Clinical Practice Guidelines for the management of locally advanced ...

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FOREWORD The management of prostate cancer is complex and often confusing for both the patient, his family and the medical and health practitioners involved in his care. The complexity is due to a range of factors including the biological evolution of prostate cancer, the difficulties arising from the lack of a specific and sensitive non-invasive test that can provide early diagnosis and predict the subsequent progression of the disease. Further, many of the treatment modalities are associated with side effects that can significantly influence the quality of life of the patient. In some instances, the lack of properly controlled clinical trials has resulted in the absence of an evidence base on which to select the best treatment for each patient. These clinical practice guidelines have been developed following an extensive analysis of papers that can inform the decision making process for the patient, his family and those involved in managing his care. The results of these analyses have been reviewed by the Working Party of the Australian Cancer Network with further support from the Cancer Council Australia. The recommendations encompass the range of treatment modalities and include psycho-social care, complementary and alternatives therapies and the socioeconomic aspects of advanced prostate cancer. One of the major strengths of this set of recommendations is that it provides the reader with an assessment of the quality of the evidence on which they are based. This enables all concerned in the patient’s management to assess the risk-benefit ratios for the range of modalities concerned. The educational value of this document is very high and will assist the decision makers in their difficult decisions. It also sets out the needs of this area of medicine and it challenges all those concerned to continue the search for the best management of the patient and enables the patient to have an involvement in this challenging activity. I congratulate all involved in this extensive process and hope that the value placed on this document will be some recompense for their work in making this happen. Emeritus Professor David de Kretser Monash University, Clayton, Victoria, Australia vi Clinical practice guidelines for the management of locally advanced and metastatic prostate cancer
PREFACE Attitudes to prostate cancer have changed dramatically over the last 30 years, prior to that time prostate cancer was often considered to require little treatment as it was considered to occur primarily in elderly men and was more often than not metastatic at the time of diagnosis and the only treatment plan often was orchidectomy. A number of factors have brought about this very significant change in attitude to the management of prostate cancer. The discovery of prostate specific antigen (PSA) coupled with ultra sound guided biopsy of the prostate has meant that prostate cancer is now diagnosed at least a decade or more earlier than was the case in the 1970’s and is more likely to be confined to the prostate. The development of nerve sparing techniques and the increased familiarity with radical prostatectomy also the introduction of high dose and more focussed external beam radiation as well as the introduction of brachytherapy have all made local treatment more effective and with reduced morbidity. However, in spite of these advances a significant proportion of men will still be identified with or develop metastatic disease. This is usually determined now on the basis of a rising PSA after attempts at cure by one of the previously described modalities. However, even in this situation Pound et al 1999 1 data indicated that the median actuarial time for death was 13 years after the initial PSA rise. We cannot cure metastatic disease but given the long life expectancy after the initial PSA rise it is important that men in this situation received the most appropriate treatment to ensure both prolongation of and high quality of life. These guidelines attempt to bring together the best evidence currently available to achieve this goal. I would like to recognise the work of Professor Dianne O’Connell who has managed the process on behalf of the steering committee and her dedicated small group of researchers who have reviewed the tens of thousands of articles necessary to support this process. Dr Carol Pinnock for developing the consumer guide and Emeritus Professor Tom Reeve AC CBE, whose experience in guideline development and direction has been vital to the success of the project. I would also like to acknowledge the contribution of the members of the steering committee who have freely given of their time and expertise to bring this project to fruition. The scope of the exercise turned out to be far greater than we envisaged when we embarked on the project and if it had not been for the generous financial support of Andrology Australia, The Prostate Cancer Foundation of Australia, Cancer Council New South Wales and the Australian Cancer Network we would not have been able to undertake what we believe is the most comprehensive review of the evidence for the management of advanced and metastatic prostate cancer that has been undertaken to date. (See Appendix 1 – Guideline development process). Professor Villis Marshall AC Chair, Management of Metastatic Prostate Cancer Guidelines Working Party Reference 1. Pound CR, Partin AW, Eisenberger MA, Chan DW, Pearson JD, Walsh PC. Natural History of Progression After PSA Elevation Following Radical Prostatectomy JAMA. 1999;281:1591-1597. Contents vii
Page 1: Clinical Practice Guidelines for th
Page 4 and 5: 4 Biochemical relapse .............
