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Prostate Cancer N EAU - EANM - ESTRO - ESUR - SIOG Guidelines on Prostate Cancer N. Mottet (Chair), P. Cornford (Vice-chair), R.C.N. van den Bergh, E. Briers (Patient Representative), M. De Santis, S. Fanti, S. Gillessen, J. Grummet, A.M. Henry, T.B. Lam, M.D. Mason, T.H. van der Kwast, H.G. van der Poel, O. Rouvière, I.G. Schoots. D. Tilki, T. Wiegel Guidelines Associates: T. Van den Broeck, M. Cumberbatch, N. Fossati, G. Gandaglia, N. Grivas, M. Lardas, M. Liew, L. Moris, D.E. Oprea-Lager, P-P.M. Willemse © European Association of Urology 2020 TABLE OF CONTENTS PAGE 1. INTRODUCTION 10 1.1 Aims and scope 10 1.2 Panel composition 10 1.2.1 Acknowledgement 10 1.3 Available publications 10 1.4 Publication history and summary of changes 10 1.4.1 Publication history 10 1.4.2 Summary of changes 10 2. METHODS 15 2.1 Data identification 15 2.2 Review 16 2.3 Future goals 16 3. EPIDEMIOLOGY AND AETIOLOGY 16 3.1 Epidemiology 16 3.2 Aetiology 16 3.2.1 Family history/genetics 16 3.2.2 Risk factors 17 3.2.2.1 Metabolic syndrome 17 3.2.2.1.1 Diabetes/metformin 17 3.2.2.1.2 Cholesterol/statins 17 3.2.2.1.3 Obesity 17 3.2.2.2 Dietary factors 17 3.2.2.3 Hormonally active medication 18 3.2.2.3.1 5-alpha-reductase inhibitors 18 3.2.2.3.2 Testosterone 18 3.2.2.4 Other potential risk factors 18 3.2.3 Summary of evidence and guidelines for epidemiology and aetiology 19 4. CLASSIFICATION AND STAGING SYSTEMS 19 4.1 Classification 19 4.2 Gleason score and International Society of Urological Pathology 2014 grade 20 4.3 Prognostic relevance of stratification 21 4.4 Guideline for classification and staging systems 21 5. DIAGNOSTIC EVALUATION 21 5.1 Screening and early detection 21 5.1.1 Screening 21 5.1.2 Early detection 22 5.1.3 Guidelines for screening and early detection 24 5.2 Clinical diagnosis 24 5.2.1 Digital rectal examination 24 5.2.2 Prostate-specific antigen 24 5.2.2.1 PSA density 24 5.2.2.2 PSA velocity and doubling time 25 5.2.2.3 Free/total PSA ratio 25 5.2.2.4 Additional serum testing 25 5.2.2.5 Urine tests: PCA3 marker/SelectMDX/Mi Prostate score (MiPS)/ExoDX 25 5.2.2.6 Guidelines for risk-assessment of asymptomatic men 26 5.2.3 Baseline biopsy 26 5.2.4 The role of imaging in clinical diagnosis 26 5.2.4.1 Transrectal ultrasound and ultrasound-based techniques 26 5.2.4.2 Multiparametric magnetic resonance imaging 26 5.2.4.2.1 Multiparametric magnetic resonance imaging performance in detecting ISUP grade > 2 PCa 26 2 PROSTATE CANCER - LIMITED UPDATE 2020 5.2.4.2.2 Multiparametric magnetic resonance imaging performance in detecting ISUP grade 1 PCa 26 5.2.4.2.3 Does targeted biopsy improve the detection of ISUP grade > 2 as compared to systematic biopsy? 26 5.2.4.2.4 Does MRI-TBx reduce the detection of ISUP grade 1 PCa as compared to systematic biopsy? 