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Reference No: Title: Systemic anti cancer therapy (SACT) clinical management guidelines for Advanced/metastatic Prostate Cancer Author(s) Dr Darren Mitchell Consultant Clinical Oncologist on behalf of the Genitourinary oncology group. Belfast City Hospital Ownership: NICaN Approval by: NICaN Drugs & Therapeutics committee Approval date: June 2016 Operational Date: July 2018 Next Review: July 2018 Version No. 2.0 Supersedes 1.0 Links to NICaN Prostate SACT protocols other policies Version control for drafts: Date Version Author Comments 2/12/2013 1.0 Dr D Mitchell Final version issued June 2016 2.0 Dr D Mitchell Updated to reflect new NICE guidance SACT for Prostate Cancer v2.0 Page 1 of 12 Authorisation of Systemic Anti-Cancer Therapy (SACT) Guidelines for Prostate Cancer These SACT guidelines are being submitted by the author on behalf of the Genitourinary Oncology group. SACT for Prostate Cancer v2.0 Page 2 of 12 1.0 INTRODUCTION / PURPOSE OF POLICY 1.1 Background Prostate cancer which has metastasized may be seen either at the time of initial diagnosis or following radical treatment for localised or locally advanced disease which subsequently demonstrates evidence of metastatic disease. In either scenario the mainstay of initial treatment is with hormonal manipulation which can maintain disease control for many years. Once there is evidence of progressive disease despite hormonal manipulation the disease is termed ‘castration resistant’ and the aim of management is to maintain quality of life and prolongation of survival were possible with systemic therapy, palliative radiotherapy, palliative radionucleotide therapy and palliative care input. 1.2 Purpose To ensure consistent use of SACT for patients with Prostate cancer. 2.0 SCOPE OF THE POLICY This document is aimed at all clinical staff involved in the management of patients receiving SACT for Prostate cancer. 3.0 ROLES/RESPONSIBILITIES It is the responsibility of all clinical staff involved in the management of patients receiving SACT for Prostate cancer to familiarise themselves with these guidelines. SACT for Prostate Cancer v2.0 Page 3 of 12 4.0 KEY POLICY PRINCIPLES The treatment options for metastatic prostate cancer are tabulated below. Diagnosis within 3/12 and fit for Upfront Docetaxel (hormone sensitive) Diagnosis >3/12 or not fit for Docetaxel 1st line 2nd line 3rd line ADT Up-front Docetaxel Enzalutamide Or Abiraterone (TA259) Or Cabazitaxel Enzalutamide (TA 377) Or Abiraterone (TA 387) Radium (TA 376) Consider re challenge Docetaxel or MItoxantrone ADT Rapid CRPC and fit for Docetaxel ADT Docetaxel Pt not suitable for docetaxel 75, still suitable for chemo Not suitable for chemo ADT Enzalutamide (TA377) Or Abiraterone (TA 387) Enzalutamide (TA 377) Or Abiraterone (TA 387) ADT Docetaxel (if fit) Consider Weekly docetaxel or Mitoxantrone Enzalutamide (TA 316) Or Abiraterone (TA 259) Or Cabizitaxel Docetaxel weekly MItoxantrone 4th line 5th line Enzalutamide (TA 316) Or Abiraterone (TA 259) Radium (TA 376) Radium (TA 376) Consider re challenge Docetaxel or MItoxantrone Radium (TA 376) Enzalutamide (TA 316) Or Abiraterone (TA 259) Radium (TA 376) 4.1.1 Docetaxel The use of Docetaxel chemotherapy in men with prostate cancer can be considered in two clinical scenarios. 1) Docetaxel chemotherapy has been classically used in men with advanced prostate cancer who have become resistant to ADT. These men have either symptomatic progression or rapid PSA progression in the absence of symptoms having previously received androgen deprivation therapy. It is NICE approved in this scenario (NICE TA101). (1-2) 2) The use of docetaxel in hormone naïve metastatic/high risk prostate cancer (within 12weeks of commencing ADT) has recently been recognised in two large randomised studies to provide a significant improvement in overall survival when compared to men receiving hormone treatment alone at diagnosis. (3-4) Docetaxel in this ‘up-front’ role is an 'off label use' but NICE guidance is available to recommend its use. (Clinical Commissioning Policy Statement: Docetaxel in combination with androgen deprivation therapy for the treatment of hormone naïve metastatic prostate cancer. NHS England Reference: [B15/PS/a].) (NICE ESUOM50 (Evidence Summaries Unlisensed or Off label Medicines)) SACT for Prostate Cancer v2.0 Page 4 of 12 The side effects of docetaxel can be substantial and it may not be possible to use docetaxel if the disease has progressed to a stage where it is causing significant symptoms. Some men who may not tolerate docetaxel at the 75mg/m2 21D regimen may tolerate the 30mg/m2 weekly (5/6) scheduling as it appears to have a better toxicity profile. It should however be noted that it does not provide a significantly better survival benefit than Mitoxantrone + Prednisolone which was inferior to the Docetaxel 75mg/m2. (1) Patient selection 1 Metastatic castration resistant prostate cancer with clinical and or