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Active Surveillance for Localized Prostate Cancer: A New Paradigm for Clinical Management PDF

212 Pages·2012·3.09 MB·English
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Current Clinical Urology Eric A. Klein, MD, Series Editor For further volumes: http://www.springer.com/series/7635 wwwwwwwwwwww Laurence Klotz, MD, FRCSC Editor Active Surveillance for Localized Prostate Cancer A New Paradigm for Clinical Management Editor Laurence Klotz, MD, FRCSC Division of Urology University of Toronto Sunnybrook Health Sciences Centre Toronto, ON, Canada ISBN 978-1-61779-911-2 ISBN 978-1-61779-912-9 (eBook) DOI 10.1007/978-1-61779-912-9 Springer New York Heidelberg Dordrecht London Library of Congress Control Number: 2012937992 © Springer Science+Business Media New York 2012 This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifi c ally the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on micro fi lms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. Exempted from this legal reservation are brief excerpts in connection with reviews or scholarly analysis or material supplied speci fi cally for the purpose of being entered and executed on a computer system, for exclusive use by the purchaser of the work. Duplication of this publication or parts thereof is permitted only under the provisions of the Copyright Law of the Publisher’s location, in its current version, and permission for use must always be obtained from Springer. Permissions for use may be obtained through RightsLink at the Copyright Clearance Center. Violations are liable to prosecution under the respective Copyright Law. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a speci fi c statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. While the advice and information in this book are believed to be true and accurate at the date of publication, neither the authors nor the editors nor the publisher can accept any legal responsibility for any errors or omissions that may be made. The publisher makes no warranty, express or implied, with respect to the material contained herein. Printed on acid-free paper Humana Press is a brand of Springer Springer is part of Springer Science+Business Media (www.springer.com) Preface On 21 May 2012, the US Preventive Services Task Force announced its fi nal recommendation for PSA screening: “Level D,” “moderate or high certainty that the service has no bene fi t or that the harms outweigh the bene fi ts.” This sent shock waves through the prostate cancer community. The main concern driving this recommendation was the risk of overdiag- nosis and overtreatment of clinically insigni fi cant prostate cancer. Many prostate cancer experts believed that this recommendation was inappropriate, in large part because adoption of active surveillance for favorable risk patients addressed the overtreatment problem effectively. The recommendation, and the response to it, was, in a sense, a vindica- tion of a 15-year saga of a growing movement to shift the “Zeitgeist” of management of prostate cancer from radical therapy for all to a more selective approach characterized by conservative management of low-risk disease and aggressive treatment of intermediate- and high-risk cancer. The genesis of the active surveillance approach occurred at a lunch meeting of a small multidisciplinary genitourinary oncology group at Sunnybrook Health Sciences Centre in 1995. The meeting was attended by Richard Choo and Cyril Danjoux, both radiation oncologists, and myself. PSA had been introduced about 5 years earlier in Canada, and at that time, we were in the midst of the dramatic increase in prostate cancer incidence which accompanied the introduction of PSA-based prostate cancer detection. We were seeing a large increase in the number of patients with small-volume low-grade disease. “Watchful waiting,” meaning con- servative management until symptomatic metastatic disease occurred, had been described for many years. We were uncomfortable with this approach because it denied patients who needed it the opportunity for cure. However, patients diagnosed with T1a prostate cancer after TURP had been man- aged conservatively for years with little controversy. At that time, it was unclear what the signi fi cance of PSA kinetics was. We knew, however, that most patients with advanced disease had a high PSA. Thus, seeking a way out of the Hobson’s choice of overtreatment for many (if all were treated) or undertreatment for some (“watchful waiting”), it seemed rea- sonable to propose a strategy of initial conservative management, with selective therapy for those with a rapid rise in PSA over time. We called this “active surveillance.” v vi Preface We proposed this approach as a prospective clinical trial to our local research ethics board and were awarded a small grant from the Prostate Cancer Research Foundation of Canada to embark on this study. Patients signed an informed consent. It was considered experimental and daring by many of our colleagues. Somewhat to our surprise, patients embraced this approach. The study accrued rapidly, and within a few years, we had 300 patients managed in this way. We found that patients’ initial anxiety turned to ebullience after a few years without progression, as they avoided the side effects of ther- apy without any apparent consequences. PSA doubling time identi fi ed a subset with clearly more aggressive disease that was offered de fi nitive therapy. In most cases, this was effective. We have learned a great deal over the years. These lessons can be summarized as follows: 1. About 25% of low-risk patients harbor intermediate- or high-risk disease. 2. Repeat biopsy is critical to identify these patients in a timely fashion. 3. PSA kinetics frequently gives a false trigger for intervention. 