Page 8 and 9: SUMMARY OF CLINICAL PRACTICE RECOMM
Page 10 and 11: SUMMARY OF RECOMMENDATIONS Chapter
Page 12 and 13: Chapter Recommendations Grade Refs
Page 20 and 21: 1 INTRODUCTION 1.1 Natural history
Page 22 and 23: 2 PSYCHOSOCIAL CARE The diagnosis a
Page 24 and 25: 2.2 Effect of psychological and cog
Page 26 and 27: Evidence summary Level References T
Page 28 and 29: Recommendation Men with advanced pr
Page 30 and 31: An Australian cross-sectional study
Page 32 and 33: 10. Dunn J, et al. A review of peer
Page 34 and 35: 41. Sharpley CF, Christie DRH. An a
Page 36 and 37: different treatments from different
Page 38 and 39: Evidence summary Level References I
Page 40 and 41: Evidence summary Level References F
Page 42 and 43: Despite these reservations and the
Page 44 and 45: For non-metastatic disease there we
Page 46 and 47: Evidence summary Level References T
Page 48 and 49: monotherapy for low-to-intermediate
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Page 52 and 53: for surgery, suggesting that surger
Page 54 and 55: Microscopic fully resected node pos
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All three trials demonstrated impro
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Evidence summary Level References B
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of an international multicentre ran
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45. Melton LJ, III, Alothman KI, Kh
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76. Little DJ, Kuban DA, Levy LB, Z
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105. Thompson IM, Tangen CM, Parade
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4.2 Androgen deprivation therapy (e
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Evidence summary Level References F
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therapy since such studies would be
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apparent in trials comparing CAB wi
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QLQ instrument published by Cleary
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Note: Larger well-powered studies h
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Eight trials examined acute toxicit
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half of patients experienced pain r
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olus) in addition to radiotherapy a
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References 1. Seidenfeld J, Samson
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Cooperative Group. Scandinavian Jou
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Oncology Group, TROG 96.05). Radiot
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trial. European Journal of Cancer 1
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6 CASTRATION-RESISTANT PROSTATE CAN
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the median overall survival for pat
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There are two points regarding bisp
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with bone pain at study entry. At n
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Recently, there have been reports o
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of these studies 56, 58 and in the
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Side effects (toxicity) As these ra
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hydrocortisone respectively. Tannoc
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5. Manikandan R, Srirangam SJ, Pear
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33. Elomaa I, Kylmala T, Tammela T
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60. Janknegt RA, Abbou CC, Bartolet
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physiotherapists, occupational ther
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7.5 Q2: Symptom control There was e
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Informal or family caregivers deriv
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8. Hughes SL, Weaver FM, Giobbie-Hu
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8 COMPLEMENTARY AND ALTERNATIVE (UN
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corresponding benefit in obstructiv
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3. Eisenberg DM, Kessler RC, Van Ro
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areas of the state were more likely
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8 Miller DC, Litwin MS, Bergman J,
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10 EMERGING THERAPIES It is impossi
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APPENDIX 1 GUIDELINE DEVELOPMENT PR
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study type. Studies published befor
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Grade of recommendation Description
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2. National Health and Research Cou
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Dr Carole Pinnock AM Principal rese
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Surgery Professor Villis Marshall A
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APPENDIX 3 TNM CLASSIFICATION OF PR
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Summary Prostate T1 T2 T3 T4 N1 M1a
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APPENDIX 4 ABBREVIATIONS AND GLOSSA
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Glossary Actuarial survival A metho
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Effectiveness The extent to which a
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Lymph nodes Small, generally pea-si
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Each stage is divided into subgroup
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APPENDIX 6 - ORGANISATIONS WHICH PR
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Consultant Urologist, Royal Brisban
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No conflict of interest to declare.
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Index to Clinical practice guidelin
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cardiovascular mortality 19, 54, 55
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androgen deprivation therapy (ADT)
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and surgery 32-34 survival 18 toxic
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and chemotherapy 89-90 see also bon
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spinal cord compression 62-63 see a
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systemic 141 Tasmania Association f
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