Precise, Minimally Invasive Prostate Cancer Removal Learn why da Vinci Surgery may be your best treatment option 1 Beyond Minimally Invasive For Prostate Cancer 1
Facing Prostate Cancer Prostate cancer is among the most common cancers diagnosed in men. In the US, one in six men will be diagnosed in their lifetimes. 1 While no one will say that facing prostate cancer is easy, the good news is that with increased awareness and screening, more men are diagnosed early. Thus, most cancers are diagnosed while still localized. Treatment Options for Prostate Cancer When prostate cancer is believed to be localized, there are five common treatment options available to a patient: 1. Surgery to remove the cancerous prostate (radical prostatectomy) 2. Radiation of the cancerous prostate, through either external radiation or radioactive seed implants (radiation therapy or brachytherapy, respectively) 3. Freezing of the cancerous prostate (cryotherapy) 4. Hormonal therapy, which is non-curative and often done in conjunction with radiation therapy or cryotherapy 5. Observation (watchful waiting) Patients should discuss the advantages and disadvantages of each treatment approach with their doctor. For localized prostate cancer, radical prostatectomy has traditionally been considered the definitive way to treat the cancer, by removing it. 2 This guide was designed to provide patients with information on the surgical treatment of prostate cancer, which can be performed in a very precise, minimally invasive manner using the da Vinci Surgical System. 1
Surgery: The Definitive Treatment for Prostate Cancer Because the entire prostate gland is removed with radical prostatectomy, the major potential benefit of this procedure is a cancer cure in patients in whom the prostate cancer is truly localized. 2-2007 American Urological Association Clinical Guidelines It is estimated that 91% of the prostate cancers diagnosed in the US are clinically localized, 2 which means that most men are potential candidates for cancer removal. Choosing Surgery: Patient Perspectives James Porter, MD da Vinci Surgeon and da Vinci Prostatectomy patient We often see a lot more cancer in the prostate than we would have predicted based on the biopsy. I knew with surgery that I was going to get the final word with regard to how much cancer I had... I guess you could call it the need to know. Donald Sosin da Vinci Prostatectomy patient You have a chance with this kind of surgery to get rid of the cancer... If I had to do it again, I would do it again except sooner. Visit www.davincistories.com for more perspectives on why patients chose da Vinci Surgery to treat their prostate cancer. 2
Surgery: Confidence in Knowing Your Status Removing the cancerous prostate lets your doctor see the extent and nature of the cancer. This step can be critical: In clinical studies, up to 35% of tumors are undergraded; in other words, they are more aggressive than the pre-surgery assessment and biopsy results indicated. 3 Margin status refers to whether or not there is cancer present at the very edge (the margin) of the removed prostate gland. A negative margin means that all edges of the prostate are free from cancer cells. A negative margin is a good indicator that all of the cancer has been removed. Surgery: Preserving Your Options Choosing surgery over radiation can make it easier for your doctor to detect a cancer recurrence, through careful PSA* monitoring, after a radical prostatectomy than after radiation therapy. 4 It can also help preserve your radiation treatment options if your cancer returns. After radiation therapy, there may be damage to the tissue surrounding the prostate. If you have tissue damage, nerve-sparing surgery may no longer be an option should your cancer recur. However, radiation usually remains an option for patients who have had surgery to treat their prostate cancer. 5 *PSA= Prostate-Specific Antigen, a protein that may indicate the presence of cancer. 3
Long-Term Survival and Localized Prostate Cancer With any cancer treatment, the first priority is survival. Several large studies suggest that there is a greater chance of long-term survival for patients undergoing surgery over other potential treatments. 15-Year Relative Risk of Death Lower with Radical Prostatectomy than with Radiation Cancer Specific Mortality Overall Mortality 40% 38% A study of 3,159 patients found that 15 years after treatment, those who had undergone radical prostatectomy had a 40% lower risk of death from prostate cancer than radiation patients. 6 4
