Update of the results of the Spanish branch of the European Randomized Study on Screening for Prostate Cancer (ERSPC)

Abstract

Objective: The role of prostate cancer (PC) screening is currently being questioned. The objective of the European Randomized Study of Screening for Prostate Cancer (ERSPC) was to demonstrate whether PC screening reduced mortality from this disease. The results from the Spanish branch of this study are presented: all-cause and cancer-specific mortality, the characteristics of the detected tumors, primary treatments and progression to advanced disease.

Material and methods: A total of 18,612 men, between the ages of 45 and 70, were invited to participate in the study, excluding those with a life expectancy of less than 10 years. The men were randomized to the screening arm (serum prostate-specific antigen [PSA] reading) or the control arm (no diagnostic tests). Randomized transrectal ultrasound-guided sextant prostate biopsies were indicated for the men in the screening arm with PSA levels ≥3ng/ml. The detected PCs were identified (stage and primary treatment), as well as the deaths that occurred (date and cause of death).

Results: The study was performed with 4276 men (2415 in the screening arm and 1861 in the control arm). The median age and serum PSA level were 57 years and 0.90ng/mL, respectively. The median follow-up time was 15.8 years. A total of 242 PCs were diagnosed, 162 (6.7%) in the screening arm and 80 (4.3%) in the control arm (P<.001). Of these, 214 (88.4%) had an organ-confined clinical stage at onset (91.4% in the screening arm vs. 82.5% in the control arm; P=.024). A total of 112 patients (46.3%) underwent radical prostatectomy, 53 (21.9%) underwent prostate radiation therapy, 24 (9.9%) underwent hormone therapy and 47 (19.4%) were kept under observation. A total of 18 PCs progressed to advanced disease (M+ or PSA levels >100ng/mL), with no differences between the study arms (P=.938). A total of 618 (14.5%) patients died during follow-up: 340 (14.1%) in the screening arm and 278 (14.9%) in the control arm, with no differences between the arms in terms of cancer-specific (P=.907) or all-cause (P=.399) mortality. The main causes of death were neoplasia (54.0%), cardiovascular (17.6%), respiratory (8.7%) and gastrointestinal (4.0%), with no difference between study arms. Of the 334 patients who died from neoplasia, only 12 (3.6%) died from PC.

Conclusions: PC screening results in a shifting of the diagnosis towards earlier stages. Nevertheless, we have not demonstrated a benefit in terms of overall or cancer-specific survival after more than 15 years of follow-up. The low mortality from this disease in our community could be one of the main factors that explain these results.

Keywords: Cáncer de próstata; Mortalidad; Mortality; Prostate cancer; Screening.