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.