Cryoablation Of The Prostate Ask Dr Barken Call In Show

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

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

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

Cryotherapy Technology

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

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

Step #3 Probe Placement Under ultrasound probes are placed

Step # Freezing Circulating argon gas freezes cancer cells

Cryotherapy Eligibility and Technique

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 months as nerves regenerate slowly.

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

Comparison of ALL papers published in the last 5 years ( ) – 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

RadicalCryoBrachy Beam RT IMRT Combo 79% 1 72% 2 89% 3 69% 4 93% 5 63% 6 89% 7 40% 8 94% 9 88% % 11 92% 12 Moderate Risk 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): Ciezki et al, Int J Radiat Oncol Biol Phys Dec 1;60(5): Bahn et al, Urology Aug;60(2 Suppl 1): Bahn et al, Urology Aug;60(2 Suppl 1): Lawton et al, Int J Radiat Oncol Biol Phys Jan 1;67(1): Kwok et al, Int J Radiat Oncol Biol Phys Jul 1;53(3): Ciezki et al, Int J Radiat Oncol Biol Phys Dec 1;60(5): Goldner et al, Strahlenther Onkol Sep;182(9): De Meerler et al Radiother Oncol Jan 11; [Epub ahead of print] 10. Kupelian et al, Int J Radiat Oncol Biol Phys Dec 1;63(5): Sylvester et al, Int J Radiat Oncol Biol Phys Jan 1;67(1): Sylvester et al, Int J Radiat Oncol Biol Phys Jan 1;67(1): 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% High Risk 5-year PSA comparison from all literature reports 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

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 Sep 12;347(11):790-6; 2. Abou-Elela et al, Eur J Surg Oncol. 2007; 33:96-101; 3. Long et al, Urology Mar;57(3):518-23; 4. Donnelly et al, Urology 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 Jul 15;62(4):956-64; 7. Matalinska et al, J Clin Oncol Mar 15;19(6): ; 8. Potosky et al, J Natl Cancer Inst Oct 4;92(19): ; 9. Zelefsky et al, Int J Radiat Oncol Biol Phys Aug 1;53(5):1111-6; 10. Brabbins et al, Int J Radiat Oncol Biol Phys Feb 1;61(2): c Incontinence 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)

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 % 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;

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

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 < T2b % Moderate-Risk = All Others % High-Risk = PSA > 20, Gleason > 7, Stage >T2b %

Primary Cryotherapy 27 Cryosurgeons Nationwide Outcomes 12 months: - 4.8% (any leak whatsoever) - 2.9% (any pad use) Return to intercourse: % (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

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

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