National practice guideline on the treatment of localised prostate cancer
Authors: Tombal Bertrand , Desomer Anja , Jonckheer Pascale , Veereman Geneviève , D'Hont Chris , Van Velthoven Roland , Feyaerts Axel , Schrijvers Dirk , Gil Thierry , Renard Laurette , De Meerleer Gert , Rorive Sandrine , Spinnewijn, Bram , Servaes Alain , Van Damme Nancy , Van Brabandt Hans 
Published: January 2025

SCIENTIFIC REPORT 9 -- 1 INTRODUCTION 9 -- 1.1 BACKGROUND 9 -- 1.2 THE NEED FOR A GUIDELINE 9 -- 1.3 OVERALL OBJECTIVES 9 -- 1.4 TARGET USERS OF THE GUIDELINE 10 -- 1.5 SCOPE 10 -- 1.5.1 TNM classification of prostate cancer 10 -- 1.5.2 Risk stratification of prostate cancer 10 -- 1.5.3 Scope of the present guideline 11 -- 1.6 STATEMENT OF INTENT 11 -- 1.7 FUNDING AND DECLARATION OF INTEREST 12 -- 2 RECOMMENDATIONS 13 -- 2.1 PATIENT INFORMATION 13 -- 2.2 RADICAL TREATMENT 13 -- 2.3 HIGH INTENSITY FOCUSED ULTRASOUND (HIFU) 14 -- 2.4 HORMONES IN MONO-THERAPY.. 14 -- 3 ALGORITHM 15 -- 4 METHODOLOGY 16 -- 4.1 THE GUIDELINE DEVELOPMENT GROUP (GDG), AUTHORS, EXTERNAL EXPERTS AND STAKEHOLDERS 16 -- 4.2 CLINICAL RESEARCH QUESTIONS 16 -- 4.3 GENERAL APPROACH OF THE GUIDELINE PRODUCTION 19 -- 4.4 SEARCH FOR EXISTING PRACTICE GUIDELINES 19 -- 4.4.1 Search strategy 19 -- 4.4.2 Quality appraisal 19 -- 4.4.3 Source Guideline: the 2014 NICE Prostate Cancer Guideline 20 -- 4.5 SEARCH FOR EVIDENCE FOR DE NOVO RECOMMENDATIONS 21 -- 4.5.1 Study design and date limits 21 -- 4.5.2 Databases 21 -- 4.5.3 Search strategy 22 -- 4.5.4 Quality appraisal 22 -- 4.5.5 Data extraction 22 -- 4.6 GRADING THE QUALITY OF THE EVIDENCE (LEVEL OF EVIDENCE  LOE) 22 -- 4.6.1 Quality of evidence of de novo recommendations 22 -- 4.6.2 Quality of evidence of adapted recommendations 25 -- 4.7 FORMULATION OF RECOMMENDATIONS 25 -- 4.8 GRADING THE STRENGTH OF RECOMMENDATION (SOR) 25 -- 4.9 LAY-OUT OF CHAPTERS DESCRIBING THE RECOMMENDATIONS ADAPTATION PROCESS. 28 -- 4.10 EXTERNAL REVIEW AND STAKEHOLDERS INVOLVEMENT 28 -- 4.10.1 Healthcare professionals 29 -- 4.10.2 Patient representatives 29 -- 4.11 FINAL VALIDATION 29 -- 5 EXTRACT FROM PART-1 OF THE BELGIAN PROSTATE CANCER GUIDELINE 29 -- 6 RECOMMENDATIONS ON PATIENT INFORMATION 30 -- 6.1 SEXUAL DYSFUNCTION AFTER TREATMENT 30 -- 6.1.1 NICEs Systematic Review, assessment and recommendations 30 -- 6.1.2 Belgian GDG Assessment 30 -- 6.1.3 Stakeholders considerations 30 -- 6.2 URINARY AND GASTRO-INTESTINAL ADVERSE EFFECTS OF TREATMENT 31 -- 6.2.1 NICEs Systematic Review, assessment and recommendations 31 -- 