P A A C T, I N C. PROSTATE CANCER COMMUNICATION PROSTATE CANCER COMMUNICATION NEWSLETTER • VOLUME 23, NUMBER 2 • June 2007 FOUNDER: LLOYD J. NEY, SR. – FOUNDED 1984 President and Chairperson: Janet E. Ney Board of Directors: Edwin Kuberski Treasurer Newton Dilley Helen Mellema Peter Noor Jr. Richard H. Profit Jr. Anthony Staicer Honorary Board Member: PLEASE NOTIFY US IF A MEMBER IS DECEASED AND YOU NO LONGER WISH TO RECEIVE THE NEWSLETTER. UNLESS YOU NOTIFY US, WE HAVE NO WAY OF KNOWING TO REMOVE THE MEMBER FROM OUR MAILING LIST. ************************************************************************************ WHAT THE HECK HAS BEEN GOING ON IN MY WORLD-PART 15!!! By Mark A. Moyad, M.D., M.P.H. (Note: You can now log on to www.drmoyad.com to get info on how to sign up for the latest clinical information edited by me - shameless plug #4310) Let me see if I get this straight (sounds like an erectile dysfunction commercial). Ohio State got the Gluteus Maximus kicked out of them by Florida in the National Championship Game twice (basketball and football). But at least they got to the title game. The Big Ten will rise again. Next year, the University of Michigan will win the National Championship in football, and I have no comment on basketball. Russell Osbun Medical Advisory Board: Richard J. Ablin, Ph.D. V. Elayne Arterbery, M.D. Robert A. Badalament, M.D. Duke K. Bahn, M.D. Israel Barken, M.D. E. Roy Berger, M.D. Michael J. Dattoli, M.D. Fernand Labrie, M.D. Fred Lee Sr. M.D. Robert Leibowitz, M.D. Mark Moyad, M.D., M.P.H. Charles E. Myers Jr. M.D. Gary M. Onik, M.D. Haakon Ragde, M.D. Oliver Sartor, M.D. Stephen B. Strum, M.D., FACP Donald Trump, M.D. Steven J. Tucker, M.D. Ronald E. Wheeler, M.D. I apologize, but this issue will be short from my end because in the next issue there will be a lot. In the meantime you can go to www.seminarsprevaltmed.com to subscribe to the medical journal or save some money and wait until the next issue. 87) High-dose antioxidant or dietary supplements combined with radiation treatment for certain types of cancer may not help and could be quite dangerous in some cases. (Reference: -Bairati I, Meyer F, Jobin E, et al: Antioxidant vitamins supplementation and mortality: a randomized trial in head and neck cancer patients. Int J Cancer 119:2221-2224, 2006.) There has always been an issue of combining high-dose dietary supplements with any form of radiation treatment for cancer patients. Do highdose dietary supplements block the beneficial effects of radiation, do they boost the impact of radiation, or do they have no impact or interaction with radiation treatment at all? A lot of questions have been asked but with no clear-cut answers. Finally, there is at least some potential clarity on this issue, at least for some types of cancer patients. A total of 540 patients with stage I or II squamous cell cancer of the head and neck were recruited from 5 treatment centers in the Quebec, Canada area. The average age of the patients was 63 years, and about two-thirds Let’s Conquer Cancer in OUR Lifetime CANCER COMMUNICATON Published Quarterly by: PAACT, Inc. Patient Advocates for Advanced Cancer Treatments 1143 Parmelee NW Grand Rapids, MI 49504 Director…Richard Profit Editors….Richard Profit/Molly Meyers Assistant….Molly Meyers Web Services….Omega Systems Postmaster: Send address changes to: Prostate Cancer Communication P.O. Box 141695 Grand Rapids, MI 49514 Phone: 616/453-1477 Fax: 616/453-1846 E-Mail: paact@paactusa.org PAACT Web Page: http://www.paactusa.org Newsletter: http://www.paactusa.org Editor: Articles authored by other than the editor may not fully reflect the views of the corporation but are printed with the understanding that the patient has the right to make his own interpretation of the efficacy of the information provided. In an effort to conserve space and be able to insert as much material as possible in the newsletter, references from various articles are intentionally omitted. If you would like to obtain those references, please contact PAACT, we keep all of the original articles and the references used on file. INDEX Page 1. What the Heck Has Been Going on in My World – Part 15 (Mark A. Moyad, MD, MPH) 3. Book – “Men at Risk, A Rush to Judgement” Chapter 1 – Part II (Ronald E. Wheeler, MD) 7. New Book by Dr. Charles “Snuffy” Myers 8. PCRI 2007 National Conference Announcement 8. The Paget Foundation Symposium Announcement 9. Nerve Sparing Robotic Prostatectomy: A Novel and Minimally Invasive Treatment of Prostate Cancer (Ashutosh Tewari, MD, Rajan Ramanathan, MD, Mani Menon, MD) 21. Acknowledgements 23. Financial Summary 24. Membership Form (66%) of them had been smokers the year before the study started. Approximately 80% were male, and a similar number were diagnosed with laryngeal cancers. Patients were given 400 IU of vitamin E (273 patients) daily or placebo (263 patients) during radiation treatment and for 3 years beyond this time. Patients in the vitamin E group also received 30 mg a day of a single beta-carotene dietary supplement, but this was discontinued after the first year of the study because of other studies showing negative potential outcomes, such as an increased risk of lung cancer among smokers taking betacarotene. Researchers were primarily trying to determine if this supplement could reduce the risk of another cancer from occurring. The average duration of the radiation treatment was 43 days, and the median amount of time that patients took vitamin E supplements or placebo was 3.1 years. During the first part of the study, patients taking vitamin E had a higher risk of developing another cancer, a higher risk of recurrence of the initial tumor or a higher risk of just being diagnosed with another cancer while they were taking the supplements. At this point in the study patients had been followed a median of 52 months. Overall, the chances of being cancer free was similar in both groups, but there were actually less overall serious side effects reported during radiation in the supplement group (19%) compared to the placebo group (24%). The overall reduction in side effects was about 28% when comparing the two groups. However, when just comparing the combination of vitamin E and beta-carotene there was a 62% reduction overall, and a similar impact on reducing the impact of laryngeal damage. Quality of life after 1 month of radiation treatment was no different between the supplement and placebo groups. There was significantly less sleep problems in the supplement group, but more diarrhea in this same group, and this was especially true when combining both supplements versus placebo. What should be concluded from the first part of this first time ever completed randomized study? It should be kept in mind the study was initiated by the researchers because they believed that vitamin E and beta-carotene supplements might reduce the risk and severity of the side effects of radiation and improve quality of life without impacting the effect of the treatment on the cancer itself. The supplements actually did reduce side effects, especially those that impact the larynx of the throat. This did not occur when vitamin E was taken by itself. So, there was a concern in this trial that the prevention of side effects came at a high price, which is the reduction in the effectiveness of the radiation itself. The authors of this study also mentioned at the time of publication that there were only three legitimate studies on the impact of using supplements to reduce the risk of the side effects of radiation therapy, and in one of the largest past studies there was an increase in the risk of dying early with high-dose supplements. Regardless, the results of the largest study on this subject ever completed, agree with past studies that show that supplements can reduce the side effects of radiation. However, once again the concern is that the impact of the radiation treatment on the cancer is also compromised. A few years later the authors of the largest study decided to provide another publication on the further follow-up of patients, and the results went from bad to worse for taking high-dose