PSA TESTING AND EARLY MANAGEMENT OF TEST …

1 PSA TESTING AND. EARLY MANAGEMENT . OF TEST-DETECTED. prostate CANCER. CLINICAL PRACTICE GUIDELINES. A guideline for health professionals PSA TESTING AND EARLY MANAGEMENT OF. TEST-DETECTED prostate CANCER.. prostate Cancer Foundation of Australia and Cancer Conflict of interest Council Australia The development of these clinical practice guidelines has been undertaken by a non-remunerated Expert Advisory ISBN: 978-0-9941841-5-3. Panel of prostate Cancer Foundation of Australia and Date published: 20 January 2016 Cancer Council Australia. This work is copyright. Apart from any use as permitted Some members of the Expert Advisory Panel have under the Copyright Act 1968, no part may be reproduced received sponsorship to attend scientific meetings, been by any process without prior written permission from supported in the conducting of clinical trials, or have been prostate Cancer Foundation of Australia and Cancer involved in an advisory capacity by pharmaceutical and Council Australia.

2 Requests and enquiries concerning biochemical companies. (Refer to Appendix 6). reproduction and rights should be addressed to the Copyright Officer: Periodic updates prostate Cancer Foundation of Australia and Cancer Cancer Council Australia Council Australia plan to review the guidelines as a whole GPO Box 4708 every three years. Readers should check for any reviews Sydney NSW 2001 or updates of these guidelines. Australia New information arising in areas considered to be of importance will be posted periodically on Cancer Council Australia's website at This information will be included as appropriate in future editions of the Disclaimer document. This document is a general guide to appropriate practice, to be followed subject to the clinician's judgment and the Suggested citation patient's preference in each individual case.

3 prostate Cancer Foundation of Australia and Cancer The guidelines are designed to provide information to Council Australia PSA TESTING Guidelines Expert Advisory assist in decision-making. The guidelines are not meant Panel. Draft clinical practice guidelines for PSA TESTING to be prescriptive. and EARLY MANAGEMENT of test-detected prostate cancer. prostate Cancer Foundation of Australia and Cancer Council Australia, Sydney (2016). These guidelines and associated documentation ( Administrative and Technical Reports) can be accessed and downloaded at: Publication Approval The guidelines (recommendations) on pages ix-xv of this document were approved by the Chief Executive Officer of the National Health and Medical Research Council (NHMRC) on 2 November 2015 under section 14A of the National Health and Medical Research Council Act 1992.

4 In approving the guidelines (recommendations), NHMRC considers that they meet the NHMRC standard for clinical practice guidelines. This approval is valid for a period of five years and applies only to the guidelines (recommendations), not to any other supporting material published in this document. NHMRC is satisfied that the guidelines (recommendations) on pages ix-xv are systematically derived, based on the identification and synthesis of the best available scientific evidence, and developed for health professionals practising in an Australian health care setting. This publication reflects the views of the authors and not necessarily the views of the Australian Government. These guidelines are dedicated to the memory of Dr Ian Roos OAM, who passed away on 10 April 2015 after a long battle with prostate cancer.

5 Ian was a scholar, scientist, administrator, educator, guide, philosopher and friend of Cancer Council Australia and prostate Cancer Foundation of Australia. His work as a consumer representative, patient advocate and policy advisor, since his diagnosis with an aggressive prostate cancer 16 years ago, set him apart. Dr Roos will be greatly missed. CONTENTS. Foreword iii Preface iv About this guideline v Summary vi Summary of clinical practice recommendations viii Introduction 1. 1 Risk 10. 2 TESTING 16. Decision support for men considering PSA TESTING 17. PSA TESTING strategies 18. Role of digital rectal examination 46. PSA TESTING and life expectancy 48. TESTING with variants of PSA to improve sensitivity after an initial total PSA ng/mL 51.

6 TESTING with variants of PSA or repeat PSA TESTING to improve specificity after an initial total PSA > ng/mL 54. 3 prostate biopsy & multiparametric MRI 65. Biopsy quality criteria 66. Follow-up to a negative prostate biopsy 69. 4 Active surveillance 80. 5 Watchful waiting 86. 6 Sociocultural aspects of PSA TESTING in Australia 92. Appendix 1: Guideline development process 96. Appendix 2: Committee members & contributors 107. Appendix 3: List of clinical questions 118. Appendix 4: TNM classification of prostate tumours 122. Appendix 5: Abbreviations & glossary 126. Appendix 6: Conflict of interest register 133. i TABLES & FIGURES. Table i Definition of types of recommendations viii Table ii Definition of grades for evidence-based recommendations viii Table Relative risk of dying from prostate cancer for men with a first-degree relative 13.

7 Diagnosed with prostate cancer, compared with those without a first-degree relative diagnosed with prostate cancer or the general male population Table Summary of results of ERSPC study up to 11 years (as used for this guideline) and 22. up to 13 years (published after last date of systematic review searches) in the core age group (55-69 years). Table Modelled outcomes of a range of PSA TESTING protocols sorted in decreasing order 26. of probability of death from prostate cancer prevented for protocols reported by Heijnsdijk et al 2012. Table Modelled outcomes of a range of PSA TESTING protocols reported by Pataky et 27. al 2014, sorted in decreasing order of probability of death from prostate cancer prevented Table Modelled outcomes of a range of PSA TESTING protocols reported by Gulati et 29.

8 Al 2013, sorted in decreasing order of probability of death from prostate cancer prevented Table Comparisons of outcomes of TESTING using different ages at TESTING (55 69 years 33. or 50 69 years; 50 69 years or 50 74 years; 50 69 or 40 69 years) and different intervals between tests (4 years or 2 years) with the PSA criterion for investigation and the other PSA TESTING protocol components (interval between tests or age at TESTING ) held constant Table Estimates of increments in absolute percentage cumulative risk of prostate cancer 38. death above the risk at a baseline PSA of < 1 ng/mL (Orsted et al, 2012) or the lowest quarter of the PSA distribution (Vickers et al 2013) by age, length of follow- up and baseline PSA level Table Estimated increase in prostate cancer-specific mortality rate (annual number of 41.)

9 Deaths per 100,000 men) over the next 10 years for Australian men aged 40, 45. and 50 years who are at average risk of prostate cancer, and those who are at two- to ten-fold increased risk of prostate cancer Table Modelled estimates of harms, benefits and balance of harms to benefits of 45. recommended PSA TESTING protocols Table Additional months of life needed to compensate men for each persistent 59. treatment-related adverse effect of diagnosis of prostate cancer in excess of a base case of mild loss of libido with no other problems and 12-year life expectancy Table A1 Designations of levels of evidence according to type of research question 101. (NHMRC, 2009). Table A2 Grading of recommendations 102. Table A3 Overall recommendation grades 103.

10 Table A4 NHMRC approved recommendation types and definitions 103. Figure Plots of false positive to true positive ratios at each PSA threshold in the eight 35. studies reviewed Figure Trade-off between detecting true positives and adding false positives for PSA 47. alone and in combination with DRE. Figure Percentage of Australian men of a given age remaining alive after 7 years from 49. ages 50 to 100. ii FOREWORD. As Patron of the prostate Cancer Foundation of Australia I am well aware of the health risks posed by prostate cancer. Every year almost 20,000 Australian men are diagnosed with this disease and sadly 3,300 men die of it. This makes prostate cancer the second most common cause of male cancer deaths in Australia and the fourth most common cause of male deaths overall.