Prostate cancer incidence and mortality in the Spanish section of the European Randomized Study of Screening for Prostate Cancer (ERSPC).

BACKGROUND

To present the long-term results of a prostate cancer (PC) screening trial conducted in a Mediterranean setting.

METHODS

A total of 4276 men aged 45-70 years were randomized to screening arm (PSA test performed) and control arm (no tests). Transrectal ultrasonography-guided sextant prostate biopsy was conducted when PSA > or = 3 ng ml(-1). Date and cause of death were retrieved from death certificates. PC incidence, and disease-specific and overall mortality curves were plotted and comparison between arms was made. Analysis of causes of death was also performed.

RESULTS

Median age at randomization was 57.0 years. Median follow-up time was 15.2 years. A total of 241 men were diagnosed with PC, 161 (6.7%) in the screening arm and 80 (4.3%) in the control arm (P<0.01). Eventually, 554 men (13%) died. No difference in all-cause mortality was found between arms (P=0.34). Only 10 men (10/4276, 0.23%) died from PC, no differences between arms (P=0.67). Overall, the main causes of death were malignancy (54.2%), cardiovascular (17.9%) and respiratory (9.2%) diseases. Main cancer causes of death were lung and bronchus cancer (37.2%), colorectum (15.0%) and stomach (9.0%) cancer. PC only accounted for 3.0% of all malignant causes of death (ranked 10th).

CONCLUSIONS

Our study failed to demonstrate benefits of PC screening in terms of all-cause and PC-specific mortality after a median follow-up of 15 years. The limited sample size and the low long-term PC mortality observed in our setting were probably the most important factors to explain these results.