Cryotherapy for the Treatment of Prostate Cancer C

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Cryotherapy for the Treatment of Prostate Cancer C. Ryan Barnes, MD Virginia Urology This

Cryotherapy for the Treatment of Prostate Cancer C. Ryan Barnes, MD Virginia Urology This information is provided for general information on Cryoablation and is notintendedto toaddressthe thetreatmentfor of any particular patient. . Providers must consult System Operator's Manual for complete instructions. 2012, 2013 Health. Tronics, Inc. All rights reserved HTUS/EU-00058 a ©© 2012,

Localized Prostate Cancer Management Options �Active Surveillance �Hormone therapy �Radical prostatectomy �Open �Laparoscopic (with

Localized Prostate Cancer Management Options �Active Surveillance �Hormone therapy �Radical prostatectomy �Open �Laparoscopic (with or without a robot) �Brachytherapy (seed implantation) �External beam radiation �Cryotherapy (Cryoablation, Cryosurgery) 2 This information is provided for general information on Cryoablation and is not intended to address the treatment of any particular patient. Providers must consult System Operator's Manual for complete instructions. © 2012, 2013 Health. Tronics, Inc. All rights reserved HTUS/EU-00058 a

Prostate Cryotherapy This information is provided for general information on Cryoablation and is not

Prostate Cryotherapy This information is provided for general information on Cryoablation and is not intended to address the treatment of any particular patient. Providers must consult System Operator's Manual for complete instructions. © 2012, 2013 Health. Tronics, Inc. All rights reserved HTUS/EU-00058 a

AUA Best Practice Statement August 2008 A review of the historical evolution of cryosurgery

AUA Best Practice Statement August 2008 A review of the historical evolution of cryosurgery provides two overriding messages, the first being that there is evidence of therapeutic benefit, and the second, that treatment-associated morbidity has been reduced as technological refinements have emerged. Babbian et al. J Urol 2008; 180(5): 1993 -2004 4 This information is provided for general information on Cryoablation and is not intended to address the treatment of any particular patient. Providers must consult System Operator's Manual for complete instructions. © 2012, 2013 Health. Tronics, Inc. All rights reserved HTUS/EU-00058 a

Cryotherapy Refinements �Transrectal Ultrasound (TRUS) �Argon and helium �Thermocouple monitoring �Urethral warming �Variable ice

Cryotherapy Refinements �Transrectal Ultrasound (TRUS) �Argon and helium �Thermocouple monitoring �Urethral warming �Variable ice lengths (short ice) �Multiple cryoprobe controls 5 This information is provided for general information on Cryoablation and is not intended to address the treatment of any particular patient. Providers must consult System Operator's Manual for complete instructions. © 2012, 2013 Health. Tronics, Inc. All rights reserved HTUS/EU-00058 a

How Ice Destroys Cancer �Ice formation ruptures and destroys cells �Destruction occurs at time

How Ice Destroys Cancer �Ice formation ruptures and destroys cells �Destruction occurs at time of treatment �Tumor blood supply damaged beyond repair �Harmless scar tissue left behind Baust, et al. Curr Opin Urol 2009 This information is provided for general information on Cryoablation and is not intended to address the treatment of any particular patient. Providers must consult System Operator's Manual for complete instructions. © 2012, 2013 Health. Tronics, Inc. All rights reserved HTUS/EU-00058 a

Cryotherapy History � 19 th Century �Ice used for local control of cervical cancer

Cryotherapy History � 19 th Century �Ice used for local control of cervical cancer � 1960’s �Closed metal tube with tissue contact for Parkinson’s disease � 1960’s to 1980’s �Evolution of urologic application from open approaches to transurethral to transperineal Ahmed L, et al. J Endouro 2006; 20(7): 471 -474. 7 This information is provided for general information on Cryoablation and is not intended to address the treatment of any particular patient. Providers must consult System Operator's Manual for complete instructions. © 2012, 2013 Health. Tronics, Inc. All rights reserved HTUS/EU-00058 a

