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Prostate Cancer Guidelines on Prostate Cancer N. Mottet (Chair), J. Bellmunt, E. Briers (Patient Representative), R.C.N. van den Bergh (Guidelines Associate), M. Bolla, N.J. van Casteren (Guidelines Associate), P. Cornford, S. Culine, S. Joniau, T. Lam, M.D. Mason, V. Matveev, H. van der Poel, T.H. van der Kwast, O. Rouvière, T. Wiegel © European Association of Urology 2015 TABLE OF CONTENTS PAGE 1. INTRODUCTION 9 1.1 Aims and scope 9 1.2 Panel composition 9 1.2.1 Acknowledgement 9 1.2.2 Potential conflict of interest 9 1.3 Available publications 9 1.4 Publication history and summary of changes 9 1.4.1 Publication history 9 1.4.2 Summary of changes 9 2. METHODS 16 2.1 Data identification and evidence sources 16 2.2 Review 16 2.3 Future plans 16 3. EPIDEMIOLOGY, AETIOLOGY AND PATHOLOGY 16 3.1 Epidemiology 16 3.2 Risk factors and chemoprevention 16 3.2.1 Guideline for preventative measures 17 4. CLASSIFICATION AND STAGING SYSTEMS 17 4.1 Classification 17 5. DIAGNOSTIC EVALUATION 19 5.1 Screening and early detection 19 5.1.1 Guidelines for screening and early detection 20 5.2 Clinical diagnosis 20 5.2.1 Digital rectal examination 21 5.2.2 Prostate-specific antigen 21 5.2.2.1 PSA density 21 5.2.2.2 PSA velocity and doubling time 21 5.2.2.3 Free/total PSA ratio 21 5.2.2.4 Prostate Health Index (PHI) test 21 5.2.2.5 PCA3 marker 22 5.2.3 Prostate biopsy 22 5.2.3.1 Baseline biopsy 22 5.2.3.2 Repeat biopsy after previously negative biopsy 22 5.2.3.3 Saturation biopsy 22 5.2.3.4 Sampling sites and number of cores 22 5.2.3.5 Diagnostic transurethral resection of the prostate 22 5.2.3.6 Seminal vesicle biopsy 22 5.2.3.7 Transition zone biopsy 23 5.2.3.8 Antibiotics prior to biopsy 23 5.2.3.9 Local anaesthesia prior to biopsy 23 5.2.3.10 Fine-needle aspiration biopsy 23 5.2.3.11 Complications 23 5.2.4 Role of imaging 23 5.2.4.1 TRUS 23 5.2.4.2 Multiparametric MRI (mpMRI) 23 5.2.4.3 Guidelines for imaging 24 5.2.5 Pathology of prostate needle biopsies 24 5.2.5.1 Processing 24 5.2.5.2 Microscopy and reporting 24 5.2.6 Histopathology of radical prostatectomy specimens 25 5.2.6.1 Processing of radical prostatectomy specimens 25 5.2.6.1.1 Guidelines for processing prostatectomy specimens 25 5.2.6.2 RP specimen report 25 5.2.6.2.1 Gleason score 26 2 PROSTATE CANCER - UPDATE MARCH 2015 5.2.6.2.2 Interpreting Gleason score 26 5.2.6.2.3 Definition of extraprostatic extension 26 5.2.6.3 Prostate cancer volume 27 5.2.6.4 Surgical margin status 27 5.2.6.5 Other factors 27 5.2.7 Guidelines for the clinical diagnosis of prostate cancer 27 5.3 Diagnosis: Clinical staging 27 5.3.1 T-staging 27 5.3.1.1 Definitions 27 5.3.1.2 DRE, PSA level and biopsy findings 27 5.3.1.3 Transrectal ultrasound (TRUS) 28 5.3.1.4 Multiparametric magnetic resonance imaging (MRI) 28 5.3.2 N-staging 28 5.3.2.1 PSA level and biopsy findings 28 5.3.2.2 Nodal staging using computed tomography (CT) and magnetic resonance imaging (MRI) 29 5.3.2.3 Lymphadenectomy 29 5.3.3 M-staging 29 5.3.3.1 Alkaline phosphatase 29 5.3.3.2 Bone scan 29 5.3.4 New imaging modalities 29 5.3.4.1 Nodal metastases 29 5.3.4.2 Bone metastasis 30 5.3.5 Guidelines for staging of prostate cancer 30 6. DISEASE