Prostate Cryoablation Outcomes Data Review

References Kupelian PA, Thakkar VV, Khuntia D, Reddy CA, Klein EA, Mahadevan A.Hypofractionated intensity-modulated radiotherapy (70 gy at 2.5 Gy per fraction) for localized prostate cancer: long-term outcomes.Int J Radiat Oncol Biol Phys Dec 1;63(5): Zelefsky MJ, Fuks Z, Hunt M, Lee HJ, Lombardi D, Ling CC, Reuter VE, Venkatraman ES, Leibel SA.High dose radiation delivered by intensity modulated conformal radiotherapy improves the outcome of localized prostate cancer.J Urol Sep;166(3): Erratum in: J Urol 2001 Nov;166(5):1839.Sharkey J, Cantor A, Solc Z, Huff W, Chovnick SD, Behar RJ, Perez R, Otheguy J, Rabinowitz R. 103Pd brachytherapy versus radical prostatectomy in patients with clinically localized prostate cancer: a 12-year experience from a single group practice. Brachytherapy. 2005;4(1):34-44.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.Ciezki JP, Klein EA, Angermeier K, Ulchaker J, Chehade N, Altman A, Mahadevan A, Reddy CA.A retrospective comparison of androgen deprivation (AD) vs. no AD among low-risk and intermediate-risk prostate cancer patients treated with brachytherapy, external beam radiotherapy, or radical prostatectomy. Int J Radiat Oncol Biol Phys Dec 1;60(5): Long JP, Bahn D, Lee F, Shinohara K, Chinn DO, Macaluso JN Jr. Five-year retrospective, multi-institutional pooled analysis of cancer-related outcomes after cryosurgical ablation of the prostate. Urology Mar;57(3): Bahn DK, Lee F, Badalament R, Kumar A, Greski J, Chernick M. Targeted cryoablation of the prostate: 7-year outcomes in the primary treatment of prostate cancer. Urology Aug;60(2 Suppl 1):3-11.Sharkey J, Cantor A, Solc Z, Huff W, Chovnick SD, Behar RJ, Perez R, Otheguy J, Rabinowitz R. 103Pd brachytherapy versus radical prostatectomy in patients with clinically localized prostate cancer: a 12-year experience from a single group practice. Brachytherapy. 2005;4(1):34-44.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.Ciezki JP, Klein EA, Angermeier K, Ulchaker J, Chehade N, Altman A, Mahadevan A, Reddy CA.A retrospective comparison of androgen deprivation (AD) vs. no AD among low-risk and intermediate-risk prostate cancer patients treated with brachytherapy, external beam radiotherapy, or radical prostatectomy. Int J Radiat Oncol Biol Phys Dec 1;60(5): Kwok Y, DiBiase SJ, Amin PP, Naslund M, Sklar G, Jacobs SC.Risk group stratification in patients undergoing permanent (125)I prostate brachytherapy as monotherapy. Int J Radiat Oncol Biol Phys Jul 1;53(3): Merrick GS, Butler WM, Galbreath RW, Lief JH.Five-year biochemical outcome following permanent interstitial brachytherapy for clinical T1-T3 prostate cancer. Int J Radiat Oncol Biol Phys Sep 1;51(1):41-8.Peschel RE, Colberg JW, Chen Z, Nath R, Wilson LD.Iodine 125 versus palladium 103 implants for prostate cancer: clinical outcomes and complications. Cancer J May-Jun;10(3):170-4.Stone NN, Stock RG, Unger P. Intermediate term biochemical-free progression and local control following 125iodine brachytherapy for prostate cancer. J Urol Mar;173(3):803-7.Livsey JE, Cowan RA, Wylie JP, Swindell R, Read G, Khoo VS, Logue JP.Hypofractionated conformal radiotherapy in carcinoma of the prostate: five-year outcome analysis. Int J Radiat Oncol Biol Phys Dec 1;57(5): 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.Ciezki