Today: Endocare, Inc � Integrated or external ultrasound � Fold-down keyboard � Probe holder

Today: Endocare, Inc � Integrated or external ultrasound � Fold-down keyboard � Probe holder and testing rack 8 This information is provided for general information on Cryoablation and is not intended to address the treatment of any particular patient. Providers must consult System Operator's Manual for complete instructions. © 2012, 2013 Health. Tronics, Inc. All rights reserved HTUS/EU-00058 a

Cryoprobes produce various iceballs These isotherms represent measurements collected using gelatin formula which approximates

Cryoprobes produce various iceballs These isotherms represent measurements collected using gelatin formula which approximates performance (± 5 mm) in soft tissue at 100% gas for 10 minutes. The actual isotherms may vary. 9 This information is provided for general information on Cryoablation and is not intended to address the treatment of any particular patient. Providers must consult System Operator's Manual for complete instructions. © 2012, 2013 Health. Tronics, Inc. All rights reserved HTUS/EU-00058 a

Cryotherapy Applications �Primary Treatment �Salvage Treatment for Post-Radiotherapy Recurrence 10 This information is provided

Cryotherapy Applications �Primary Treatment �Salvage Treatment for Post-Radiotherapy Recurrence 10 This information is provided for general information on Cryoablation and is not intended to address the treatment of any particular patient. Providers must consult System Operator's Manual for complete instructions. © 2012, 2013 Health. Tronics, Inc. All rights reserved HTUS/EU-00058 a

Primary Cryotherapy 11 This information is provided for general information on Cryoablation and is

Primary Cryotherapy 11 This information is provided for general information on Cryoablation and is not intended to address the treatment of any particular patient. Providers must consult System Operator's Manual for complete instructions. © 2012, 2013 Health. Tronics, Inc. All rights reserved HTUS/EU-00058 a

Primary Cryotherapy Patient Selection 2008 AUA Best Practice Statement: Any patient with biopsy proven

Primary Cryotherapy Patient Selection 2008 AUA Best Practice Statement: Any patient with biopsy proven localized prostate cancer. � Reasonable Ideal patients: size gland (Consider neoadjuvant reduction for large glands) � No prior TURP � PSA < 10 ng/m. L � Patients with high risk of positive margins � Non-surgical candidates � Patients for whom potency is low priority Babbian et al. J Urol 2008; 180(5): 1993 -2004 12 This information is provided for general information on Cryoablation and is not intended to address the treatment of any particular patient. Providers must consult System Operator's Manual for complete instructions. © 2012, 2013 Health. Tronics, Inc. All rights reserved HTUS/EU-00058 a

Primary Cryotherapy Data Highlights 3 �Timeframes up to 10 years 1 -8 �Over 6,

Primary Cryotherapy Data Highlights 3 �Timeframes up to 10 years 1 -8 �Over 6, 000 patients studied 1 -8 �Overall BDFS = 73%-90% 3 �Return to potency as high as 51% after 4 years �Utilized active rehabilitation 1, 3, 5 -8 �Rectal injury ≤ 0. 5% 1, 4 -8 �Incontinence < 8% 1 Dhar et al, J Urol 2010; 183(4 Supl): e 184 Abstract 467. 2 Donnelly et al, Cancer 2010; 116(2): 323 -30. 3 Cohen et al, Urology 2008; 71(3): 515 -8. 4 Di. Blasio et al, IBJU 2008; 34: 443 -50. 5 Ellis et al, Urology 2007; 69(2): 306 -10. 6 Prepelica et al, Cancer 2005; 103(8): 1625 -30. 7 Bahn et al, Urology 2002; 60(Supl 2 A): 3 -11. 8 Long et al, Urology 2001; 57(3): 518 -23. 13 This information is provided for general information on Cryoablation and is not intended to address the treatment of any particular patient. Providers must consult System Operator's Manual for complete instructions. © 2012, 2013 Health. Tronics, Inc. All rights reserved HTUS/EU-00058 a