Cancer Survival Comparison of Multiple Treatment Methods 1.0 Cumulative Survival, % 0.8 0.6 Prostatectomy Watchful waiting Radiotherapy Other therapy Hormone therapy 0 1 2 3 4 5 6 7 8 9 10 11 12 No. of Years After Diagnosis In a study of 844 patients with localized prostate cancer, the patients who had undergone prostatectomy showed a higher prostate cancer survival rate than men choosing other treatments. 7 5
Precision with da Vinci Surgery The da Vinci System provides your doctor with several clinical advantages that can allow him or her to perform a more precise surgery: Precision The da Vinci System s tiny wristed instruments have an even greater range of motion than the human hand. da Vinci seamlessly filters any tremors from your surgeon s hands and scales his or her motions, translating them into more precise movements of the instrument tips. da Vinci Surgical System instruments are approximately the diameter of a pencil. Vision High-definition 3D vision and 10x magnification enable your doctor to see both the cancer and healthy tissues and blood vessels at a level of detail far beyond what is possible with open surgery or conventional laparoscopic surgery. Control The da Vinci System s Intuitive Motion provides control through an interface that allows your doctor to use natural movements similar to traditional surgery. 6 5 6
Precision Matters: Cancer Control Bladder Rectum Urethra Prostate The prostate gland is attached to nerves, the rectum and the bladder. The goal of nerve-sparing surgery is to maximize preservation of important nerves, blood vessels and structures that control urinary continence and sexual function, without compromising cancer control. In Prostate Cancer Treatment, Precision Matters In prostate cancer treatment, millimeters matter. Nerve fibers and blood vessels are attached to the prostate gland. To spare these nerves, they must be delicately separated from the prostate before its removal. In comparison, radiation beam treatment can vary by several millimeters. In one study of newer radiation beam therapy the average variation of the beam target was 3mm between sessions. 8 This variation can cause different amounts of radiation energy to be delivered to the edges of the prostate where the nerves are located. 7
Precision Matters: Cancer Control Surgeons use the precision, vision and control provided by the da Vinci System to assist them in removal of the cancerous prostate while preserving important nerves and blood vessels. In several large published studies, da Vinci Prostatectomy has shown equal or lower rates of positive surgical margins (the measurement of cancer cells left behind) than large studies of other forms of surgery. Effective Cancer Control Shown with da Vinci Surgery (T2 positive margins) 4.5% 10 4.6%11 4.8% 12 2.5% 9 Study 1 Study 2 Study 3 Study 4 Cancer control is variable and based on each patient s specific cancer type. Surgeon experience is also an important factor. Talk to your doctor about what your individual expectations should be regarding cancer control. Please visit www.davinciprostatectomy.com for more cancer control data. 8
Precision Matters: Urinary Symptoms Studies have shown that patients who have undergone da Vinci Prostatectomy may experience a faster return of urinary continence following their surgery, compared with other surgical patients. Surgery patients also report lower rates of urinary pain than radiation (brachytherapy) patients. Speed of Return to Urinary Continence 89.8% 13 95% 13 80% 14 77% 15 54% 14 62% 15 3 Months 6 Months da Vinci Prostatectomy Open Surgery Laparoscopic Surgery Increased Urinary Pain 63.7% 16 18.4% 16 19% 16 Surgery Radiation 2% 16 2 Months 24 Months 9
