Cryoablation of Prostate- Improving Efficacy and Safety

Main Article Content

J. M. Baust T. J. Polascik Van Buskirk J. G. Baust

Abstract

Cryoablation has been shown to be an effective therapy for all stages of prostate cancer. Though judged efficacious, complications of treatment and persistent disease, although minimal, show the need for improvement. To this end, research has focused on new technology design for cryosurgical apparatus and imaging techniques. Adjunctive therapy, focusing on increasing cell death by apoptosis, also plays a role in this new direction with the intent of increasing cell death in the frozen tissue. Additionally, incorporating methods of protecting adjacent structures, including the urethra, bladder neck sphincter, urogenital diaphragm, neurovascular bundles, and rectum, are critical to achieving a successful outcome and continue to evolve. Several strategies to protect these structures are now commonplace as part of a cryosurgical procedure. These strategies include real-time temperature monitoring, visualization of ice growth during freezing, active heating and even the injection of protective media have emerged as methods to protect these structures. Another more recent procedural application is partial gland ablation or image-targeted focal therapy, developed to maintain cancer control yet minimize the risk of collateral damage to the various structures. Each of these methods has been shown in vitro, in vivo, and clinically to be beneficial. This article describes the directions that cryoablation has taken in an effort to improve procedural efficacy while reducing/eliminating associated co-morbidities.

Keywords: Cryosurgery, focal therapy, co-morbidity, Temperature Monitoring, Nerve Sparing, apoptosis, cryotherapy, neuroprotection, selective protection

Article Details

How to Cite
BAUST, J. M. et al. Cryoablation of Prostate- Improving Efficacy and Safety. Medical Research Archives, [S.l.], v. 8, n. 5, may 2020. ISSN 2375-1924. Available at: <https://esmed.org/MRA/mra/article/view/2106>. Date accessed: 22 dec. 2024. doi: https://doi.org/10.18103/mra.v8i5.2106.
Section
Research Articles

References

1. Cohen, J. K., Miller, R. J. Jr, Ahmed, S., Lotz, M. J., and Baust, J. Ten-year biochemical disease control for patients with prostate cancer treated with cryosurgery as primary therapy. Urology.2008; 71 (3). 515-518.
2. Babaian, R. J., Donnelly, B., Bahn, D., Baust, J. G., Dineen, M., Ellis, D., Katz, A., Pisters, L., Rukstalis, D., Shinohara, K., and Thrasher, J. B. Best practice statement on cryosurgery for the treatment of localized prostate cancer. J Urol.2008; 180 ( 5). 1993-2004.
3. Bahn, D. K., Lee, F., Badalament, R., Kumar, A., Greski, J., and Chernick, M. Targeted cryoablation of the prostate: 7-year outcomes in the primary treatment of prostate cancer. Urology.2002; 60 (2 Suppl 1). 3-11.
4. Long, J. P., Bahn, D., Lee, F., Shinohara, K., Chinn, D. O., and Macaluso, J. N. Jr. Five-year retrospective, multi-institutional pooled analysis of cancer-related outcomes after cryosurgical ablation of the prostate. Urology.2001; 57 (3). 518-523.
5. Prepelica, K. L., Okeke, Z., Murphy, A., and Katz, A. E. Cryosurgical ablation of the prostate: high risk patient outcomes. Cancer.2005; 103 (8). 1625-1630.
6. Touma, N. J., Izawa, J. I., and Chin, J. L. Current status of local salvage therapies following radiation failure for prostate cancer. J Urol.2005; 173 (2). 373-379.
7. Mouraviev, V. and Polascik, T. J. Update on cryotherapy for prostate cancer in 2006. Curr Opin Urol.2006; 16 (3). 152-156.
8. Peters M, Moman MR, van der Poel HG, Vergunst H, de Jong IJ, Vijverberg PL, Battermann JJ, Horenblas S, van Vulpen M. Patterns of outcome and toxicity after salvage prostatectomy, salvage cryosurgery and salvage brachytherapy for prostate cancer recurrences after radiation therapy: a multi-center experience and literature review. World J Urol. 2013; 31(2):403-9.
