1. Cryoablation Of The Prostate Ask Dr Barken Call In Show

2. Cryotherapy Defined Cryo = Greek for cold Therapy Therapy = Greek for healing Cold Healing

3. Cryotherapy Features No major incision, blood loss, or radiation Destroys cancer during the procedure Dead cells are reabsorbed by the body Outpatient or overnight hospital stay Rapid return to normal activity FDA cleared, Medicare approved Repeatable procedure

4. Cryotherapy Procedure Ultrasound used to position probes 6-8 thin cryoprobes inserted in prostate Circulate argon gas inside probes (-180ºC) Achieve -40ºC temp throughout prostate Visually see the process as it happens Double freeze/thaw destroys cancer

5. Cryotherapy Technology

6. Step #1 Ultrasound Image Capture Capture live ultrasound image of the prostate

7. 1) Prostate margin 2) Urethra 3) Denonvilliers Fascia 1) Prostate margin 2) Urethra 3) Denonvilliers Fascia Step #2 Probe Planning Outline

8. Step #3 Probe Placement Under ultrasound probes are placed

9. Step # Freezing Circulating argon gas freezes cancer cells

10. Cryotherapy Eligibility and Technique

11. Total Prostate Freeze Eligibility Primary or recurrent prostate cancer patients (following radiation) with moderate to high risk tumors where the goal is complete ablation of the prostate gland. Technique Blue area represents freezing within and beyond gland; small circles indicate computer-determined location of 6 probes. Outcomes Low incontinence (<6%), 47% chance of regaining erectile function within 12-36 months as nerves regenerate slowly.

12. Eligibility Primary or recurrent prostate cancer patients (following radiation) with low risk tumors confined to one side where the goal is targeted ablation and avoidance of one or both neurovascular bundles. Technique Blue area shows partial freeze on one side of gland and beyond gland margin on the same side. Opposite side of gland is untreated. Outcomes Low incontinence (<1%), 87% chance of maintaining erectile function. Focal Prostate Freeze

13. Comparison of ALL papers published in the last 5 years (2002-2007) – Radical prostatectomy – Brachytherapy – External beam radiation therapy – 3-D conformal radiation therapy Comparative Review – Cancer Control (Based on PSA levels) – Morbidity (Side effects) – Quality of Life Prostate Cryo Outcomes Cancer Control & Side Effects

14. 0 20 40 60 80 100 RadicalCryoBrachy Beam RT IMRT Combo 79% 1 72% 2 89% 3 69% 4 93% 5 63% 6 89% 7 40% 8 94% 9 88% 10 100% 11 92% 12 Moderate Risk 0 20 40 60 80 100 Radical CryoBrachy Beam RT IMRT Combo 94% 1 84% 2 92% 3 65% 4 97% 5 85% 6 93% 7 55% 8 100% 9 97% 10 94% 11 92% 12 Low Risk 1. Sharkey et al, Brachytherapy. 2005;4(1):34-44. 2. Ciezki et al, Int J Radiat Oncol Biol Phys. 2004 Dec 1;60(5):1347-50. 3. Bahn et al, Urology. 2002 Aug;60(2 Suppl 1):3-11. 4. Bahn et al, Urology. 2002 Aug;60(2 Suppl 1):3-11. 5. Lawton et al, Int J Radiat Oncol Biol Phys. 2007 Jan 1;67(1):39-47. 6. Kwok et al, Int J Radiat Oncol Biol Phys. 2002 Jul 1;53(3):588-94. 7. Ciezki et al, Int J Radiat Oncol Biol Phys. 2004 Dec 1;60(5):1347-50. 8. Goldner et al, Strahlenther Onkol. 2006 Sep;182(9):537-42. 9. De Meerler et al Radiother Oncol. 2007 Jan 11; [Epub ahead of print] 10. Kupelian et al, Int J Radiat Oncol Biol Phys. 2005 Dec 1;63(5):1463-8. 11. Sylvester et al, Int J Radiat Oncol Biol Phys. 2007 Jan 1;67(1):57-64. 12. Sylvester et al, Int J Radiat Oncol Biol Phys. 2007 Jan 1;67(1):57-64. Radical CryoBrachy Beam RT IMRT Combo 69% 1 23% 2 89% 3 64% 4 88% 5 24% 6 81% 7 28% 8 75% 9 70% 10 91% 11 55% 12 0 20 40 60 80 100 High Risk 5-year PSA comparison from all literature reports 2002 - 2007 Low-Risk Disease: - PSA  10 ng/ml, GG  6, and Stage  T2a Moderate-Risk Disease: -One of any of the following: -PSA>10 ng/ml, GG  7, or Stage  T2b High-Risk Disease: -2 or 3 of the following: -PSA>10 ng/ml, GG  7 or Stage  T2b