2010: Patients Followed Over 10 Years Cancer Specific Survival = 92% (Only 8% died

2010: Patients Followed Over 10 Years Cancer Specific Survival = 92% (Only 8% died due to prostate cancer) 14 This information is provided for general information on Cryoablation and is not intended to address the treatment of any particular patient. Providers must consult System Operator's Manual for complete instructions. © 2012, 2013 Health. Tronics, Inc. All rights reserved HTUS/EU-00058 a

Primary Cryotherapy Efficacy Comparison 15 This information is provided for general information on Cryoablation

Primary Cryotherapy Efficacy Comparison 15 This information is provided for general information on Cryoablation and is not intended to address the treatment of any particular patient. Providers must consult System Operator's Manual for complete instructions. © 2012, 2013 Health. Tronics, Inc. All rights reserved HTUS/EU-00058 a

Cryoablation versus EBRT Cancer 2010; 116: 323 -330 “Significantly fewer positive biopsies were documented

Cryoablation versus EBRT Cancer 2010; 116: 323 -330 “Significantly fewer positive biopsies were documented after cryoablation than after radiotherapy. ” 16 This information is provided for general information on Cryoablation and is not intended to address the treatment of any particular patient. Providers must consult System Operator's Manual for complete instructions. © 2012, 2013 Health. Tronics, Inc. All rights reserved HTUS/EU-00058 a

PSA Stability for low-risk cancer Graph and references from Katz and Rewcastle, Current Onc

PSA Stability for low-risk cancer Graph and references from Katz and Rewcastle, Current Onc Reports 2003; 5: 231 -238. Used with permission 17 This information is provided for general information on Cryoablation and is not intended to address the treatment of any particular patient. Providers must consult System Operator's Manual for complete instructions. © 2012, 2013 Health. Tronics, Inc. All rights reserved HTUS/EU-00058 a

PSA Stability for moderate-risk cancer Graph and references from Katz and Rewcastle, Current Onc

PSA Stability for moderate-risk cancer Graph and references from Katz and Rewcastle, Current Onc Reports 2003; 5: 231 -238. Used with permission 18 This information is provided for general information on Cryoablation and is not intended to address the treatment of any particular patient. Providers must consult System Operator's Manual for complete instructions. © 2012, 2013 Health. Tronics, Inc. All rights reserved HTUS/EU-00058 a

PSA Stability for high-risk cancer Graph and references from Katz and Rewcastle, Current Onc

PSA Stability for high-risk cancer Graph and references from Katz and Rewcastle, Current Onc Reports 2003; 5: 231 -238. Used with permission 19 This information is provided for general information on Cryoablation and is not intended to address the treatment of any particular patient. Providers must consult System Operator's Manual for complete instructions. © 2012, 2013 Health. Tronics, Inc. All rights reserved HTUS/EU-00058 a

Primary Cryotherapy Morbidity Comparison 20 This information is provided for general information on Cryoablation

Primary Cryotherapy Morbidity Comparison 20 This information is provided for general information on Cryoablation and is not intended to address the treatment of any particular patient. Providers must consult System Operator's Manual for complete instructions. © 2012, 2013 Health. Tronics, Inc. All rights reserved HTUS/EU-00058 a