9. Finley DS, Belldegrun AS. Salvage cryotherapy for radiation-recurrent prostate cancer: outcomes and complications. Curr Urol Rep. 2011; 12(3):209-15.
10. Mouraviev V, Johansen TE, Polascik TJ. Contemporary results of focal therapy for prostate cancer using cryoablation. J Endourol. 2010; 24(5):827-34.
11. Witzsch UK, Becht E. Cryoablation of prostate cancer. Urologe A. 2015; 54(2):191-201.
12. Kongnyuy M, Halpern DM, Kosinski KE, Katz AE. Cryosurgery, an alternative treatment option for organ-confined prostate cancer: current beliefs and practice patterns of urologists. Int Urol Nephrol. 2017; 49(1):43-48.
13. Stokes, S.H. Comparison of biochemical disease-free survival of patients with localized carcinoma of the prostate undergoing radical prostatectomy, transperineal ultrasound-guided radioactive seed implantation, or definitive external beam irradiation. International Journal of Radiation Oncology, Biology, Physics. 47 (1): 129-136. 2000
14. D'Amico AV, Whittington R, Malkowicz SB, Cote K, Loffredo M, Schultz D, Chen MH, Tomaszewski JE, Renshaw AA, Wein A, Richie JP. Biochemical outcome after radical prostatectomy or external beam radiation therapy for patients with clinically localized prostate carcinoma in the prostate specific antigen era. Cancer. 2002 Jul 15;95(2):281-6
15. Fiveash JB, Hanks G, Roach M, Wang S, Vigneault E, McLaughlin PW, Sandler HM. 3D conformal radiation therapy (3DCRT) for high grade prostate cancer: a multi-institutional review. Int J Radiat Oncol Biol Phys. 2000 May 1;47(2):335-42.
16. Hanks GE, Hanlon AL, Schultheiss TE, Freedman GM, Hunt M, Pinover WH, Movsas B. Conformal external beam treatment of prostate cancer. Urology. 1997 Jul;50(1):87-92.
17. Stokes SH. Comparison of biochemical disease-free survival of patients with localized carcinoma of the prostate undergoing radical prostatectomy, transperineal ultrasound-guided radioactive seed implantation, or definitive external beam irradiation. Int J Radiat Oncol Biol Phys. 2000 Apr 1;47(1):129-36.
18. Ragde H, Blasko JC, Grimm PD, Kenny GM, Sylvester JE, Hoak DC, Landin K, Cavanagh W Interstitial iodine-125 radiation without adjuvant therapy in the treatment of clinically localized prostate carcinoma. Cancer. 1997 Aug 1;80(3):442-53.
19. Ritch, C. R. and Katz, A. E. Prostate cryotherapy: current status. Curr Opin Urol.2009; 19 (2). 177-181.
20. Baust, JM, Rabin, Polascik, T, Santucci, KL, Snyder, KK, Van Buskirk, RG and Baust, JG. Review Paper: Defeating cancers' adaptive defensive -strategies using thermal ablative therapies. Technol. Cancer Res. Treat. 2018; 17:1-16.
21. Baust JG, Gage AA, Bjerklund Johansen TE, Baust JM. Mechanisms of cryoablation: Clinical consequences on malignant tumors. Cryobiology. 2014; 68(2):1-11.
22. Baust, J. G. and Gage, A. A. The molecular basis of cryosurgery. BJU Int.2005; 95 (9). 1187-1191.
23. Baust, J. G., Gage, A. A., Klossner, D., Clarke, D., Miller, R., Cohen, J., Katz, A., Polascik, T., Clarke, H., and Baust, J. M. Issues critical to the successful application of cryosurgical ablation of the prostate. Technol Cancer Res Treat.2007; 6 (2). 97-109.