15. 0 10 20 30 40 50 Radical Prostatectomy CryoBrachyExternal Beam RT IMRT 8% 3 1% 4 49% 1 5% 2 10% 5 1% 6 7% 7 4% 8 15% 9 0% 10 Occurrence (%) 1. Steineck et al, N Engl J Med. 2002 Sep 12;347(11):790-6; 2. Abou-Elela et al, Eur J Surg Oncol. 2007; 33:96-101; 3. Long et al, Urology. 2001 Mar;57(3):518-23; 4. Donnelly et al, Urology. 2002 Oct;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 Jul 15;62(4):956-64; 7. Matalinska et al, J Clin Oncol. 2001 Mar 15;19(6):1619-28; 8. Potosky et al, J Natl Cancer Inst. 2000 Oct 4;92(19):1582-92; 9. Zelefsky et al, Int J Radiat Oncol Biol Phys. 2002 Aug 1;53(5):1111-6; 10. Brabbins et al, Int J Radiat Oncol Biol Phys. 2005 Feb 1;61(2):400-8. c Incontinence 0 20 40 60 80 100 Radical Prostatectomy CryoBrachyExternal Beam RT IMRT 93% 3 53% 4 91% 1 14% 2 51% 5 5% 6 63% 7 41% 8 NOT REPORTED Occurrence (%) Impotence Range of published rates (since 2000)

16. Rectal Morbidity Severe (fistula) Moderate (bleeding, urgency, diarrhea) Radical Prostatectomy < 0.5 %1-19 % Cryoablation< 0.5 %0 % Brachytherapy < 0.5 %4-11 % Beam radiation 12-43 % IMRT 0-25 % Shrader-Bogen Cancer 1997; Talcott J Clin Oncol 1998; Lim Urology 1995; Ragde Cancer 1997; Theodorescu Cancer 2000; Merrick Int J Radiat Oncol Biol Phys 1999; Merrick Int J Radiat Oncol Biol Phys 2000; Donnelly Urology 2002; Long Urology 2001; Zelefsky Radiother Oncol; Brabbins Int J Radiat Oncol Biol Phys. 2005;

17. Quality of Life Comparison FACT-P Survey/ Analysis Tool Reference Source: MedReviews

18. Primary Cryotherapy ASTRO – 3 Successive PSA rises Source: Cryo On Line Data- Registry COLD-Registry: Endocare 1. Low: 84.7% 2. Moderate: 73.4% 3. High: 75.3% Primary Cryoablation – Total Gland 5-Year Biochemical Survival Risk Factors ( 2003 D’Amico) Number of Patients Percent Low-Risk = PSA < 10, Gleason < 7, Stage < T2b27322.8% Moderate-Risk = All Others47539.7% High-Risk = PSA > 20, Gleason > 7, Stage >T2b45037.6%

19. Primary Cryotherapy 27 Cryosurgeons Nationwide Outcomes Incontinence @ 12 months: - 4.8% (any leak whatsoever) - 2.9% (any pad use) Return to intercourse: - 16.8% (8.8% no assistance) Fistula: 0.4% 5-Year Biochemical Survival: 77.1% Patient Demographics Database: 1,198 Age: 69.8 ± 7.5 years PSA: 9.6 ± 8.6 ng/ml Gleason: 7 (median) Source: Cryo On Line Data- Registry COLD-Registry: Endocare

20. Why Consider Cryo Minimally invasive treatment No major surgery or radiation Can fit Gleason grade and tumor stage Rapid recovery Availability of “focal Cryo” for nerve sparing Repeatable Positive outcome data

21. Thank You