27 5.2.4.2.5 The added value of systematic and targeted biopsy 27 5.2.4.2.6 Number of biopsy procedures potentially avoided in the ‘MR pathway’ 28 5.2.4.2.7 Other considerations 28 5.2.4.2.7.1 Multiparametric magnetic resonance imaging reproducibility 28 5.2.4.2.7.2 Targeted biopsy accuracy and reproducibility 29 5.2.4.2.7.3 Role of risk-stratification 29 5.2.4.3 Summary of evidence and practical considerations on pre-biopsy mpMRI 31 5.2.4.4 Guidelines for imaging in PCa detection 31 5.2.5 Repeat biopsy 32 5.2.5.1 Repeat biopsy after previously negative biopsy 32 5.2.5.1.1 Tests to select men for a repeat biopsy 32 5.2.5.2 Saturation biopsy 32 5.2.6 Prostate biopsy procedure 32 5.2.6.1 Sampling sites and number of cores 32 5.2.6.2 Antibiotics prior to biopsy 33 5.2.6.3 Local anaesthesia prior to biopsy 33 5.2.6.4 Complications 33 5.2.6.5 Seminal vesicle biopsy 34 5.2.6.6 Transition zone biopsy 34 5.2.7 Pathology of prostate needle biopsies 34 5.2.7.1 Processing 34 5.2.7.2 Microscopy and reporting 34 5.2.7.3 Tissue-based prognostic biomarker testing. 35 5.2.7.4 Histopathology of radical prostatectomy specimens 35 5.2.7.4.1 Processing of radical prostatectomy specimens 35 5.2.7.4.1.1 Guidelines for processing prostatectomy specimens 35 5.2.7.4.2 Radical prostatectomy specimen report 36 5.2.7.4.3 ISUP grade in prostatectomy specimens 36 5.2.7.4.4 Definition of extraprostatic extension 37 5.2.7.4.5 PCa volume 37 5.2.7.4.6 Surgical margin status 37 5.2.8 Guidelines for the clinical diagnosis of prostate cancer 37 5.3 Diagnosis - Clinical Staging 37 5.3.1 T-staging 37 5.3.1.1 TRUS 37 5.3.1.2 mpMRI 38 5.3.2 N-staging 38 5.3.2.1 Computed tomography (CT) and magnetic resonance imaging 38 5.3.2.2 Choline PET/CT 38 5.3.2.3 Prostate-specific membrane antigen-based PET/CT 38 5.3.3 M-staging 39 5.3.3.1 Bone scan 39 5.3.3.2 Fluoride PET and PET/CT, choline PET/CT and MRI 39 5.3.3.3 Prostate-specific membrane antigen-based PET/CT 39 5.3.4 Summary of evidence and practical considerations on initial N/M staging 40 5.3.5 Guidelines for staging of prostate cancer 40 5.4 Evaluating life expectancy and health status 40 5.4.1 Introduction 40 5.4.2 Life expectancy 41 PROSTATE CANCER - LIMITED UPDATE 2020 3 5.4.3 Health status screening 41 5.4.3.1 Comorbidity 42 5.4.3.2 Nutritional status 42 5.4.3.3 Cognitive function 42 5.4.3.4 Physical function 42 5.4.4 Conclusion 42 5.4.5 Guidelines for evaluating health status and life expectancy 44 6. TREATMENT 44 6.1 Treatment modalities 44 6.1.1 Deferred treatment (active surveillance/watchful waiting) 44 6.1.1.1 Definitions 44 6.1.1.2 Active surveillance 45 6.1.1.3 Watchful Waiting 45 6.1.1.3.1 Outcome of watchful waiting compared with active treatment 45 6.1.1.4 The ProtecT study 46 6.1.2 Radical prostatectomy 46 6.1.2.1 Introduction 46 6.1.2.2 Pre-operative preparation 47 6.1.2.2.1 Pre-operative patient education 47 6.1.2.3 Surgical techniques 47 6.1.2.3.1 Robotic anterior versus Retzius-sparing dissection 48 6.1.2.3.2 Pelvic lymph node dissection 48 6.1.2.3.3 Sentinel node biopsy analysis 48 6.1.2.3.4 Prostatic anterior fat pad dissection and histologic analysis 48 6.1.2.3.5 Management of the dorsal venous complex 49 6.1.2.3.6 Nerve-sparing surgery 49 6.1.2.3.7 Lymph-node-positive patients during radical prostatectomy 49 6.1.2.3.8 Removal of seminal vesicles 49 6.1.2.3.9 Techniques of vesico-urethral anastomosis 49 6.1.2.3.10 Bladder neck management 50 6.1.2.3.11 Urethral length preservation 50 6.1.2.3.12 Cystography prior to catheter removal 51 6.1.2.3.13 Urinary catheter 51 6.1.2.3.14 Use of a pelvic drain 51 6.1.2.4 Acute and chronic complications of