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Prostate Cancer N EAU - EANM - ESTRO - ESUR - ISUP - SIOG Guidelines on Prostate Cancer N. Mottet (Chair), P. Cornford (Vice-chair), R.C.N. van den Bergh, E. Briers, Expert Patient Advocate (European Prostate Cancer Coalition/Europa UOMO), M. De Santis, S. Gillessen, J. Grummet, A.M. Henry, T.H. van der Kwast, T.B. Lam, M.D. Mason, S. O’Hanlon, D.E. Oprea-Lager, G. Ploussard, H.G. van der Poel, O. Rouvière, I.G. Schoots. D. Tilki, T. Wiegel Guidelines Associates: T. Van den Broeck, M. Cumberbatch, A. Farolfi, N. Fossati, G. Gandaglia, N. Grivas, M. Lardas, M. Liew, L. Moris, P-P.M. Willemse © European Association of Urology 2021 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 / hereditary prostate cancer 16 3.2.1.1 Germline mutations and prostate cancer 17 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 18 3.2.2.1.3 Obesity 18 3.2.2.2 Dietary factors 18 3.2.2.3 Hormonally active medication 18 3.2.2.3.1 5-alpha-reductase inhibitors (5-ARIs) 18 3.2.2.3.2 Testosterone 18 3.2.2.4 Other potential risk factors 19 3.2.3 Summary of evidence 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 Guidelines 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 23 5.1.3 Genetic testing for inherited prostate cancer 24 5.1.4 Guidelines for germline testing* 25 5.1.5 Guidelines for screening and early detection 25 5.2 Clinical diagnosis 25 5.2.1 Digital rectal examination 25 5.2.2 Prostate-specific antigen 25 5.2.2.1 PSA density 26 5.2.2.2 PSA velocity and doubling time 26 5.2.2.3 Free/total PSA ratio 26 5.2.3 Biomarkers in prostate cancer 26 5.2.3.1 Blood based biomarkers: PHI/4K score/IsoPSA 26 5.2.3.2 Urine biomarkers: PCA3/SelectMDX/Mi Prostate score (MiPS)/ExoDX 27 5.2.3.3 Tests to select men for a repeat biopsy 27 5.2.3.4 Guidelines for risk-assessment of asymptomatic men 28 5.2.4 The role of imaging in clinical diagnosis 28 5.2.4.1 Transrectal ultrasound and ultrasound-based techniques 28 5.2.4.2 Multiparametric magnetic resonance imaging 28 2 PROSTATE CANCER - LIMITED UPDATE 2021 5.2.4.2.1 Multiparametric magnetic resonance imaging performance in detecting PCa 28 5.2.4.2.2 Targeted biopsy improves the detection of ISUP grade > 2 cancer as compared to systematic biopsy. 28 5.2.4.2.3 MRI-TBx without systematic biopsy reduces the detection of ISUP grade 1 PCa as compared to systematic biopsy. 29 5.2.4.2.4 The added value of systematic and targeted biopsy 29 5.2.4.2.5 Number of biopsy procedures potentially avoided in the ‘MR pathway’ 30 5.2.4.2.6 Other considerations 30 5.2.4.2.6.1 Multiparametric magnetic resonance imaging reproducibility 30 5.2.4.2.6.2 Targeted biopsy accuracy and reproducibility 31 5.2.4.2.6.3 Role of risk-stratification 31 5.2.4.2.6.4 Pre-biopsy MRI and MRI-TBx may induce an ISUP prostate cancer grade shift, as a result of improved diagnosis 33 5.2.4.2.7 Summary of evidence and practical considerations on pre-biopsy MRI and MRI-TBx 33 5.2.4.3 Guidelines for imaging in PCa detection 