Investigation into changes in Prostate Specific Antigen (PSA) testing rate over time: A join point analysis

Study type
Protocol
Date of Approval
Study reference ID
20_130
Lay Summary

In the UK, prostate cancer is the most common male cancer and the second commonest cause of cancer deaths in males.

There is no organised screening programme for prostate cancer in the UK, but men can ask for a prostate-specific antigen (PSA) test, and if this exceeds a threshold (typically 3ng/ml) the man will be referred for a prostate biopsy. The controversy surrounding PSA-based, population wide screening for prostate cancer in the UK and worldwide remains, largely because of concerns about overtreatment in the face of limited benefit. The Cluster randomised trial of PSA testing for prostate cancer (‘CAP’), after a median 10 years follow-up reported no evidence of differences in prostate cancer specific or all-cause mortality between groups. These results have informed national and international guidelines for the use of PSA as a screening tool for prostate cancer detection. The impact of the trial on clinical behaviour in primary care is unknown.

Our specific aims are to:
i) investigate temporal trends in PSA testing and prostate biopsy rates
ii) determine if temporal trends vary by broad age groups and geographical area
iii) identify any changes in trends using join-point analysis and relate these to the dates of key publications and policy documents.
iv) assess changes in rates of prostate cancer metastases and all-cause mortality.

The results from this study will help us understand whether the updated policy guidelines have changed clinical practice. We will feedback these results to key stakeholders such as the UK National Steering Committee.

Technical Summary

The controversy surrounding population based, PSA screening for prostate cancer remains, largely because of concerns about overtreatment in the face of limited benefit. CAP provided the first and only robust evidence comparing a low-intensity PSA-based screening strategy (single screen) with no screening, designed to reduce over-detection/over-treatment while seeking a mortality benefit. After median 10 years follow-up there was no evidence of differences in prostate cancer specific or all-cause mortality. These data have informed national and international guidelines for the use of PSA testing for prostate cancer, however the impact on clinical care is unknown.

Our specific aims are to:
i) investigate temporal trends in PSA testing and prostate biopsy rates
ii) determine if temporal trends vary by broad age groups and geographical area
iii) identify any changes in trends using join-point analysis and relate these to the dates of key publications and policy documents.
iv) assess changes in rates of prostate cancer metastases and all-cause mortality

We will employ join point regression to quantify any changes in PSA testing and biopsy rates, prostate cancer metastases and mortality over time, overall and stratified by age group and geographical location.

We will conduct a join point regression analysis to:
i) pinpoint the timing (with 95% CIs) of trend quantify per annum rates of change (with 95% Cis);
ii) test the strength of statistical evidence for any observed rate changes.

We will relate the timing of trend change to CAP publication with consideration of Cis.

READ codes will be used to identify PSA, prostate biopsy, prostate cancer diagnosis and metastases, and mortality. Codes for family history of prostate cancer, urinary symptoms, and other factors will be used to attempt to classify reasons for PSA testing. Results will help us understand whether the updated policy guidelines have changed clinical practice.

Health Outcomes to be Measured

PSA testing rates; biopsy rates; prostate cancer rates; prostate cancer metastases, all-cause mortality.

Collaborators

Richard Martin - Chief Investigator - University of Bristol
Emma Turner - Corresponding Applicant - University of Bristol
Chris Metcalfe - Collaborator - University of Bristol

Linkages

Patient Level Index of Multiple Deprivation;Practice Level Index of Multiple Deprivation