Change Notice: Any information related to Prostate-Specific Antigen (PSA) in the following guideline may have been revised in the American Urological Association's (AUA) PSA Best Practice Statement: 2009 Update. In the case of any discrepency in recommendations between guidelines pertaining to PSA, please refer to the AUA's PSA Best Practice Statement: 2009 Update for the latest AUA recommendation regarding PSA testing. Prostate Cancer Members, (specialty): Ian Thompson, M.D., Chair, (Urology) James Brantley Thrasher, M.D., Co-Chair, (Urology) Gunnar Aus, M.D., (Urology) Arthur L. Burnett, M.D., (Sexual Medicine) Edith D. Canby-Hagino, M.D., (Urology) Guideline for the Michael S. Cookson, M.D., (Urology) Anthony V. D’Amico, M.D., Ph.D., (Radiation Oncology) Roger R. Dmochowski, M.D., (Urology) David T. Eton, Ph.D., (Health Services Research) Jeffrey D. Forman, M.D., (Radiation Oncology) S. Larry Goldenberg, O.B.C., M.D., (Urology) Management of Clinically Javier Hernandez, M.D., (Urology) Celestia S. Higano, M.D., (Medical Oncology) Stephen R. Kraus, M.D., (Neurourology) Judd W. Moul, M.D., (Urology) Catherine M. Tangen, Dr. P.H., (Biostatistics and Clinical Trials) Localized Prostate Consultants: Hanan S. Bell, Ph.D. Patrick M. Florer Diann Glickman, Pharm.D. Scott Lucia, M.D. Timothy J. Wilt, M.D., M.P.H., Data Extraction Cancer: 2007 Update AUA Staff: Monica Liebert, Ph.D. Edith Budd This publication was supported by Grant Number C12/CCC323617-01 Michael Folmer from Centers for Disease Control and Prevention. Its contents are solely Katherine Moore the responsibility of the authors and do not necessarily represent the official views of Centers for Disease Control and Prevention. Table of Contents Introduction..................................................................................................................................... 4 Context............................................................................................................................................ 5 Definitions and Terminology.......................................................................................................... 6 Screening Tests.........................................................................................................................................................6 PSA.......................................................................................................................................................................6 DRE......................................................................................................................................................................7 Prostate Biopsy ....................................................................................................................................................7 Tumor Characteristics...............................................................................................................................................7 Tumor Grade........................................................................................................................................................7 High-Grade Cancer .............................................................................................................................................8 Tumor Stage .........................................................................................................................................................8 Initial Evaluation and Discussion of Treatment Options with the Patient...................................... 8 Life Expectancy and Health Status...........................................................................................................................9 Tumor Characteristics...............................................................................................................................................9 Risk Strata.................................................................................................................................................................9 Treatment Options ..................................................................................................................................................10 Watchful Waiting and Active Surveillance.........................................................................................................10 Interstitial Prostate Brachytherapy....................................................................................................................12 External Beam Radiotherapy .............................................................................................................................12 Radical Prostatectomy .......................................................................................................................................14 Primary Hormonal Therapy...............................................................................................................................14 Other Treatments ...............................................................................................................................................15 Methodology................................................................................................................................. 16 Search and Data Extraction, Review, and Categorization ......................................................................................16 Data Limitations .....................................................................................................................................................23 Guideline Statement Definitions.............................................................................................................................25 Deliberations and Conclusions of the Panel ...........................................................................................................26 Future Prostate Cancer Guideline Panel Activities.................................................................................................26 Treatment Alternatives.................................................................................................................. 27 Treatment Recommendations ....................................................................................................... 27 Treatment of the Low-Risk Patient.........................................................................................................................27 Treatment of the Intermediate-Risk Patient............................................................................................................29 Treatment of the High-Risk Patient ........................................................................................................................30 Additional Treatment Guidelines............................................................................................................................31 Copyright © 2007 American Urological Association Education and Research, Inc.® 2 Treatment Complications.............................................................................................................. 32 Summary of Treatment Complications...................................................................................................................32 Analysis of Treatment Complications ....................................................................................................................37 Incontinence and Other Genitourinary Toxicity ................................................................................................38 Gastrointestinal Toxicity....................................................................................................................................39 Erectile Dysfunction...........................................................................................................................................39 Quality of Life and Treatment Decisions: A Major Patient Concern in Clinically Localized Prostate Cancer ............................................................................................................................. 41 Randomized Controlled Trials...................................................................................................... 42 Introduction ............................................................................................................................................................42 RCTs Comparing Different Treatment Modalities .................................................................................................43 Watchful Waiting Versus Radical Prostatectomy...............................................................................................43 Adjuvant Bicalutamide Therapy.........................................................................................................................45 RCTs Within Treatment Modalities........................................................................................................................46 External Beam Radiotherapy .............................................................................................................................46 External Beam Radiotherapy Fractionation ......................................................................................................47 The Role of Combined Therapy .............................................................................................................................47