biochemical progression ECOG performance status ≤ 2 (KPS >60) Satisfactory renal function (CrCl > 60ml/min) Satisfactory haematinics Adequate hepatic and cardiac function 2 Hormone naïve metastatic prostate cancer for: Men either commencing, or who have commenced within 12 weeks, long-term ADT for metastatic disease for the first time; and Men of sufficient performance status to be treated with 6 cycles of docetaxel chemotherapy. ECOG performance status ≤ 2 (KPS >60) Satisfactory renal function (CrCl > 60ml/min) Satisfactory haematinics Adequate hepatic and cardiac function Treatment regimen Docetaxel PROST Docetaxel 75mg/m2 D1 in combination with prednisolone 10mg/day on a 21day cycle planned for up to 10 cycles pending response. (maximum of 6 cycles in the ‘up front’ regimen) It should be discontinued if severe adverse advents occur or in the presence of progression of disease as evidenced by clinical or laboratory criteria, or by imaging studies. SACT for Prostate Cancer v2.0 Page 5 of 12 Follow-up As clinically directed PSA 3 monthly. 4.1.2 Abiraterone Abiraterone (5-6) in combination with prednisolone is recommended (TA 259) as an option for the treatment of castration-resistant metastatic prostate cancer in adults, if: their disease has progressed on or after one docetaxel-containing chemotherapy regimen, and the manufacturer provides Abiraterone with the discount agreed in the patient access scheme. It can be used in combination with prednisone or prednisolone is within its marketing authorisation, as an option for treating metastatic hormonerelapsed prostate cancer: in people who have no or mild symptoms after androgen deprivation therapy has failed, and before chemotherapy is indicated (TA 387) only when the company rebates the drug cost of abiraterone from the 11th month until the end of treatment for people who remain on treatment for more than 10 months. (3-4) Abiraterone is maintained until evidence of progressive disease. Patient selection As above As above ECOG performance status ≤ 2 Satisfactory renal function (CrCl > 60ml/min) Satisfactory haematinics Adequate hepatic function Adequate blood pressure control Treatment regimen Abiraterone acetate 1000mg (4x250mg tablets) po od plus prednisolone ec 5mg po bd continuously SACT for Prostate Cancer v2.0 Page 6 of 12 Follow-up As clinically directed PSA 3 monthly. 4.1.3 Mitoxantrone Mitoxantrone chemotherapy in combination with prednisolone has been demonstrated to improve quality of life and disease response in men with metastatic castration resistant prostate cancer. No improvement in overall survival has been demonstrated with this combination and it was found to provide inferior overall survival when compared to 3weekly Docetaxel (1-2). Its use as primary chemotherapy in castration resistant disease is therefore limited to men with a contra-indication to Docetaxel. It has been used in the TROPIC clinical trial post Docetaxel as a comparator to Cabazitaxel and is noted to achieve PSA control in approx 17% of men (7). However overall survival was inferior when compared to Cabazitaxel.. Patient selection Patient has castration resistant prostate cancer with either symptomatic progression or rapidly rising PSA. ECOG performance status ≤ 2 Docetaxel chemotherapy is contra-indicated or patient has progressed on or following previous Docetaxel chemotherapy Satisfactory renal function (CrCl > 60ml/min) Satisfactory haematinics Adequate hepatic and cardiac function Treatment regimen Mitox/pred Mitoxantrone 12mg/m2 iv infusion in 100ml N/Saline over 15 mins on day 1 only. Prednisolone e/c 5mg bd orally continuously during treatment. 21 day cycle Follow-up As clinically directed PSA 3 monthly SACT for Prostate Cancer v2.0 Page 7 of 12 4.1.4 Enzalutamide Enzalutamide (8-9) Is indicated in metastatic castration resistant prostate cancer. Either: In men who have no or mild symptoms after androgen deprivation therapy has failed, and before chemotherapy is indicated (9) (provided the company supplies it with the discount agreed in the patient access scheme). [Enzalutamide for treating metastatic hormone-relapsed prostate cancer before chemotherapy TA377] Or In men with metastatic castration resistant prostate cancer whose disease has progressed during or after docetaxel containing chemotherapy (8). (If the manufacturer provides enzalutamide with the discount agreed in the patient access scheme) [TA316] Patient selection As above ECOG performance status ≤ 2 Satisfactory renal function (CrCl > 60ml/min) Satisfactory haematinics Adequate hepatic function Adequate blood pressure control Treatment regimens Enzalutamide Enzalutamide 160mg od on a 28day cycle Follow-up As clinically directed PSA 3 monthly SACT for Prostate Cancer v2.0 Page 8 of 12 4.1.5 Zolendronic Acid. Bisphosphonates for pain relief may be considered for men with hormonerefractory prostate cancer when other treatments (including analgesics and palliative radiotherapy) have failed. (NICE) Bisphosphonates are not