Precision Matters: Sexual Function The prostate is surrounded by a delicate layer of nerves that support erectile function. Many patients are candidates for a nerve-sparing prostatectomy, where the prostate gland is removed but the surgeon maximizes preservation of these nerves. Return of sexual function at one year 79% 17 81% 18 87% 19 96% 20 Study 1 Study 2 Study 3 Study 4 Several studies have shown that patients potent prior to surgery have experienced a high level of recovery of sexual function (defined as an erection sufficient for intercourse) within a year following da Vinci Surgery. Talk to your surgeon about reasonable expectations for recovery of sexual function and ask about a rehabilitation program that may include exercises and drug therapy. Radiation and Sexual Function Radiation can cause long-term damage to the nerves and important structures involved in sexual function. Many patients undergoing brachytherapy or external beam radiation treatment develop erectile dysfunction (as many as 50% in several studies.) 21, 22 Many radiation patients 10 are also placed on hormone therapy, which can have an immediate negative impact on sexual function. 23 10
da Vinci: Get Back to Your Life As a minimally invasive treatment, da Vinci Surgery for prostate cancer offers numerous potential benefits compared to traditional open surgery. Using da Vinci, surgeons operate through tiny 5-12mm incisions which is roughly the diameter of a pencil. Potential benefits include: Shorter hospital stay 24 Significantly less pain 25 Less blood loss and fewer transfusions 26 Less scarring Faster return to normal activities 27 Open Surgical Incision da Vinci Prostatectomy Incision Learn more at www.davinciprostatectomy.com 11
da Vinci Surgery: Beyond Minimally Invasive Surgery With the added precision, vision and control provided by the da Vinci System, your surgeon can offer you the gold standard treatment surgery with all the potential benefits of a minimally invasive procedure. da Vinci Surgery provides a minimally invasive approach while preserving the potential outcome benefits of traditional open surgery. Its exceptional precision can provide you with effective cancer removal, as well as a better chance of preserving delicate nerve structures responsible for sexual function and urinary continence, as compared with traditional surgery or radiation. In summary, da Vinci Surgery can help to put cancer behind you so you can get back to your life as quickly as possible. Important Considerations with da Vinci Prostatectomy While clinical studies support the use of the da Vinci Surgical System as an effective tool for minimally invasive surgery, individual results may vary. da Vinci Prostatectomy is a surgical procedure, and all surgery carries inherent risks. Though data suggests that da Vinci Surgery can provide excellent cancer control, faster return to sexual function and to urinary continence as compared with other treatment options, all prostate cancer treatments, including surgery, can increase risk of incontinence and/or urinary symptoms and impotence. Additionally, there is no guarantee of the benefits described for every patient. For example, some individuals may not be candidates for a full nerve-sparing procedure due to the extent of their cancer. And as with any surgical treatment, results of da Vinci Surgery are in part surgeon-dependent and can improve significantly with surgeon experience. 12 12
Clinical References 1 http://www.prostatecancerfoundation.org/site/c.itiwk2osg/b.70619/k.446e/risk_factors.htm. 2 Prostate cancer clinical guideline update panel. Guideline for the management of clinically localized prostate cancer: 2007 update. Linthicum (MD): American Urological Association Education and Research, Inc. 2007; 82. 3 King CR, Patterns of prostate cancer biopsy grading: trends and clinical implications. Int J. Cancer (Radiat. Oncol. Invest.) 2000; 90,305-311. 4 Di Blasio, C. J., A. C. Rhee, et al. Predicting clinical end points: treatment nomograms in prostate cancer. Semin Oncol. 2005; 30(5):567-86. 5 Carlucci JR, Nabizada-Pace F, Samadi DB. Organ-confined prostate cancer and the emergence of robotic prostatectomy: What primary care physicians and geriatricians need to know. Geriatrics. 2009; 64(2):8-14. 6 Tewari A, Raman JD, Chang P, Rao S, Divine G, Menon M. Long-term survival probability in men with clinically localized prostate cancer treated either conservatively or with definitive treatment (radiotherapy or radical prostatectomy). Urology. 2006 Dec; 68(6):1268-74. 7 Merglen A, et al. Short- and long-term mortality with localized prostate cancer. Arch Intern Med 2007; 167:1944-1950. 