แนวทางการตรวจคัดกรอง วินิจฉัยและรักษาโรคมะเร็งต่อมลูกหมาก

Objectives

This 2017 clinical practice guideline provides an evidence-informed framework for the prevention, early detection, diagnosis, staging, risk classification, treatment and follow-up of prostate cancer.[1][2]Its central objective is to support risk-adapted clinical management across localised, locally advanced, recurrent, metastatic and castration-resistant disease, rather than to establish a broader cancer-control policy or programme mission.[3][4]

• Standardise assessment through prostate-specific antigen testing, biopsy, pathology reporting, tumour-node-metastasis staging, imaging and risk grouping based on prostate-specific antigen, Gleason score, International Society of Urological Pathology Grade Group and clinical T stage.[5][6][7]
• Support early detection and diagnostic decision-making, including repeat biopsy where persistent clinical, imaging or biomarker concerns remain after an initially negative biopsy.[2][6]
• Match localised-disease management to disease risk, life expectancy and treatment harms through active surveillance, watchful waiting, radical prostatectomy, radiotherapy, brachytherapy, cryotherapy or high-intensity focused ultrasound.[3][7][8]
• Guide treatment of locally advanced, recurrent and metastatic disease through surgery, radiotherapy, androgen-deprivation therapy, systemic chemotherapy, radiopharmaceuticals and palliative interventions.[9][10][11][12]
• Address advanced and metastatic castration-resistant prostate cancer with treatment pathways that include docetaxel, enzalutamide, abiraterone with prednisolone, cabazitaxel, radium-223, mitoxantrone and selected bone-targeted therapies.[13][14][15]
• Reduce treatment-related harms and skeletal complications by addressing adverse effects of androgen-deprivation therapy, pathological fractures, bone metastases and skeletal-related events.[16][17][18]
• Promote consistent imaging and pathology interpretation through multiparametric magnetic resonance imaging, Prostate Imaging and Reporting Data System scoring, Gleason scoring, Grade Group assignment and specimen-specific pathology reporting.[19][20][21][22]

Implementation

The guideline uses an organised clinical pathway from screening and diagnosis through staging, treatment selection and follow-up.[2]It combines clinical assessment, laboratory testing, imaging, pathology, risk stratification and evidence-graded therapeutic recommendations.[5][23][24]The supplied material does not identify named implementing institutions, programme governance arrangements, financing mechanisms, workforce plans or stakeholder responsibilities.[2][13][14]

• Assess suspected prostate cancer using prostate-specific antigen testing, digital rectal examination, life expectancy and imaging findings; consider repeat prostate-specific antigen testing where results may be affected by prostate manipulation.[23][25]
• Perform pre-biopsy multiparametric magnetic resonance imaging and ultrasound-guided biopsy where indicated, using approximately 10 to 12 peripheral-zone cores with antibiotic prophylaxis.[25]
• Process specimens with patient identification, clinical-information recording and fixation in 10% neutral buffered formalin, and report tumour type, Gleason score or Grade Group, positive and total cores, invasion features and surgical-margin status.[26][21]
• Stage disease using tumour, regional lymph-node and distant-metastasis categories, supplemented as appropriate by bone scanning, computed tomography, magnetic resonance imaging and other clinical investigations.[5][6][7]
• Use active surveillance for carefully selected low-risk patients with curative intent and scheduled prostate-specific antigen, digital rectal examination, repeat biopsy and magnetic resonance imaging review; use watchful waiting as symptom-led palliative observation, particularly when expected survival is below 10 years.[8]
• Deliver radical prostatectomy, including seminal-vesicle removal and bilateral pelvic lymph-node dissection where indicated, through open, laparoscopic or robot-assisted approaches; consider adjuvant or salvage radiotherapy and androgen-deprivation therapy according to pathological risk and recurrence.[27][9]
• Provide definitive, adjuvant, salvage and palliative radiotherapy using external-beam radiotherapy, brachytherapy and androgen-deprivation therapy combinations selected by risk, life expectancy and treatment setting.[10][28]External-beam delivery may use conventional, moderate or extreme hypofractionation, including intensity-modulated radiotherapy, stereotactic body radiotherapy and image guidance.[29]
• Use permanent low-dose-rate or temporary high-dose-rate brachytherapy for selected patients, with post-implant dosimetry for permanent implantation and suitability assessment that considers urinary symptoms and previous transurethral resection of the prostate.[28][30]
• Manage biochemical recurrence through prostate-specific antigen assessment and localisation imaging, followed where appropriate by salvage radiotherapy, androgen-deprivation therapy or salvage lymphadenectomy.[9][30]
• Manage metastatic disease with medical or surgical castration, systemic therapy and palliative care.[31][12]Medical options include luteinising hormone-releasing hormone agonists or antagonists, while surgical castration is bilateral orchiectomy.[31]
• Add docetaxel for selected patients with extensive or high-volume castration-sensitive metastatic disease and good performance status, and use further systemic options for castration-resistant disease according to metastatic burden, visceral involvement and prior treatment.[12][32][33]
• Use radium-223 for selected patients with castration-resistant metastatic disease and painful bone metastases, with blood-count thresholds and haematological toxicity monitoring during treatment.[11]
• Prevent or manage skeletal-related events using bone-modifying agents such as zoledronate, pamidronate or denosumab, alongside local radiotherapy, radiopharmaceuticals or surgery where clinically indicated.[15][18][34]
• Monitor treatment using prostate-specific antigen, testosterone during androgen-deprivation therapy, clinical examination, relevant blood tests and imaging for suspected progression.[16][12][32]The excerpts specify clinical follow-up criteria but not programme-level indicators, reporting systems, audit mechanisms or accountability structures.[35][16][12]