supplements during radiation treatment. The median time individuals were followed in this study was approximately 6.5 years in the placebo group and in the vitamin E group. A total of 179 deaths occurred during the study; 102 were in the vitamin E group and 77 were in the placebo group. The overall survival time was significantly lower in the vitamin E group (p = 0.033). There was a 43% increased risk of dying earlier while on vitamin E compared to the placebo! The longest follow-up time of the largest supplement study ever published with radiation therapy demonstrates an enormous potential problem. Patients had greater risk of dying from any cause if they were in the supplement group compared to the control group. Initially, it looked as if the supplements reduced the side effects of radiation, and this did seem to be the case in the short-term, but it simply might have come with a tremendous catch. Bottom Line High-dose vitamin E supplements (400 IU DL-alpha-tocopherol/day = synthetically derived) with or without betacarotene supplements (30 mg/day for 1-year) taken during radiation treatment for head and neck cancer and for 3 years after this time, seems to slightly reduce the risk of side effects from radiation in the short-term, but had no impact on overall quality of life. However, most concerning is that high-dose supplements seemed to increase the risk of dying early from any cause compared to the placebo group when patients were followed-up for at least 6-years. Taking most highdose supplements during and after radiation treatment for any cancer simply does not make sense right now until researchers can figure out what is going on. This is one of the most troubling findings I have come across from a powerful study in a long time. How does this translate into the breast or prostate cancer world is unknown, but can someone explain to me why it would be better to be sorry than safe here? Therefore, less is more when it comes to dietary supplementation and radiation treatment until someone can demonstrate otherwise. WELL, THIS IS ALL THAT I CAN COVER FOR NOW. HOPE THIS HELPS AND I HOPE THAT YOU HAVE A BEAUTIFUL SUMMER FILLED WITH MODERATE ALCOHOL CONSUMPTION OR LOW-CALORIE NON-ALCOHOLIC DRINK CONSUMPTION (if you do not drink alcohol - a politically correct moment on my part). IN THE NEXT NEWSLETTER WE WILL COVER THE LATEST ISSUES FROM ALL THE RECENT MEDICAL MEETINGS INCLUDING THE LATEST ON PROSTATE CANCER VACCINES (very exciting), SUPPLEMENTS, FOOTBALL SCORE PREDICTIONS AND WHY SO MANY PEOPLE WATCH THE TV SHOW “AMERICAN IDOL.” Book – “Men at Risk, A Rush to Judgment” Chapter 1-Part II “Too Many Radicals and Too Many Failures” By Ronald E. Wheeler, M.D. The Prostatitis & Prostate Cancer Center Sarasota, FL 941-957-0007 Let’s take a look at a typical clinical case that allows us to better understand the present state of prostate cancer treatment and the associated angst that comes with the diagnosis. Jon Freda, a 54 year old Caucasian male, was diagnosed with prostate cancer with a Gleason score of 6 (3+3) associated with a PSA of 4.2 ng/ml. A Gleason 6 prostate cancer designation comprises the most common cancer cell type identified, as well as recognized, as the cancer type that predicts the most favorable clinical outcome. This is the group of patients that Pat Walsh, M.D. and the team at Johns Hopkins and other major centers of excellence use to show their respective level of confidence in their outcome data, to validate their treatment choice of radical prostatectomy for prostate cancer. This is also the group of cancers that many experts believe are over treated. In other words, many men in this category would do equally well with a radical prostatectomy (assuming cure) or with a more conservative approach like chronic disease management (reference the Prospective Diet & Nutritional Study) or active surveillance if offered. It is for this reason that word needs to be promulgated throughout the world that Chronic Disease Management (CDM) is a viable alternative to radical prostatectomy or radiation when this category of cancer is diagnosed. Based on Jon’s relative youth and fear of impending death from a presumably, less than predictable disease, the patient agreed to a radical prostatectomy at the urging of his family and surgeon. Now 6 years later the patient’s PSA (prostate specific antigen) is rising consistent with treatment failure. A progressive rise in PSA following any attempt to cure signals the failure of the operation or radiation to cure the disease. This is also called biochemical failure or disease relapse. A rise in PSA despite the removal of the prostate tells you that the disease had escaped the prostate while looking to find a new source of nourishment in your lymph nodes or bones (or both). It is estimated that the range of disease recurrence following radical prostatectomy or radiation is 30-40% and possibly as high as 40-60% by 7-10 years. The earlier the rise in PSA following surgery or radiation and/or the failure to nadir the PSA to less than 0.5 ng/ml suggests that the disease is more aggressive and was likely systemic at the time when the disease was thought to be localized or confined to the prostate. Unfortunately this information does not help us after the fact except to predict a troubled and probable aggressive clinical course that will likely hasten our demise. The only way to have avoided this misstep is to have avoided the surgery that you thought would get rid of the disease in the first place. Confused? Join the millions, who like you, are going to learn first hand from this book and the experiences of others. Minimally the failure of Jon Freda to be cured calls into question the ability to cure anyone with certainty and should slow the march of the ignorant or educationally challenged to the operating room door. Our data suggests the failure to cure a patient when radical prostatectomy or radiation is performed, bodes poorly for the patient. Specifically, according to Anthony D’Amico and colleagues, when the PSA doubling time (the time it takes for the PSA number to double) is less than 3 months following radical prostatectomy or radiation, the patient has a 20 times increased chance of dying from prostate cancer within 6-10 years. Importantly, our clinical research concurs showing the clinical course observed for the patient who isn’t cured by radical prostatectomy or radiation will be a much more aggressive battle to fight than the individual who chose the more conservative treatment concept associated with a strategic chronic disease management protocol, whereby, the patient learns to live with the disease. Examples will be provided through out this book that will make this point very clear. Returning to the case of Jon Freda; again, a gentleman who could have lived with this disease very easily, there were issues other than a rising PSA following the failed attempt at cure with radical prostatectomy. Ever since the operation, this patient has been a sexual cripple; meaning that he cannot achieve adequate erections despite the use of erectile stimulating drugs like Viagra (the little blue pill) or Caverject. He also complains of urinary leakage but this would be manageable if only the operation was a success. What is sad is that this patient should have been cured as his disease characteristics could not have been more favorable; suggesting that anything short of cure is a significant failure. This case history establishes very clearly why a more conservative approach may have been the better first choice. Unfortunately, Jon had never been told that he could live a long and prosperous life with the prostate remaining untouched using a chronic disease management protocol. Had this happened Jon would not have been the first patient discussed in this chapter. While hind site is 20/20, this is the reason, nonetheless, that patients must become increasingly aware that radical prostatectomy is not what it is made out to be. There are no guarantees even when you hear…the treatment represented gives you your best chance at cure. Improved awareness and understanding of the topic is the only defense that will