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

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Eight trials examined acute toxicity. 52, 53, 55-57, 62, 63, 65 There were no statistically significant increases in short-term adverse outcomes with single-dose radiotherapy other than for the flare (p=0.03, Roos 2005 55 ). In one study, more severe toxicity (grade 2–4) was significantly decreased in the single fraction arm (p = 0.02, Hartsell 2005). 56 These results support the conclusion that there is no evidence to suggest any dose response for initial pain response rates when comparing a single fraction of 8Gy versus multiple fractions ranging from 20Gy/5f to 30Gy/10f. That is, single fraction of 8Gy is not worse than a course of multi-fraction treatment for the endpoint of initial pain response. This is in agreement with the meta-analysis by Sze et al 67 and updated, 68 which included additional trials that did not meet the inclusion criteria for these guidelines. Greater patient convenience and lower cost may make single fractions an attractive option for treatment even at the expense of higher re-treatment and fracture rates. However, two studies demonstrated that a significant proportion of patients may prefer multiple fractions if that will result 69, 70 in lower re-treatment and fracture rates. Evidence summary Level References Low-dose external beam radiotherapy There are no controlled trials comparing EBRT with no treatment. As EBRT is a recognised treatment of metastatic bone pain, RCTs comparing radiotherapy with no therapy would be considered unethical. Poorer outcomes at lower doses support the notion that EBRT is an effective treatment of metastatic bone pain. Single versus multi-fraction higher-dose EBRT No dose response exists for pain response rates when comparing a single fraction of 8Gy versus multiple fractions ranging from 20Gy/5f to 30Gy/10f. That is, a single fraction of 8Gy is not worse than a course of multi-fraction treatment for the endpoint of pain response. Fracture rates following radiation are low (
12 months in those with more extensive disease. The optimal management of these patients remains far from clear. There are no randomised studies addressing the role of pelvic radiotherapy. However a number of retrospective studies suggest that a fractionated course of high-dose palliative pelvic radiation treatment can be extremely useful in obtaining growth restraint and alleviating the symptoms arising from the disease process. 71-79 Bleeding (haematuria) responds particularly well. Similar results were found in a more recent case series. 80 A small subset of patients can also present with significant metastatic nodal disease within the pelvis, abdomen, chest and supraclavicular or lower neck region. The enlarged nodes can result in significant pain or obstructive symptoms due to the extrinsic compression on the adjacent organs. No randomised or retrospective studies have specifically addressed the role of radiation treatment in this setting. It is unlikely that any such studies will be undertaken. Evidence summary Level References Although there are no randomised prospective trials to address whether radiotherapy has a beneficial effect on incurable prostate cancer and its soft tissue metastases, the question of benefit remains clinically important. Therefore, nine case series have been reviewed noting that these all pertain to locally advanced prostate cancer. There were no significant publications reviewing soft tissue metastases. Recommendation IV 71-79 Radiotherapy can be considered for palliation of symptoms secondary to locally progressive disease. Grade D Spinal cord compression/nerve root compression (with or without surgery) Spinal cord compression is an oncological emergency. It is a potentially devastating complication of metastatic prostate cancer that can result in pain, paraplegia, incontinence and loss of independence. It is not uncommon for sequelae of metastatic disease to occur in between 1% and 12% of patients. 81 No randomised controlled trials were found that examined treatments for spinal cord compression specifically for prostate cancer patients. Therefore, the systematic reviews were broadened to cover any trials that included prostate cancer patients. Radiotherapy is an effective and well-tolerated treatment for metastatic bone pain. It has been the cornerstone of management for malignant spinal cord compression (MSCC) for decades as it is a noninvasive approach and associated with relatively low toxicity. Its effectiveness is based largely on retrospective outcomes from single institution series. There are no randomised trials comparing radiotherapy alone with either surgery alone or dexamethasone alone for malignant spinal cord compression. There is one randomised trial of 276 patients comparing two fractionation schedules (16Gy/2f vs 30Gy/8f) that gives outcome data of radiation alone. 82 In this trial only 14% of the entire cohort were prostate patients. The Maranzano 82 trial confirms the importance of radiotherapy in the management of spinal cord compression, with 90% of ambulatory patients still walking at one month and 28% of non-ambulatory patients regaining ability to walk. 82 However, regaining ambulation if paraplegic is rare. More than Clinical practice guidelines for the management of locally advanced and metastatic prostate cancer 62
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Clinical Practice Guidelines for th
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4 Biochemical relapse .............
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FOREWORD The management of prostate
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SUMMARY OF CLINICAL PRACTICE RECOMM
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SUMMARY OF RECOMMENDATIONS Chapter
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Chapter Recommendations Grade Refs
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1 INTRODUCTION 1.1 Natural history
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2 PSYCHOSOCIAL CARE The diagnosis a
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2.2 Effect of psychological and cog
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Evidence summary Level References T
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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
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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
Page 56 and 57: All three trials demonstrated impro
Page 58 and 59: Evidence summary Level References B
Page 60 and 61: of an international multicentre ran
Page 62 and 63: 45. Melton LJ, III, Alothman KI, Kh
Page 64 and 65: 76. Little DJ, Kuban DA, Levy LB, Z
Page 66 and 67: 105. Thompson IM, Tangen CM, Parade
Page 68 and 69: 4.2 Androgen deprivation therapy (e
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Page 72 and 73: therapy since such studies would be
Page 74 and 75: apparent in trials comparing CAB wi
Page 76 and 77: QLQ instrument published by Cleary
Page 78 and 79: Note: Larger well-powered studies h
Page 82 and 83: half of patients experienced pain r
Page 84 and 85: olus) in addition to radiotherapy a
Page 86 and 87: References 1. Seidenfeld J, Samson
Page 88 and 89: Cooperative Group. Scandinavian Jou
Page 90 and 91: Oncology Group, TROG 96.05). Radiot
Page 92 and 93: trial. European Journal of Cancer 1
Page 94 and 95: 6 CASTRATION-RESISTANT PROSTATE CAN
Page 96 and 97: the median overall survival for pat
Page 98 and 99: There are two points regarding bisp
Page 100 and 101: with bone pain at study entry. At n
Page 102 and 103: Recently, there have been reports o
Page 104 and 105: of these studies 56, 58 and in the
Page 106 and 107: Side effects (toxicity) As these ra
Page 108 and 109: hydrocortisone respectively. Tannoc
Page 110 and 111: 5. Manikandan R, Srirangam SJ, Pear
Page 112 and 113: 33. Elomaa I, Kylmala T, Tammela T
Page 114 and 115: 60. Janknegt RA, Abbou CC, Bartolet
Page 116 and 117: physiotherapists, occupational ther
Page 118 and 119: 7.5 Q2: Symptom control There was e
Page 120 and 121: Informal or family caregivers deriv
Page 122 and 123: 8. Hughes SL, Weaver FM, Giobbie-Hu
Page 124 and 125: 8 COMPLEMENTARY AND ALTERNATIVE (UN
Page 126 and 127: corresponding benefit in obstructiv
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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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