The Prostate Testing for Cancer and Treatment (ProtecT) trial reported excellent outcomes for patients with localized prostate cancer (PCa) managed with radical prostatectomy (RP), radiotherapy, or active monitoring. We aimed at assessing the generalizability of the ProtecT trial to contemporary patients undergoing RP at two high-volume institutions. Overall, 29147 PCa patients treated with RP between 1999 and 2016 were included. We evaluated changes in disease characteristics over time. Competing-risk analyses estimated the 10-yr cancer-specific mortality (CSM) and other-cause mortality (OCM) rates. Overall, 20598 (71%) patients were eligible for the ProtecT trial, ranging from 76% in 1999-2005 to 67% in 2014-2016. The proportion of prostate-specific antigen (PSA) ≥20ng/ml, biopsy grade group 4-5, and high-risk disease increased over time (all p<0.001). Among men potentially eligible for the ProtecT trial included in our study, median PSA and grade group 4-5 were higher as compared with the ProtecT trial (6.5 vs 4.7ng/ml and 9% vs 2%), especially in individuals treated in more recent years (7.1ng/ml and 16% for 2014-2016). Median follow-up was 50 mo. When considering patients eligible for the ProtecT trial, the 10-yr OCM rate exceeded the CSM rate (7% vs 2%). Conversely, when focusing on patients not eligible due to disease aggressiveness, the risk of CSM exceeded that of OCM (10% vs 7%). Clinicians should carefully consider the inverse stage migration toward more aggressive disease among surgical candidates in more recent years. Individuals not eligible for the ProtecT trial are more likely to die from PCa than from OCM, thus being the optimal candidates for testing the role of primary treatments. PATIENT SUMMARY: Contemporary prostate cancer surgery candidates harbor more aggressive disease features at presentation as compared with men included in the Prostate Testing for Cancer and Treatment (ProtecT) trial and are, in turn, at an increased risk of progression and mortality. Clinicians should take this into consideration when generalizing the results of the ProtecT trial with a particular emphasis on the oncologic safety of active monitoring in contemporary patients not included in structured prostate-specific antigen-based screening programs.
Keywords: Active monitoring; Local treatment; Prostate Testing for Cancer and Treatment trial; Prostate cancer; Radical prostatectomy; Radiotherapy.
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