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Guidelines on Prostate Cancer Guidelines on Prostate Cancer N. Mottet (chair), P.J. Bastian, J. Bellmunt, R.C.N. van den Bergh, M. Bolla, N.J. van Casteren, P. Cornford, S. Joniau, M.D. Mason, V. Matveev, T.H. van der Kwast, H. van der Poel, O. Rouvière, T. Wiegel © European Association of Urology 2014 TABLE OF CONTENTS PAGE 1. INTRODUCTION 9 1.1 Introduction 9 1.2 Data identification and evidence sources 9 1.3 Level of evidence and grade of recommendation 9 1.4 Publication history 10 1.5 Summary of updated information 10 1.5.1 Acknowledgement 10 1.6 Potential conflict of interest statement 11 1.7 References 11 2. BACKGROUND 11 2.1 References 12 3. CLASSIFICATION 12 3.1 References 13 4. RISK FACTORS AND CHEMOPREVENTION 14 4.1 Recommendation for preventative measures 14 4.2 References 15 5. SCREENING AND EARLY DETECTION 15 5.1 Recommendations for screening and early detection 17 5.2 References 17 6. DIAGNOSIS 18 6.1 Digital rectal examination 18 6.2 Prostate-specific antigen 18 6.2.1 Free/total PSA ratio 19 6.2.2 PSA velocity and PSA doubling time 19 6.2.3 PCA3 marker 19 6.3 Prostate biopsy 19 6.3.1 Baseline biopsy 19 6.3.2 Repeat biopsy 20 6.3.3 Saturation biopsy 20 6.3.4 Sampling sites and number of cores 20 6.3.5 Diagnostic transurethral resection of the prostate 20 6.3.6 Seminal vesicle biopsy 20 6.3.7 Transition zone biopsy 20 6.3.8 Antibiotics prior to biopsy 20 6.3.9 Local anaesthesia prior to biopsy 20 6.3.10 Fine-needle aspiration biopsy 20 6.3.11 Complications 20 6.4 The role of imaging 21 6.4.1 TRUS 21 6.4.2 Multiparametric MRI 21 6.4.3 Recommendation for imaging 21 6.5 Pathology of prostate needle biopsies 22 6.5.1 Grossing and processing 22 6.5.2 Microscopy and reporting 22 6.6 Pathohistology of radical prostatectomy specimens 23 6.6.1 Processing of radical prostatectomy specimens 23 6.6.1.1 Recommendations for processing a prostatectomy specimen 23 6.6.2 RP specimen report 23 6.6.2.1 Gleason score 24 6.6.2.2 Interpreting the Gleason score 24 6.6.2.3 Definition of extraprostatic extension 24 6.6.3 Prostate cancer volume 25 6.6.4 Surgical margin status 25 2 PROSTATE CANCER - UPDATE APRIL 2014 6.6.5 Other factors 25 6.7 Recommendations for the diagnosis of prostate cancer 25 6.8 References 26 7. CLINICAL STAGING 32 7.1 T-staging 32 7.1.1 DRE, PSA level and biopsy findings 32 7.1.2 TRUS 32 7.1.3 Multiparametric MRI 32 7.2 N-staging 35 7.2.1 PSA level and biopsy findings 35 7.2.2 Nodal staging using CT and MRI 35 7.2.3 Lymphadenectomy 36 7.3 M-staging 36 7.3.1 Alkaline phosphatase 36 7.3.2 Bone scan 36 7.3.3 New imaging modalities 37 7.4 Guidelines for the diagnosis and staging of PCa 38 7.5 References 39 8. TREATMENT: DEFERRED TREATMENT (ACTIVE SURVEILLANCE/ WATCHFUL WAITING) 45 8.1 Introduction 45 8.1.1 Definition 45 8.1.1.1 Active surveillance 45 8.1.1.2 Watchful waiting 46 8.2 Deferred treatment of localized PCa (stage T1-T2, Nx-N0, M0) 46 8.2.1 Active surveillance 46 