JP, Klein EA, Angermeier K, Ulchaker J, Chehade N, Altman A, Mahadevan A, Reddy CA.A retrospective comparison of androgen deprivation (AD) vs. no AD among low-risk and intermediate-risk prostate cancer patients treated with brachytherapy, external beam radiotherapy, or radical prostatectomy. Int J Radiat Oncol Biol Phys Dec 1;60(5): Kupelian P, Kuban D, Thames H, Levy L, Horwitz E, Martinez A, Michalski J, Pisansky T, Sandler H, Shipley W, Zelefsky M, Zietman A.Improved biochemical relapse-free survival with increased external radiation doses in patients with localized prostate cancer: the combined experience of nine institutions in patients treated in 1994 and Int J Radiat Oncol Biol Phys Feb 1;61(2):415-9.Livsey JE, Cowan RA, Wylie JP, Swindell R, Read G, Khoo VS, Logue JP.Hypofractionated conformal radiotherapy in carcinoma of the prostate: five-year outcome analysis. Int J Radiat Oncol Biol Phys Dec 1;57(5): Galalae RM, Martinez A, Mate T, Mitchell C, Edmundson G, Nuernberg N, Eulau S, Gustafson G, Gribble M, Kovacs G.Long-term outcome by risk factors using conformal high-dose-rate brachytherapy (HDR-BT) boost with or without neoadjuvant androgen suppression for localized prostate cancer. Int J Radiat Oncol Biol Phys Mar 15;58(4): Kupelian PA, Thakkar VV, Khuntia D, Reddy CA, Klein EA, Mahadevan A.Hypofractionated intensity- modulated radiotherapy (70 gy at 2.5 Gy per fraction) for localized prostate cancer: long-term outcomes.Int J Radiat Oncol Biol Phys Dec 1;63(5): Zelefsky MJ, Fuks Z, Hunt M, Lee HJ, Lombardi D, Ling CC, Reuter VE, Venkatraman ES, Leibel SA.High dose radiation delivered by intensity modulated conformal radiotherapy improves the outcome of localized prostate cancer.J Urol Sep;166(3): Erratum in: J Urol 2001 Nov;166(5):1839.Sharkey J, Cantor A, Solc Z, Huff W, Chovnick SD, Behar RJ, Perez R, Otheguy J, Rabinowitz R. 103Pd brachytherapy versus radical prostatectomy in patients with clinically localized prostate cancer: a 12-year experience from a single group practice. Brachytherapy. 2005;4(1):34-44.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.Ciezki JP, Klein EA, Angermeier K, Ulchaker J, Chehade N, Altman A, Mahadevan A, Reddy CA.A retrospective comparison of androgen deprivation (AD) vs. no AD among low-risk and intermediate-risk prostate cancer patients treated with brachytherapy, external beam radiotherapy, or radical prostatectomy. Int J Radiat Oncol Biol Phys Dec 1;60(5): Long JP, Bahn D, Lee F, Shinohara K, Chinn DO, Macaluso JN Jr. Five-year retrospective, multi-institutional pooled analysis of cancer-related outcomes after cryosurgical ablation of the prostate. Urology Mar;57(3): Bahn DK, Lee F, Badalament R, Kumar A, Greski J, Chernick M. Targeted cryoablation of the prostate: 7-year outcomes in the primary treatment of prostate cancer. Urology Aug;60(2 Suppl 1):3-11.Donnelly BJ, Saliken JC, Ernst DS, Ali-Ridha N, Brasher PM, Robinson JW, Rewcastle JC. Prospective trial of cryosurgical ablation of the prostate: five-year results. Urology Oct;60(4):645-9.Sharkey J, Cantor A, Solc Z, Huff W, Chovnick SD, Behar RJ, Perez R, Otheguy J, Rabinowitz R. 103Pd brachytherapy versus radical prostatectomy in patients with clinically localized prostate cancer: a 12-year experience from a single group practice. Brachytherapy. 