A newly published article has concluded that, among the 4,000+ men enrolled in the Spanish cohort of the European Randomized Study of Screening for Prostate Cancer (ERSPC), there were no differences in overall or prostate cancer-specific mortality at 15 years of follow-up.
As a reminder, the ERSCP trial — data from which was first published 3 years ago in the New England Journal of Medicine — accumulated data from several different countries, and each country used slightly different screening principles. To date, only one well-defined subset of all the patients included in the ERSPC study has clearly suggested a prostate cancer-specific mortality benefit from screening (the patients in the Göteborg group of the Swedish cohort). It has previously been shown that there was no overall or prostate cancer-specific benefit in the Rotterdam cohort from the Netherlands, and even the patients in the Göteborg group showed no overall survival benefit.
According to the new article by Luján et al., the Spanish cohort of the ERSPC enrolled and randomized 4,278 men aged between 45 and 70 years of age between 1996 and 1999. If they were in the screening arm of the study, these men were given a PSA test every 4 years and a prostate biopsy when their PSA was ≥ 3 ng/ml. The men in the control arm of the study were given no tests. Relevant data were collected on all enrollees on an annual basis.
Here are the results reported by Luján et al.:
- 2,416 men were recruited and randomized to the screening arm.
- 1,862 men were recruited and randomized to the control arm.
- The average (mean) age of the patients was 57.8 years.
- The median follow-up was 13.3 years.
- 427 deaths occurred in total and just nine of these were from prostate cancer.
- Prostate cancer accounted for 2.1 percent of all deaths (9/427).
- 9/4,278 men (0.2 percent) died of prostate cancer.
- 6/2,416 men in the screening group (0.25 percent) died of prostate cancer.
- 3/1,862 men in the control group (0.16 percent) died of prostate cancer.
- Most relevant causes of death were malignant tumors (52.9 percent), cardiovascular disease (17.3 percent), and respiratory disorders (8.9 percent).
The authors conclude that the Spanish arm of ERSPC failed to reproduce the long-term results shown in the whole study and that these results suggest limited value of regular, mass screening for risk of prostate cancer screening in Spanish men.
These data are beginning to confirm prior suggestions that only the data from the Göteborg cohort of the ERSPC actually demonstrate a prostate cancer-specific survival benefit from mass screening for risk of prostate cancer.