4. The concept of active surveillance is not dif fi cult to communicate to patients, regardless of their scienti fi c literacy, socioeconomic status, or language barriers. 5. Anxiety about “untreated cancer” is prevalent but can be managed with close monitoring and accurate information. 6. Managed appropriately, patients on active surveillance have an extremely low risk of prostate cancer mortality. 7. Development of better tools to identify the higher risk patients early on is a major research priority. MRI and biomarkers will likely play an important role going forward. This book is an overview of every aspect of surveillance as it is prac- ticed in 2012 and has contributions from clinicians and scientists at the top of the fi eld. These authors have made outstanding contributions. We believe it will be useful to physicians who manage patients on active surveillance and to scienti fi cally literate patients and their fami- lies and friends who are interested in a conservative approach to early prostate cancer. The book is dedicated to my wife Ursula and children Alex and Betsy. It is also dedicated to my mentor, Willet Whitmore, who memorably questioned the limitations of prostate cancer management and the primary role of tumor biology in determining patient outcome, long before this was fashionable. His famous dictum, ‘Treatment is often insuf fi cient when it is necessary and suf fi cient when it is unnecessary’ was prescient. Indeed, exploring when treatment is necessary and suf fi cient, and when unnecessary, is the focus of this book. Laurence Klotz Contents 1 The Problem of Cancer Overdiagnosis and Overtreatment .................................................................. 1 Laurence Klotz 2 Patient Selection for Active Surveillance .............................. 9 John B. Eifler and H. Ballentine Carter 3 Predicting High-Risk Disease Using Tissue Biomarkers ..... 23 Michael J. Donovan and Carlos Cordon-Cardo 4 Predicting High-Risk Disease Using Serum and DNA Biomarkers .............................................................................. 35 Danny Vesprini and Robert Nam 5 Triggers for Intervention in Men on Surveillance ................ 55 S.Y. Jackie Sham and Chris Parker 6 The Role of MRI in Active Surveillance ............................... 67 Caroline M. Moore, Clare Allen, and Mark Emberton 7 Active Surveillance: The European Experience ................... 81 Meelan Bul, Monique J. Roobol, and Chris H. Bangma 8 Active Surveillance: The Canadian Experience ................... 95 Laurence Klotz 9 Psychosocial Aspects of AS .................................................... 107 Meredith Wallace Kazer, Dwanna M. Ward-Boahen, David M. Latini, and Donald E. Bailey Jr. 10 Statistical Considerations for Patient Selection and Triggers for Intervention in Active Surveillance .......... 121 Andrew J. Vickers 11 Interpreting PSA Kinetics Using GLMM Technique .......... 131 Liying Zhang and Laurence Klotz vii viii Contents 12 The Potential Benefits of Diet and Physical Activity Among Active Surveillance Patients with Low-Burden Prostate Cancer ........................................ 139 Stacey A. Kenfield, J. Kellogg Parsons, and June M. Chan 13 The Role of 5a-Reductase Inhibitors (5-ARIs) in Expectant Management of Low-Risk Prostate Cancer ....................................................................... 153 David Margel and Neil Fleshner 14 Urologists’ Opinion on Active Surveillance: USA Versus the Netherlands .................................................. 157 Lionne D.F. Venderbos, Chris H. Bangma, and Ida J. Korfage 15 Clinical “Pearls” in Managing Patients on Surveillance ........................................................................ 169 Laurence Klotz 16 Active Surveillance, Focal Therapy, and the Future ............ 173 Mark Emberton 17 The Economics of Active Surveillance for Prostate Cancer ................................................................. 179 Marc A. Dall’Era and Christopher P. Evans 18 The Future of Active Surveillance ......................................... 187 Sima P. Porten, Jared M. Whitson, and Peter R. Carroll Index ................................................................................................. 201 Contributors Clare Allen, F.R.C.R. Imaging Department , University College London Hospitals Trust , London , UK Donald E. Bailey Jr., Ph.D., R.N. School of Nursing , Duke University , Durham , NC , USA Chris H. Bangma, M.D., Ph.D. Urology Department , Erasmus Medical Centre , Rotterdam , The Netherlands Meelan Bul, M.D. Urology Department , Erasmus University Medical Centre , Rotterdam , The Netherlands Peter R. Carroll, M.D., M.P.H. Department of Urology , University of California, San Francisco , CA , USA H. Ballentine Carter, M.D. The James Buchanan Brady Urological Institute , Johns Hopkins Medical Institutes , Baltimore , MD , USA June M. Chan, Sc.D. Epidemiology & Biostatistics and Urology, Cancer Epidemiology , University of California San Francisco , San Francisco , CA , USA Carlos Cordon-Cardo, M.D., Ph.D. Department of Genetics and Genomic Sciences , The Mount Sinai School of Medicine , New York , NY , USA Department of Pathology , The Mount Sinai Hospital , New York , NY , USA Marc A. Dall’Era, M.D. Urology Department, Davis School of Medicine , University of California , Sacramento , CA , USA Michael J. Donovan, M.D., Ph.D. Department of Pathology , The Mount Sinai Hospital , New York , NY , USA John B. Ei fl er, M.D. The James Buchanan Brady Urological Institute , Johns Hopkins Medical Institutes , Baltimore , MD , USA Mark Emberton, M.D., F.R.C.S. Division of Surgical and Interventional Science , University College London , London , UK Surgery Division, Urology Department , University College London Hospitals Trust , London , UK Christopher P. Evans, M.D., F.A.C.S. Urology Department, Davis School of Medicine , University of California , Sacramento , CA , USA ix

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