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

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4.2 Androgen deprivation therapy (early versus delayed) If radiation therapy is not undertaken following surgery, the decision would be whether to start hormone treatments due to the rising PSA or wait until metastases become evident through scans. The time to a cancer becoming evident on a scan after a rising PSA is very variable. If the PSA is rising slowly (slow doubling time) and the cancer recurred two years following surgery, only 15% of patients will have cancer seen on a scan at seven years. If however the PSA recurred before two years and the PSA doubled at a rate of less than every 10 months, then 90% of patients have disease on a scan at seven years. 5 There is only one RCT in this scenario 6 and this involved the use of a 5-alpha reductase inhibitor as a hormonal manipulation with potency sparing properties. The results were presented in terms of change in PSA levels and are of no clinical relevance to routine practice. Evidence summary Level References There is no level I or II evidence providing guidance for any intervention. Recommendation 49 Biochemical relapse II 6 The optimal timing of androgen deprivation therapy in patients with biochemical relapse of disease without evidence of overt metastatic disease is not defined. Eligible patients should be informed about the current TROG Trial (www.ranzcr.edu.au/affiliatedgroups/trog/healthprofessionals/hptrials/open/TROG_0306.cf) comparing early versus delayed hormonal therapy in this group. Grade N/A See chapter 10 Emerging therapies for more on treatments being examined in continuing clinical trials. References 1. Horwitz EM, Levy LB, Thames HD, Kupelian PA, Martinez AA, Michalski JM. Biochemical and clinical significance of the posttreatment prostate-specific antigen bounce for prostate cancer patients treated with external beam radiation therapy alone: a multiinstitutional pooled analysis. Cancer 2006;107(7):1496-1502. 2. Crook J, Gillan C, Yeung I, Austen L, McLean M, Lockwood G. PSA kinetics and PSA bounce following permanent seed prostate brachytherapy. Int J Radiat Oncol Biol Phys 2007;69(2):426- 433. 3. Harman SM, Metter EJ, Tobin JD, Pearson J, Blackman MR. Longitudinal effects of aging on serum total and free testosterone levels in healthy men. Baltimore Longitudinal Study of Aging. J Clin Endocrinol Metab 2001;86(2):724-731. 4. Stephenson AJ, Scardino PT, Kattan MW et al. Predicting the outcome of salvage radiation therapy for recurrent prostate cancer after radical prostatectomy. J Clin Oncol 2007;25(15):2035-2041. 5. 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(17):1591- 1597. 6. Andriole G, Lieber M, Smith J et al. Treatment with finasteride following radical prostatectomy for prostate cancer. Urology 1995;45(3):491-7.
5 OVERT METASTATIC DISEASE AND/OR LOCO-REGIONAL PROGRESSIVE DISEASE 5.1 Androgen deprivation therapy 5.1.1 Choice of androgen deprivation therapy When commencing ADT for a patient with locally advanced or metastatic disease, one has to be mindful and counsel the patient on the risks and benefits for the specific clinical situation and the variations of therapy that can be employed. This is especially true when commencing ADT for a man with metastatic hormone-sensitive prostate cancer as the therapy clearly has a side-effect profile that can have an impact not only on quality of life but also the ability to cause disease regression, lessen symptoms from cancer and prolong overall survival. It is not possible to counsel a patient on how much of an improvement there is on overall survival from ADT versus no ADT because the known efficacy of ADT makes a no-treatment control arm unethical in the metastatic setting. Moreover, as discussed elsewhere, the available data do not demonstrate a clear-cut benefit for starting ADT early or immediately to treat metastatic disease versus waiting until evidence of progression (while under close observation). The question then arises as to whether one form of hormonal therapy may be better than another in terms of survival outcomes for metastatic disease. This has been addressed in a sensitivity analysis for M1 patients of a single meta-analysis of the numerous trials comparing various hormone therapies with orchidectomy. 1, 2 The trials date from the 1970s to the 1990s, a period during which staging with bone scans and PSA levels was evolving, and thus the populations with metastatic disease in these trials may be quite heterogeneous. There has been only one trial published post-2000. Some trials included men with locally advanced disease as well as metastatic cancer and thus subgroup analyses are reported. There are also trials comparing various ADTs with oestrogens. However these were not considered further as oestrogen therapies are associated with increased cardiovascular complications and as a result are not advocated for use as a first-line hormone therapy. The meta-analysis found that there was no difference in survival between therapies used to induce castrate levels of testosterone (LHRH agonists versus orchidectomy) and that anti-androgens were inferior to orchidectomy with a hazard ratio of 1.13 (95% CI=0.99 to 1.3) for steroidal anti-androgens and 1.25 (95% CI=0.99 to 1.59) for non-steroidal androgens. These data strongly suggest there is a lower overall survival if a patient with metastatic prostate cancer is treated with anti-androgens as monotherapy, be they steroidal or nonsteroidal. These data therefore inform treating physicians and support current practice that androgen deprivation (medical or surgical castration) can be used interchangeably and that anti-androgens should not be used as monotherapy for patients with metastatic prostate cancer. In essence, the data indicate that castration-based treatment increases overall survival when compared with less effective therapy and presumably would be better again than no therapy. However, there is at best a minimal survival benefit in commencing ADT early in men with metastatic prostate cancer compared with late commencement of LHRH agonist or bilateral orchidectomy therapy (see 5.1.3 Early versus delayed androgen deprivation), and these treatments have significant unwanted effects. Therefore judgment should be exercised in relation to the optimal time to introduce these treatments for individual patients with metastatic disease. Clinical practice guidelines for the management of locally advanced and metastatic prostate cancer 50
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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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Page 20 and 21: 1 INTRODUCTION 1.1 Natural history
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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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