Monitoring & Evaluation

Monitoring is primarily clinical and diagnostic rather than programme-wide. The guideline uses evidence grading, structured staging, pathology reporting, imaging classifications and follow-up criteria to support treatment decisions, but does not establish a national indicator set, surveillance architecture, audit cycle, reporting schedule or institutional accountability framework.[5][6][36]

• Apply a therapeutic evidence hierarchy ranging from Level 1A systematic reviews of homogeneous randomised controlled trials to Level 5 expert opinion or physiological and first-principles evidence.[5]
• Use tumour, regional lymph-node and distant-metastasis categories for staging, including bone metastasis as M1b and other distant sites as M1c.[5]
• Record patient identification and relevant clinical information during pathology processing to support specimen traceability and diagnostic accountability.[26]
• Report pathology findings including histological type, Gleason score or Grade Group, positive and total biopsy cores, tumour involvement, perineural and lymphovascular invasion, extraprostatic extension, seminal-vesicle invasion and surgical-margin status.[21][37]
• Assign Grade Groups from Gleason patterns, from Grade Group 1 for Gleason 3+3=6 to Grade Group 5 for Gleason 9–10 patterns.[24][22]
• Use the Prostate Imaging and Reporting Data System five-point classification to report the likelihood of clinically significant cancer, applying zone-specific interpretation of T2-weighted, diffusion-weighted and dynamic contrast-enhanced imaging.[20][36]
• Monitor possible persistent or recurrent disease through prostate-specific antigen testing, repeat assessment where PSA is rising or persistently elevated, and imaging, biomarkers or further biopsy where clinical findings remain concerning.[6][9]
• Follow patients on active surveillance using scheduled digital rectal examination and PSA testing, with repeat biopsy and multiparametric magnetic resonance imaging as appropriate; assess watchful-waiting patients principally according to symptoms.[8]
• Assess biochemical recurrence after prostatectomy with PSA and appropriate imaging, and define post-prostatectomy biochemical failure for salvage radiotherapy consideration by a detectable or rising PSA above 0.2 ng/ml.[9][30]
• Monitor PSA after treatment at approximately 6–12-week intervals when assessing biochemical failure after radiotherapy, using the Phoenix Consensus definition of a rise of at least 2 ng/mL above the PSA nadir.[35]
• Use post-implant dosimetry to assess permanent low-dose-rate brachytherapy implantation.[28]
• Monitor blood counts during radium-223 treatment, including haematological toxicity; reported grade 3–4 toxicities include neutropenia at 2%, thrombocytopenia at 3% and anaemia at 6%.[11]
• Monitor testosterone and PSA during androgen-deprivation therapy, with castrate testosterone identified as below 50 ng/dL or 1.7 nmol/L; assess intermittent treatment through PSA thresholds, testosterone recovery and clinical progression.[16][17]
• Assess patients receiving androgen-deprivation therapy through physical examination, PSA, blood urea nitrogen, creatinine, liver-function tests, haemoglobin and fasting blood sugar every 3–6 months, using imaging when clinical progression is suspected.[12]
• Monitor clinical progression and skeletal-related events, including pathological fracture, and consider creatinine clearance for bone-modifying agents and neutrophil counts for cabazitaxel safety.[17][18][38]

Outcome measures referred to in treatment decisions include clinical progression, survival benefit, biochemical progression-free survival and cancer-specific survival.[27][9]Although the source cites leading-cancer data for Thailand using mean annual age-standardised rates for 2010–2012, the supplied material does not provide a complete reliable dataset or connect these data to a formal monitoring framework.[39]

Costing & Financing

No programme budget, costed implementation plan, financing source, funding allocation, resource-mobilisation strategy, funding gap or economic assumption is specified across the supplied guideline material.[10][12][40]The document identifies extensive clinical resource requirements, including imaging, pathology processing, surgery, radiotherapy, brachytherapy, radiopharmaceuticals, systemic medicines and laboratory follow-up, but provides no financial values for these inputs.[25][29][14]

• Recognise that surgical castration is described as having lower treatment costs than medical castration, while luteinising hormone-releasing hormone antagonist medicines are identified as particularly costly; no prices, currencies or quantified comparisons are supplied.[31]
• Note that a cited reference concerns an economic analysis of single- versus multiple-fraction radiotherapy for bone metastases, but the extract provides neither the analysis findings nor financial assumptions for the guideline.[41]
• Distinguish clinical treatment quantities, such as radiotherapy dose, medicine dose and treatment frequency, from financial costs because the source presents these as clinical regimens rather than budget figures.[30][11][40]
• Note that no machine-readable financial cost items can be extracted because no explicit numeric monetary amount, currency, allocation or funding value is provided.[11][35][31]

The supplied bibliographic and poorly legible sections do not add interpretable information on financing, budgets, economic assumptions or resource mobilisation.[42][43]