24. Gage, A. A. and Baust, J. Mechanisms of tissue injury in cryosurgery. Cryobiology.1998; 37 (3). 171-186.
25. Klossner, D. P., Robilotto, A. T., Clarke, D. M., VanBuskirk, R. G., Baust, J. M., Gage, A. A., and Baust, J. G. Cryosurgical technique: assessment of the fundamental variables using human prostate cancer model systems. Cryobiology.2007; 55 (3). 189-199.
26. Gage, A. A. and Baust, J. G. Cryosurgery for tumors. J Am Coll Surg.2007; 205 (2). 342-356.
27. Baust JM, Robilotto AT, Snyder KK, Santucci KL, et al. Assessment of Cryosurgical Device Performance Using an In Vivo-Like 3-D Tissue Engineered Cancer Model. Tech Cancer Res Treat. 2017; 16 (6): 900-909.
28. Baust JM, Robilotto, AT., Gage, AA. Baust JG. Enhanced Cryoablative Methodologies. In: Multiscale Technologies for Cryomedicine. Eds: Bishof, J. and Xi, Y. WSPC Publishers. http://www.worldscientific.com/doi/full/10.1142/9789814733199_0001. 2016. p3-24
29. Littrup PJ, Jallad B, Vorugu V, Littrup G, Currier B, George M, et al. Lethal isotherms of cryoablation in a phantom study: effects of heat load, probe size, and number. J Vasc Interv Radiol. 2009; 20(10):1343-51.
30. Shah T, Arbel U, Foss S, Zachman A, Rodney AAmad H, Arya M. Modeling cryotherapy ice ball dimensions and isotherms in a novel gel-based model to determine optimal cryo-needle configurations and settings for potential use in clinical practice. Urology, 2016; 91; 234 – 240
31. Robilotto, A.T., Baust, JM, Santucci, KL, Snyder, KK, Van Buskirk, RG and Baust, JG. Assessment of a Novel Supercritical Nitrogen Cryosurgical Device Using Prostate and Renal Cancer Tissue Engineered Models. Medical Devices and Diagnostic Engineering. 2019; 5:1-8.
32. Baust JG, Bischof JC, Jiang-Hughes J, Polascik TJ, RukstalisDB, Gage AA, Baust JM. Re-purposing cryoablation: a combinatorial ‘therapy’ for the destruction of tissue. Prostate cancer and Prostatic Diseases; 2015; 18(2):87-95.
33. Hollister, W. R., Mathew, A. J., Baust, J. G., and Van Buskirk, R. G. Effects of freezing on cell viability and mechanisms of cell death in a human prostate cell line. Mol. Urol.1998; 2: 213-218 .
34. Baust, J. G. , Gage, A. A., Robilotto, A., and Baust, J. M. The Pathophysiology of Thermoablation. Curr. Opin. Urol.2009; 19 (2). 127-132
35. Goel, R., Anderson, K., Slaton, J., Schmidlin, F., Vercellotti, G., Belcher, J., and Bischof, J. C. Adjuvant approaches to enhance cryosurgery. J Biomech Eng.2009; 131 (7). 074003.
36. Robilotto, A.T., Van Buskirk, R.G., Gage, A.A. and Baust, J.G. Temperature-dependent Activation of Differential Apoptotic Pathways During Cryoablation in a Human Prostate Cancer Model. Prostate Cancer and Prostatic Diseases. 2013; 16(1). 41-49.
37. Clarke, D. M., Hollister, W. R., Baust, J. G., and Van Buskirk, R. G. Cryosurgical Modeling: Sequence of Freezing and Cytotoxic Agent Application Affects Cell Death. Mol Urol. 1999; 3 (1). 25-31.
38. Pham, L., Dahiya, R., and Rubinsky, B. An in vivo study of antifreeze protein adjuvant cryosurgery. Cryobiology. 1999; 38 (2). 169-175.
39. Hanai, A., Yang, W. L., and Ravikumar, T. S. Induction of apoptosis in human colon carcinoma cells HT29 by sublethal cryo-injury: mediation by cytochrome c release. Int J Cancer.2001; 93 (4). 526-533.