33 5.2.5 Baseline biopsy 34 5.2.6 Repeat biopsy 34 5.2.6.1 Repeat biopsy after previously negative biopsy 34 5.2.6.2 Saturation biopsy 34 5.2.7 Prostate biopsy procedure 34 5.2.7.1 Sampling sites and number of cores 34 5.2.7.2 Antibiotics prior to biopsy 35 5.2.7.2.1 Transperineal prostate biopsy 35 5.2.7.2.2 Transrectal prostate biopsy 35 5.2.7.3 Summary of evidence and recommendations for performing prostate biopsy (in line with the Urological Infections Guidelines Panel) 36 5.2.7.4 Local anaesthesia prior to biopsy 37 5.2.7.5 Complications 38 5.2.7.6 Seminal vesicle biopsy 38 5.2.7.7 Transition zone biopsy 38 5.2.8 Pathology of prostate needle biopsies 38 5.2.8.1 Processing 38 5.2.8.2 Microscopy and reporting 38 5.2.8.2.1 Recommended terminology for reporting prostate biopsies 39 5.2.8.3 Tissue-based prognostic biomarker testing 39 5.2.8.4 Histopathology of radical prostatectomy specimens 40 5.2.8.4.1 Processing of radical prostatectomy specimens 40 5.2.8.4.1.1 Guidelines for processing prostatectomy specimens 40 5.2.8.4.2 Radical prostatectomy specimen report 40 5.2.8.4.3 ISUP grade in prostatectomy specimens 41 5.2.8.4.4 Definition of extraprostatic extension 41 5.2.8.4.5 PCa volume 42 5.2.8.4.6 Surgical margin status 42 5.3 Diagnosis - Clinical Staging 42 5.3.1 T-staging 42 5.3.1.1 TRUS 42 5.3.1.2 MRI 42 5.3.2 N-staging 43 5.3.2.1 Computed tomography and magnetic resonance imaging 43 5.3.2.2 Risk calculators incorporating MRI findings 43 5.3.2.3 Choline PET/CT 43 5.3.2.4 Prostate-specific membrane antigen-based PET/CT 43 5.3.3 M-staging 44 PROSTATE CANCER - LIMITED UPDATE 2021 3 5.3.3.1 Bone scan 44 5.3.3.2 Fluoride PET and PET/CT, choline PET/CT and MRI 44 5.3.3.3 Prostate-specific membrane antigen-based PET/CT 45 5.3.4 Summary of evidence and practical considerations on initial N/M staging 45 5.3.5 Summary of evidence and guidelines for staging of prostate cancer 46 5.4 Estimating life expectancy and health status 46 5.4.1 Introduction 46 5.4.2 Life expectancy 46 5.4.3 Health status screening 47 5.4.3.1 Co-morbidity 47 5.4.3.2 Nutritional status 47 5.4.3.3 Cognitive function 48 5.4.3.4 Physical function 48 5.4.3.5 Shared decision-making 48 5.4.4 Conclusion 48 5.4.5 Guidelines for evaluating health status and life expectancy 50 6. TREATMENT 50 6.1 Treatment modalities 50 6.1.1 Deferred treatment (active surveillance/watchful waiting) 50 6.1.1.1 Definitions 51 6.1.1.2 Active surveillance 51 6.1.1.3 Watchful Waiting 52 6.1.1.3.1 Outcome of watchful waiting compared with active treatment 52 6.1.1.4 The ProtecT study 52 6.1.2 Radical prostatectomy 53 6.1.2.1 Introduction 53 6.1.2.2 Pre-operative preparation 53 6.1.2.2.1 Pre-operative patient education 53 6.1.2.3 Surgical techniques 54 6.1.2.3.1 Robotic anterior versus Retzius-sparing dissection 54 6.1.2.3.2 Pelvic lymph node dissection 55 6.1.2.3.3 Sentinel node biopsy analysis 55 6.1.2.3.4 Prostatic anterior fat pad dissection and histologic analysis 55 6.1.2.3.5 Management of the dorsal venous complex 56 