Interventional procedure overview of focal therapy using high-intensity focused ultrasound for localised prostate cancer
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Outcome measures
Prostate cancer risk stratification
Risk stratification for prostate cancer is typically based on 3 factors: PSA levels, tumour staging (T-stage), and the Gleason score. There may be 3 risk levels (low, intermediate, and high, as per the D'Amico classification), or 5 levels (as per the Cambridge Prognostic Group [CPG]).
Gleason score
The Gleason scoring system is an internationally recognised grading system, based on examination of the architectural differentiation of prostate tissue. When the prostate is biopsied, 10 to 12 cores are taken from different parts of the gland (5 or 6 per side). The 2 most common tumour patterns are analysed and graded from 1 to 5:
Grade 1: small, uniform glands with minimal nuclear changes.
Grade 2: medium-sized acinii, separated by stromal tissue but more closely arranged.
Grade 3: marked variation in glandular size and organization and infiltration of stromal and neighbouring tissues.
Grade 4: marked atypical cytology with extensive infiltration.
Grade 5: sheets of undifferentiated cells.
The Gleason score is the sum of these 2 grades. For example, if the grade given to the most common growth pattern is 4 and the grade given to the second most common growth pattern is 4, the total Gleason score is 8 (4 + 4). A Gleason score of 2 is the most well differentiated tumour, and 10 is the most poorly differentiated. Lower scores are associated with a better prognosis than higher scores.
Low-grade tumour: Gleason score ≤6.
Intermediate-grade tumour: Gleason score 7.
High-grade tumour: Gleason score 8 to 10.
Tumour staging
Taken from the Tumour Node Metastasis classification, the T-stage refers to the size of the tumour and whether it invades surrounding structures:
T0 No evidence of primary tumour
T1 Clinically inapparent tumour that is not palpable
T1a Tumour incidental histological finding in 5% or less of tissue resected
T1b Tumour incidental histological finding in more than 5% of tissue resected
T1c Tumour identified by needle biopsy (for example, because of elevated PSA)
T2 Tumour that is palpable and confined within the prostate
T2a Tumour involves half of one lobe or less
T2b Tumour involves more than half of one lobe, but not both lobes
T2c Tumour involves both lobes
T3 Tumour extends through the prostatic capsule
T3a Extracapsular extension (unilateral or bilateral)
T3b Tumour invades seminal vesicle(s)
T4 Tumour is fixed or invades adjacent structures other than seminal vesicles: bladder neck, external sphincter, rectum, levator muscles, and/or pelvic wall.
Risk classification
The D'Amico and CPG classifications combine PSA levels, Gleason score, and T-stage to estimate risk:
Low risk (similar to CPG 1):
T-stage of T1 to T2a, and
Gleason score no higher than 6, and
PSA level less than 10 ng/ml
Intermediate risk (similar to CPG 2 and 3):
T-stage of T2b, or
Gleason score of 7, or
PSA level between 10 and 20 ng/ml
High risk (similar to CPG 4 and 5):
Functional and QoL outcomes
IPSS
The International prostate symptom score (IPSS) is an 8-item instrument to measure urinary symptoms (7-items) and overall quality of life (QoL; 1-item). Symptoms include incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Symptoms are scored from 1 to 5 and the QoL item is scored from 1 to 6. Higher scores indicate worse symptoms/QoL.
EPIC
The Expanded Prostate Cancer Index Composite (EPIC) is a 32-item instrument that assesses functional outcomes in people with prostate cancer. The questionnaire includes items covering urinary function, bowel habits, sexual function, hormonal function, and treatment satisfaction.
ICSmaleSF
The International Continence Society male short form (ICSmaleSF) is an 11-item instrument that assesses voiding and incontinence. Higher scores indicate worse voiding and incontinence.
IIEF
The International Index of Erectile Function (IIEF) questionnaire is a 15-item instrument that assesses erectile function, orgasm, sexual desire, intercourse satisfaction, and overall satisfaction. Lower scores indicate worse function.
FACT-P
The Functional Assessment of Cancer Therapy – Prostate (FACT-P) questionnaire is a 39-item instrument that assesses QoL across physical well-being, social/family well-being, emotional well-being, functional well-being, and a prostate cancer subscale.
Complications grading
Clavien–Dindo system
The Clavien–Dindo system is widely used in urological surgery for grading adverse events which occur because of surgical procedures. The system ranges from:
Grade I
Any deviation from the normal postoperative course not requiring surgical, endoscopic or radiological intervention. This includes the need for certain drugs (for example antiemetics, antipyretics, analgesics, diuretics and electrolytes), treatment with physiotherapy and wound infections that are opened at the bedside.
Grade II
Complications requiring drug treatments other than those allowed for Grade I complications; this includes blood transfusion and total parenteral nutrition.
Grade III
Complications requiring surgical, endoscopic or radiological intervention.
Grade IIIa - intervention not under general anaesthetic
Grade IIIb - intervention under general anaesthetic
Grade IV
Life-threatening complications: this includes central nervous system complications (for example brain haemorrhage, ischaemic stroke, subarachnoid haemorrhage) which require intensive care, but excludes transient ischaemic attacks.
Grade IVa - single-organ dysfunction (including dialysis)
Grade IVb - multi-organ dysfunction
Grade V
Death of the person
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