2005;4(1):34-44.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.Ciezki JP, Klein EA, Angermeier K, Ulchaker J, Chehade N, Altman A, Mahadevan A, Reddy CA.A retrospective comparison of androgen deprivation (AD) vs. no AD among low-risk and intermediate-risk prostate cancer patients treated with brachytherapy, external beam radiotherapy, or radical prostatectomy. Int J Radiat Oncol Biol Phys Dec 1;60(5): Kwok Y, DiBiase SJ, Amin PP, Naslund M, Sklar G, Jacobs SC.Risk group stratification in patients undergoing permanent (125)I prostate brachytherapy as monotherapy. Int J Radiat Oncol Biol Phys Jul 1;53(3): Merrick GS, Butler WM, Galbreath RW, Lief JH.Five-year biochemical outcome following permanent interstitial brachytherapy for clinical T1-T3 prostate cancer. Int J Radiat Oncol Biol Phys Sep 1;51(1):41-8.Livsey JE, Cowan RA, Wylie JP, Swindell R, Read G, Khoo VS, Logue JP.Hypofractionated conformal radiotherapy in carcinoma of the prostate: five-year outcome analysis. Int J Radiat Oncol Biol Phys Dec 1;57(5): 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.Ciezki JP, Klein EA, Angermeier K, Ulchaker J, Chehade N, Altman A, Mahadevan A, Reddy CA.A retrospective comparison of androgen deprivation (AD) vs. no AD among low-risk and intermediate-risk prostate cancer patients treated with brachytherapy, external beam radiotherapy, or radical prostatectomy. Int J Radiat Oncol Biol Phys Dec 1;60(5): Kupelian P, Kuban D, Thames H, Levy L, Horwitz E, Martinez A, Michalski J, Pisansky T, Sandler H, Shipley W, Zelefsky M, Zietman A.Improved biochemical relapse-free survival with increased external radiation doses in patients with localized prostate cancer: the combined experience of nine institutions in patients treated in 1994 and Int J Radiat Oncol Biol Phys Feb 1;61(2):415-9.Livsey JE, Cowan RA, Wylie JP, Swindell R, Read G, Khoo VS, Logue JP.Hypofractionated conformal radiotherapy in carcinoma of the prostate: five-year outcome analysis. Int J Radiat Oncol Biol Phys Dec 1;57(5): Ellis RJ, Vertocnik A, Sodee B, Zhou H, Kim E, Young B, Fu P, Colussi V, Spirnak JP, Dinchman KH, Resnick MI.Combination conformal radiotherapy and radioimmunoguided transperineal 103Pd implantation for patients with intermediate and unfavorable risk prostate adenocarcinoma. Brachytherapy. 2003;2(4): Galalae RM, Martinez A, Mate T, Mitchell C, Edmundson G, Nuernberg N, Eulau S, Gustafson G, Gribble M, Kovacs G.Long-term outcome by risk factors using conformal high-dose-rate brachytherapy (HDR-BT) boost with or without neoadjuvant androgen suppression for localized prostate cancer. Int J Radiat Oncol Biol Phys Mar 15;58(4): Kupelian PA, Thakkar VV, Khuntia D, Reddy CA, Klein EA, Mahadevan A.Hypofractionated intensity-modulated radiotherapy (70 gy at 2.5 Gy per fraction) for localized prostate cancer: long-term outcomes.Int J Radiat Oncol Biol Phys Dec 1;63(5): Zelefsky MJ, Fuks Z, Hunt M, Lee HJ, Lombardi D, Ling CC, Reuter VE, Venkatraman ES, Leibel SA.High dose radiation delivered by intensity modulated conformal radiotherapy improves the outcome of localized prostate cancer.J Urol Sep;166(3): Erratum in: J Urol 2001 Nov;166(5):1839.Sharkey J, Cantor A, Solc Z, Huff W, Chovnick SD, Behar RJ, Perez R, Otheguy J, Rabinowitz R. 103Pd brachytherapy versus radical prostatectomy in patients with clinically localized prostate cancer: a 12-year experience from a single group practice. Brachytherapy. 