6.1.2.3.6 Nerve-sparing surgery 56 6.1.2.3.7 Lymph-node-positive patients during radical prostatectomy 56 6.1.2.3.8 Removal of seminal vesicles 56 6.1.2.3.9 Techniques of vesico-urethral anastomosis 56 6.1.2.3.10 Bladder neck management 57 6.1.2.3.11 Urethral length preservation 57 6.1.2.3.12 Cystography prior to catheter removal 57 6.1.2.3.13 Urinary catheter 58 6.1.2.3.14 Use of a pelvic drain 58 6.1.2.4 Acute and chronic complications of surgery 58 6.1.2.4.1 Effect of anterior and posterior reconstruction on continence 58 6.1.2.4.2 Deep venous thrombosis prophylaxis 59 6.1.2.4.3 Early complications of extended lymph node dissection 59 6.1.3 Radiotherapy 59 6.1.3.1 External beam radiation therapy 59 6.1.3.1.1 Technical aspects: intensity-modulated external-beam radiotherapy and volumetric arc external-beam radiotherapy 59 6.1.3.1.2 Dose escalation 60 6.1.3.1.3 Hypofractionation 61 6.1.3.1.4 Neoadjuvant or adjuvant hormone therapy plus radiotherapy 63 4 PROSTATE CANCER - LIMITED UPDATE 2021 6.1.3.1.5 Combined dose-escalated radiotherapy and androgen- deprivation therapy 64 6.1.3.2 Proton beam therapy 65 6.1.3.3 Spacer during external beam radiation therapy 65 6.1.3.4 Brachytherapy 65 6.1.3.4.1 Low-dose rate (LDR) brachytherapy 65 6.1.3.4.2 High-dose rate brachytherapy 66 6.1.3.5 Acute side effects of external beam radiotherapy and brachytherapy 66 6.1.4 Hormonal therapy 67 6.1.4.1 Introduction 67 6.1.4.1.1 Different types of hormonal therapy 67 6.1.4.1.1.1 Testosterone-lowering therapy (castration) 67 6.1.4.1.1.1.1 Castration level 67 6.1.4.1.1.1.2 Bilateral orchiectomy 67 6.1.4.1.1.1.3 Oestrogens 67 6.1.4.1.1.1.4 Luteinising-hormone-releasing hormone agonists 67 6.1.4.1.1.1.5 Luteinising-hormone-releasing hormone antagonists 67 6.1.4.1.1.1.6 Anti-androgens 68 6.1.4.1.1.1.6.1 Steroidal anti-androgens 68 6.1.4.1.1.1.6.2 Non-steroidal anti-androgens 68 6.1.4.1.1.2 New androgen receptor pathway targetting agents (ARTA) 68 6.1.4.1.1.2.1 Abiraterone acetate 68 6.1.4.1.1.2.2 Apalutamide, darolutamide, enzalutamide (alphabetical order) 68 6.1.4.1.1.3 New compounds 69 6.1.4.1.1.3.1 PARP inhibitors 69 6.1.4.1.1.3.2 Immune checkpoint inhibitors 69 6.1.4.1.1.3.3 Protein kinase B (AKT) inhibitors 69 6.1.5 Investigational therapies 69 6.1.5.1 Background 69 6.1.5.2 Cryotherapy 69 6.1.5.3 High-intensity focused ultrasound 70 6.1.5.4 Focal therapy 70 6.1.6 General guidelines for the treatment of prostate cancer 71 6.2 Treatment by disease stages 72 6.2.1 Treatment of low-risk disease 72 6.2.1.1 Active surveillance 72 6.2.1.1.1 Active surveillance - inclusion criteria 72 6.2.1.1.2 Tissue-based prognostic biomarker testing 72 6.2.1.1.3 Imaging for treatment selection 72 6.2.1.1.4 Monitoring during active surveillance 73 6.2.1.1.5 Active Surveillance - when to change strategy 74 6.2.1.2 Alternatives to active surveillance for the treatment of low-risk disease 74 6.2.1.3 Summary of evidence and guidelines for the treatment
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