recommended for use in men with hormonerefractory prostate cancer for the prevention of bone metastases or to prevent or reduce the complications of bone metastases. Bisphosphonates are not recommended in the prevention of osteoporosis in men on androgen deprivation therapy. (NICE) Careful attention to renal function in this patient group is required and in view of risk of osteonecrosis of mandible, dental examination should be considered and appropriate preventative treatment prior to treatment in patients with concomitant risk factors. RADIUM 223 Radium 223 (10) is NICE approved for men who have had Docetaxel for Metastatic castration resistant prostate cancer and have symptomatic bone metastasis and no visceral metastasis. (NICE TA 376) Eligibility Criteria • Patient has symptomatic metastatic castration resistant prostate cancer • Previously treated with docetaxel chemotherapy • ECOG performance status ≤ 2 • Satisfactory haematinics Cabazitaxel Cabazitaxel in combination with prednisone or prednisolone (7) has recently been recommended by NICE (TA391) as an option for treating metastatic hormone-relapsed prostate cancer in people whose disease has progressed during or after docetaxel chemotherapy. The guidance does not cover patients who have had docetaxel followed by either enzalutamide, abiraterone or radium. It can be offered if: the person has an eastern cooperative oncology group (ECOG) performance status of 0 or 1 the person has had 225 mg/m2 or more of docetaxel SACT for Prostate Cancer v2.0 Page 9 of 12 treatment with cabazitaxel is stopped when the disease progresses or after a maximum of 10 cycles (whichever happens first) NHS trusts purchase cabazitaxel in pre-prepared intravenous-infusion bags, not in vials, and the company provides cabazitaxel with the discount agreed in the patient access scheme. Treatment regimens Cabazitaxel 25mg/m2 every 3weeks in combination with prednisolone. It should be discontinued if severe adverse advents occur or in the presence of progression of disease as evidenced by clinical or laboratory criteria, or by imaging studies. Follow-up As clinically directed PSA 3 monthly. 5.0 IMPLEMENTATION OF POLICY 5.1 Dissemination This policy will be agreed by all consultant oncologists treating patients with SACT for Bladder cancer. The guideline will form the basis for development of the SACT regimen specific protocols. It will be available on the intranet for use by all doctors, nurses and pharmacists involved in all stages of SACT assessment and delivery in patients with bladder cancer. 6.0 MONITORING Use of these guidelines will be monitored using audit. SACT for Prostate Cancer v2.0 Page 10 of 12 7.0 EVIDENCE BASE / REFERENCES NICE CG175 Prostate cancer: full clinical guideline http://www.nice.org.uk/nicemedia/live/14348/66232/66232.pdf 1 Tannock IF, de Wit R, Berry WR et al Docetaxel plus Prednisone or Mitoxantrone plus Prednisone for Advanced Prostate Cancer. New Eng J Med 2004; 351: 1502-1512 2 Berthold DR, Pond GR, Soban F et al. Docetaxel Plus Prednisone or Mitoxantrone Plus Prednisone for Advanced Prostate Cancer: Updated Survival in the TAX 327 Study JCO 2008; 26: 242-245 3 James ND,et al. Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial. The Lancet http://www.thelancet.com/pdfs/journals/lancet/PIIS01406736(15)01037-5.pdf 4 Sweeney CJ, Chen Y, Cardussi M et al Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer. NEJM 2015; 373: 737-746 5 Abiraterone for castration resistant metastatic prostate cancer previously treated with a docetaxel-containing regimen. NICE technology appraisal guidance 259 (2012) http://www.nice.org.uk/nicemedia/live/13775/59723/59723.pdf 6 de Bono JS, Logothetis CJ, Molina A et al Abiraterone and Increased Survival in Metastatic Prostate Cancer. N Engl J Med 2011; 364:1995-2005 7 de Bono JS, Oudard S, Ozguroglu M et al. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. The Lancet 2010; 376: 1147-1154 8 Scher HI, Fizazi K, Saad F et al.Increased Survival with Enzalutamide in Prostate Cancer after Chemotherapy N Engl J Med 2012; 367:1187-1197 9 Beer T, Armstrong AJ, Rathkpf D.E et al Enzalutamide in Metastatic Prostate Cancer before Chemotherapy. N Engl J Med 2014; 371: 424–433. SACT for Prostate Cancer v2.0 Page 11 of 12 10 Parker C, Nilsson S, Heinrich D et al. Alpha Emitter Radium-223 and Survival in Metastatic Prostate Cancer. N Engl J Med. 2013;369(3):213–23. 8.0 CONSULTATION PROCESS Genito-urinary oncology group. 9.0 APPENDICES / ATTACHMENTS Authorisation signature sheet. 10.0 EQUALITY STATEMENT In line with duties under the equality legislation (Section 75 of the Northern Ireland Act 1998), Targeting Social Need Initiative, Disability discrimination and the Human Rights Act 1998, an initial screening exercise to ascertain if this policy should be subject to a full impact assessment has been carried out. The outcome of the Equality screening for this policy is: Major impact Minor impact No impact. SACT for Prostate Cancer v2.0 Page 12 of 12