, INC.; AMS RESEARCH CORPORATION; AMERICAN MEDICAL SYSTEMS, INC.; LASERSCOPE
To: DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT
Reel/Frame 032491/0440 →
RELEASE OF PATENT SECURITY INTEREST Recorded Mar 3, 2014
From: MORGAN STANLEY SENIOR FUNDING, INC., AS ADMINISTRATIVE AGENT
To: AMS RESEARCH CORPORATION
Reel/Frame 032380/0053 →
SECURITY AGREEMENT Recorded Jul 22, 2011
From: AMS RESEARCH CORPORATION
To: MORGAN STANLEY SENIOR FUNDING, INC., AS ADMINISTRATIVE AGENT
Reel/Frame 026632/0535 →
RELEASE OF SECURITY INTEREST (SUPERCEEDING RELEASE RECORDED ON JULY 30, 2004 AT REEL/FRAME 015621/0551) Recorded Jul 19, 2006
From: BANK OF AMERICA, N.A., AS AGENT
To: AMERICAN MEDICAL SYSTEMS, INC.
Reel/Frame 017957/0644 →
RELEASE OF SECURITY INTEREST Recorded Jul 30, 2004
From: BANK OF AMERICA, N.A.
To: AMERICAN MEDICAL SYSTEMS, INC.
Reel/Frame 015621/0551 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 21, 2003
From: AMERICAN MEDICAL SYSTEMS, INC.
To: AMS RESEARCH CORPORATION
Reel/Frame 013812/0567 →
NOTICE OF GRANT OF SECURITY INTEREST Recorded Jun 27, 2003
From: AMERICAN MEDICAL SYSTEMS, INC.
To: BANK OF AMERICA, N.A., AS AGENT
Reel/Frame 014210/0936 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 21, 2002
From: NEISZ, JOHANN, J.; ESCANDON, M. ALEJANDRO SOUSA
To: AMERICAN MEDICAL SYSTEMS, INC.
Reel/Frame 013391/0949 →