8 Boda-Heggemann J, Kohler FM, Wertz H, et al. Intrafraction motion of the prostate during an IMRT session: a fiducial-based 3D measurement with Cone-beam CT. Radiat Oncol. 2008 Nov 5; 3(1):37. 9 Patel VR, Thaly R, Shah K. Robotic radical prostatectomy: outcomes of 500 cases. BJU Int. 2007 May; 99(5):1109-12. 10 Ahlering TE, Woo D, Eichel L, Lee DI, Edwards R, Skarecky DW. Robot-assisted versus open radical prostatectomy: a comparison of one surgeon s outcomes. Urology. 2004 May; 63(5):819-22. 11 Kaul, S, A Savera, K Badani, M Fumo, A Bhandari, M Menon. Functional outcomes and oncological efficacy of Vattikuti Institute prostatectomy with Veil of Aphrodite nerve-sparing: an analysis of 154 consecutive patients. BJU Int. 2006; 97:467-72. 12 Tewari et al. Total reconstruction of the vesico-urethral junction, BJU international. 2008; 101, 871 877. 13 Patel VR, Thaly R, Shah K. Robotic radical prostatectomy: outcomes of 500 cases. BJU Int. 2007 May; 99(5):1109-12. 14 Walsh PC. Patient-reported urinary continence and sexual function after anatomic radical prostatectomy. J Urol. 2000 Jul; 164(1):242, 59. 15 Goeman L., Salomon L., La De Taille A, et al. Long-term functional and oncological results after retroperitoneal laparoscopic prostatectomy according to a prospective evaluation of 550 patients. World J Urol. 2006; 24, 281-288 16 Buron C, Le Vu B, et al. Brachytherapy versus prostatectomy in localized prostate cancer: Results of a French multicenter prospective medico-economic study. Int J Radiat Oncol Biol Phys. 2007; 67(3):812-22. 17 Badani KK, Kaul S, Menon M. Evolution of robotic radical prostatectomy: assessment after 2766 procedures. Cancer. 2007 Sep; 24;110(9):1951-1958. 18 Mottrie A, Van MP, De NG, Schatteman P, Carpentier P, et al. Robot-assisted laparoscopic radical prostatectomy: oncologic and functional results of 184 cases. Eur Urol. 2007; 52:746 51. 19 Mikhail A, et al. Robotic-assisted laparoscopic prostatectomy in overweight and obese patients. Urology. 2006; 67(4): 774-9. 20 Kaul S, Savera A, Badani K, Fumo M, Bhandari A, Menon M. Functional outcomes and oncological efficacy of Vattikuti Institute prostatectomy with Veil of Aphrodite nerve-sparing: an analysis of 154 consecutive patients. BJU Int. 2006; 97:467-72. 21 Zelefsky M, Chan H, Hunt M, Yamada Y, Shippy A, Amols H. Long-term outcome of high dose intensity modulated radiation therapy for patients with clinically localized prostate cancer. journal of urology.2006; 176 (4): 1415-1419. 22 Merrick G. Erectile function after prostate brachytherapy. Int J Radiat Oncol Biol Phys. 2005 Jun; 62(2): 437-47. 23 Sharifi N, Gulley J, and Dahut W. Androgen deprivation therapy for prostate cancer. JAMA. 2005 Jul; 294(2): 238-244. 24 Ahlering TE, Woo D, Eichel L, Lee DI, Edwards R, Skarecky DW. Robot-assisted versus open radical prostatectomy: a comparison of one surgeon s outcomes. Urology. 2004 May;63(5): 819-22. 25 Menon M, Tewari A, Baize B, Guillonneau B, Vallancien G. Prospective comparison of radical retropubic prostatectomy and robot-assisted anatomic prostatectomy: the Vattikuti Urology Institute experience. J Urol. 2003 Jul;170(1):318-9. 26 Boris RS, Kaul SA, Sarle RC, Stricker HJ. Radical prostatectomy: a single surgeon comparison of retropubic, perineal, and robotic approaches. Can J Urol. 2007 Jun;14(3):3566-70. 27 Miller J, Smith A, Kouba E, Wallin E, Pruthi R. Prospective evaluation of short-term impact and recovery of health-related quality of life in men undergoing robotic-assisted laparoscopic radical prostatectomy versus open radical prostatectomy. J Urol. 2007 Jul; 178 (3 pt 1): 854-859 13 While clinical studies support the effectiveness of the da Vinci System when used in minimally invasive surgery, individual results may vary. Surgery with the da Vinci Surgical System may not be appropriate for every individual. Always ask your doctor about all treatment options, as well as their risks and benefits. 2009 Intuitive Surgical. All rights reserved. Intuitive, Intuitive Surgical, da Vinci, da Vinci S and EndoWrist are trademarks or registered trademarks of Intuitive Surgical. PN 870298 Rev. B 5/09 13
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For more information about da Vinci Prostate Cancer Surgery visit: www.davinciprostatectomy.com 15