Range of Incontinence Rates (2000 -05) 49%1 50 Occurrence (%) 40 30 20 15%9

Range of Incontinence Rates (2000 -05) 49%1 50 Occurrence (%) 40 30 20 15%9 8%3 10 7%2 0 Radical Prostatectomy 10%5 7%7 1%4 1%6 4%8 0%10 Cryo Brachy External Beam RT IMRT 1 Steineck et al, NEJM 2002; 347(11): 790 -6; 2 Walsh et al, J Urol 2000; 163(6): 1802 -7. 3 Long et al, Urology 2001; 57(3): 518 -23. 4 Donnelly et al, Urology 2002; 60(4): 645 -9. 5 Reis et al, Int Urol Nephrol 2004; 36(2): 187 -90. 6 Feigenberg et al, Int J Radiat Oncol Biol Phys 2005; 62(4): 956 -64. 7 Matalinska et al, J Clin Oncol 2001; 19(6): 1619 -28. 8 Potosky et al, J NCI 2000; 92(19): 1582 -92. 9 Zelefsky et al, Int J Radiat Oncol Biol Phys 2002; 53(5): 1111 -6. 10 Brabbins et al, Int J Radiat Oncol Biol Phys 2005; 61(2): 400 -8. 21 This information is provided for general information on Cryoablation and is not intended to address the treatment of any particular patient. Providers must consult System Operator's Manual for complete instructions. © 2012, 2013 Health. Tronics, Inc. All rights reserved HTUS/EU-00058 a

Range of Impotence Rates (2000 -05) 100 91%1 93%3 Occurrence (%) 80 63%7 60

Range of Impotence Rates (2000 -05) 100 91%1 93%3 Occurrence (%) 80 63%7 60 49%9 51%5 53%4 40 41%8 32%10 20 14%2 0 Radical Prostatectomy 5%6 Cryo Brachy External Beam RT IMRT 1 Matalinska et al, J Clin Oncol 2001; 19(6): 1619 -28. 2 Walsh et al, J Urol 2000; 163(6): 1802 -7. 3 Bahn et al, Urology 2002; 60(Supl 2 A): 3 -11. et al, Urology 2002; 60(4): 645 -9. 5 Incrocci et al, Acta Oncol 2005; 44(7): 673 -8. 6 Incrocci et al, Acta Oncol 2005; 44(7): 673 -8. 7 Potosky et al, JNCI 2000; 92(19): 1582 -92. 8 Matalinska et al, J Clin Oncol 2001; 19(6): 1619 -28. 9 Zelefsky et al, J Urol 2006; 176(4): 1415 -9. 10 Skala et al, Int J Radiat Onco Biol Phys 2007; 68(3): 690 -8. 4 Donnelly 22 This information is provided for general information on Cryoablation and is not intended to address the treatment of any particular patient. Providers must consult System Operator's Manual for complete instructions. © 2012, 2013 Health. Tronics, Inc. All rights reserved HTUS/EU-00058 a

Rectal Morbidity Severe (fistula) Moderate (bleeding, urgency, diarrhea) Radical Prostatectomy 1 -19%1, 2 Cryotherapy

Rectal Morbidity Severe (fistula) Moderate (bleeding, urgency, diarrhea) Radical Prostatectomy 1 -19%1, 2 Cryotherapy < 0. 5%3 0%4 Brachytherapy < 0. 5%5 “Rare”-27%6, 7 Beam radiation 12 -43%1, 2 IMRT 0 -25%8, 9 1 Shrader-Bogen et al, Cancer 1997; 79: 1977 -86. 2 Talcott et al, J Clin Oncol 1998; 16(1): 275 -83. 3 Dhar et al, J Urol 2010; 183(4 Supl): e 184 Abstract 467. 4 Donnelly et al, Urology 2002; 60(4): 645 -9. 5 Theodorescu et al, Cancer 2000; 89(10): 2085 -91. 6 Ragde et al, Cancer 1997; 80(3): 442 -52. 7 Merrick et al, Int J Radiat Oncol Biol Phys 2000; 48(3): 667 -74. 8 Zelefsky et al, Radiother Oncol; 55: 241 -9. 9 Brabbins et al, Int J Radiat Oncol Biol Phys. 2005; 61(2): 400 -8. 23 This information is provided for general information on Cryoablation and is not intended to address the treatment of any particular patient. Providers must consult System Operator's Manual for complete instructions. © 2012, 2013 Health. Tronics, Inc. All rights reserved HTUS/EU-00058 a

Primary Cryotherapy Summary �Efficacies appear to be similar across treatments �Cryoablation may be better