allow the patient to comprehend the options discussed; but more importantly, to walk away and rethink what has been discussed absent the emotion of the moment. While our patient Jon Freda paid the ultimate sacrifice, in my opinion, for an unnecessary chance at success, I believe he would have been willing to live with quality of life limiting side effects of impotency and incontinence had the cure been achieved. At this junction in Jon’s life, he is now facing off with the next set of questions that will require intelligent decisions related to how the disease will be managed. His choice at this point is to consider radiation or chronic disease management (active surveillance). Radiation, replete with its own set of side effects, including rectal bleeding and radiation cystitis, is also likely to worsen his already limited potency as well as worsen his ability to control his bladder. A much more reasonable approach would be the use of a CDM (chronic disease management) or active surveillance protocol. At this point, his cancer will respond very favorably to hormone manipulation via anti-androgens (Flutamide, Casodex or Nilutamide) given intermittently. While his PSA is just beginning to rise from the nadir of 0.2 ng/ml, no one knows that the disease will not stabilize when conservative measures are employed as no two cancers are alike. Besides, earlier treatment with an LHRH-analog or anti-androgen at a lower PSA number will hasten the onset of hormone refractivity (disease resistance to a particular therapy), a well known consequence of hormonal manipulation. Furthermore, I would not discount the role of diet and nutrition to assist holding the cancer in check by extending the doubling time of the PSA rise. In an effort to prevent the PSA from rising to a higher and more definable number, I would use various products or formulas associated with various mechanisms of action versus the disease process in an effort to enhance a successful outcome, and thereby, prolong life. Remember, while there is no clear decision choice, there are also no tests that can tell us with certainty where the cancer is located or whether the cancer will respond to conservative measures; now that radical prostatectomy has failed to be the treatment to cure the disease. At this point, I will assist Jon regardless of the choice he makes and do all I can to foster his success, including the application of a CDM protocol in the event radiation is chosen and fails. It is not as important why this clinical scenario happened with Jon, but rather, how we can prevent this from happening to other men, like: Paul, Jack, Scott, Brad, Mike, Steve, Bill, Dave, Harry and all other male members of the human race! Carl Lackey’s case history and clinical experience is equally riveting for even the most learned or savvy prostate cancer patient! A 60 year old former All-American hockey defenseman at Michigan State University, who now resides in Green Bay, Wisconsin, Carl learned he had prostate cancer when his PSA reached 8.2 ng/ml in October, 2004. The year prior, his PSA was 3.9 ng/ml. It is unfortunate, but when he asked if there was anything that could be done to try to lower the PSA, he was told by his Urologist that it was still in the normal range and not to be concerned. A 12 core biopsy, performed based on the 8.2 ng/ml PSA, yielded a Gleason 4+4 cancer in 3 out of 6 biopsies on the left side and a cancer precursor cell type, High Grade PIN (prostatic intraepithelial neoplasia), on the right side (See Glossary and Pathology Chapter for an improved understanding of this term). His biopsy stage was T2b meaning that significant disease (cancer) was located in more than one area on the left side of his prostate. Following the biopsy, the PSA value reached a high of 13.0 ng/ml. Given the poorly differentiated cancer cell type, Carl went about the process of trying to determine the best way to defeat the disease. 3 Urologists representing 3 different Urology practices had recommended that a radical prostatectomy was his only chance to survive the disease. One urologist went so far as to state; if he did not have the radical surgery, he would be dead within 1 year. Concerned for his well being and quite frankly scared beyond belief, Carl had decided hastily that surgery seemed like the only option. He had completed his pre-op evaluation and had received the hospital wrist band identifying him to all hospital personnel. At home, his wife Sandy was feverishly looking for other options as she did not feel good about the choice that the man of her life had made. Several days prior to his early morning arrival at the hospital for the expected surgical procedure, Carl’s life changed. Sandy had come across my website, www.TheProstateCenter.com and placed a toll free call to the clinic. While I can’t recall if it was that day or the next day, I had a chance to talk to the man with the disease about his treatment and what, if any, was his expectation from the surgery. After a brief factual and straightforward discussion, Carl cut the hospital wrist band from his arm and scheduled an appointment at my clinic in Sarasota, Florida. In our conversation, I had said nothing that would diminish his hope for a successful outcome, although, I had informed him that while radical prostatectomy may have provided his greatest percent chance for cure, as represented by his 3 urologic consults, no one informed him, the percent chance of cure was only 15%. In other words, 85% of all prostate cancer represented by Gleason Scores of 8, 9, or 10 have disease recurrence within 5 years. He was incredibly disappointed that no one had discussed the literature based facts on the historical, surgical futility associated with this cancer grade, but rather, opted for a leap of faith to save his life. No one had allowed Carl and Sandy the opportunity to understand that what they were about to do, made little sense and was obviously the wrong approach based on well documented statistics and therefore, should have been out of the question as an option. By making the commitment to see me in the clinic, Carl and Sandy had become a member of my extended family. During the 3 hour plus clinical evaluation and interview process, I reviewed viable options including the option of allowing Carl to live with the disease through a protocol of chronic disease management. Minimally, this option would buy us some time while not burning a bridge; allowing us to be more aggressive later if an option presented itself that made sense when the risk-reward discussion took place. My clinical experience allowed me to share other patient success stories using the CDM concept. Together we created and accepted a treatment strategy that was intended to minimally stabilize the cancer disease process. I made it very clear that we were in this together and I was as close as a telephone call. He could count on me as a brother as I was confident we could make a difference. Based on his heightened disease status and dangerous Gleason Score, I elected to start him on a CDM protocol that included various mechanisms of action to suppress the disease or make it less aggressive or even dormant. Without going into a lot of detail here, he was placed on a patented prostatitis formula called, Peenuts®. This is a synergistic blend of vitamins, minerals, herbs, and amino acids that has shown the unique ability to resolve the signs and symptoms of prostatitis. This was an important step as prostatitis has been shown to evolve into prostate cancer by many research experts including the American Association of Cancer Research (AACR) and David Bostwick, M.D., world renowned Pathologist. Carl was also started on Avodart at 0.5 mg daily to decrease the conversion of Testosterone to Dihydrotestosterone (DHT) as well as promote an anti-angiogenic component (decreases new blood vessel formation) while reducing the size of the prostate. He knew full well that the PSA would be decreased by some number less than half based on the presence of benign prostatic hyperplasia cells and cancer cells. I was also cognizant of the benefit demonstrated by the Prostate Cancer Prevention