40. Clarke, D. M., Baust, J. M., Van Buskirk, R. G., and Baust, J. G. Chemo-cryo combination therapy: an adjunctive model for the treatment of prostate cancer. Cryobiology.2001; 42 (4). 274-285.
41. Clarke, D. M., Baust, J. M., Van Buskirk, R. G., and Baust, J. G. Addition of anticancer agents enhances freezing-induced prostate cancer cell death: implications of mitochondrial involvement. Cryobiology.2004; 49 (1). 45-61.
42. Koushafar, H. and Rubinsky, B. Effect of antifreeze proteins on frozen primary prostatic adenocarcinoma cells. Urology. 1997; 49 (3). 421-425.
43. Clarke, D. M., Robilotto, A. T., Van Buskirk, R. G., Baust, J. G., Gage, A. A., and Baust, J. M. Targeted induction of apoptosis via TRAIL and cryoablation: a novel strategy for the treatment of prostate cancer. Prostate Cancer Prostatic Dis.2007; 10 (2). 175-184.
44. Sabel, M. S. Cryo-immunology: a review of the literature and proposed mechanisms for stimulatory versus suppressive immune responses. Cryobiology.2009; 58 (1). 1-11.
45. Burton, S. A., Paljug, W. R., Kalnicki, S., and Werts, E. D. Hypothermia-enhanced human tumor cell radiosensitivity. Cryobiology. 1997; 35 (1). 70-78.
46. Le Pivert, P. J., Morrison, D. R., Haddad, R. S., Renard, M., Aller, A., Titus, K., and Doulat, J. Percutaneous Tumor Ablation: Microencapsulated Echo-guided Interstitial Chemotherapy Combined with Cryosurgery Increases Necrosis in Prostate Cancer. Technol Cancer Res Treat.2009; 8 (3). 207-216.
47. Muldrew, K., Rewcastle, J., Donnelly, B. J., Saliken, J. C., Liang, S., Goldie, S., Olson, M., Baissalov, R., and Sandison, G. Flounder antifreeze peptides increase the efficacy of cryosurgery. Cryobiology.2001; 42 (3). 182-189.
48. Baust JM, Klossner D, Robilotto AT, Van Buskirk RG, Gage AA, Mouraviev V, Polascik TJ, Baust JG Vitamin D3 Cryosensitization Increases Prostate Cancer Susceptibility to Cryoablation via Apoptosis. British Journal of Urology International. 2012; 109(6). 949-958.
49. Santucci KL, Snyder KK., Baust JM, Van Buskirk RG, Mouraviev V, Polascik TJ, Gage AA, Baust JG. The use of 1,25α Dihydryoxyvitamin D3 as a Cryosensitizing Agent in a Murine Prostate Cancer Model Prostate Cancer and Prostatic Disease. 2011; 12(2):97-104.
50. Baust, JG, Klossner, D, Van Buskirk, R, Gage, A, Mouraviev V, Polascik, T, and Baust, JM. Integrin Expression Increase Freeze Resistance in Androgen-Insensitive Prostate Cancer. Prostate Cancer and Prostatic Disease.2010; 13(2):151-161.
51. Kimura, M., Rabbani, Z., Mouraviev, V., Tsivian, M., Mayes, J., Vujaskovic, Z., Satoh, T., Baba, S. Baust, JM., Baust, JG., and Polascik, T. Cryoablation Increased Intratumoral Hypoxia and Necrosis in Orthotopic Prostate Cancer and its Relationship with Microvessel Density and Apoptosis. Cryobiology. 2010; 61(1): 148-154.
52. Kimura M, Rabbani Z, Mouraviev V, Tsivian M, Caso J, Satoh T, Baba S, Vujaskovic Z, Baust JM, Baust JG, Polascik TJ. Role of Vitamin D(3) as a Sensitizer to Cryoablation in a Murine Prostate Cancer Model: Preliminary In Vivo Study. Urology.2010; 76(3):764 e.14-20.