Primary Cryotherapy Summary �Efficacies appear to be similar across treatments �Cryoablation may be better for high risk patients �Morbidities differ across treatments �Urinary function may be better for cryoablation over surgery �Bowel function may be better for cryoablation over radiation �Impotence is likely after primary cryoablation � May be reduced with active rehabilitation �Patients must discuss specific circumstances and possible risks and benefits of cryoablation with their urologist 24 This information is provided for general information on Cryoablation and is not intended to address the treatment of any particular patient. Providers must consult System Operator's Manual for complete instructions. © 2012, 2013 Health. Tronics, Inc. All rights reserved HTUS/EU-00058 a

Salvage Cryotherapy for Post-Radiotherapy Recurrence 25 This information is provided for general information on

Salvage Cryotherapy for Post-Radiotherapy Recurrence 25 This information is provided for general information on Cryoablation and is not intended to address the treatment of any particular patient. Providers must consult System Operator's Manual for complete instructions. © 2012, 2013 Health. Tronics, Inc. All rights reserved HTUS/EU-00058 a

Radiation Therapy Failure � 46, 870 localized Ca. P, XRT/brachy � 32% biopsy proven

Radiation Therapy Failure � 46, 870 localized Ca. P, XRT/brachy � 32% biopsy proven failures = 15, 000 �Reported treatments for radiation failures: �Hormone therapy 93. 5 % �Radical prostatectomy 0. 9 % �Cryotherapy 3. 0 % Agarwal PK et al. Cancer 2008; 112: 307 26 This information is provided for general information on Cryoablation and is not intended to address the treatment of any particular patient. Providers must consult System Operator's Manual for complete instructions. © 2012, 2013 Health. Tronics, Inc. All rights reserved HTUS/EU-00058 a

Salvage Cryotherapy Patient Selection 2008 AUA Best Practice Statement Men with organ confined disease

Salvage Cryotherapy Patient Selection 2008 AUA Best Practice Statement Men with organ confined disease with positive biopsy confirming disease in prostate. � � � Ideal Patient PSA < 10 ng/m. L* (≤ 4 ng/m. L is optimal**) Long PSA doubling time No evidence of seminal vesicle invasion Life expectancy > 10 years Negative metastatic evaluation *Definition of Low Risk **More detail on next slides Babbian et al. J Urol 2008; 180(5): 1993 -2004 27 This information is provided for general information on Cryoablation and is not intended to address the treatment of any particular patient. Providers must consult System Operator's Manual for complete instructions. © 2012, 2013 Health. Tronics, Inc. All rights reserved HTUS/EU-00058 a

Salvage Cryotherapy Data Highlights 5 �Timeframes up to 7 years 1 -7 �Over 1,

Salvage Cryotherapy Data Highlights 5 �Timeframes up to 7 years 1 -7 �Over 1, 000 patients studied 1 -7 �Overall b. DFS = 42%-69% � 42% b. DFS study still showed 96% disease-specific survival 2 1 �Return to potency for largest study = 40% 1, 3, 4, 7 �Rectal injury ≤ 2. 2% 1, 3, 4, 7 �Incontinence ≤ 13% 1 Dhar et al, J Urol 2010; 183(4 Supl): e 184 Abstract 467. 2 Pisters et al, J Urol 2009; 182(2): 517 -27. 3 Ismail et al, J Urol 2008; 179(4 Supl): 184 Abstract 525. 4 Donnelly et al, Pros Can Pros Dis 2005; 8(3): 235 -42. 5 Bahn et al, Clin Pros Can 2003; 8(3): 111 -4. 6 Izawa et al, J Clin Oncol 2002; 20(11): 2664 -71. 7 Katz et al, Rev in Urol 2002; 4(Supl 2): S 18 -23. This information is provided for general information on Cryoablation and is 28 not intended to address the treatment of any particular patient. Providers must consult System Operator's Manual for complete instructions. © 2012, 2013 Health. Tronics, Inc. All rights reserved HTUS/EU-00058 a