surgery 51 6.1.2.4.1 Effect of anterior and posterior reconstruction on continence 51 6.1.2.4.2 Deep venous thrombosis prophylaxis 52 6.1.2.4.3 Early complications of extended lymph node dissection 52 6.1.2.5 Comparing effectiveness of radical prostatectomy versus other interventions for localised disease 52 6.1.2.5.1 Radical prostatectomy versus deferred treatment 52 6.1.2.5.2 Radical prostatectomy versus radiotherapy 53 6.1.2.5.3 Neoadjuvant androgen deprivation therapy 53 6.1.3 Radiotherapy 53 6.1.3.1 External beam radiation therapy 53 6.1.3.1.1 Technical aspects: intensity-modulated external-beam radiotherapy and volumetric arc external-beam radiotherapy 53 6.1.3.1.2 Dose escalation 53 6.1.3.1.3 Hypofractionation 54 6.1.3.1.4 Neoadjuvant or adjuvant hormone therapy plus radiotherapy 56 6.1.3.1.5 Combined dose-escalated radiotherapy and androgen- deprivation therapy 57 6.1.3.2 Proton beam therapy 58 4 PROSTATE CANCER - LIMITED UPDATE 2020 6.1.3.3 Brachytherapy 58 6.1.3.3.1 Low-dose rate brachytherapy 58 6.1.3.3.2 High-dose rate brachytherapy 58 6.1.3.4 Acute side-effects of external beam radiotherapy and brachytherapy 59 6.1.4 Hormonal therapy 59 6.1.4.1 Introduction 59 6.1.4.1.1 Different types of hormonal therapy 59 6.1.4.1.1.1 Testosterone-lowering therapy (castration) 59 6.1.4.1.1.1.1 Castration level 59 6.1.4.1.1.1.2 Bilateral orchiectomy 59 6.1.4.1.1.2 Oestrogens 59 6.1.4.1.1.3 Luteinising-hormone-releasing hormone agonists 60 6.1.4.1.1.4 Luteinising-hormone-releasing hormone antagonists 60 6.1.4.1.1.5 Anti-androgens 60 6.1.4.1.1.5.1 Steroidal anti-androgens 60 6.1.4.1.1.5.1.1 Cyproterone acetate 60 6.1.4.1.1.5.2 Non-steroidal anti-androgens 60 6.1.4.1.1.5.2.1 Nilutamide 61 6.1.4.1.1.5.2.2 Flutamide 61 6.1.4.1.1.5.2.3 Bicalutamide 61 6.1.4.1.1.6 New compounds 61 6.1.4.1.1.6.1 Abiraterone acetate 61 6.1.4.1.1.6.2 Enzalutamide 61 6.1.4.1.1.6.3 Apalutamide 61 6.1.4.1.1.6.4 Darolutamide 61 6.1.5 Investigational therapies 61 6.1.5.1 Background 61 6.1.5.2 Cryotherapy 62 6.1.5.3 High-intensity focused ultrasound 62 6.1.5.4 Focal therapy 62 6.1.6 General guidelines for active treatment 63 6.1.7 Discussing treatment options 64 6.2 Treatment by disease stages 64 6.2.1 Treatment of low-risk disease 64 6.2.1.1 Active surveillance 64 6.2.1.1.1 Active surveillance - inclusion criteria 64 6.2.1.1.2 Biological markers 64 6.2.1.1.3 Imaging for treatment selection 64 6.2.1.1.4 Monitoring during active surveillance 65 6.2.1.1.5 Active Surveillance - when to change strategy 65 6.2.1.2 Guidelines for the treatment of low-risk disease 66 6.2.2 Treatment of Intermediate-risk disease 66 6.2.2.1 Active Surveillance 66 6.2.2.2 Surgery 66 6.2.2.3 Radiation therapy 67 6.2.2.3.1 Recommended external beam radiation therapy for intermediate-risk PCa 67 6.2.2.3.2 Brachytherapy monotherapy 67 6.2.2.4 Other options for the primary treatment of intermediate-risk PCa (experimental therapies) 67 6.2.2.5 Guidelines for the treatment of intermediate-risk disease 68 6.2.3 Treatment of high-risk localised disease 68 6.2.3.1 Radical prostatectomy 68 6.2.3.1.1 ISUP grade 4-5 68 6.2.3.1.2 Prostate-specific antigen > 20 ng/mL 68 6.2.3.1.3 Radical prostatectomy in cN0
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