Trial (PCPT) where this class of drug (Avodart or Proscar) was associated with a decreased incidence of prostate cancer by 25% when compared to placebo. While I had no data to show specific benefit versus prostate cancer with this drug, I did not want the cancer to be exposed to DHT, the more desirable form of the cancer growth promoting male hormone. Vitamin D3 (the active form of Vitamin D) was added for its benefit in decreasing prostate cancer cell proliferation. Additionally, Omega 3 fatty acids were added to enhance the Omega 6: Omega 3 fatty acid ratio, thereby, enhancing heart health and a possible mechanism versus pros- tate cancer. The modified Mediterranean Diet was the diet of choice (rationale for this diet will be discussed comprehensively in the diet section). The last integral piece of the treatment strategy was the use of Casodex (Bicalutamide), a nonsteroidal anti-androgen, used at 150 mg per day, similar to the dose effectively used in Europe. I have had tremendous experience using Casodex at the aforementioned dose as a monotherapy. This represents a higher dose than that typically used in the United States but is quite safe and effective when used intermittently. Specifically, the anti-androgen blocks the prostate cancer cell receptor, thereby, inhibiting the growth of cancer. To state this differently, Testosterone, which remains normal to high in this treatment scenario, is preferentially blocked from its usual action of attaching to the cell receptor in the presence of the anti-androgen. The concept is analogous or similar to what you would expect to see when you put plastic child safety caps on an electrical outlet. No matter how hard you try to connect the cord of a lamp (as example) to the source of electricity, you can’t do it. Thusly, Casodex blocks the interaction of DHT with the cell receptor and promotes cell death preferentially over cell growth. While there are a few side effects from the use of Casodex, as a monotherapy, including but not limited to a transient elevation in liver enzymes, mild breast tenderness or swelling, and the potential for diarrhea, the side effect profile is acceptable for the anticipated short duration of usage. The side effect profile, nonetheless, can be avoided using additional medications or supplements that would minimize and/or eliminate these concerns. Using this approach, we were able to avoid an LHRH-analog (Luteinizing Hormone Releasing Hormone), thereby, by-passing chemical castration associated with its host of undesirable side effects including but not limited to: lethargy, increased fasting blood sugars secondary to decreased insulin resistance, muscle wasting, hypercholesterolemia, anemia, bone loss, hot flashes, cognitive changes, depression, mood swings, and weight gain. When used as a monotherapy, intermittently, disease specific anti-androgen therapy has a tremendous lifestyle advantage when compared to the more traditional monotherapy of an LHRH-analog alone or in combination with an anti-androgen (combined androgen blockade). The decision was made to use the anti-androgen intermittently between PSA action points of 10.0 ng/ml and 1.0 ng/ml. 10.0 ng/ml or higher would mark the point where Casodex would begin and 1.0 ng/ml or lower would mark the point where the Casodex is discontinued. Carl remained on the protocol for 17 months in total. The Casodex was used only for the first two months, dropping the PSA (the marker of disease activity) from 13.0 ng/ml to 0.3 ng/ml. In effect, Carl had been off of Casodex for 15 months, while his PSA had remained stable at 1.7 ng/ml. This response represents a truly remarkable turn of events for a very bad cancer, possibly never recorded before in the annals of medicine. In his yearly follow-up appointment to the clinic, Carl’s white blood cell count associated with the expressed prostatic secretion had gone from TNTC (too numerous too count) down to 45 white blood cells when reviewed under 400X (microscopically). This represented a 91% decrease in the inflammatory response; a process that promotes prostate cancer evolution, while mitigated by the patented prostate nutritional formula, Peenuts®. His urinary symptoms had improved from 10.5 (moderate symptoms on the International Prostate Symptom Score Index (IPSS-Index) of 1-35) to 1.5 (mild symptoms) in the same time frame representing an improvement in symptoms of 86%; again, attributed to the same nutritional formula (refer to the addendum for the complete IPSS-Index). In his follow up, rather than discussing his demise or worse yet, death, as predicted by his previous Urologist, the three of us celebrated a measure of victory versus an unpredictable and potentially deadly disease. We had demonstrated the success of chronic disease management in a very difficult case presentation. While I believe this case represents one of the more spectacular responses of prostate cancer to chronic disease management, highlighting Casodex as a monotherapy, we should not diminish the impact of key nutrients and medications as outlined previously. While I am sure I will hear from my colleagues that this case is “too good to be true,” I always welcome calls from any of my critics. More importantly Carl and Sandy would be happy to share their joyous experience with those who care to contact them. Maybe some day, Carl and Sandy will be able to tell their story on a bigger stage, thereby bringing more than just hope to the hundreds of thousands of men who face the uncertainty of prostate cancer everyday. Now, with the disease suppressed, the Lackeys decided to take yet, another step; in effect, a calculated risk to get rid of the disease once and for all, by undergoing High Intensity Focused Ultrasound (HIFU) at a site outside of the U.S.A. under my supervision. HIFU is still under FDA scrutiny and therefore not offered on U.S. soil as of June, 2006. Carl’s progress will be monitored by a spectral analysis of his prostate, using the 3.0 Tesla magnet from General Electric to validate an absence of disease without the need for additional biopsies to confirm. I refer you to the section on Magnetic Resonance Imaging Spectroscopy (MRIS) for an improved understanding of this technique, as well as rationale, for why prostate biopsies may soon be a technique of the past as the procedure of choice commonly used to confirm treatment success. So when the diagnosis of prostate cancer is made in your case, what will you do? Will you try to live with the disease or do you have to remove the cancer at any cost? Is your goal a cure and if so, is this realistic? While I never want to deprive you of hope, false hope and unrealistic expectations is unfair to you, the patient, who so desperately wants to succeed. If cure is possible, what are the chances of success? Is it worth the risk when your chance of success is less than 50%? If cure is impossible, what is the best strategy to ensure the best outcome? This is not as simple as applying a radical prostatectomy or radiation to a cancer but rather lies in a multi-factorial approach that may include a radical prostatectomy or radiation, but only if the odds of success are overwhelmingly in your favor and you are willing to take the risk. Based on the inability to predict success predictably versus prostate cancer suggests that we should take our time and consider all options including CDM before the commitment is made to proceed. Get a second and a third opinion! If you act on impulse and make the incorrect choice, you will have, what will appear to be, a lifetime to lament the error in judgment. William Fair, M.D., former Chairman of the Departments of Urology and Surgery at the esteemed Memorial SloanKettering Cancer Center was so frustrated with his inability to predict a successful outcome with radical prostatectomy or radiation for prostate cancer patients that he stated in a now famous speech from 2000; “Based on everything we know about prostate cancer, I am not sure that it should not be treated as a chronic disease.” While I am not saying that radical prostatectomy is obsolete yet, I am saying that if we continue to apply the same therapy to every patient