8.2.2 Watchful waiting 48 8.3 Deferred treatment for locally advanced PCa (stage T3-T4, Nx-N0, M0) 50 8.4 Deferred treatment for metastatic PCa (stage M1) 51 8.5 Recommendations on active surveillance and watchful waiting 52 8.6 References 52 9. TREATMENT: RADICAL PROSTATECTOMY 57 9.1 Introduction 57 9.2 Low-risk prostate cancer: cT1-T2a, Gleason score < 6 and prostate-specific antigen < 10 ng/mL 57 9.2.1 Stage T1a-T1b prostate cancer 57 9.2.2 Stage T1c and T2a prostate cancer 58 9.3 Intermediate-risk, localized prostate cancer: cT2b-T2c or Gleason score = 7 or prostate-specific antigen 10-20 ng/mL 58 9.3.1 Oncological results of radical prostatectomy in low- and intermediate-risk prostate cancer 58 9.4 High-risk localized and locally advanced prostate cancer: cT3a or Gleason score 8-10 or prostate-specific antigen > 20 ng/mL 59 9.4.1 Locally advanced prostate cancer: cT3a 59 9.4.2 High-grade prostate cancer: Gleason score 8-10 60 9.4.3 Prostate cancer with prostate-specific antigen > 20 ng/mL 60 9.5 Very-high-risk prostate cancer: cT3b-T4 N0 or any T, N1 61 9.5.1 cT3b-T4 N0 62 9.5.2 Any T, N1 62 9.6 Indication and extent of extended pelvic lymph node dissection 63 9.6.1 Extent of extended lymph node dissection 63 9.6.2 Therapeutic role of extended lymph node dissection 63 9.6.3 Morbidity 64 9.6.4 Conclusions for extended lymph node dissection 64 9.7 Recommendations for radical prostatectomy and eLND in low-, intermediate- and high-risk prostate cancer 64 9.8 Neoadjuvant hormonal therapy and radical prostatectomy 64 PROSTATE CANCER - UPDATE APRIL 2014 3 9.8.1 Recommendations for neoadjuvant and adjuvant hormonal treatment and radical prostatectomy 65 9.9 Complications and functional outcome 65 9.10 Summary of indications for nerve-sparing surgery 66 9.11 Conclusions and recommendations for radical prostatectomy 67 9.12 References 67 10. TREATMENT: DEFINITIVE RADIOTHERAPY 73 10.1 Introduction 73 10.2 Technical aspects: three-dimensional conformal radiotherapy (3D-CRT) and intensity- modulated external-beam radiotherapy (IMRT) 74 10.3 Radiotherapy for localized PCa 74 10.3.1 Dose escalation 74 10.3.1.1 MD Anderson study 74 10.3.1.2 Prog 95-09 study 74 10.3.1.3 MRC RT01 study 75 10.3.1.4 Dutch randomized phase III trial 75 10.3.1.5 Phase III trial of the French Federation of Cancer Centres 75 10.3.1.6 Conclusion 75 10.3.2 Neoadjuvant or adjuvant hormone therapy plus radiotherapy 75 10.3.2.1 EORTC 22863 study 75 10.3.2.2 RTOG 85-31 study 75 10.3.2.3 RTOG 86-10 study 75 10.3.2.4 Boston trial 76 10.3.2.5 RTOG 94-08 study 76 10.3.2.6 EORTC 22991 study 76 10.3.2.7 Conclusion 76 10.3.3 Duration of adjuvant or neoadjuvant ADT in combination with radiotherapy 76 10.3.3.1 EORTC-22961 study 76 10.3.3.2 Trans-Tasman Oncology Group (TROG) trial 76 10.3.3.3 RTOG 94-13 study 76 10.3.3.4 RTOG 92-02 study 76 10.3.4 Combined dose-escalated RT and ADT 77 10.3.5 Proposed EBRT treatment policy for localized PCa 77 10.3.5.1 Low-risk PCa 77 10.3.5.2 