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

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of these studies 56, 58 and in the third study 59 with small numbers of prostate cancer patients (n=12), the effects were not significant. Samarium 153 has a shorter half-life and thus it has been hypothesised may have a quicker response. However, there is currently no evidence available to support this. Five RCTs examined the effect of strontium 89 on disease progression in men with prostate cancer. Both trials examining the addition of strontium 89 to external beam radiotherapy suggested that strontium 89 delays progression of bony disease. In the larger (n=126) and better-quality study the delay is statistically significant, 52, 53 whereas in the second study 54 the delay is not statistically significant for the prostate cancer patient subgroup. In one of the trials comparing strontium 89 with external beam radiotherapy, strontium-89 resulted in a statistically significant delay in disease progression, 48 whereas in the other, local external beam radiotherapy was associated with better progression-free survival. 49 Evidence summary Level References Men with hormone refractory prostate cancer and painful bone metastases strontium 89 Limited evidence suggests that strontium 89 is effective as a treatment for pain relief. There is no randomised control trial evidence comparing the efficacy of strontium 89 with that of modern-day taxane-based chemotherapy or bisphosphonates samarium 153 A small volume of low- to moderate-quality grade II consistent evidence suggests that samarium 153 is an effective treatment for relief of bone metastases pain. There is only one randomised trial showing a benefit. There is no randomised control trial evidence comparing its efficacy with that of strontium 89, modern-day taxane-based chemotherapy or bisphosphonates. Recommendation II 46-48,52,53 II 56-59 Unsealed radioisotopes may be considered for the management of multifocal bone pain alongside other options of treatment in patients with hormone refractory prostate cancer. Grade C Overall survival Six RCTs report survival outcomes. Results were conflicting for the four strontium 89 trials. The trial comparing strontium 89 alone with placebo reported a statistically significant improvement in survival in patients receiving strontium 89. 46 This was one old trial with small sample size (n=44) and only actuarial survival was reported. In contrast, the addition of strontium to local radiotherapy appeared to provide no survival benefit. 52, 53 The larger (n=203) trial comparing strontium 89 with local external beam radiotherapy reported a statistically significant improvement in survival in patients receiving radiotherapy 49 , whereas the smaller trial comparing strontium 89 with local (n=111) or hemibody (n=106) external beam radiotherapy showed a beneficial but not statistically significant improvement in survival with strontium 89. 48 57, 58 No survival benefit was seen with samarium 153. 85 Castration-resistant prostate cancer
Evidence summary Level References Men with hormone refractory prostate cancer and painful bone metastases The trials examining the effect of unsealed radioisotopes on overall survival have been heterogeneous in study design, contained small patient numbers and provided conflicting results. As such no firm conclusions can be made. The role of radioisotopes in the context of modern-day systemic therapy (chemotherapy and bisphosphonates) has not been defined. Recommendation II 46,48,52, 53,49,57,58 The impact of unsealed radioisotopes on overall survival in men with castrate-resistant metastatic prostate cancer is undefined. The relative roles of unsealed radioisotopes and the newer chemotherapeutic agents (e.g. taxanes) and bisphosphonates have also not been defined. Grade D Quality of life There are four low- to medium-quality RCTs testing the effect of treatment with Strontium-89 that assess a ‘quality of life endpoint’. The assessed quality of life endpoints were different, in no trial was a validated instrument used, and in only one trial was assessment solely patient reported. Neither study comparing strontium 89 with external beam radiation showed statistical evidence of effect. In the study comparing strontium 89 with placebo 47 and the study examining the effect of addition of strontium 89 to local external beam radiation, 52, 53 the strontium treatment appeared to have modest but inconsistent beneficial effects on quality of life endpoints. Evidence summary Level References Men with hormone refractory prostate cancer and painful bone metastases There are few studies examining the effect of strontium 89 on quality-of-life endpoints and these are generally dissimilar in design and the examined endpoint. The design of these studies is not high quality. In studies that show some beneficial effect, the effects are modest at best, with many patients also exhibiting a worsening of quality-of-life endpoints. Recommendation 48, 49 II 47-49,52,53 It is not known what effect unsealed radioisotopes have on quality of life for men with metastatic prostate cancer. Grade C Clinical practice guidelines for the management of locally advanced and metastatic prostate cancer 86
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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
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An Australian cross-sectional study
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10. Dunn J, et al. A review of peer
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41. Sharpley CF, Christie DRH. An a
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different treatments from different
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Evidence summary Level References I
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Evidence summary Level References F
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Despite these reservations and the
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For non-metastatic disease there we
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Evidence summary Level References T
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monotherapy for low-to-intermediate
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Evidence summary Level References M
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for surgery, suggesting that surger
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Page 56 and 57: All three trials demonstrated impro
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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
Page 70 and 71: Evidence summary Level References F
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 80 and 81: Eight trials examined acute toxicit
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
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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
Page 128 and 129: 3. Eisenberg DM, Kessler RC, Van Ro
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Page 132 and 133: 8 Miller DC, Litwin MS, Bergman J,
Page 134 and 135: 10 EMERGING THERAPIES It is impossi
Page 136 and 137: APPENDIX 1 GUIDELINE DEVELOPMENT PR
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Page 140 and 141: Grade of recommendation Description
Page 142 and 143: 2. National Health and Research Cou
Page 144 and 145: Dr Carole Pinnock AM Principal rese
Page 146 and 147: Surgery Professor Villis Marshall A
Page 148 and 149: APPENDIX 3 TNM CLASSIFICATION OF PR
Page 150 and 151: Summary Prostate T1 T2 T3 T4 N1 M1a
Page 152 and 153: 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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