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Data presented are for clinically localized, low-risk primary prostate cancer, generally defined as PSA ≤10 ng/mL, Gleason score ≤6, clinical stage T1 or T2a.

Chart was researched and compiled by Synteract, a third party CRO. The information provided in the chart may not include all potential risk, recovery and outcome information. For further details a complete list of references is provided below.

IMPORTANT INFORMATION: The Sonablate 500 is not approved for use in the U.S. The Sonablate 500 remains investigational in the U.S. and is being studied for the treatment of prostate cancer in clinical trials in the U.S. FDA has made no decision as to the safety or efficacy of the Sonablate 500 for the treatment of prostate cancer. Currently, the device is approved for the treatment of prostate cancer in Canada and the Dominican Republic, authorized in Argentina, and available in the Bahamas and Mexico.

General references

Thompson I, Thrasher JB, Aus G et al. Guideline for the Management of Clinically Localized Prostate Cancer: 2007 Update. J Urol 177:2106-2131, 2007

Prostate Cancer Treatment GuideTM http://www.prostate-cancer.com/ Prostate Cancer Treatments, Prostate Cancer Institute Online http://www.prostate-cancer-institute.org/prostate-cancer-

treatment/prostate-cancer-treatment.html

Sanda MG, Dunn RL, Michalski J et al. Quality of like and satisfaction with outcome among prostate-cancer survivors. NEJM 358:1250-1261, 2008

HIFU
Uchida T, Ohkusa H, Yamashita H et al. Five years experience of transrectal high-intensity focused ultrasound using the Sonablate device in the treatment of localized prostate cancer. Intl J Urol 13:228-233, 2006

Uchida T, Ohkusa H, Nagata Y et al. Treatment of localized prostate cancer using high-intensity focused ultrasound. BJU Int 97:56- 61, 2005

Cryosurgery

Cooperberg M, Carroll P, Shinohara K. Prostate Cancer: Cryotherapy. http://www.emedicine.com/med/TOPIC3539.HTM Mouraviev V and Polascik TJ. Update on cryotherapy for prostate cancer in 2006. Current Opinion Urol 16:152-156, 2006

Bahn DK, Lee F, Badalament R et al. Targeted cryoablation of the prostate: 7-year outcomes in the primary treatment of prostate cancer. Urology 60 (Suppl 2A):3-11, 2002

Han KR, Cohen JK, Miller RJ et al. Treatment of organ confined prostate cancer with third generation cryosurgery: preliminary multicenter experience. J Urol 170:1126-1130, 2003

Long JP, Bahn D, Lee F et al. Five-year retrospective, multi-institutional pooled analysis of cancer-related outcomes after cryosurgical ablation of the prostate. Urology 57:518-523

Lam JS, Shvarts O and Belldegrun AS. Cryotherapy for PCa: the next generation. Contemporary Urol 16:2-12, 2004

Radical Prostatectomy

Han M, Partin AW, Zahurak M et al.: Biochemical (prostate specific antigen) recurrence probability following radical prostatectomy for clinically localized prostate cancer. J Urol 169: 517-523, 2003

Potosky AL, Davis WW, Hoffman RM et al.: Five-year outcomes after prostatectomy or radiotherapy for prostate cancer: the Prostate Cancer Outcomes Study. J Natl Cancer Inst 96(18):1358-1367, 2004

Roehl KA, Han M, Ramos CG et al.: Cancer progression and survival rates following anatomical radical retropubic prostatectomy in 3,478 consecutive patients: long-term results. J Urol 172:910-914, 2004

Ung JO, Richie JP, Chen M-H et al.: Evolution of the presentation and pathologic and biochemical outcomes after radical prostatectomy for patients with clinically localized prostate cancer diagnosed during the PSA era. Urology 60:458-463, 2002

External Beam Radiation Therapy

Madalinska JB, Essink-Bot M-L, de Koning HJ et al. Health-related Quality-of-Life effects of radical prostatectomy and primary radiotherapy for screen-detected or clinically diagnosed localized prostate cancer. J Clin Oncol 19:1619-1628, 2001.

Potosky AL, Legler J, Albertsen PC et al. Health outcomes after prostatectomy or radiotherapy for prostate cancer: results from the Prostate Cancer Outcomes Study. J Natl Cancer Inst 92:1582-1592, 2000.

Rosser CJ, Chichakli R, Levy LB et al. Biochemical disease-free survival in men younger than 60 years with prostate cancer treated with external beam radiation. J Urol 168:536-541, 2002.

Zietman AL, Chung CS, Cohen JJ et al. 10-Year outcome for men with localized prostate cancer treated with external radiation therapy: results of a cohort study. J Urol 171:210-214, 2004.

Brachytherapy
Grimm PD, Blasko JC, Sylvester JE et al. 10-Year biochemical (prostate-specific antigen) control of prostate cancer with 125I brachytherapy. Int J Radiation Oncology Biol Phys 51:31-40.

Potters L, Morgenstern C, Calugaru E et al. 12-Year outcomes following permanent prostate brachytherapy in patients with clinically localized prostate cancer. J Urol 173:1562-1566, 2005

Talcott JA, Clark JA, Stark PC et al. Long-term treatment related complications of brachytherapy for early prostate cancer: a survey of patients previously treated. J Urol 166:494-499, 2001