Intermediate-risk PCa 77 10.3.5.3 High-risk PCa 77 10.3.6 The role of radiotherapy in locally advanced PCa: T3-4 N0, M0 77 10.3.6.1 MRC PR3/PR07 study - The National Cancer Institute of Canada (NCIC)/UK Medical Research Council (MRC)/Southwest Oncology Group (SWOG) intergroup PR3/PR07 study 77 10.3.6.2 The Groupe d’Etude des Tumeurs Uro-Génitales (GETUG) trial 78 10.3.6.3 The SPCG-7/SFUO-3 randomized study (32) 78 10.3.7 Benefits of lymph node irradiation in PCa 78 10.3.7.1 Prophylactic irradiation of pelvic lymph nodes in high-risk localized PCa 78 10.3.7.2 Very high-risk PCa: c or pN1, M0 78 10.4 Proton beam and carbon ion beam therapy 78 10.5 Transperineal brachytherapy 79 10.6 Late toxicity 80 10.6.1 Immediate (adjuvant) post-operative external irradiation after RP 81 10.6.1.1 EORTC 22911 81 10.6.1.2 ARO trial 82 10.6.1.3 SWOG 8794 trial 82 10.6.1.4 Conclusion 82 10.7 Guidelines for definitive radiotherapy 83 10.8 References 83 4 PROSTATE CANCER - UPDATE APRIL 2014 11. OPTIONS OTHER THAN SURGERY AND RADIOTHERAPY FOR THE PRIMARY TREATMENT OF LOCALIZED PROSTATE CANCER 89 11.1 Background 89 11.2 CSAP 89 11.2.1 Indication for CSAP 89 11.2.2 Results of modern cryosurgery for PCa 89 11.2.3 Complications of CSAP for primary treatment of PCa 90 11.3 HIFU of the prostate 90 11.3.1 Results of HIFU in PCa 90 11.3.2 Complications of HIFU 92 11.4 Focal therapy of PCa 92 11.4.1 Pre-therapeutic assessment of patients 92 11.4.2 Patient selection for focal therapy 93 11.5 Conclusions and recommendations for experimental therapeutic options to treat clinically localized PCa 93 11.6 References 93 12. HORMONAL THERAPY; RATIONALE AND AVAILABLE DRUGS 96 12.1 Introduction 96 12.1.1 Basics of hormonal control of the prostate 96 12.1.2 Different types of hormonal therapy 96 12.2 Testosterone-lowering therapy (castration) 96 12.2.1 Castration level 96 12.2.2 Bilateral orchiectomy 97 12.3 Oestrogens 97 12.3.1 Diethylstilboesterol (DES) 97 12.3.2 Strategies to counteract the cardiotoxicity of oestrogen therapy 97 12.4 LHRH agonists 97 12.4.1 Achievement of castration levels 97 12.4.2 Flare-up phenomenon 97 12.5 LHRH antagonists 98 12.5.1 Abarelix 98 12.5.2 Degarelix 98 12.6 Anti-androgens 98 12.6.1 Steroidal anti-androgens 98 12.6.1.1 Cyproterone acetate (CPA) 98 12.6.1.2 Megestrol acetate and medroxyprogesterone acetate 98 12.6.2 Non-steroidal anti-androgens 99 12.6.2.1 Nilutamide 99 12.6.2.2 Flutamide 99 12.6.2.3 Bicalutamide 99 12.7 New compounds 99 12.7.1 Abiraterone acetate 99 12.7.2 Enzalutamide 99 12.8 References 99 12.9 Side-effects, QoL and cost of hormonal therapy 101 12.9.1 Sexual function 101 12.9.2 Hot flashes 101 12.9.3 Other systemic side-effects of ADT 101 12.9.3.1 Non-metastatic bone fractures 102 12.9.3.2 Metabolic effects 102 12.9.3.3 Cardiovascular disease 103 12.9.3.4 Fatigue 103 12.10 Quality of life (QoL) 103 12.11 Cost-effectiveness of hormonal therapy options 104 12.12 References 104 13.
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