New national guidelines on active surveillance for prostate cancer

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Reference: August 2025 | Issue 8 | Vol 11 | Page 31

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In April 2025, the National Cancer Control Programme (NCCP) published new evidence-based recommendations on the active surveillance of patients with prostate cancer.¹ The new guideline supersedes the recommendations set out in the active surveillance section of the national clinical guideline on the diagnosis, staging, and treatment of patients with prostate cancer.²

The new guideline sets out the eligibility criteria for active surveillance, as well as the type and timing of diagnostics tests, and criteria for escalation to active treatment.

Biopsy

In a significant divergence from current National Institute of Clinical Excellence (NICE) and European Association of Urology (EAU) guidelines, the NCCP recommends against routine confirmatory biopsy.^3,4 The guidelines state that for patients with prostate cancer being considered for active surveillance, a confirmatory biopsy is not routinely recommended. However, all patients must have undergone pre-biopsy MRI followed by systematic and targeted biopsies prior to consideration for enrolment and this negates the need for a confirmatory biopsy.

The EAU prostate cancer guidelines suggest that, in men eligible for active surveillance based on systematic biopsy findings alone and who did not have a pre-biopsy MRI, a re-biopsy should be performed within six to 12 months to exclude sampling error.⁴

However, the NCCP has based its decision on findings from the Detective study, which indicate that men who are eligible for active surveillance after a combined systematic and MRI-targeted biopsy do not require a confirmation biopsy.⁵ A Detective consensus statement also states that a change in PSA requires repeat MRI and repeat biopsy. The consensus also recommends a confirmed biopsy before active surveillance if abnormalities are found on a subsequent MRI.⁵

Eligibility

Eligibility criteria for active surveillance have been reviewed based on new evidence. For patients with low-risk prostate cancer and a life expectancy of >10 years, active surveillance is recommended if the following criteria are met:

• Any Gleason 3+3 (Grade Group 1)
• PSA <20µg/L
• ≤cT2.

For patients with intermediate-risk prostate cancer and a life expectancy of >10 years, it is recommended that active surveillance be considered (if clinically and pathologically favourable) according to the following criteria:

• Any Gleason 3+4 (Grade Group 2)
• Absence of intraductal or cribriform pattern
• PSA <20µg/L
• ≤cT2.

In the intermediate-risk patient population, it is advised that consideration also be given to the following:

• Has the patient had a targeted biopsy,
• Per cent positive cores,
• Per cent pattern 4,
• Pattern 4 subtypes,
• PSA density.

The recommended eligibility criteria incorporate evidence from the 2023 paper by Hamdy et al, which reported on 15 years of follow-up in the ProtecT trial. Of the study cohort, 66 per cent (n=973) had low-risk prostate cancer, and in this patient population, 10- and 15-year disease specific survival was similar for patients in the active monitoring group, the prostatectomy group, and the radiotherapy group.⁶

All-cause mortality was also similar between groups. Of 104 men diagnosed with metastasis, 51 (9.4%) were in the active monitoring group, 26 (4.7%) in the prostatectomy group, and 27 (5.0%) in the radiotherapy group. However, the NCCP says it is “important to note that these patients were not on a formal active surveillance programme, instead monitoring was based almost entirely on PSA”.

In a 2022 meta-analysis evaluating the outcomes of active surveillance among patients with intermediate-risk prostate cancer, the 10-year treatment-free and metastasis-free rates ranged from 19.4 per cent to 69 per cent and 80.8 per cent to 99 per cent, respectively.⁷ Cancer-specific survival ranged from 88.2 per cent to 99 per cent, and overall survival ranged from 59.4 per cent to 83.9 per cent, respectively.⁷

Intermediate-risk patients had similar treatment-free survival to low-risk patients (risk ratio [RR] 1.16; 95% CI 0.99-1.36; p=0.07), but significantly higher risks of metastasis (RR 5.79; 95% CI 4.61-7.29; p<0.001). Prostate cancer-specific mortality (RR 3.93; 95% CI 2.93-5.27; p<0.001) and all-cause mortality (RR 1.44; 95% CI 1.11-1.86; p=0.005) were also higher.⁷

In a subgroup analysis of studies that included patients with Gleason Grade ≤2 only, treatment-free survival and metastasis-free survival were similar between low-risk and intermediate-risk patients.⁷

Repeat biopsy may be considered for patients where there is an increased risk of disease progression requiring intervention, for example, discordance between the MRI and biopsy findings.

DRE is not recommended as a routine part of the active surveillance protocol, especially if standard imaging procedures, such as transrectal ultrasound or mpMRI, are being performed.

The new national guidelines state that MRI imaging must be performed in accordance with the latest version of PI-RADS. MRI should be performed if PSA is rising and other causes of a rising PSA has been ruled out (PSA-doubling time <3 years). Progression on MRI should be evaluated using the latest version of PRECISE (Prostate Cancer Radiological Estimation of Change in Sequential Evaluation). An upward change in MRI findings based on PRECISE criteria should trigger a biopsy.

TABLE 1: Modified STRATCANS risk-stratified follow-up schedule and intervals of outpatient appointments, PSA testing, MRI scans, and recommendations for biopsy

Follow-up

Both NICE and the EAU currently recommend identical active surveillance follow-up schedules for all patients with prostate cancer.^3,4 However, the NCCP guidelines recommend that all patients being considered for active surveillance should be risk stratified and followed up using the modified three-tier STRATified CANcer Surveillance (STRATCANS) strategy.

This incorporates the findings of a single centre prospective study, which found that men in the highest intensity follow-up tier (STRATCANS 3) had the greatest risk of any pathological progression or progression to Cambridge Prognostic Group ≥3 (22.2% and 7.4%, respectively).⁸ In contrast, men in the lowest follow-up tier (STRATCANS 1) had the least likelihood of progression, with over 95 per cent remaining on active surveillance or converting to watchful waiting.⁸

The recommendation also considers five-year follow-up data published earlier this year, which demonstrated that this model is safe and durable, with low treatment rates and high patient compliance.⁹

It is recommended that a repeat MRI should be performed every three years if there is no lesion present (PIRADS 1-2). This is reduced to intervals of 18 months where an equivocal lesion is detected (PI-RADS 3), and every 12 months for a positive lesion (PI-RADS 4-5). Patients in the highest risk STRATCANS group should have an annual MRI, regardless of lesion positivity.

The modified STRATCANS risk-stratified follow-up schedule is detailed in Table 1.

In patients with a life expectancy of <10 years, consideration should be given to moving from active surveillance to a watch-and-wait approach.

This guideline is scheduled for review in 2028.