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

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10 EMERGING THERAPIES It is impossible to undertake a comprehensive review of all published material in the development of any set of guidelines. However it seemed useful to add an appendix to these guidelines for reference by clinicians looking for outcomes of randomised control trials in the management of locally advanced and metastatic prostate cancer. The therapies itemised were therapies for advanced or metastatic prostate cancer currently being studied in randomised controlled trials. The National Institute of Health (NIH) registry 1 website and the World Health Organization (WHO) primary and partner registries 2 (found at www.who.int/ictp/network) were searched for randomised controlled phase III trials of treatments for advanced prostate cancer which were ongoing (trial registry updated 2000 or onwards). These registries included the National Cancer Institute’s Physician Data Query cancer clinical trials registry (www.cancer.gov) and the Australian New Zealand Clinical Trials Registry (www.anzctr.org.au). Readers are referred to these two registries for details of ongoing clinical trials for prostate cancer treatments that are recruiting in Australia.. Trials described as complete were checked for publications and trials described as terminated were checked where possible for the reasons they were terminated. Trials with mature data included in the systematic reviews or their appendices were not included. It should be noted that in most cases this summary depends on the information provided by the trial register, which is not always accurate, clear or current, and thus it is not a comprehensive review. 10.1 For men with locally advanced disease There are numerous continuing trials examining different radiotherapy techniques, including intensity modulated radiotherapy (IMRT) and hypofractionation, dose escalation, and the addition of radiotherapy to hormone therapy and to brachytherapy. Similarly, there are numerous trials examining different regimens and types of hormone therapy as a monotherapy, as an adjuvant or neo-adjuvant to definitive therapy, and as an addition to adjuvant radiotherapy. There are also continuing trials examining docetaxel as an adjuvant to definitive therapy with or without hormone therapy, and one study currently recruiting patients for a trial of chemohormonal therapy as a neoadjuvant to prostatectomy. In contrast, only two trials were identified that examined surgery (prostatectomy and cryoablation) and it is unclear whether they include men with locally advanced disease. There are at least two trials that appear to be ongoing, which are examining the effects of zoledronic acid. A trial is planned to assess the effect of a multidisciplinary support program for patients undergoing definitive radiotherapy and a trial has been completed of the isoflavenoid genistein. For men on hormone therapy there are at least four trials testing various exercise regimens as well as a trial of green tea extract. 10.2 For men with biochemical relapse following definitive therapy There are at least two trials examining salvage radiotherapy; numerous trials examining various hormone therapy modalities and regimens, including immediate versus delayed; and at least three trials examining chemotherapy, including docetaxel, as an adjuvant to hormone therapy. Thalidomide and rosiglitazone are also being studied. In addition, several dietary interventions are being trialled, including pomegranate juice, lycopene with vitamin E, and an intensive nutritional intervention focusing on a low-fat diet high in fibre, fruit, vegetable, green tea and vitamin E. 10.3 For men with metastatic disease There are numerous trials studying the addition of bisphosphonates, primarily zoledronic acid, to hormone therapy. There are trials examining various hormone therapy regimens and modalities and the addition of doctaxel to hormone therapy. One trial is examining the benefits of prostate radiotherapy in addition to hormone therapy for men diagnosed with metastatic prostate cancer. For 115 Emerging therapies
painful bone metastases, the bisphosphonate ibandronate is being studied as alternative to or in addition to radiotherapy. For spinal metastases with microfractures or compression fractures, vertebroplasty is being studied as an addition to radiotherapy. A trial of suramin in addition to hormone therapy has been completed. Suramin is a molecule that interferes with the action of a number of growth factors, including those involved in angiogenesis. 10.4 For men with castrate-resistant prostate cancer For men with castrate-resistant prostate cancer without clinical evidence of metastases, docetaxel chemotherapy and endothelin-A receptor antagonists atrasentan and zibotentan (ZD4054) are being trialled. These patients may also be included in continuing trials for the treatment of castrate-resistant or hormone refractory prostate cancer with abiraterone, which blocks testosterone synthesis; diethylstilbestrol; the bisphosphonate risedronate; the RANK ligand antibody denosumab; the PDGFR inhibitor leflunomide; and a peptide vaccine. A trial of immediate versus delayed psychological intervention for patients with advanced cancer has been completed. For men with castrate-resistant prostate cancer with metastases there are continuing trials of the bonetargeting radioisotope radium-223; the addition of strontium 89 to docetaxel chemotherapy; the addition of zoledronic acid to standard therapy; dexamethasone regimens; the taxoid XPR6258; doxorubicin; endothelin A antagonists atrasentan and zibotentan (ZD4054); sunitinib, a receptor kinase inhibitor, aflibercept and bevacizumab, which target VEGF, which drives angiogenesis: prinomastat, which inhibits matrix metalloproteases involved in tumour invasion, angiogenesis and metastasis; and Provenge, dendritic stem cell precursors activated by exposure to prostatic acid phosphatase. The GVax prostate vaccine trials have been terminated due to an imbalance of deaths. Finally, there is a continuing trial of Auron Misheil Therapy 2003, a combination of camomile extract calcium, vitamins, anti-histamine and insulin. References 1. National Institute of Health (NIH) registry website accessed September/October 2008. 2. World Health Organization (WHO) Primary Registry website accessed September/October 2008. Clinical practice guidelines for the management of locally advanced and metastatic prostate cancer 116
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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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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
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
Page 128 and 129: 3. Eisenberg DM, Kessler RC, Van Ro
Page 130 and 131: areas of the state were more likely
Page 132 and 133: 8 Miller DC, Litwin MS, Bergman J,
Page 136 and 137: APPENDIX 1 GUIDELINE DEVELOPMENT PR
Page 138 and 139: study type. Studies published befor
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
Page 154 and 155: Glossary Actuarial survival A metho
Page 156 and 157: Effectiveness The extent to which a
Page 158 and 159: Lymph nodes Small, generally pea-si
Page 160 and 161: Each stage is divided into subgroup
Page 162 and 163: APPENDIX 6 - ORGANISATIONS WHICH PR
Page 164 and 165: Consultant Urologist, Royal Brisban
Page 166 and 167: No conflict of interest to declare.
Page 168 and 169: Index to Clinical practice guidelin
Page 170 and 171: cardiovascular mortality 19, 54, 55
Page 172 and 173: androgen deprivation therapy (ADT)
Page 174 and 175: and surgery 32-34 survival 18 toxic
Page 176 and 177: and chemotherapy 89-90 see also bon
Page 178 and 179: spinal cord compression 62-63 see a
Page 180 and 181: systemic 141 Tasmania Association f
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