Table 2.

Prostate Cancer UK Expert Reference Group on active surveillance (AS) consensus statements on best practice of AS

Inclusion criteria

Gleason score: 3 + 3 – primary treatment recommended is AS

Consider AS for men with prostate cancer with the following characteristics: Gleason score: 3 + 4 AND mpMRI T stage: ≤T2* AND Biopsy and MRI should be concordant AND PSA density of ≤0.2 ng/mL2 AND Men enrolled onto AS should be considered fit for radical treatment Note: Men who are suitable for AS should have access to specialist information and support during the decision‐making stage. Patient priorities should be considered, and all potential treatments, side effects and risks should be discussed prior to AS enrolment. *For men not suitable for mpMRI, clinical T‐stage should be used.

Exclusion criteria

Men not suitable for AS include: Gleason score ≥4 + 3 with pattern 4 disease in > 2 cores or >5 mm of cancer in a single core** OR mpMRI T stage: ≥T3a* *For men not suitable for mpMRI, clinical T‐stage should be used. ** Very‐low‐ volume Gleason 4 + 3 – consider re‐biopsy if patient wishes to have AS. [Low volume defined as Gleason 4 pattern disease in 1 or 2 cores or <5 mm of cancer in any core.]

AS follow‐up protocol

Men on AS should have access to a clinical specialist nurse Men should be offered and have access to support /counselling during their time on AS

Year 1 of AS Men should be provided with a personalized AS plan, including details of PSA interval, individualized PSA threshold for re‐assessment and follow‐up. The personalized plan should be communicated to the patient's GP. A repeat PSA test should be carried out in line with the recommended PSA interval and threshold† communicated by the patient's Urology Consultant within the personalized AS plan. † The factors that will influence a patient's PSA interval could include: PSA history; mpMRI results; and PSA density. If the patient's individualized PSA threshold is breached then the GP should check a mid‐stream urine specimen for infection, and re‐check the PSA after 6 weeks if the urine is negative for infection. If the PSA threshold remains breached, then the GP should re‐refer the patient for further diagnostics. A repeat mpMRI scan should be conducted at 12 months after baseline. Consider deferring routine 12‐month biopsy if patient is considered low risk of progression or re‐classification, e.g. stable mpMRI and PSA. A DRE should be performed at 12 months where mpMRI is contraindicated. A repeat biopsy should be offered when mpMRI shows a suspicion of progression or if there is evidence of PSA changes (e.g. the individualized PSA threshold is breached).

Year 2+ of AS Men should be provided with an updated personalized AS plan that should be communicated to their GP. A repeat PSA test should be carried out in line with the recommended PSA interval and threshold† communicated by the patient's Urology Consultant within the personalized AS plan. † The factors that will influence a patient's PSA interval could include: PSA history; mpMRI results; and PSA density. If the patient's individualized PSA threshold is breached then the GP should check a mid‐stream urine specimen for infection, and re‐check the PSA after 6 weeks if the urine is negative for infection. If the PSA threshold remains breached, then the GP should re‐refer the patient for further diagnostics. A repeat mpMRI scan should be considered if a lesion was visible at baseline or the PSA rises and breaches the individualized PSA threshold. A DRE should be considered on an individual basis. A repeat biopsy should be offered when mpMRI shows a suspicion of progression. Clinical assessment of suitability for radical treatment should be reviewed periodically.

When to stop AS The decision to change from AS to radical treatment or watchful waiting should be made in light of the individual man's personal preferences, in addition to clinical features, comorbidities, functional impairment (i.e. e‐Frailty index) and life expectancy.

AS, active surveillance; mpMRI, multiparametric MRI. The AS follow‐up protocol acknowledges: that there are limitations of using PSA kinetics as a predictor of biopsy reclassification, hence, some men, especially those who are risk averse, may opt for an interval biopsy even if MRI images and PSA tests remain stable; that it is not clear, from currently available evidence, what the ideal intervals for AS follow‐up should be; and that the recommended surveillance protocol remains dynamic and will respond to evolving evidence.