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Prostate Cryoablation Outcomes Data Review

Prostate Cryoablation Outcomes Data Review. References.

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Prostate Cryoablation Outcomes Data Review

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  1. Prostate Cryoablation OutcomesData Review

  2. 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. 2005 Dec 1;63(5):1463-8.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. 2001 Sep;166(3):876-81. 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. 2004 Dec 1;60(5):1347-50.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. 2001 Mar;57(3):518-23.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. 2002 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. 2004 Dec 1;60(5):1347-50.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. 2002 Jul 1;53(3):588-94.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. 2001 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. 2004 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. 2005 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. 2003 Dec 1;57(5):1254-9.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. 2004 Dec 1;60(5):1347-50.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 1995. Int J Radiat Oncol Biol Phys. 2005 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. 2003 Dec 1;57(5):1254-9.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. 2004 Mar 15;58(4):1048-55. 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. 2005 Dec 1;63(5):1463-8.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. 2001 Sep;166(3):876-81. 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. 2004 Dec 1;60(5):1347-50.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. 2001 Mar;57(3):518-23.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. 2002 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. 2002 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. 2004 Dec 1;60(5):1347-50.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. 2002 Jul 1;53(3):588-94.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. 2001 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. 2003 Dec 1;57(5):1254-9.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. 2004 Dec 1;60(5):1347-50.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 1995. Int J Radiat Oncol Biol Phys. 2005 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. 2003 Dec 1;57(5):1254-9.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):215-22.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. 2004 Mar 15;58(4):1048-55. 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. 2005 Dec 1;63(5):1463-8.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. 2001 Sep;166(3):876-81. 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. 2003 Jan;169(1):157-63.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. 2001 Mar;57(3):518-23.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. 2002 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. 2002 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. 2002 Jul 1;53(3):588-94.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. 2001 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. 2003 Dec 1;57(5):1254-9.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 1995. Int J Radiat Oncol Biol Phys. 2005 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. 2003 Dec 1;57(5):1254-9.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):215-22.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. 2004 Aug 1;59(5):1352-9.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. 2004 Mar 15;58(4):1048-55.

  3. Primary CryoablationSalvage CryoablationFocal Cryoablation Outcomes Data Review

  4. Primary Cryoablation

  5. Risk Factors PSA>10, GG>6, Stage>T2a Low Risk Patients having no risk factors Moderate Risk Patients having one risk factor High Risk Patients having two or more risk factors Disease Classification

  6. Low-Risk Primary Prostate Cancer All BDFS Results Published (2000-2005) 100 80 60 Biochemical Disease Free Rate (%) 40 20 0 IMRT Combo Beam RT Cryo Brachy Radical Prostatectomy

  7. Moderate-Risk Primary Prostate Cancer All BDFS Results Published (2000-2005) 100 80 60 Biochemical Disease Free Rate (%) 40 20 0 IMRT Combo Beam RT Cryo Brachy Radical Prostatectomy

  8. High-Risk Primary Prostate Cancer All BDFS Results Published (2000-2005) 100 80 60 Biochemical Disease Free Rate (%) 40 20 0 IMRT Combo Beam RT Cryo Brachy Radical Prostatectomy

  9. Published Incontinence Rates (2000-2005) 1. Steineck et al, N Engl J Med. 2002 Sep 12;347(11):790-6; 2. Walsh et al, J Urol. 2000 Jun;163(6):1802-7; 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.

  10. Published Impotence Rates (2000-2005) 1. Matalinska et al, J Clin Oncol. 2001 Mar 15;19(6):1619-28; 2. Walsh et al, J Urol. 2000 Jun;163(6):1802-7; 3. Bahn et al, Urology. 2002 Aug;60(2 Suppl 1):3-11; 4. Donnelly et al, Urology. 2002 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. 2000 Oct 4;92(19):1582-92; 8. Matalinska et al, J Clin Oncol. 2001 Mar 15;19(6):1619-28; 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.

  11. Rectal Morbidity 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;

  12. 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

  13. 2006 AUA Presentation Primary Cryosurgical Ablation of the Prostate (TCAP): 8-Year Experience Aaron E. Katz, Brian Stone, Kristofer Prepelica, Puneet Masson. • n=182 • Biochemical survival @ 8 yrs: 81% • Negative biopsy rate: 72% • Incontinence: 2.2% • Fistula 0% • Retention 2.4% • Rectal pain 2.3%

  14. 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

  15. Salvage Cryoablation

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

  17. Salvage TherapyTreatment Options • Hormone therapy delays progression • Potentially curative treatment options: • Salvage Radical Prostatectomy • Salvage Cryoablation Fowler JE Cancer 1998; 82: 1112-7, Schellhammer PF J Urol 1993; 150: 1851-5

  18. BDFS Comparison of Salvage Cryoablation and Salvage Radical Prostatectomy Range of Published Results 1. Bahn et al Clin Prostate Cancer. 2003 Sep;2(2):111-4.2. Zincke et al J Urol 147(3 pt 2): 894-899, 1992 3. Brenner et al Br J Urol 75(1): 44-47, 1995

  19. 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.

  20. 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 2003 2. Katz and Ghafar Rev Urol 4(Suppl 2):S18-S23, 2002 3. Neerhut et al J Urol 140:544, 1988 4. Rainwater and Zincke J Urology 140:1455, 1988

  21. Salvage Morbidity Incontinence 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 2003 2. Katz and Ghafar Rev Urol 4(Suppl 2):S18-S23, 2002 3. Neerhut et al J Urol 140:544, 1988 4. Rainwater and Zincke J Urology 140:1455, 1988

  22. Salvage Morbidity Comparison 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.

  23. Publication of Note • n=59 • 59 % = PSA < 0.5 • 69 % = PSA < 1.0 @ 7 years • 5 year mortality of 27 % • Incontinence 4.7 % • 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

  24. 2006 AUA Salvage Cryo Presentation • n=215 – Ten year experience • Biochemical survival: 73% • Negative biopsy rate: 72% • Incontinence: 4.0% • Fistula 0% Salvage Cryosurgical Ablation of the Prostate (TCAP) for Patients Failing Radiation: Efficacy and TolerabilityAaron E. Katz, Kristofer Prepelica, James M. McKiernan, Carl A. Olsson, Mitchell C. Benson.

  25. Focal Cryoablation

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

  27. Focal BiopsyPatient Selection 1. Standard biopsy shows evidence of cancer only on one side2. Saturation biopsy (every 5 mm) to confirm no cancer on the contralateral side

  28. Focal Clinical Data Onik et al. Urology. 2002 Jul; 60 (1): 109-14. Focal "nerve-sparing" cryosurgery for treatment of primary prostate cancer: a new approach to preserving potency. • 9 patients • F/U 6-72 months, mean of 36 • 5 of 9 patients moderate risk • All stable PSA, 6 /6 negative bx

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

  30. Focal Clinical Data AUA 2005 – San Antonio Focal Cryosurgery: Encouraging Health Outcomes for Unifocal Prostate Cancer Puneet Masson, Aaron E. Katz, et al.Columbia University, NY • 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%

  31. Focal Cryoablation • 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.

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