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Latest in PSA Screening, How to Avoid Litigation, Robotics Mr Naveed Afzal, MBBS, FRCS, FRCS Urol, Dip Urol, FEBU Lead Consultant Urologist Robotic Surgeon & MDT Chair West Dorset Hospitals NHS FT BMI The Winterbourne Hospital www.dorchesterurology.co.uk Insert logo Here ERSPC – European Randomized Study of Screening for Prostate Cancer, Oct 2014 The ERSPC is the largest randomized trial of screening for prostate cancer with 162,388 men screened with regular prostate-specific antigen (PSA) testing every 2-4 years in the intervention arm and usual care with no screening offered in the control arm. 900 prostate cancer related deaths. ERSPC Published Lancet, Oct 14, 2014 In this update of the ERSPC with followup truncated at 13 years, a significant 21% relative reduction in prostate cancer deaths was found in intention to screen analyses, and 27% in men who actually attended screening. The absolute risk reduction of death from prostate cancer at 13 years, with 1.28 fewer prostate cancer deaths per 1,000 men. ERSPC – European Randomized Study of Screening for Prostate Cancer, Oct 2014 Despite showing a clear prostate cancer mortality reduction, the findings are not sufficient to justify population-based screening. We still need further quantification of harms of screening and better strategies to overcome overdiagnosis and overtreatment for both more targeted screening and assessment of prostate cancer risk, such as multivariate risk stratification. In the meantime, wellinformed men suitable for screening should have access to PSA-testing. New Fast Track Ref Guidelines, NICE 2015 EAU Guidelines for screening and early detection of prostate cancer An individualised risk-adapted strategy for early detection might be offered to a wellinformed man with a good performance status and at least 10-15 years of life expectancy. 3 B Early PSA testing should be offered to men at elevated risk for Pca EAU Guidelines for screening and early detection of prostate cancer The age at which early screening diagnosis of PCa should be stopped is influenced by life expectancy and performance status; men who have < 15-year life expectancy are unlikely to benefit based on the PIVOT and the ERSPC trials. Clinical diagnosis Prostate cancer is usually suspected on the basis of digital rectal examination (DRE) EAU Guidelines for screening and early detection of prostate cancer Risk groups are: • men over 50 years of age • men over 45 years of age and a family history of PCa • African-Americans • men with a PSA level of > 1 ng/mL at 40 years of age • men with a PSA level of > 2 ng/mL at 60 years of age 2b A A risk-adapted strategy might be considered (based on initial PSA level), which may be every 2 years for those initially at risk, or postponed up to 8 years in those not at risk. 3 C Who Should Be Screened, and Why? AUA’s recommendation:1 Talk to your doctor about a baseline screening for men age 40+ with an expected life of 10+ years Why? Easier to identify changes later Early diagnosis could mean more treatment options1 Five-year survival rate is nearly 100% for localized cancer.2 9 1. http://www.auanet.org/content/media/psa1.pdf 2. http://www.cancer.org/cancer/prostatecancer/detailedguide/prostate-cancer-survival-rates Incidence of Prostae cancer in UK Prostate cancer is the most common male cancer in UK Nearly 40,000 men are diagnosed every year • 11,000 people die every year. 1 out of 8 men will get prostate Cancer in UK Prostate cancer is the most common cancer in Europe for males, and the third most common cancer overall, Around 417,000 new cases diagnosed in 2012 (3% of male cases and 12% of the total). In Europe (2012), the highest World agestandardised incidence rates for prostate cancer are in Norway; the lowest are in Albania. UK prostate cancer incidence rates are estimated to be the 17th highest in Europe. Dorset has the highest incidence of Prostate Ca in UK (NHS England 2015) 1 in 8 men in UK are at risk of having Prostate Cancer 1 in 6 men in Dorset are at risk. Is it the elderly population ? Is it the dietary habits ? Is it the good quality Dorset beef ? Prostate (C61): 2013 Proportion of Cancers Diagnosed at Each Stage, All Ages, England Stage at Diagnosis Percentage of Cases (%) Stage I 29.2 Stage II 19.1 Stage III 16.8 Stage IV 16.7 Stage Not Known 18.2 What We Will Talk About Today 14 Managing Prostate Cancer was never so easy Raised Age specific PSA / DRE Abnormality Fast Track Referral We will arrange a Multi-parametric MRI Reviewed at MDT with the Radiologist Peripheral abnormality-RAPSA clinic & TRUS Anterior abnormality-Urgent OPA then TPTB MRI NAD ? RAPSA & TRUS or OPA ? No Bx Age specific reference range Age range (Years) PSA ng/ml 40-49 0-2 50-59 0-3 60-69 0-4 70-79 0–6 Diagnosis TRUS Transperineal Template Prostate Biopsies (TPTB) Dorchester Template Bx Map Transperineal Template Prostate Biopsies (TPTB) HOW TO AVOID LITIGATION Considering 2015 new NICE Guidelines re PSA Offer a single baseline PSA for all men over 50 with 10 year life expectancy (Majority of men over 50 have LUTS, Nocturia) Separate Doves and Hawks PSA <2, Dove. No need for yearly PSA checks. Only concentrate on PSA >2 Old strategy:Talk out of PSA. New: talk in Minimally Invasive Robotic-Assisted Surgery About 80% of prostatectomy patients choose da Vinci® Surgery1 da Vinci® Surgery Potential Patient Benefits Excellent Cancer control2,3,4 Faster return of sexual function3,4 Faster return of urinary continence3,4 Open Surgical Incision Shorter hospital stay4,5,6,7 Low level of pain5 Less blood loss, fewer transfusions3,4,5,6,8,9 Lower risk of infection, complications6,8 Faster recovery and return to normal activities5,7,9 22 1. Based on 2008 U.S. data. Data on file at Intuitive Surgical, Inc. 2. Ahlering TE, et al. Urology. May 2004;63(5):819822. 3. Coelho RF, et al. J Endourol. 2010 Dec;24(12):2003-15. Epub 2010 Oct 13. 4. Ficarra V, et al. BJU Int. 2009 Aug;104(4):534-9. Epub 2009 Mar 5. 5. Menon M, et al. Urology. 2002 Nov;60(5):864-8. 6. Boris RS, et al. Can J Urol. 2007 Jun;14(3):3566-70. 7. Hohwu L, et al. Scand. J. Urol. Nephrol. Apr 7 2009:1-6. 8. Carlsson S, et al. Urology. 2010 May;75(5):1092-7. 9. Miller J, et al J Urol. 2007 Sep;178(3 Pt 1):854-8; discussion 859. Epub 2007 Jul 16. da Vinci® Surgical Incision Surgery: da Vinci® Surgery 23 Surgery: da Vinci® Surgery 24 Surgeon is immersed in a 3D-HD surgical field with up to 10x zoom Surgeon directs every move of the tiny instruments, using console controls Robotic system scales and replicates movements, while eliminating hand tremors Allows surgeon to operate with increased dexterity & precision, vital for nerve-sparing surgery What is the prostate? What does it do? Male sex gland Bladder Adds nutrients and fluids for sperm The urethra (urine channel) runs through the middle of the prostate Rectum Urethra Prostate Testes 25 1. http://cancer.gov/cancertopics/pdq/treatment/prostate/Patient Seminal Vesicles What is Prostate Cancer? Abnormal cells growing out of control Begins in the prostate gland Can spread and invade other tissues, organs, and bones 26 Normal Prostate Prostate Cancer How Common Is It? How many men are affected by prostate cancer in America? (A) 1 in 3 (B) 1 in 6 (C) 1 in 12 (D) 1 in 24 Answer: B, about 1 in 6 men.1 (Compared to 1 in 8 women for breast cancer2) Prostate cancer is the 2nd leading cause of cancer death in men.1 27 Every minutes, a man is newly diagnosed Every minutes, a man dies of prostate cancer 1. http://www.cancer.org/cancer/prostatecancer/detailedguide/prostate-cancer-key-statistics 2. http://www.cancer.org/Cancer/BreastCancer/DetailedGuide/breast-cancer-key-statistics Risk Factors for Prostate Cancer1 Age MYTH: Prostate cancer is only an old man’s disease. Family history FACT: NOT true! Risk increases with age, but men of all ages should know their personal risk factors. Father Brother Son Race African-American men are more than twice as likely to die from prostate cancer than white men.2 28 1. http://www.cdc.gov/cancer/prostate/basic_info/risk_factors.htm 2. http://www.cancer.org/Cancer/ProstateCancer/DetailedGuide/prostate-cancer-risk-factors