General application of the National Institute for Health and Clinical Excellence (NICE) guidance for active surveillance for men with prostate cancer is not appropriate in unscreened populations

Study Type - Therapy (case series) Level of Evidence 4 What's known on the subject? and What does the study add? Active surveillance (AS) is a well-recognised management strategy to minimise the morbidity associated with radical treatment of prostate cancer. The National Institute for Health and Clinical Excellence guidelines initially suggested that all men with low-risk prostate cancer should first be offered AS. The cohort of men with upstaging and upgrading of prostate cancer from diagnosis to final pathology has been described in North American and European populations. As the rate of PSA testing in Britain is lower than North America and parts of Europe, the risk of more advanced disease at diagnosis of prostate cancer is higher. The present study is one of the first to examine this cohort in a British population and found the rate of features of advanced disease (extracapsular extension, seminal vesicle involvement and Gleason 4 + 3, or 8-10) to be 37.2%.

Objective: To determine if the National Institute for Health and Clinical Excellence (NICE) guidelines for men with low-risk prostate cancer were generally applicable in unscreened populations.

Patients and methods: Retrospective analysis of prospectively collected case series from a single tertiary care centre in England. In all, 700 consecutive men treated for prostate cancer from 2005 by robot-assisted laparoscopic prostatectomy (RALP) were included. Patients satisfying NICE criteria for low-risk disease (PSA level < 10 ng/mL and Gleason score ≤ 6 and cT1-2a) had their pathological samples analysed for advanced disease, defined as extracapsular extension (ECE: pT3), seminal vesicle involvement (SVI), Gleason sum 7, or 8-10 or node-positive disease.

Results: In all, 275 patients (39.2%) met the NICE low-risk criteria, but pathologically advanced disease was found in 37.2% of this group. There was ECE in 71 patients (25.8%), 10 had SVI (3.6%), nine (3.3%) had Gleason score 7(4 + 3), and 12 had Gleason sum 8-10 (4.4%).

Conclusions: The NICE guidance was developed largely on data from North America where populations are highly screened using PSA testing. In the UK, many men with low-risk disease features have high-risk disease and the general applicability of the NICE guidance is questionable in unscreened populations. We recommend that radical therapy is discussed as an alternative option to active surveillance.