53. Niu L, Chen J, He L, Liao M, Yuan Y, Zeng J, et al. Combination treatment with comprehensive cryoablation and immunotherapy in metastatic pancreatic cancer. Pancreas. 2013; 42(7):1143-9
54. Shao, Q., O' Flanagan, S., Lam, T., Roy, P., Pelaez, F., Burbach, B., Azarin, S., Shimizu, Y. and Bischof, J. Engineering T cell response to cancer antigens by choice of focal therapeutic conditions, International Journal of Hyperthermia. 2019; 36:1, 130-138.
55. Baust, J.G., Snyder, K.K., Santucci, K.L., Robilotto, A.T., Van Buskirk, R.V., Baust, J.M. Cryoablation: Physical and Molecular Basis with Putative Immunological Consequences, Intl. J. Hyperthermia.2019; 36:sup1, 10-16.
56. Onik, G. Image-guided prostate cryosurgery: state of the art. Cancer Control.2001; 8 (6). 522-531.
57. Saliken, J. C., Donnelly, B. J., and Rewcastle, J. C. The evolution and state of modern technology for prostate cryosurgery. Urology.2002; 60 (2 Suppl 1). 26-33.
58. Cohen, J. K. and Miller, R. J. Thermal protection of urethra during cryosurgery of prostate. Cryobiology. 1994; 31 (3). 313-316.
59. Rubinsky, B. Use of cryoprotective agent compounds during cryosurgery. 6,041,787 ed.2000.
60. Mouraviev, V. G., Prokhorov, D., and Prokhorov, G. A. Rectal and Urethral Sphincter Protection during Aggressive Prostate Cryosurgery: The Possible Clinical Application of Special Antifreeze Cocktail for an Injection into Anterior and Posterior Paraprostatic Spaces. Advances in Cryomedicine. 2001; 111-113.
61. Bischof, J. C., Merry, N., and Hulbert, J. Rectal protection during prostate cryosurgery: design and characterization of an insulating probe. Cryobiology. 1997; 34 (1). 80-92.
62. Cytron, S., Paz, A., Kravchick, S., Shumalinski, D., and Moore, J. Active rectal wall protection using direct transperineal cryo-needles for histologically proven prostate adenocarcinomas. Eur Urol.2003; 44 (3). 315-320.
63. Cohen, J. K. , Miller, R. J., and Shuman, B. A. Urethral warming catheter for use during cryoablation of the prostate. Urology. 1995; 45 (5). 861-864.
64. Cozzi, P. J. , Lynch, W. J., Robson, N., Vonthethoff, L., Lumley, T., and Morris, D. L. In vitro and in vivo assessment of urethral warming catheters for the transperineal cryoablation of prostatic carcinoma. Br J Urol. 1996; 78 (4). 589-595.
65. Rabin, Y. and Stahovich, T. F. The thermal effect of urethral warming during cryosurgery. Cryo Letters.2002; 23 (6). 361-374.
66. De La Taille, A., Benson, M. C., Bagiella, E., Burchardt, M., Shabsigh, A., Olsson, C. A., and Katz, A. E. Cryoablation for clinically localized prostate cancer using an argon-based system: complication rates and biochemical recurrence. BJU Int.2000; 85 (3). 281-286.
67. Takeda T, Tin AL et al: Topography of prostate cancer recurrence after radiation therapy: A detailed mapping study of salvage radical prostatectomy specimens. Eur Urol 73(4): 488-490, 2018
68. Rukstalis, D. B., Goldknopf, J. L., Crowley, E. M., and Garcia, F. U. Prostate cryoablation: a scientific rationale for future modifications. Urology.2002; 60 (2 Suppl 1). 19-25.
69. Gage, A. A. and Baust, J. G. Cryosurgery - a review of recent advances and current issues. Cryo Letters.2002; 23 (2). 69-78.
70. Gage, A. A., Baust, J. M., and Baust, J. G. Experimental cryosurgery investigations in vivo. Cryobiology.2009; 59 (3). 229-43.
71. Perpelica, K. and Rewcastle, J. C. Five and Seven Year Follow-up Validates and Promotes Advancement of Prostate Cryoablation. ESU Cryosurgery.2003; 8: 8-11.
