A cross sectional description of prostate cancer subgroups

Study type
Protocol
Date of Approval
Study reference ID
18_234
Lay Summary

Prostate cancer (pca) is the most common cancer for males in the UK. Between 2013 and 2015, approximately 47,700 new cases a year were diagnosed, accounting for 26% of all new cancers in males in the UK (www.cancerresearchuk.org). Whilst the incidence and prevalence of pca has been reliably reported, there is very little information on patient subgroups by clinical states.

In this study, we aim to 1) report the frequency and proportion of patients with prostate cancer among clinical states at the beginning of the calendar year; 2) establish the frequency and proportion of pca patients who progressed to other clinical states within 12 months; and 3) describe patients' characteristics among clinical states including age, comorbidities, number of hospital inpatient visits, hospital inpatient length of stay, number of hospital outpatient visits.

This information will allow us to characterise clinical pathways for prostate cancer and provide a platform for evidence generation strategies.

Technical Summary

This is a descriptive study of pca patients using the CPRD, HES and ONS. The aim of this study is to identify prevalent pca patients by clinical states: primary diagnosis, hormone sensitive with/without metastasis, castration resistant with/without metastasis, and all-cause mortality.
The frequency and proportion of pca patients in each clinical state at the beginning of the calendar year and their movement to clinical states by the end of the year will be reported along with their key characteristics such as age and number of hospital inpatient visits.

For patients in the non-metastatic castration resistant state, a stratification analysis will be performed based on speed of disease progression, i.e. patients that took less than 6 months and those that took 6months or more to enter this state.

Sensitivity analysis will be also carried out in order to account for potential censored data and missing covariate data. Details of statistical analysis are described in section N.

Health Outcomes to be Measured

In this study, we aim to report the number prostate cancer patients by clinical state (point prevalence), report key characteristics at the clinical state level, progression to other states 12months later, and the healthcare resource use in those 12months. The clinical states are primary diagnosis, hormone sensitive with/without metastasis, castrate resistance with/without metastasis and all-cause mortality.

Collaborators

Billy Sagoo - Chief Investigator - Astellas Pharma Europe Ltd. - UK
Billy Sagoo - Corresponding Applicant - Astellas Pharma Europe Ltd. - UK
Amanda Hart - Collaborator - Astellas Pharma US Inc
Chad Dau - Collaborator - Astellas Pharma Europe Ltd. - UK
Sasha Hazaray - Collaborator - Astellas Pharma US Inc

Former Collaborators

Amit Kiran - Chief Investigator - Astellas Pharma Europe Ltd. - UK
Amit Kiran - Corresponding Applicant - Astellas Pharma Europe Ltd. - UK
Robert Snijder - Collaborator - Astellas Pharma Europe Ltd. - UK
Silvia Colicino - Collaborator - Astellas Pharma Europe Ltd. - UK
Waldemar Ockert - Collaborator - Astellas Pharma Europe Ltd. - UK

Linkages

HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data