6.2.2 Belgian GDG Assessment 31 -- 6.2.3 Stakeholders considerations 32 -- 6.3 COLORECTAL CANCER AFTER RADIOTHERAPY 32 -- 6.3.1 NICEs Systematic Review, assessment and recommendations 32 -- 6.3.2 Belgian GDG Assessment 33 -- 6.3.3Stakeholders considerations 33 -- 6.4 SOCIO-ECONOMIC ASPECTS OF RADICAL TREATMENT 34 -- 7 RECOMMENDATIONS ON RADICAL TREATMENT 34 -- 7.1 RADICAL SURGERY AND RADICAL RADIOTHERAPY 34 -- 7.1.1 NICEs Systematic Review, assessment and recommendations 34 -- 7.1.2 Belgian GDG Assessment 35 -- 7.2 RADICAL SURGERY 37 -- 7.2.1 NICEs Systematic Review, assessment and recommendations 37 -- 7.2.2 Belgian GDG Assessment 39 -- 7.3 ADJUVANT HORMONAL THERAPY AFTER RADICAL SURGERY 40 -- 7.3.1 NICEs Systematic Review, assessment and recommendation 41 -- 7.3.2 Belgian GDG Assessment 41 -- 7.4 RADICAL EXTERNAL BEAM RADIOTHERAPY 42 -- 7.4.1 NICEs Systematic Review, assessment and recommendations 42 -- 7.4.2 Belgian GDG Assessment 42 -- 7.5 COMBINED EXTERNAL BEAM RADIOTHERAPY AND BRACHYTHERAPY 43 -- 7.5.1 NICEs Systematic Review, assessment and recommendation 43 -- 7.5.2 Belgian GDG Assessment 45 -- 7.6 RADICAL RADIOTHERAPY COMBINED WITH ANDROGEN DEPRIVATION THERAPY 46 -- 7.6.1 NICEs Systematic Review, assessment and recommendation on the combination of external beam radiotherapy and hormones 46 -- 7.6.2 Belgian GDG Assessment 48 -- 7.7 OPTIMAL DURATION OF HORMONE THERAPY COMBINED WITH EXTERNAL BEAM RADIOTHERAPY 48 -- 7.7.1 NICEs Systematic review, assessment and recommendations 49 -- 7.7.2 Belgian GDG Assessment 51 -- 8 HIFU 52 -- 8.1 BACKGROUND 52 -- 8.2 LITERATURE SEARCH RESULTS 53 -- 8.2.1 Systematic reviews 54 -- 8.2.2 Primary studies 54 -- 8.3 GDG CONCLUSIONS 63 -- 8.4 STAKEHOLDERS CONSIDERATIONS 63 -- 9 HORMONES IN MONO-THERAPY 64 -- 9.1 BACKGROUND 64 -- 9.2 LITERATURE SEARCH RESULTS 64 -- 9.2.1 Systematic reviews 66 -- 9.2.2 Randomised controlled trials 66 -- 9.3 EVIDENCE SUPPORTING THE USE OF HORMONE-THERAPY IN LOCALISED PROSTATE CANCER 66 -- 9.3.1 Hormone versus placebo 66 -- 9.3.2 Hormone versus hormone 69 -- 9.3.3 Hormone versus hormone + radiotherapy 73 -- 9.4 GDG CONCLUSIONS 75 -- 9.5 STAKEHOLDERS CONSIDERATIONS 75 -- 10 IMPLEMENTATION AND UPDATING OF THIS GUIDELINE 76 -- 10.1 IMPLEMENTATION 76 -- 10.1.1 Multidisciplinary approach 76 -- 10.1.2 Patient-centred care 76 -- 10.1.3 Barriers and facilitators for implementation of this guideline 76 -- 10.1.4 Actors of the implementation of this guideline 76 -- 10.2 MONITORING QUALITY OF CARE 77 -- 10.3 GUIDELINE UPDATE 77 -- REFERENCES 78