without an improved understanding for treatment success as well as limiting the procedure to only those who best qualify, the future of radical prostatectomy will be doomed based on the public’s perception suggesting a lack of physician understanding of the disease, greed and/or inappropriate dogma tied to a disease we know too little about. What Bill Fair may truly have been seeking was a moratorium on radical prostatectomy and radiation therapy until he and other research experts could figure out the natural history of the disease, thereby, selecting patients for a treatment based on a sound strategy as opposed to a “one size fits all” mentality. There is rarely a doctor among us who will share Dr. Fair’s commentary with his newly diagnosed prostate cancer patients, much less, investigate valid conservative options as appropriate care. These conservative, yet effective, options will be addressed in chapters on minimally invasive treatment like cryosurgery and high intensity focused ultrasound (HIFU) later in this book. For men with PSA levels of greater than 1.0 ng/ml, it is not too premature to begin to think about the educational process as you will learn later in this book that 20-30% of all prostate cancers are in the range of 1.0-4.0 ng/ml. If you wait, you could face the same tough decisions that faced Jon Freda who never knew he had another option or you can think ahead and begin planning your strategy as if you had the disease and have the success of Carl Lackey. Will you be a willing participant when a biopsy is recommended when the PSA exceeds 4.0 ng/ml (20-30% of biopsies are positive in this range) or will you reach out to an improved technology like that available at the Diagnostic Center for Disease in Sarasota for a confirmational MRIS first, noting that more biopsy procedures are negative than positive? Random biopsies should be discouraged based on the sampling bias as well as the relatively low risk of prostate cancer on any given prostate biopsy procedure; not to mention the risk of spreading cancer cells (if present) beyond the prostate. Will what you have read thus far stimulate you to be proactive and try to avoid an inevitable disease by controlling prostatitis with a patented, scientifically proven, prostatitis formula called Peenuts® or are you content to be reactive and take your chances that the disease won’t come your way? Whatever your personality, whatever your choice, I am dedicated to making a difference with you when the time comes. If cancer is inevitable, I want your case to be predictably successful giving you the opportunity to continue to take from life all that is yours. The remaining chapters in this book are instructional and will make you think. What makes this book different from other prostate books is that I will not pretend to be the expert in every facet of prostate cancer. For this reason, I have brought together national, if not world experts who are prepared to present the facts in a fair and balanced format as well as respond to tough questions where they may not have the answer. For these and other reasons, I encourage you to use this book as a learning tool, as a reference and as a guide to keep you health conscious while protecting your prostate and your heart. It has taken me years to do my research and years to write this book, so please take your time to read it carefully and absorb it so that you are equipped to face the battle, should the disease present itself. NEW BOOK BY DR CHARLES "SNUFFY" MYERS In the words of Dr. Charles "Snuffy" Myers, "treating prostate cancer is a lot like golf because you need to play it as it lies." In this unique volume, both practical and highly accessible, Myers puts over thirty years of experience with this disease to work for the benefit of survivors everywhere. As one of the most influential physicians in the prostate cancer field today, Myers has created the most hands-on and comprehensive resource on hormonal therapy and diet on the market. As a prostate cancer survivor with an undetectable PSA, Myers infuses this book with the life-saving hope that led to his own recovery. Utilizing a simple golf metaphor to outline the twists and turns of diagnosis and treatment, the book addresses metastatic patients, the newly diagnosed and healthcare professionals alike. Topics include: Hormonal Therapy Regimens; Diet/Lifestyle; Radiation, Surgery, and many others. The book is $25 plus $5 shipping and handling. To order call 1-800-305-2432 or go to www.prostateforum.com. NERVE SPARING ROBOTIC PROSTATECTOMY: A NOVEL AND MINIMALLY INVASIVE TREATMENT OF PROSTATE CANCER By Ashutosh Tewari, MD, Rajan Ramanathan, MD (Weill Cornell Medical School, New York Presbyterian Hospital, Brady Urologic Health Center, New York, NY) and Mani Menon, MD (Henry Ford Hospital, Detroit, MI) CONTACT DETAILS OF ASH TEWARI Ash Tewari, MD, M.Ch. Ronald P. Lynch Associate Professor of Urologic-Oncology Director Robotic Prostatectomy and Urologic Oncology Outcomes, Associate Attending NYPH Weill Medical College of Cornell University New York Presbyterian Hospital Brady Urologic Health Center 525 East 68th Street Starr 900 New York, NY 10021 Phone: 212 746-5643 (Nurse Practitioner) 212 746 5638 (Secretary) Fax: 212 746 8396 E mail: akt2002@med.cornell.edu For Appointments: RoboticCoordinator@med.cornell.edu Acknowledgements: Dissections were aided by Dr Atsushi Takenaka, Associate Professor of Urology from Kobe University, Japan, during the time he spent at Cornell in 2006. We also acknowledge the help and support given by Dr Georg Bartsch (University of Innsbruck Austria) and Dr Peter N Schlegel and Dr E Darracott Vaughan (Weill Medical College of Cornell University NY) Our team includes: Dr Anil Mandhani, Mh, Fellow, Roy Berryhill, PA, Dr Juan Salamanca, MD, Fellow, Dr Sandhya Rao, MD, Fellow, Dr Jay Raman MD, Urology Resident, Dr Kevin Bigelow MD, Urology Resident, Robert Leung, MPH, Fellow INTRODUCTION Robotic surgery for the prostate is fast becoming the standard of care. Robotic surgery ushered in a new era of minimally invasive surgery that has challenged conventional open surgery.[1] Robotic surgery involves tele-manipulation devices that allow the performance of complex surgical tasks with dexterity and minimal fatigue due to their ergonomic design, expanded degree of movements, tremor filtering, and 3-D Stereoscopic visualization. The excellent view of the operative field provided by this device coupled with the unrestricted ability to execute almost any surgical task, has ensured that robotic surgery is becoming increasingly popular, and is now being routinely used for complex urological procedures such as pyeloplasty, radical cystectomy, donor nephrectomy, and radical prostatectomy.[2-4] BACKGROUND Goals of treatment- Treatments for prostate cancer have two fundamental competing goals: complete eradication of cancer coupled with minimal morbidity and negligible deterioration of quality of life. In order to meet these goals, we use a da Vinci master-slave robot system and have developed a minimally invasive, robot-assisted radical prostatectomy technique by standardizing a unique sequence of surgical steps, appropriate visual angles using different lenses, optimal retraction strategies, precise suturing steps, anatomical sparing of the neurovascular structures and by incorporating time-tested open surgical principles.[5, 6] This has been topped by an understanding of the local anatomy of the nerves and meticulous dissection without the use of thermal energy to control bleeders. This technique, which we call ART (Athermal Robotic Technique) results in excellent oncological and surgical outcomes, causes minimal bleeding, and, can be completed in 90 to 160 minutes. With this technique, patients and their families have been able to appreciate the cosmetic benefits, and significantly reduced hospital stays. Most patients can revert back to their normal lifestyle in less than two weeks. The primer for this technique was developed in Detroit (Vattikuti Institute of Urology) and has been popularized at several centers in the U.S.A.