2005;4(1):34-44.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.Grossfeld GD, Latini DM, Lubeck DP, Mehta SS, Carroll PR. Predicting recurrence after radical prostatectomy for patients with high risk prostate cancer. J Urol Jan;169(1): Long JP, Bahn D, Lee F, Shinohara K, Chinn DO, Macaluso JN Jr. Five-year retrospective, multi-institutional pooled analysis of cancer-related outcomes after cryosurgical ablation of the prostate. Urology Mar;57(3): Bahn DK, Lee F, Badalament R, Kumar A, Greski J, Chernick M. Targeted cryoablation of the prostate: 7-year outcomes in the primary treatment of prostate cancer. Urology Aug;60(2 Suppl 1):3-11.Donnelly BJ, Saliken JC, Ernst DS, Ali-Ridha N, Brasher PM, Robinson JW, Rewcastle JC. Prospective trial of cryosurgical ablation of the prostate: five-year results. Urology Oct;60(4):645-9.Sharkey J, Cantor A, Solc Z, Huff W, Chovnick SD, Behar RJ, Perez R, Otheguy J, Rabinowitz R. 103Pd brachytherapy versus radical prostatectomy in patients with clinically localized prostate cancer: a 12-year experience from a single group practice. Brachytherapy. 2005;4(1):34-44.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.Kwok Y, DiBiase SJ, Amin PP, Naslund M, Sklar G, Jacobs SC.Risk group stratification in patients undergoing permanent (125)I prostate brachytherapy as monotherapy. Int J Radiat Oncol Biol Phys Jul 1;53(3): Merrick GS, Butler WM, Galbreath RW, Lief JH.Five-year biochemical outcome following permanent interstitial brachytherapy for clinical T1-T3 prostate cancer. Int J Radiat Oncol Biol Phys Sep 1;51(1):41-8.Livsey JE, Cowan RA, Wylie JP, Swindell R, Read G, Khoo VS, Logue JP.Hypofractionated conformal radiotherapy in carcinoma of the prostate: five-year outcome analysis. Int J Radiat Oncol Biol Phys Dec 1;57(5): 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.Kupelian P, Kuban D, Thames H, Levy L, Horwitz E, Martinez A, Michalski J, Pisansky T, Sandler H, Shipley W, Zelefsky M, Zietman A.Improved biochemical relapse-free survival with increased external radiation doses in patients with localized prostate cancer: the combined experience of nine institutions in patients treated in 1994 and Int J Radiat Oncol Biol Phys Feb 1;61(2):415-9.Livsey JE, Cowan RA, Wylie JP, Swindell R, Read G, Khoo VS, Logue JP.Hypofractionated conformal radiotherapy in carcinoma of the prostate: five-year outcome analysis. Int J Radiat Oncol Biol Phys Dec 1;57(5): Ellis RJ, Vertocnik A, Sodee B, Zhou H, Kim E, Young B, Fu P, Colussi V, Spirnak JP, Dinchman KH, Resnick MI.Combination conformal radiotherapy and radioimmunoguided transperineal 103Pd implantation for patients with intermediate and unfavorable risk prostate adenocarcinoma. Brachytherapy. 2003;2(4): Stock RG, Cahlon O, Cesaretti JA, Kollmeier MA, Stone NN.Combined modality treatment in the management of high-risk prostate cancer. Int J Radiat Oncol Biol Phys Aug 1;59(5): Galalae RM, Martinez A, Mate T, Mitchell C, Edmundson G, Nuernberg N, Eulau S, Gustafson G, Gribble M, Kovacs G.Long-term outcome by risk factors using conformal high-dose-rate brachytherapy (HDR-BT) boost with or without neoadjuvant androgen suppression for localized prostate cancer. Int J Radiat Oncol Biol Phys Mar 15;58(4):