MANAGEMENT 30 6.1 Treatment: Deferred treatment (active surveillance/watchful waiting) 30 6.1.1 Introduction 30 6.1.1.1 Definition 30 6.1.1.1.1 Active surveillance 30 6.1.1.1.2 Watchful waiting 31 6.1.2 Deferred treatment of localised PCa (stage T1/T2, Nx/N0, M0) 31 6.1.2.1 Active surveillance 31 6.1.2.2 Watchful waiting 32 6.1.3 Deferred treatment for locally advanced PCa (stage T3-T4, Nx-N0, M0) 34 6.1.4 Deferred treatment for metastatic PCa (stage M1) 34 6.1.5 Guidelines for active surveillance and watchful waiting 34 6.2 Treatment: Radical prostatectomy 35 6.2.1 Introduction 35 6.2.2 Low-risk prostate cancer 36 6.2.3 Intermediate-risk, localised prostate cancer 36 6.2.3.1 Oncological results of radical prostatectomy in low- and intermediate-risk prostate cancer 36 6.2.4 High-risk and locally advanced prostate cancer 36 6.2.4.1 High-risk prostate cancer 37 6.2.4.1.1 Gleason score 8-10 37 6.2.4.1.2 Prostate-specific antigen > 20 ng/mL 37 6.2.4.2 Locally advanced prostate cancer: 37 6.2.5 Rationale for RP in patients with cN0 but pathologically confirmed lymph node invasion (pN1) PCa 38 6.2.6 Indication and extent of pelvic lymph node dissection (LND) 38 6.2.6.1 Extent of lymph node dissection 38 6.2.6.2 Therapeutic role of extended lymph node dissection (eLND) 39 6.2.6.3 Morbidity 39 6.2.7 Guidelines for eLND in prostate cancer 39 6.2.8 Neoadjuvant and adjuvant hormonal therapy and radical prostatectomy 39 6.2.9 Complications and functional outcomes 40 6.2.10 Indications for nerve-sparing surgery 40 6.2.11 Guidelines for radical prostatectomy 41 6.3 Treatment: definitive radiotherapy 41 PROSTATE CANCER - UPDATE MARCH 2015 3 6.3.1 Introduction 41 6.3.2 Technical aspects: three-dimensional conformal radiotherapy (3D-CRT) and intensity-modulated external-beam radiotherapy (IMRT) 41 6.3.3 Radiotherapy for localised PCa 42 6.3.3.1 Dose escalation 42 6.3.3.2 Hypofractionation (HFX) 43 6.3.3.3 Neoadjuvant or adjuvant hormone therapy plus radiotherapy 44 6.3.3.4 Neoadjuvant chemotherapy plus radiotherapy 46 6.3.3.5 Combined dose-escalated radiotherapy (RT) and androgen-deprivation therapy (ADT) 46 6.3.3.6 Recommended external beam radiation therapy (EBRT) treatment policy for localised PCa 46 6.3.3.6.1 Low-risk PCa 46 6.3.3.6.2 Intermediate-risk PCa 46 6.3.3.6.3 Localised High-risk PCa 46 6.3.3.6.4 Locally advanced PCa: T3-4 N0, M0 46 6.3.3.3.6.4.1 MRC PR3/PR07 study - The National Cancer Institute of Canada (NCIC)/UK Medical Research Council (MRC)/ Southwest Oncology Group (SWOG) intergroup PR3/PR07 study 47 6.3.3.6.4.2 The TAP 32 trial 47 6.3.3.6.4.3 The SPCG-7/SFUO-3 randomised study 47 6.3.3.7 Lymph node irradiation 47 6.3.3.7.1 Prophylactic lymph node irradiation in clinically N0 PCa (estimated cN0) 47 6.3.3.7.2 Clinical, or pathological node positive, M0 disease 47 6.3.4 Proton beam therapy 48 6.3.5 Low-dose rate (LDR) and high-dose rate (HDR) brachytherapy 48 6.3.5.1 LDR brachytherapy 48 6.3.5.2 HDR brachytherapy 49 6.3.5.3 Side effects of percutaneous irradiation and brachytherapy 49 6.3.6 Immediate (adjuvant) post-operative external irradiation after RP (cN0 or pN0) 50 6.3.6.1 EORTC 22911 50 6.3.6.2 ARO trial 50 6.3.6.3 SWOG 8794 trial 50 6.3.6.4 Conclusion 50 6.3.7 Immediate (adjuvant) post-operative external irradiation after radical prostatectomy (RP) (pN1) 51 6.3.8 Conclusion and Guidelines for definitive radiotherapy 51 6.4 Treatment: Options other than surgery and radiotherapy for the primary treatment of localised prostate cancer 52 6.4.1 Background 52 6.4.2 Cryosurgery 52 6.4.2.1 Indication for cryosurgery 52 6.4.2.2 Results of modern cryosurgery for PCa 53 6.4.2.3 Complications of cryosurgery for primary treatment of PCa 53 6.4.3 High-intensity focused ultrasound of the prostate 53 6.4.3.1 Results of high-intensity focused ultrasound in PCa 54 6.4.4 Focal therapy of PCa 55 6.4.4.1 Pre-therapeutic assessment of patients 55 6.4.4.2 Patient selection for focal therapy 55 6.4.5 Conclusions and guidelines for experimental therapeutic options to treat clinically localised PCa 56 6.5 Treatment: Hormonal therapy - rationale and available drugs 56 6.5.1 Introduction 56 6.5.1.2 Different types of hormonal therapy 56 6.5.2 Testosterone-lowering therapy (castration) 56 6.5.2.1 Castration level 56 4 PROSTATE CANCER - UPDATE MARCH 2015 6.5.2.2 Bilateral orchiectomy 57 6.5.3 Oestrogens 57 6.5.3.1 Diethylstilboesterol (DES) 57 6.5.3.2 Strategies to counteract the cardiotoxicity of oestrogen therapy 57 6.5.4 Luteinising-hormone-releasing hormone agonists 57 6.5.4.1 Achievement of castration levels 57 6.5.4.2 Flare-up phenomenon 57 6.5.5 Luteinising-hormone-releasing hormone antagonists 57 6.5.5.1 Abarelix 57 6.5.5.2 Degarelix 58 6.5.6 Anti-androgens 58 6.5.6.1 Steroidal anti-androgens 58 6.5.6.1.1 Cyproterone acetate (CPA) 58 6.5.6.1.2 Megestrol acetate and medroxyprogesterone acetate 58 6.5.6.2 Non-steroidal anti-androgens 58 6.5.6.2.1 Nilutamide 58 6.5.6.2.2 Flutamide 58 6.5.6.2.3 Bicalutamide 59 6.5.7 New compounds (for the castrate resistant status only) 59 6.5.7.1 Abiraterone acetate 59 6.5.7.2 Enzalutamide 59 6.5.8 Cost-effectiveness of hormonal therapy options 59 6.6 Treatment: Metastatic prostate cancer 59 6.6.1 Introduction 59 6.6.2 Prognostic factors 59 6.6.3 First-line hormonal treatment 59 6.6.3.1 Prevention of flare-up 60 6.6.4 Combination therapies 60 6.6.4.1 Complete androgen blockade (CAB) 60 6.6.4.2 Non-steroidal anti-androgen (NSAA) monotherapy 60 6.6.4.3 Intermittent versus continuous androgen deprivation therapy (IAD) 60 6.6.4.3.1 Potential other benefits of intermittent androgen deprivation 62 6.6.4.3.2 Practical aspects for intermittent androgen deprivation 62 6.6.4.4 Immediate versus deferred androgen deprivation therapy 63 6.6.5 Hormonal treatment combined with chemotherapy 63 6.6.6 Guidelines for the first-line treatment of metastatic prostate cancer 63 6.6.7 Guidelines for hormonal treatment of metastatic prostate cancer 63 6.6.8 Contraindications for various therapies 64 6.7 Management of prostate cancer in older men 64 6.7.1 Evaluating health status in senior adults 64 6.7.1.1 Introduction 64 6.7.1.2 Evaluation of life expectancy, comorbidity and health status 64 6.7.1.2.1 Comorbidity 64 6.7.1.2.2 Independent daily activities 65 6.7.1.2.3 Malnutrition 65 6.7.1.2.4 Cognitive impairment 65 6.7.1.2.5 Baseline screening using the G8 screening tool 65 6.7.1.2.6 Conclusions 67 6.7.1.3 Guidelines
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