Prostate cancer is the most common cancer in men in the UK. Most men who get prostate cancer will experience at least one symptom that relates to their cancer before they are diagnosed, such as waking multiple times in the night to empty their bladder. These symptoms are common in men as they get older, and most men with these symptoms don’t have prostate cancer. This can make it challenging to spot prostate cancer early.
This study will answer two research questions:
1. Which symptoms caused by a prostate cancer that hasn’t been found yet are most useful for catching it early?
2. Are prostate cancer outcomes for patients who have symptoms before diagnosis different to patients who do not have symptoms before diagnosis?
The team will analyse the data in large dataset of anonymous GP records to answer the two research questions. This study has already had input from men with prostate cancer, and members of the general public. While the study is being carried out, a group of five patients and members of the public with some experience of prostate cancer will come together to work with the study team. This group will help share the study findings with fellow patients and the public. They will also work with the team to decide what the next steps should be after this study is finished. This study aims to improve the early diagnosis of prostate cancer by helping GPs know which patients need urgent referral for further tests.
Prostate cancer is the most common cancer in men in the UK, and 45% of men still are diagnosed at a late stage. Most patients diagnosed with prostate cancer will present to their GP with symptoms prior to diagnosis, often lower urinary tract symptoms (LUTS). The National Institute for health and Care Excellence (NICE) guidance recommends performing a prostate specific antigen (PSA) blood test for men presenting to primary care with LUTS, new erectile dysfunction, or visible haematuria. The primary care evidence for the clinical utility of these symptoms in the diagnosis of early stage clinically significant prostate cancer is lacking.
This study aims to improve the early diagnosis of prostate cancer by identifying which symptom(s) are associated with clinically significant prostate cancer, and warrant referral by GPs for diagnostic testing.
Methods
A large, retrospective cohort study of men aged 50 years and older presenting to primary care with new onset LUTS will be established using the Clinical Practice Research Datalink (CPRD) Aurum, with linked National Cancer Registration and Analysis Service (NCRAS) cancer registry data. Men in CPRD Aurum with an index presentation of one or more LUTS coded for the first time between 1st January 2011 and 31st December 2016 and no history of prostate cancer will be included in this study, and followed for up to 24 months for a new diagnosis of prostate cancer. Logistic regression will be undertaken to assess which individual symptoms and combinations of symptoms are associated with early stage (T1-2N0M0) clinically significant (Gleason score ≥ 7) prostate cancer, and measures of diagnostic accuracy including Positive Predictive Values (PPVs) will be calculated. Differences in prostate cancer specific mortality, all-cause mortality, and late stage disease at diagnosis will also be compared between symptomatic and asymptomatic prostate cancer patients using chi square tests.
Clinically significant prostate cancer diagnosis; any prostate cancer diagnosis; Gleason score; TNM stage; UICC stage; prostate cancer mortality; mortality from any cause; prostate cancer treatment(s)
Sam Merriel - Chief Investigator - University of Exeter
Sam Merriel - Corresponding Applicant - University of Exeter
Gary Abel - Collaborator - University of Exeter
Peter Nickol - Collaborator - Not from an Organisation
William Hamilton - Collaborator - University of Exeter
NCRAS Cancer Registration Data;No additional NCRAS data required;ONS Death Registration Data;Patient Level Townsend Index