Primary Cryoablation Salvage Cryoablation Focal Cryoablation Outcomes Data Review

Primary Cryoablation

Risk FactorsPSA>10, GG>6, Stage>T2a Low RiskPatients having no risk factors Moderate Risk Patients having one risk factor High RiskPatients having two or more risk factors Disease Classification

Radical Prostatectomy CryoBrachy Beam RT IMRT Low-Risk Primary Prostate Cancer All BDFS Results Published ( ) Biochemical Disease Free Rate (%) Combo

Radical Prostatectomy CryoBrachy Beam RT IMRT Biochemical Disease Free Rate (%) Combo Moderate-Risk Primary Prostate Cancer All BDFS Results Published ( )

Radical Prostatectomy CryoBrachy Beam RT IMRT Biochemical Disease Free Rate (%) Combo High-Risk Primary Prostate Cancer All BDFS Results Published ( )

1. Steineck et al, N Engl J Med Sep 12;347(11):790-6; 2. Walsh et al, J Urol Jun;163(6):1802-7; 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): Published Incontinence Rates ( )

1. Matalinska et al, J Clin Oncol Mar 15;19(6): ; 2. Walsh et al, J Urol Jun;163(6):1802-7; 3. Bahn et al, Urology Aug;60(2 Suppl 1):3- 11; 4. Donnelly et al, Urology Oct;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, J Natl Cancer Inst Oct 4;92(19): ; 8. Matalinska et al, J Clin Oncol Mar 15;19(6): ; 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): Published Impotence Rates ( )

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 % 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 following Primary Cryoablation  Badalament, 1999 (retrospective) 1year post op  n=223, 96% pt satisfaction – higher than any other therapy  Robinson, 1999 (prospective) 1 year post op  n=69, QOL assessed before and after cryo  return to baseline by 12 months for all domains except sexual function in all patients  Robinson, 2002 (prospective) 3 year post op  Long term sexual function follow-up:  13 % full recovery of erectile function  34 % recovery sufficient for intercourse  No late onset morbidity

2006 AUA Presentation n=182 n=182 Biochemical 8 yrs: 81% Biochemical 8 yrs: 81% Negative biopsy rate: 72% Negative biopsy rate: 72% Incontinence: 2.2% Incontinence: 2.2% Fistula 0% Fistula 0% Retention 2.4% Retention 2.4% Rectal pain 2.3% Rectal pain 2.3% Primary Cryosurgical Ablation of the Prostate (TCAP): 8-Year Experience Aaron E. Katz, Brian Stone, Kristofer Prepelica, Puneet Masson.

Patient Selection Primary Cryoablation General: Any patient with biopsy proven localized prostate cancer. Ideal patients:  Moderate or high risk disease  High Gleason (kills the tissue not cells)  Non-diploid tumors  Patients with high risk of positive surgical margins  Non surgical candidates  Patients for whom potency is low priority

Salvage Cryoablation

Radio-Recurrence Epidemiology 200,000 + diagnoses of PCa a year 200,000 + diagnoses of PCa a year 30-40% undergo radiation (60,000 men) 30-40% undergo radiation (60,000 men) 30-40% of radiation cases fail biochemically 30-40% of radiation cases fail biochemically 18,000-32,000 radiation failures per year 18,000-32,000 radiation failures per year Modified from Brawer Rev Urol. 2002;4(Suppl 2): S1

Salvage Therapy Treatment Options  Hormone therapy delays progression  Potentially curative treatment options:  Salvage Radical Prostatectomy  Salvage Cryoablation Fowler JE Cancer 1998; 82: , Schellhammer PF J Urol 1993; 150:

1. 2. Zincke et al J Urol 147(3 pt 2): , Brenner et al Br J Urol 75(1): 44-47, Bahn et al Clin Prostate Cancer Sep;2(2): Zincke et al J Urol 147(3 pt 2): , Brenner et al Br J Urol 75(1): 44-47, 1995 BDFS Comparison of Salvage Cryoablation and Salvage Radical Prostatectomy Range of Published Results

BDFS Comparison of Salvage Cryoablation and Salvage Radical Prostatectomy No apparent difference in efficacy… this is logical: If the cancer is truly localized both salvage cryoablation and salvage radical prostatectomy will likely cure the patient of their disease.

