Screening and prostate cancer mortality: results of the European Randomised Study of Screening for Prostate Cancer (ERSPC) at 13 years of follow-up

Abstract

Background The European Randomized study of Screening for Prostate Cancer (ERSPC) is a randomized multi-center trial with a predefined centralized database, analysis plan and core age group (55–69 years) evaluating prostate-specific antigen (PSA) testing in eight European countries. Methods The present results are based on prostate cancer (PCa) incidence and mortality truncated at 9, 11, and 13 years of follow-up in the intervention arm (offered PSA testing) relative to the control arm. A secondary analysis corrected for selection bias due to non-participation was performed. Because of incomplete follow-up, only incidence and no mortality data at 9 years follow-up are reported for the French centers. Findings The rate ratio (RR) of PCa incidence between the intervention and control arms was 1.91 after 9 years (1.64 including France), 1.66 after 11 years and 1.57 after 13 years. The RR of PCa mortality was 0.85, 0.78 and 0.79 at 9, 11 and 13 years respectively (95% confidence interval 13-year 0.69–0.91, p = 0.001). This corresponds to a relative risk reduction of 21% and an absolute risk reduction of death from PCa at 13 years of 0.11 per 1,000 person-years or 1.28 per 1,000 men randomized, which is equivalent to one PCa death averted per 781 men invited for screening or one per 27 additional PCa detected. PCa mortality reduction in screened men after adjustment for non–participation was 27%. Interpretation This update of ERSPC confirms a substantial PCa mortality reduction due to PSA testing, with a substantially increased absolute effect at 13 years compared to findings after 9 and 11 years. Funding All sources of funding per center are indicated in the “Web extra material” section. Trial identification This trial is registered under Current Controlled Trials number: ISRCTN49127736.

EAU-ESTRO-SIOG Guidelines on Prostate Cancer. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent

“…And yet, the European Randomized Study of (population-based) Screening for Prostate Cancer (ERSPC) showed a reduction in PCa mortality in the screening arm (RR: 0.8; 95% CI: 0.70-1.03) after a median follow-up of 9 years. Updated results from the ERSPC at 13 years of follow-up showed an unchanged cancer-specific mortality reduction 0.79 (0.69-0.91) [14], but the number-needed-to-screen (n=781) and to treat (n=27) to avoid one death from PCa decreased, and is now below the number-needed-to-screen in breast cancer trials [15] (Table 3). Furthermore, the uptake of the 2012 USPSTF recommendations against PSA testing has been associated with a substantial number of men with aggressive disease being missed [16].…”

Early detection of prostate cancer: can we have our cake and eat it too?

“…In the Prostate, Lung, Colon and Ovary screening trial, no significant improvement in survival was reported among the 76,685 patients enrolled [5]. However, in the European Randomized Study of Prostate Cancer Screening 13 year update reported in Lancet last year, they reported a 21% overall reduction in prostate cancer mortality with PSA screening [6]. Irrespectively, PSA testing remains limited by both its lack of specificity when within 'normal' ranges and sensitivity when elevated above given cut-points, rendering patients either exposed to unnecessary diagnostic biopsies or lack thereof [7].…”

Addressing overtreatment following the diagnosis of localized prostate cancer

“…Importantly, there is consensus across the board about the effectiveness of screening on cancer progression and disease-specific mortality with a number needed to treat constantly decreasing with prolonged follow-up; however, many argue that this gain is offset by the detrimental impact of screening on many patients' quality of life [6]. In other words, although experts recognize early detection as an effective tool for prostate cancer, the current therapeutic ratio -benefit to harm ratio -is considered too low and leads to overtreatment at an unacceptable rate.…”