Using real world data to bridge the evidence gap left by prostate cancer screening trials

Area of Science:

• Oncology
• Public Health
• Medical Diagnostics

Background:

• Population-based prostate cancer screening is not currently recommended in the UK due to potential harms outweighing benefits.
• Recent advancements in diagnostic pathways aim to improve safety and accuracy, but their impact on the harm-benefit ratio requires evaluation.
• Uncertainty persists regarding the net effect of updated diagnostic techniques on prostate cancer screening outcomes.

Purpose of the Study:

• To evaluate the impact of recent changes in the prostate cancer diagnostic pathway on the harm-benefit ratio.
• To quantify the reduction in harm associated with new diagnostic techniques using real-world data.
• To compare outcomes of current UK clinical practice with historical data and predictive models.

Main Methods:

• Analysis of real-world data (RWD) from two NHS registries covering 16 hospitals for men entering the current prostate cancer diagnostic pathway.
• Comparison of current UK clinical practice outcomes with historical data from the Cluster Randomised Trial of PSA Testing for Prostate Cancer (CAP)/ProtecT trial and past UK clinical practice.
• Utilisation of a predictive model representing expected outcomes from the UK current diagnostic pathway.

Main Results:

• The proportion of men diagnosed with no cancer after biopsy decreased significantly, from 9.46% in the pre-MRI era to 2.33% (RAPID) and 1.52% (South West RWD).
• Diagnoses of clinically insignificant prostate cancer reduced to 0.73% (RAPID) and 0.83% (South West RWD).
• Sepsis rates dropped from 0.10% historically to 0.02% in the RAPID pathway, with an estimated increase in clinically significant prostate cancer diagnoses.

Conclusions:

• High-quality RWD analysis estimates a 79% reduction in harm from the diagnostic process compared to the previous pathway.
• New diagnostic techniques have demonstrably reduced harm within the UK's current prostate cancer diagnostic pathways.
• These findings quantify the harm reduction achieved by implementing improved diagnostic strategies.