Salvage Morbidity Rectal Injury Range of Published Results * Mador et al reported 50% post salvage radical but n = 4 so excluded 1. Saliken et al Submitted to Cancer Katz and Ghafar Rev Urol 4(Suppl 2):S18-S23, Neerhut et al J Urol 140:544, Rainwater and Zincke J Urology 140:1455, 1988

Range of Published Results *Thompson et al 1988 reported 80 % Incontinence but n=5 so it is excluded. 1. Saliken et al Submitted to Cancer Katz and Ghafar Rev Urol 4(Suppl 2):S18-S23, Neerhut et al J Urol 140:544, Rainwater and Zincke J Urology 140:1455, 1988 Salvage Morbidity Incontinence

8 – 10 fold difference in morbidity! Changes in the tissue due to radiation result in calcifications & blurring of surgical planes. Salvage radical prostatectomy is more difficult than primary radical prostatectomy. Salvage cryoablation is more difficult than primary cryoablation but careful treatment planning and intraoperative monitoring keep morbidities low. Salvage Morbidity Comparison

Publication of Note n=59 n=59 59 % = PSA < % = PSA < % = PSA < 7 years 69 % = PSA < 7 years 5 year mortality of 27 % 5 year mortality of 27 % Incontinence 4.7 % Incontinence 4.7 % 3.4 % fistula (only early in the experience) 3.4 % fistula (only early in the experience) Salvage Cryosurgery for Recurrent Prostate Cancer After Radiation Therapy: A Seven-Year Follow-up Bahn DK et al Technology in Cancer Research and Treatment, Jun;3(3):253-8, 2004 Salvage Cryosurgery for Recurrent Prostate Cancer After Radiation Therapy: A Seven-Year Follow-up Bahn DK et al Technology in Cancer Research and Treatment, Jun;3(3):253-8, 2004

2006 AUA Salvage Cryo Presentation n=215 – Ten year experience n=215 – Ten year experience Biochemical survival: 73% Biochemical survival: 73% Negative biopsy rate: 72% Negative biopsy rate: 72% Incontinence: 4.0% Incontinence: 4.0% Fistula 0% Fistula 0% Salvage Cryosurgical Ablation of the Prostate (TCAP) for Patients Failing Radiation: Efficacy and Tolerability Aaron E. Katz, Kristofer Prepelica, James M. McKiernan, Carl A. Olsson, Mitchell C. Benson.

Focal Cryoablation

Focal cryoablation is the indiscriminant aggressive freezing of tissue which destroys the microvasculature: Hemi Freeze Hemi Freeze No Freeze

1. Standard biopsy shows evidence of cancer only on one side 2. Saturation biopsy (every 5 mm) to confirm no cancer on the contralateral side Focal Biopsy Patient Selection

Onik et al. Urology Jul; 60 (1): Focal "nerve-sparing" cryosurgery for treatment of primary prostate cancer: a new approach to preserving potency. Focal Clinical Data 9 patients 9 patients F/U 6-72 months, mean of 36 F/U 6-72 months, mean of 36 5 of 9 patients moderate risk 5 of 9 patients moderate risk All stable PSA, 6 /6 negative bx All stable PSA, 6 /6 negative bx

Focal prostate cryoablation: initial results show cancer control and potency preservation Bahn DK et al Endourology In Press, 2006  n=28  Median f/u: 70 months  BDFS (ASTRO): 93%  Negative biopsy rate: 95%  Potency: 87%  Incontinence: 0% Focal Clinical Data

 n=20 (all unifocal PCa – no RT or hormones)  Median f/u: 13 months  BDFS (ASTRO): 85%  Negative biopsy rate: 95%  Potency: 95%  Incontinence: 0% AUA 2005 – San Antonio Focal Cryosurgery: Encouraging Health Outcomes for Unifocal Prostate Cancer Puneet Masson, Aaron E. Katz, et al. Columbia University, NY Focal Clinical Data

 Early results are promising and consistent across investigators.  Focal cryoablation of all known cancer combined with vigilant follow-up may provide effective cancer control and substantially improved quality of life.  Focal cryoablation should only be performed within a clinical trail. Focal Cryoablation