Salvage Cryotherapy Efficacy Comparison 29 This information is provided for general information on Cryoablation

Salvage Cryotherapy Efficacy Comparison 29 This information is provided for general information on Cryoablation and is not intended to address the treatment of any particular patient. Providers must consult System Operator's Manual for complete instructions. © 2012, 2013 Health. Tronics, Inc. All rights reserved HTUS/EU-00058 a

Failure-Free Survival (5 Years) 60. 00% 50. 00% 40. 00% Brachytherapy 30. 00% Prostatectomy

Failure-Free Survival (5 Years) 60. 00% 50. 00% 40. 00% Brachytherapy 30. 00% Prostatectomy Cryotherapy 20. 00% 10. 00% FFS Parekh A, et al. Semin Radiat Oncol 2013; 23: 222 -234 30 This information is provided for general information on Cryoablation and is not intended to address the treatment of any particular patient. Providers must consult System Operator's Manual for complete instructions. © 2012, 2013 Health. Tronics, Inc. All rights reserved HTUS/EU-00058 a

Salvage Cryotherapy Morbidity Comparison 31 This information is provided for general information on Cryoablation

Salvage Cryotherapy Morbidity Comparison 31 This information is provided for general information on Cryoablation and is not intended to address the treatment of any particular patient. Providers must consult System Operator's Manual for complete instructions. © 2012, 2013 Health. Tronics, Inc. All rights reserved HTUS/EU-00058 a

Morbidities 60. 00% 50. 00% 40. 00% Brachytherapy 30. 00% Prostatectomy Cryotherapy 20. 00%

Morbidities 60. 00% 50. 00% 40. 00% Brachytherapy 30. 00% Prostatectomy Cryotherapy 20. 00% 10. 00% Incontinence Stricture Fistula Parekh A, et al. Semin Radiat Oncol 2013; 23: 222 -234 32 This information is provided for general information on Cryoablation and is not intended to address the treatment of any particular patient. Providers must consult System Operator's Manual for complete instructions. © 2012, 2013 Health. Tronics, Inc. All rights reserved HTUS/EU-00058 a

Salvage Cryotherapy Summary �Efficacies appear to be similar for CA, RP and BT �Morbidity

Salvage Cryotherapy Summary �Efficacies appear to be similar for CA, RP and BT �Morbidity risk for RP is significantly higher �Formidable operation with risk of blood loss, rectal injury and significant postoperative complications 1 �Stricture and fistula rates for brachytherapy are higher �Incontinence rate for brachytherapy is lower �Patients must discuss specific circumstances and possible risks and benefits of cryoablation with their urologist 1 Pisters LL, et al. J Urology 1997; 157(3): 921 -5 33 This information is provided for general information on Cryoablation and is not intended to address the treatment of any particular patient. Providers must consult System Operator's Manual for complete instructions. © 2012, 2013 Health. Tronics, Inc. All rights reserved HTUS/EU-00058 a

Prostate Cryotherapy Summary �Should be offered as an option to men seeking treatment �Any

Prostate Cryotherapy Summary �Should be offered as an option to men seeking treatment �Any grade, non-metastatic disease �Less invasive than surgery �Can be performed with spinal block �Efficacy comparable to otherapies �Minimal morbidity except for potency �Salvage for radiation recurrence �Lower morbidity than radical prostatectomy 34 This information is provided for general information on Cryoablation and is not intended to address the treatment of any particular patient. Providers must consult System Operator's Manual for complete instructions. © 2012, 2013 Health. Tronics, Inc. All rights reserved HTUS/EU-00058 a

Questions? This information is provided for general information on Cryoablation and is notintendedto toaddressthe

Questions? This information is provided for general information on Cryoablation and is notintendedto toaddressthe thetreatmentfor of any particular patient. . Providers must consult System Operator's Manual for complete instructions. 2012, 2013 Health. Tronics, Inc. All rights reserved HTUS/EU-00058 a ©© 2012,