[5, 7-18] The author (AT) was involved in the initial 800 cases performed at The Vattikuti Institute in Detroit and has recently taken over the role as Director of Robotics at the New York Presbyterian Hospital. He has to date performed around 550 robotic prostatectomies in his new program in 2 years. Patient selection- Who can undergo robotic prostatectomy: Men with clinically localized prostate cancer who choose surgical treatment are candidates for this procedure. Morbid obesity in the patient makes the procedure relatively difficult for the surgeon. However we have done this procedure in many different situations. These include patients with multiple abdominal surgeries with possible adhesions, patients with cardiac problems, patients on blood thinners and anticoagulants. Patients on anticoagulants need to stop the medication sometime before and need to be switched to another mode of anticoagulation around the time of surgery. We use survival prediction tables for selecting patients for surgical treatment. The data has been published[19] by the author and is available online at http://www.prostatecalculator.org/survival.html. Patients undergo a thorough preoperative evaluation including serum PSA testing, an international prostate symptom score (IPSS), a sexual function inventory, a quality of life score, and an incontinence questionnaire. We also record information about other co morbidities, such as stroke, cerebral aneurysm, diabetes mellitus, hypertension, COPD and history of myocardial infarctions. We specifically question each patient regarding his medical history, with emphasis on abdominal surgery, peritonitis, knee or hip surgery, or peripheral neuropathy. A history of stroke or cerebral aneurysm is a relative contraindication for this procedure, as the patient would be placed in a pronounced head down (Trendelenberg) position for 1-3 hours. Patients are admitted on the day of surgery and receive deep vein thrombosis (DVT) prophylaxis (Heparin 5000 IU SC on call to the operating room) and an antibiotic in the preoperative holding area. Venodyne boots are placed and the abdomen is shaved from the nipple to the groin. BRIEF OVERVIEW OF THE OPERATIVE TECHNIQUE Da Vinci robotic technology (Figures 1, 2 and 3): The da Vinci system uses a sophisticated master-slave robot that incorporates 3-D visualization, scaling of movement and wristed instrumentation. The system has three multi-joint robotic arms with one controlling a binocular endoscope and the other two controlling articulated instruments. Two lenses 0° or 30º are used. Two finger-controlled handles (the “masters”) that are housed in a mobile console are used to control the two robotic arms and, together with a foot pedal control, to control camera movement. Instrument movement can be scaled from 1:1, which allows exact finger movements to be transmitted to the instrument tip, to 1:3 and 1:5, which scale down the movements to allow precise and delicate dissection, (Figure 4) and the stereoscopic three-dimensional vision allows magnified (10-15 fold) vision with depth perception. This visual advantage helps in improved tissue delineation and precise dissection of delicate neurovascular tissue. Surgical Team- The robotic team includes console-side and patient-side surgeons (Figure 4). The operating surgeon sits at the console, and is not scrubbed. After the patient-side team is scrubbed, they place the ports, present the operative field to the operating surgeon, and use suction to keep the field clean. Surgical StepsANATOMIC PRINCIPLES: THREE ZONES OF NERVES (THE AUTHORS’ TRI-ZONAL CONCEPT) Based on a close collaboration between Cornell Institute of Robotic Surgery, New York, and Institute of Urology at University of Innsbruck in Austria, Dr Tewari performed fresh cadaveric dissections at Cornell Institute of Robotic Surgery, New York [20], and then visited Innsbruck to perform and standardize the �Athermal Robotic Technique’ in 15 patients in 2004. The findings based on dissection of fresh and fixed cadavers are presented herein. Learning from the anatomic studies [21-24], we appreciate the tri-zonal neural architecture (Figure 6). This means the nerves are found in 3 broad zones and not as 1 single nerve running to the cavernous tissue. Strategies to safeguard the nerves are threefold: Care to avoid damage to the Primary neural plate the PNP starts early on. The PNP covers a significant part of the proximal prostate on its lateral aspect, and can be injured when the sheet like fascia of the pelvis, called endopelvic fascia, is opened. We use the scissors to sharply open the endopelvic fascia quite medially and then meticu- lously dissect a plane between the coverings of the prostate: the prostate capsule and prostatic fascia. The next step is to understand the relation of the PNP and the bladder neck. Since the PNP is located lateral to the prostate-bladder junction, we approach the bladder neck in the center. Once the bladder is opened, posterior dissection starts by opening a “retrotrigonal layer.” Cutting this layer opens up a window through which the vasa and the seminal vesicles are seen. Third, the PNP is related to the Seminal Vesicle dissection. As seen in figure 8, PNP is located 5-10 mm (average 5 mm) lateral to the seminal vesicles and is in danger of getting thermally damaged, thus temporarily or permanently affecting recovery of erectile function. Therefore, this part of the dissection is performed athermally by developing small pedicles and controlling them with minute 5mm surgical clips close to the surface of the seminal vesicle. The second stage is to preserve the predominant neurovascular bundles (PNB)- as is seen in (Figures 6 and 7), PNB is located in a posterior-lateral groove on the side of the prostate [20]. Significant variations in the location, shape, course and composition of this bundle occurs. A muscular (levator) branch and anterior rectal component [25], [20, 21, 26] makes accurate graft anastomosis to proximal and distal segments very difficult, thereby increasing the need to preserve the nerves or use some form of nerve advancement [25]. From a practical standpoint, PNB is usually well formed in approximately 50% of cases. Since neural communications of the PNP and PNB are delicate, any stretch, or thermal damage may affect the return of erectile function; this may be temporary or permanent. The current trend is shifting towards the use of athermal techniques [27, 28]. Peri-prostatic fascia (layers of covering on the prostate)- The outer layer lining the levator ani muscle is called the levator fascia and the inner layer covering the capsule is the prostatic fascia (Figure 7). Between these two layers are a few flimsy layers in which the neurovascular structures are found, along with some fat. Safe nerve sparing should leave prostatic fascia on the specimen without excising the neurovascular structures. PNB and lateral pedicle control- Ante grade release of PNB- Using sharp and blunt dissection the prostatic pedicle is developed and controlled. When done in an antegrade fashion the dissection starts near the base of the prostate and proceeds toward the apex. Synchronous ante grade and retrograde release of PNB- Sometimes planes of dissection are obliterated due to periprostatic inflammation, tumor induced desmoplasia, extraprostatic extension and resolving hemorrhage. We then have to resort to approaching the prostatic pedicles at the end when the bundle is free at the apex and the rest of its course, except for at the pedicle. This approach provides clear demarcation of prostatic pedicles and is also useful when the prostatic pedicle is very wide and it is difficult to differentiate it from the neurovascular bundle. In select cases where we feel the tumor characteristics does not allow complete nerve sparing we do an incremental nerve excision, zone specific radicality or excision and nerve advancement with end to end anastomosis of the bundles obviating the need for an exogenous nerve graft. Preservation of accessory pathways- Accessory nerves can be found around the prostate, between prostatic and lateral prostatic fascia, posterior to the prostate and in the layers of Denonvilliers’ fascia, in