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

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.