Intervention-related Deaths in the European Randomized Study of Screening for Prostate Cancer

Area of Science:

• Oncology
• Clinical Trials
• Public Health

Background:

• Accurate assessment of benefit-to-harm ratio in screening trials requires identification of intervention-related deaths.
• The European Randomized Study of Prostate Cancer Screening (ERSPC) aimed to evaluate prostate cancer mortality reduction through screening.

Purpose of the Study:

• To investigate intervention-related deaths within each study arm of the ERSPC.
• To quantify the risk associated with prostate cancer screening interventions.

Main Methods:

• Analysis of a multicenter trial including 112,553 men in the screening arm and 128,681 in the control arm (ages 55-69) with 16-year follow-up.
• Independent national committees reviewed medical records to determine causes of death, defining intervention-related deaths as those from screening, treatment, or follow-up complications.
• Descriptive statistics were employed to analyze the data.

Main Results:

• A total of 34 intervention-related deaths were identified: 21 in the screening arm and 13 in the control arm.
• The overall risk of intervention-related death was 1.41 per 10,000 men, with variations across centers (0 to 7.0 per 10,000).
• Differences in procedures among centers limited the direct comparability of results.

Conclusions:

• Intervention-related deaths were infrequent in the ERSPC trial.
• Continued monitoring of intervention-related deaths is essential for evaluating the safety and efficacy of screening programs.
• The study highlights the importance of meticulous data collection for harm assessment in large-scale screening initiatives.