several planes between the layers of periprostatic fascia and finally even in the layers of the prostatic capsule. The physiological significance of these nerves is uncertain: some are cavernous nerves (erectile tissue), some supply the musculature (motor function), few innervate the sphincter and finally deeper ones may be involved with prostatic secretions and smooth muscle contractility. In order to preserve anterolateral pathways, Menon has described a novel approach which is called Veil technique [29]. [29-31]. Nerve preservation and apical dissection- Apical dissection is a critical step since this area is the final common pathway for the exit of cavernous nerves. PNB and accessory pathways (both anterolateral and posterior) are very intimately related to the components of apicourethral junction- distal prostate, dorsal venous plexus, urethral tube, periurethral muscles, puboperinealis, ligaments, fascial layers, and distal vascular pedicle to the prostate and neurovascular bundles in a small area, behind the pubic bone. They can be damaged during urethral transection and anastomosis. The visual angles are changed several times to allow identification of both bundles and their relationship with the sphincter (Figure 6 showing nerve bundles after removal of prostate). Careful dissection in this region also ensures good preservation of the mechanisms contributing to continence, which include the complex ligaments and muscles called Puboprostatic musculoligamentous complex which has A) a Fascioligamentous component comprising of the Arcus Tendineus and the puboprostatic ligaments, and B) a Puboperineales muscular component. Armed with these findings of anatomic studies [10], we developed our strategies for doing our Athermal robotic technique for nerve sparing (Figure 8). The details of robotic prostatectomy technique have been described previously[7, 8, 17]. We first incise the peritoneum over the bladder (Figure 4), and drop the bladder to enter the space in front of it, in order to approach the prostate from the front. The prostatic veins are then secured with a stitch and the junction between prostate and bladder is dissected precisely - we use a technique devised by the author called the “Bladder neck pinch.” We control the prostatic arteries (pedicles) by clips (Figure 9), sutures or occasionally individually coagulating the vessels by bipolar forceps. Most of the dissection proceeds without coagulating structures since we have done studies showing that heat coagulation spreads to over 1.5 cms from the point source. Since the nerves are located so close to the seminal vesicles (see previous paragraphs), this maneuver is responsible for minimizing damage to the nerves and improving on outcomes. This forms the foundation for our ATHERMAL (NO HEAT) ROBOTIC TECHNIQUE for prostatectomy. The anatomic location of the nerves are previously described[7] (Figure 6). These nerves are precisely dissected and left in the patient for future erectile function (Figure 10).[7-9, 11, 12, 18, 32] The lymph nodes are removed as would be done in any open procedure. The robot allows for even extended lymph node removal in selected cases with high-risk cancer. The opening in the bladder is then sutured to the end of the urethra to recreate the continuity. The endo-wrist technology and magnified 3-D vision brings in precision and allows anastomosis (suturing) to be more secure and water tight. We specially attempt not to damage muscles surrounding the urethra and thus leave the sphincter intact. This helps in early return of urinary control. We also preserve maximum blood supply to the urethra and other surrounding structures by precisely suturing only those vessels which are entering the prostate and absolutely are required for the safe removal of the cancerous gland. We attempt to identify any local spread by use of frozen sections and take counter measures to maximize cancer control. Retrieval of specimen and completion of surgery- The prostate gland containing cancer is entrapped (intact) in a thick plastic bag to avoid any tumor spillage. The specimen is removed after slightly enlarging the umbilical incision as required. Plastic surgical closure of the incisions is performed using steri-strips. Postoperative care and discharge- The patients are sent to recovery on intravenous fluids, antibiotics and pain meds. They usually walk on the evening of the operation and go home either on the same day or the next morning. The catheter is removed between 4-7 days after surgery. We have not had the need to transfuse even 1 patient during surgery. The pain is also much less. Patients have small cosmetic incisions and go back to work in approximately 12-14 days. Many patients, who are from distant places, fly back to their homes in 1-2 days. A few commonly asked questions have been summarized at the conclusion of this article. CONTEMPORARY RESULTS [7-9, 11, 12, 18, 32] From a patient perspective [33], the following concerns have been reported to have the most influence on prostate cancer therapy: oncologic control (margin and PSA recurrence), pain, complications, convenience (catheter duration and hospital stay) and functional outcomes (incontinence and sexual recovery). Herein, we analyze the results of our published series of patients treated with robotic prostatectomy in comparison with open radical retropubic prostatectomy[11], [34], bearing in mind the aforementioned patients’ key preference points. The following discussion is based on this work. Table 1 shows our series of 2005 and the results in 215 cases. Since then we have done over another 340 cases and have been further improving on results (manuscript under preparation for publication). Cancer Control- As shown in Table 2, the oncological results have been compared with another series with 100 RRP patients, 200 robotic patients and our series with 215 robotic patients. The surgical specimen was inked and processed for histopathological analysis. Margins were considered positive if there was a tumor present at ink. For the apex, margins were considered positive if the margins of the apical biopsies, which represent the actual margin of the apical dissection, had cancer. Percent cancer, Gleason scores, and pathological stages were comparable between the two groups. Twenty three percent of the RRP patients had a tumor at the inked margin. In the robotic prostatectomy group, we performed intra-operative biopsy to excise additional peri-apical collar of the distal tissue. The residual positive tumor was seen in fewer than 10% of the cases. Pain- As seen in Table 2, the robotic prostatectomy patients had much less post-operative pain, which was managed predominantly with oral Cox 2 inhibitors. Inconvenience- Mean hospitalization stay and duration of catheterization were significantly shorter for the robotic prostatectomy cohort (Table 2). Therefore the inconvenience of staying in the hospital and the catheter duration were less with the robotic prostatectomy procedure. Risks and Complications- As shown in Table 3, robotic prostatectomy is quite safe and the minor and major complications were one-fourth of those experienced by the patients undergoing open radical prostatectomy. Functional Results- We have developed some modifications in nerve-sparing which utilizes the benefits of robotic technology. In particular, we have improved three-dimensional stereoscopic vision and intuitive multidirectional movement of miniaturized robotic instruments. The foundations of nerve-sparing have been based on Walsh’s initial principles and later data from cadaver dissections [10]. These studies elucidated the course of nerves as seen in Figures 6, 8-10. We delicately dissect the nerves using micro scissors and delicate control of bleeders. The incidence of patient-reported sexual functions is quite encouraging. We have also made technical modifications for improved continence. The anatomy of the sphincter complex is clearly visualized and we attempt to minimize dissection in the vicinity of continence muscles and preserve its nerve and blood supply. Our results of continence are summarized in Figure 11 A) Continence: Based on