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

• US 7,015,253 B2
• Filed: 07/09/2002
• Issued: 03/21/2006
• Est. Priority Date: 07/10/2001
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: American Medical Systems Incorporated (Endo International PLC)
• Inventors: Neisz, Johann J., Escandon, M. Alejandro Sousa
• Primary Examiner(s): Low, Christopher S. F.
• Assistant Examiner(s): LEWIS, AMY A
• Application Number:
  US10/193,716
• Publication Number:
  US 20030092689A1
• Time in Patent Office: 1,351 Days
• Field of Search: 600/29, 600/31, 600/7, 604/264, 604/523, 604/528, 514/874, 514/724
• US Class Current: 514/724
• CPC Class Codes: A61B 17/32037 for removing obstructions from inner organs or blood vessels, e.g. for atherectomy
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00274 Prostate operation, e.g. prostatectomy, turp, bhp treatment
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/22082 after introduction of a substance
• CPC Class Codes: A61B 2017/2946 Locking means
• CPC Class Codes: A61B 2018/00547 Prostate
• CPC Class Codes: A61B 2090/035 preventing further rotation
• CPC Class Codes: A61B 2090/0801 Prevention of accidental cutting or pricking
• CPC Class Codes: A61M 5/486 Indicating injection pressure
• CPC Class Codes: A61M 5/488 Limiting injection pressure

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

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.