A retrospective database analysis of the epidemiology, patient characteristics, treatment patterns, and resource utilisation in patients with prostate cancer in England: A real-world data study

Study type
Protocol
Date of Approval
Study reference ID
22_001854
Lay Summary

Prostate cancer is the leading cause of cancer among men, and the second leading cause of cancer death in men. Clinical trials present a model of care that may not reflect what happens in the real world. It can, therefore, be difficult to base prostate cancer treatment guidelines and policies on such studies.

In this study we will use linked data from the cancer registry for England, primary care via the Clinical Practice Research Datalink (CPRD), hospital attendances and admissions from the Hospital Episode Statistics (HES), and death registrations from the Office for National Statistics (ONS). Using these datasets we will estimate, among the English population, the incidence and prevalence of prostate cancer between 2013 and 2018, describe the demographic and pertinent clinical characteristics of the men with prostate cancer as well as their clinical management. In particular, the study will describe the treatment therapies used among men with prostate cancer including the coverage of each treatment and the sequential order in which the treatments are administered. Finally, for the men with prostate cancer included in the study, we will describe their healthcare resource use and the costs associated with this usage.

The results of this study will provide further understanding of prostate cancer in the real world and allow policymakers to make better-informed decisions about diagnosis and treatment pathways for this condition hence impacting positively on public health.

Technical Summary

Prostate cancer is a leading cause of cancer among men and associated with a high mortality rate. Therefore, enhanced treatment options are essential and real-world data to describe the profile of men diagnosed with prostate cancer as well as their current treatment can aid improvements in their care and treatment.

We will use CPRD data linked to the cancer registry including the Systemic Anti-Cancer Therapy (SACT) and Radiotherapy Dataset (RTDS), and HES, as well as ONS death registrations to conduct a descriptive analysis of prostate cancer epidemiology and treatment in England for the period of 2013 to 2018. The primary objective of our descriptive analysis is to provide a summary of the lines of therapy, including systemic therapies, among all men who receive therapy for prostate cancer. Secondly, additional objectives of the study are to describe the incidence and prevalence of prostate cancer, along with the demographic and clinical profiles of men with prostate cancer, ascertain the healthcare resource use and cost burden associated with prostate cancer, and to measure the time to disease progression. We will use numbers, percentages, rates, and summary statistics such as mean or median, as appropriate, to describe our results. Additionally, in the analysis of time to disease progression we will use Kaplan-Meier survival curves to describe the time to progression and restricted means will be estimated using the area under the survival curve.

The results of our study should further the knowledge base with regards to routine prostate cancer care in England, guiding future treatment improvements and policy changes.

Health Outcomes to be Measured

Treatment lines; incidence; prevalence; baseline characteristics; healthcare resource use; disease progression

Collaborators

Sasha Hazaray - Chief Investigator - Astellas Pharma US Inc
Jennifer Davidson - Corresponding Applicant - Health iQ Ltd ( UK ) t/a CorEvitas
Amanda Hart - Collaborator - Astellas Pharma US Inc
Brianna Carter - Collaborator - Astellas Pharma US Inc
David Nimke - Collaborator - Astellas Pharmaceuticals
Lingtao Cao - Collaborator - Astellas Pharma US Inc
Ning Tang - Collaborator - Astellas Pharma US Inc
Robert Snijder - Collaborator - Astellas Pharma Europe Ltd. - UK
Tomomi Kimura - Collaborator - Astellas Pharma Global Development, Inc. (APGD)
Vincent Angeloni - Collaborator - Astellas Pharma US Inc
Yongmei Meng - Collaborator - Astellas Pharma US Inc

Former Collaborators

David Nimke - Collaborator - Astellas Pharmaceuticals
Federico Scivittaro - Collaborator - Astellas Pharma US Inc
Lingtao Cao - Collaborator - Astellas Pharma US Inc
Ning Tang - Collaborator - Astellas Pharma US Inc
Robert Snijder - Collaborator - Astellas Pharma Europe Ltd. - UK
Tomomi Kimura - Collaborator - Astellas Pharma Global Development, Inc. (APGD)
Yongmei Meng - Collaborator - Astellas Pharma US Inc

Linkages

HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;NCRAS Cancer Registration Data;NCRAS National Radiotherapy Dataset (RTDS) data;NCRAS Systemic Anti-Cancer Treatment (SACT) data;ONS Death Registration Data