third party telephone interviews, we used survival analysis to compute the probability of return of continence by the two groups of patients. Robotic prostatectomy patients achieved continence much more quickly than RRP patients; achieving a 50% return of continence required 160 days in the RRP arm as opposed to 44 days in the robotic prostatectomy arm (p<0.05). (Figure 12)[11] B) Sexual Function: The sexual function was also evaluated using third party telephone interviews. The response was compiled as the ability to (1) achieve erections and (2) have erections strong enough for intercourse. The analysis was limited to (1) patients who classified themselves as having normal preoperative erections and sexual intercourse and (2) the ones who underwent bilateral nerve sparing. Robotic prostatectomy patients returned to erection more than three times more quickly (50% return of erection occurred at mean follow-up of 180 days vs. 440 days for RRP patients (p<0.05). The return of intercourse was also quicker in the robotic prostatectomy arm in which 50% patients achieved intercourse at a mean follow-up of 340 days. Conversely, the RRP patients have not yet achieved 50% return of intercourse at 700 days (p<0.05). Forty two percent of robotic prostatectomy and 65% of RRP patients were known to be using Sildenafil (Viagra) at the time of analysis. (Figures 13)[11] Operative Comparisons: The robotic prostatectomy patients needed an extra 15 minutes for the setup, but the overall operative times were comparable in the two groups. On the other hand, the blood loss of the robotic prostatectomy patients was one-tenth that of the RRP patients. In laparoscopy, the surgeon uses long instruments through small openings and maneuvers them with direct hand contact. Robotic systems use even more delicate instruments that possess 2 additional degrees of movement excursion (total of 6 like a human hand) and are maneuvered by the surgeon through a computer interface while the surgeon is comfortably seated at the robot console. Laparoscopic radical prostatectomy is associated with a steep learning curve. Even in the hands of expert surgeons this technique requires extensive learning and many cases to master. On the contrary, the learning of robotic prostatectomy seems to be more intuitive and less demanding. Despite the large laparoscopic experience, the mean operative time for robotic (347 min) was less than laparoscopic prostatectomy (492 min) in one study. The estimated blood loss was comparable (< 500 cc), and there were 2 conversions in each group, but no major complications occurred. CONCLUSION Robotic prostatectomy is a safe, effective and reproducible technique for removing the prostate. In most patients, it can be performed within one and half to two hours with minimal blood loss and few complications. The procedure incorporates principles of both laparoscopic and open radical prostatectomy. The patients enjoy benefits of surgical treatment in the setting of less invasion, minimal pain, low blood loss, early function and overall recovery. WHAT TO EXPECT AFTER SURGERY Questions Answered by Dr. Ash Tewari: Will I need blood transfusions? No, generally we do not expect you to lose a significant amount of blood during the operation in order to require a blood transfusion. Less than 0.5% of patients require a blood transfusion. In fact the blood loss of Robotic Prostatectomy is approximately 10 times lesser than open prostatectomy. How long will I stay in the hospital after the operation? You will be able to leave the hospital the following afternoon. If you come from outside the New York area we do recommend that you stay at a nearby facility for convalescence until your first follow-up appointment in 4-7 days. How much pain will I have? The operation is not painless but it is in fact much less painful than open surgery. You may experience some shoulder pain after surgery because of the abdominal gas insufflation, which will decrease after the first day. You will be able to go home with oral painkillers that you take if needed. Some patients have a vague discomfort of the abdomen on the 2nd to 4th day when they are ready to have bowel movements. This usually does not require any intervention except for oral medicines. Some patients may have temporary swelling and bruising of the scrotum. It usually resolves in a few days. What kind of food will I be able to eat after surgery? We will give you a liquid diet in the hospital. You will be able to eat solid food when you pass gas and have a bowel movement. How long will the urinary catheter (Foley) stay in place? You will go home with a urinary catheter, called Foley that drains your bladder and is attached to a leg bag. Continuous urine drainage will allow better tissue healing after the operation, and prevent scarring and narrowing. The Foley will remain in place for 5 to 7 days after which it will be removed in the office. When will I be able to go back to work? The convalescence period is 2 to 3 weeks. Depending on the type of work you do, you will be able to resume non-physical work on a part time basis 2 weeks or so after surgery. Will I be impotent after surgery? Based on published data you have over an 80% chance at 6 months after surgery to regain erections with or without the need of oral medication. Over 55 % of patients who had a Robotic Prostatectomy have had intercourse 6 months after surgery. Will I leak urine after surgery? Based on published data you have a 96% chance of being dry at 6 months after surgery. Some patients do wear a liner only for security, even if they do not leak urine. Regain of sphincter control is a continuous process after surgery, but even 30% of patients will be completely continent immediately after catheter removal. A COMPARISON OF RADICAL RETROPUBIC PROSTATECTOMY (PREVIOUSLY PUBLISHED), AND OUR ART-Robotic prostatectomy DONE AT CORNELL (2005) TABLE 1: BASELINE VARIABLES IN CONTEMPORARY PATIENTS UNDERGOING PROSTATECTOMY Variable RRP ART P Value N = 100 (REF 11) N-215 (2005) Age in years 63.1 (42.8-72) 60.1 (47-72) NS Serum PSA (ng/ml) 7.3 (1.9-35) 6.1 (1.9-21.6) NS T1a T1c T2a T2b T3a 0% 58.8% 9.8% 35.3% 3.9% 0.5% 74.6% 13.6% 4.7% 6.1% 6.6 0% 3% 49% 35% 10% 3.9% 6.3 0% 0% 72.6% 22.7% >8=4.7% NS 2-4 5 6 7 8 9-10 Previous abdominal and hernia surgery 19% 19% NS NS Clinical Stage: Gleason Mean A COMPARISON OF RADICAL RETROPUBIC PROSTATECTOMY (PREVIOUSLY PUBLISHED), AND OUR ART-Robotic prostatectomy DONE AT CORNELL (2005) TABLE 2: OPERATIVE AND POSTOPERATIVE VARIABLES IN 315 PATIENTS UNDERGOING PROSTATECTOMY Variable RRP N=100 (REF 11) ART N-215 163 (86-395) 142 (71-320) Operative time (mts) 910 (200-5000) 150 (75-450) EBL (cc) (Range) Autologous No transfusion Intraoperative Blood Transfusion 56 Banked 11 0% Total 67% 7 (4-10) 3 (1-6) Post op pain score Mean (Range) 10.1 g/l (6.9-14.6) 13.5 g/dl Discharge Hemoglobin 3.5 (3-6) 1.2 (1-3) Mean Hospital Stay (Days) 0% 97% Discharged within 24 hours 15.8 (7-28) 7.1 (6-11) Duration of Catheterization (Mean in days) (Range) 85% 93% Undetectable PSA (%) 18.3 (5-90) 2-15% Percentage Cancer in specimen Gleason score 7.1 Mean 6.6 0% 2-4 0% 1% 5 1% 46% 6 41% 47.3% 7 38% >8=5.7% 8 18% 9-10 2% Path stage 17.3% T2a 18% 3.3% T2b 75% T2c/T3a/T3b T3a 4% 67.3/7.53.7% T3b 3% 2% 0% Positive Node incidence Margin positivity in Organ confined cancers (PT2a-T3a) 15% 1.2% Extensive (>1 mm) 8% 5.3% Focal (<1 mm) P Value NS <0.001 <0.001 P<0.05 P<0.05 P<0.05 P<0.001 P<.05 NS NS NS NS NS P<0.05 A COMPARISON OF RADICAL RETROPUBIC PROSTATECTOMY (PREVIOUSLY PUBLISHED), AND OUR ART-Robotic prostatectomy DONE AT CORNELL (2005) VARIABLES TABLE 3: COMPLICATIONS IN 315 PATIENTS UNDERGOING PROSTATECTOMY RRP (N=100) (REF 11 ) ART (215) P VALUE Aborted 1 (1%) 0% P<.05 Conversion NA 0% NS Rectal injuries 1 (1%) 1 (.5%) NS Post operative ileus 3 (3%) 0% NS Wound dehiscence/Hernia 1 (1%) 0 NS Fever/Pneumonia 4 (4%) 0 P<0.05 Lymphocele 2 (2%) 1 (0.5%) NS Obturator Neuropathy 2 (2%) 0 NS DVT 1 (1%) 0 NS Post operative MI 1 (1%) 0 NS Bleeding/Reexploration 4 (4%) 0 NS Total 20% 2(0.9%) <0.05 Bibliography [1] Satava RM. 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