Possible Symptoms of Prostate Cancer1 29 Trouble urinating Weak flow of urine Frequent urination, especially at night Painful or burning urination Blood in the urine or semen Pain in the back, hips or pelvis that won’t go away Painful ejaculation 1. http://www.cdc.gov/cancer/prostate/basic_info/symptoms.htm MYTH: If you don’t have symptoms, you don’t have prostate cancer. FACT: Maybe. Not all men experience symptoms with prostate cancer. Your doctors are often the first ones to detect signs of prostate cancer during check-ups. What Does Screening Involve? Both screening tests should be used1 MYTH: High PSA = Cancer, Low PSA = No Cancer PSA – blood test DRE – physical exam FACT: Wrong! High PSA could be because of prostate cancer, or other conditions. However, low PSA level does NOT mean “home free.” A big or sudden change in PSA could signal trouble, too. Biopsies are ordered after evaluating screening results and personal risk factors 30 1. http://www.auanet.org/content/media/psa1.pdf Biopsy and Grading1 Biopsy Grading: Gleason Score To confirm diagnosis Thin needle to remove small pieces (typically 12 samples) Gleason score (2-10) 31 To grade aggressiveness of the cancer cells Add the scores from 2 areas with the most cancer cells Example: Gleason 7 (3+4) 1. http://www.cancer.org/cancer/prostatecancer/detailedguide/prostate-cancer-diagnosis 1 Least Aggressive 2 3 4 5 Most Aggressive Staging1 May use bone scan, CT and MRI 32 T1, T2: localized T3, T4: spreads outside the prostate T1 T2 T3 T4 1. http://www.cancer.gov/cancertopics/pdq/treatment/prostate/Patient/page2 Treatment Considerations Goals Improve survival through cancer control Preserve urinary, sexual and bowel functions Minimize side effects Considerations 33 Benefits vs. side effects Age and expected life span Other health conditions Risk of cancer recurrence Treatments for Localized Prostate Cancer 34 Active Radiation Surveillance Surgery What it means Active monitoring of the prostate Kills cells, but does not remove them Removes the prostate and cancer cells How it’s done Closely monitor PSA/DRE Biopsy External beam Minimally or implanted invasive or “seeds” open surgery Other Treatments Kills or inhibits growth of cancer cells Cryotherapy freezes cancer cells; hormone therapy inhibits their growth Cumulative Survival % 10-Year Survival: Highest with Surgery1 Prostatectomy (surgery) Active surveillance Radiotherapy Other therapy Hormone therapy 0 1 2 35 3 4 5 6 7 8 9 10 Years after diagnosis 1. Merglen A, et al. Arch Intern Med 2007; 167:1944-1950. Active Surveillance Actively monitors disease progression without actual treatment1 36 Possibly PSA and DRE every 3-6 months; Biopsy every year Some older men with low grade prostate cancer may report a better quality of life2 An option for patients with low risk prostate cancer and a life expectancy less than 10 years1 Potential for increased risk of erectile dysfunction (ED) associated with multiple biopsies during active surveillance3 1. http://www.cancer.gov/aboutnci/ncicancerbulletin/archive/2010/011210/page2 2. Hayes, J. Journal of the American Medical Association. 2009 Dec. 3. Pavlovich C, et al. J Urol. 2009 Dec; Vol. 182, 2664-2669. Radiation External Beam Brachytherapy Uses computer and CT scan to target radiation at the cancer cells from outside the body Uses small radioactive “seeds” implanted with a needle throughout the prostate Daily visits, usually for up to 9 weeks 1 day outpatient visit, may require general anesthesia Some healthy tissue may be affected The seeds stay in the prostate permanently Side effects may be slow to appear with radiation therapy, and may include erectile dysfunction, urinary problems, bowel and bladder problems, scarring, and fatigue. 