72. Martin JW, Patel RM, Okhunov Z, Vyas A, Bajgrt D, Clayman RV. Multipoint thermal sensors associated with improved oncologic outcomes following cryoablation. 2017; 31(4): 355-360.
73. Baust, J.M., Snyder, K., Katz, J., Gage, A., Van Buskirk, R.G., Baust, J.G. Investigation of Neuronal Cell Stress Response to Transient Freezing Associated with Cryosurgical Ablation of the Prostate Cryobiology. 2010; 61(3): 364.
74. Mouraviev, V. G., Chin, J. L., Downey, D. B., and Moussa, M. Image-guided Targeted Cryoablation for Canine Prostate Model Using New Cryopreservation Cocktail for Neurovascular Bundle Protection. Advances in Cryomedicine. 2001; 108-110.
75. Onik, G., Narayan, P., Vaughan, D., Dineen, M., and Brunelle, R. Focal "nerve-sparing" cryosurgery for treatment of primary prostate cancer: a new approach to preserving potency. Urology.2002; 60 (1). 109-114.
76. Abern MR, Tsivian M, Polascik TJ. Focal therapy of prostate cancer: evidence-based analysis for modern selection criteria. Curr Urol Rep. 2012;13(2):160-9.
77. Janzen, N. K., Han, K. R., Perry, K. T., Said, J. W., Schulam, P. G., and Belldegrun, A. S. Feasibility of nerve-sparing prostate cryosurgery: applications and limitations in a canine model. J Endourol.2005; 19 (4). 520-525.
78. Polascik, T. J., Mayes, J. M., and Mouraviev, V. Nerve-sparing focal cryoablation of prostate cancer. Curr Opin Urol.2009; 19 (2). 182-187.
79. Onik, G., Vaughan, D., Lotenfoe, R., Dineen, M., and Brady, J. The "male lumpectomy": focal therapy for prostate cancer using cryoablation results in 48 patients with at least 2-year follow-up. Urol Oncol.2008; 26 (5). 500-505.
80. Shah TT, Ahmed H, Kanthabalan A, Lau B, Ghei M, Maraj B, Arya M. Focal cryotherapy of localized prostate cancer: a systematic review of the literature. Expert Rev Anticancer Ther. 2014; 14(11):1337-47.
81. Chalasani V, Williams AK, Chin J. Contemporary results of focal therapy for prostate cancer using cryotherapy. Panminerva Med. 2010; 52(3):217-22.
82. Ashrafi. A., et al. Focal therapy reduces pathological progression and radical treatment at 6 years compared to active surveillance in Gleason 6 prostate cancer. 12th International Symposium on Focal Therapy and Imaging in Prostate and Kidney Cancer. February 9-11, 2020
83. Katz, AA. Patient Selection for Focal Therapy - Rationale for salvage focal therapy. 12th International Symposium on Focal Therapy and Imaging in Prostate and Kidney Cancer. February 9-11, 2020
84. Katz, AA. Prostate Cryoablation - 20 year experience TIPS and Tricks. 12th International Symposium on Focal Therapy and Imaging in Prostate and Kidney Cancer. February 9-11, 2020
85. Polascik, T. Platforms and Performance of Focal Therapy - Talk with the Experts: Cryoablation. 12th International Sympo-sium on Focal Therapy and Imaging in Prostate and Kidney Cancer. February 9-11, 2020
86. Ready, D. et. al. Focal therapy compared to radical prostatectomy for non-metastatic prostate cancer: a propensity matched study. 12th International Symposium on Focal Therapy and Imaging in Prostate and Kidney Cancer. February 9-11, 2020
87. Tan, WP. et al. Short-term Oncological Outcomes and Functional Outcome is similar between Salvage Focal Cryotherapy and Salvage Whole Gland Therapy for Radiation Resistant Prostate Cancer. 12th International Symposium on Focal Therapy and Imaging in Prostate and Kidney Cancer. February 9-11, 2020