37 1. http://www.cancer.org/Cancer/ProstateCancer/DetailedGuide/prostate-cancer-treating-radiation-therapy Predicted 10-Year Cancer-Specific Death 10-Year Risk of Death: Lowest with Surgery1 Hormone Radiation Surgery 100-Kattan Score predicting risk of cancer return (combines PSA, stage and Gleason score) 38 1. Cooperberg, M. R., et al. Cancer, 116: 5226–5234. doi: 10.1002/cncr.25456 19% of Prostate Cancer Patients Still Had Urinary Pain 24 Months After Radiation Urinary Pain at 24-Month1 Urinary Pain at 2-Month1 Lower is better Radiation 39 Surgery. Radiation 1. Buron C, et al. Int J Radiat Oncol Biol Phys. 2007 Mar 1;67(3):812-22. Surgery . Surgery (Radical Prostatectomy) Total removal of the prostate “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.” - 2007 AUA Clinical Guidelines 40 1. King CR. Int J. Cancer (Radiat. Oncol. Invest.) 2000;90,305-311. Thinking Ahead What if cancer returns? Easier to detect with surgery1 PSA drops to zero post-surgery if there’s no cancer PSA can fluctuate post-radiation even if there’s no cancer Surgery preserves treatment options2 41 Multiple options if treated with surgery first Limited options if treated with radiation first 1. Di Blasio, C. J., et al. Semin Oncol. 2003; 30(5):567-86. 2. Carlucci JR, et al. Geriatrics. 2009; 64(2):8-14. Precision Matters: Better Cancer Control with da Vinci Surgery Cancer Control T2 Positive Margin Rate1 The lower the positive margins, the better Open Surgery da Vinci® Surgery . 1. Di Pierro GB, et al. Eur Urol. 2011 Jan;59(1):1-6. Epub 2010 Oct 21. 42 Precision Matters: Faster Return of Urinary Continence with da Vinci Surgery Continence Rates at 3-Month1 Continence Rates at 12-Month1 Higher is better Open Surgery 43 da Vinci® Surgery . Open Surgery da Vinci® Surgery . 1. Rocco B, et al. BJU Int. 2009 Oct;104(7):991-5. Epub 2009 May 5. 12-month rate difference is statistically significant (P=0.014) while 3-month rate-difference is not statistically significant (P=0.15) Precision Matters: Faster Return of Sexual Function with da Vinci Surgery Sexual Function at 1-Year1 Higher is better Open Surgery 44 1. Ficarra V, et al. BJU Int. 2009 Aug;104(4):534-9. Epub 2009 Mar 5. da Vinci® Surgery . Surgical Risks 45 All surgeries involve the risk of major complications. Before you decide on surgery, discuss all treatment options with your doctor. Understanding the risks of each treatment can help you make the best decision for your situation. Surgery with the da Vinci Surgical System may not be appropriate for everyone; it may not be applicable to your condition. Always ask your doctor about all treatment options, as well as the risks and benefits. Only your doctor can determine whether da Vinci Surgery is appropriate for you. Take Action Know your personal risk factors Talk to your family Talk to your doctor about prostate cancer screening If you are 40+, get your baseline PSA Discuss all treatment options with your doctor 46 New Fast Track Ref Guidelines, NICE 2015 RECOMENDATION Mass population screening not possible in UK Offer a single base line PSA check If normal, no need for yearly screening Target younger high risk patients Avoid un-necessary Bx on elderly patients RECOMENDATION Prevention: Diet Life style changes, Regular exercise Better awareness www.dorchesterurology.co.uk Thank You! While clinical studies support the effectiveness of the da Vinci Surgical System when used in minimally invasive surgery, individual results may vary. There are no guarantees of outcome. All surgeries involve the risk of major complications. Before you decide on surgery, discuss treatment options with your doctor. Understanding the risks of each treatment can help you make the best decision for your individual situation. Surgery with the da Vinci Surgical System may not be appropriate for every individual; it may not be applicable to your condition. Always ask your doctor about all treatment options, as well as their risks and benefits. Only your doctor can determine whether da Vinci Surgery is appropriate for your situation. All people depicted unless otherwise noted are Here models. © 2011 Intuitive Surgical. All rights reserved. Intuitive, Intuitive Surgical, da Vinci, da Vinci S, da Vinci Si, Single-Site, InSite,Insert TilePro logo and EndoWrist are trademarks or registered trademarks of Intuitive Surgical. All other product names are trademarks or registered trademarks of their respective holders. 875106 Rev. A 06/11