Prostate cancer (PC) is the most frequently diagnosed cancer among men and the second leading cause of male cancer deaths in the UK. Prostate cancer growth is often driven by male sex hormones called androgens, the most important of which is testosterone. Because of this, a common treatment option for locally advanced and metastatic prostate cancer is to lower the levels of androgens in a man’s body. Luteinizing hormone-releasing hormone (LHRH) agonist medications is a form of androgen which inhibit the pituitary gland from producing testosterone, hence causing prostate cancer cells to die or to grow more slowly and reducing the tumor size.
In patients with advanced prostate cancer, LHRH agonists have been shown to achieve improvements in survival and LHRH agonists are available in several different formulations, allowing them to be administered every 1, 2 and 3 months. The patient pathway to receive LHRH agonist injections can become complex, often consisting of multiple steps and standard of care and level of patients' involvement, as well as the steps that must be completed in order to receive an injection varies across the UK. Therefore, delayed LHRH agonist injections may occur in real-life practice impacting clinical outcomes, however, treatment patterns of LHRH agonist in prostate cancer has not been fully investigated. This study aims to determine the utilization including adherence of LHRH agonist in primary care in England.
The aim of this retrospective cohort study will include adult patients (aged ≥18 years) with a diagnosis of prostate cancer and a first prescription of luteinizing hormone-releasing hormone agonists (index date) between 1 January 2007 and 31 December 2019. We will require all patients to have at least 1-year of continuous registration in CPRD before the first recorded medications listed. To ensure that we have reliable measures of drug use and baseline covariates, we will require all patients to have at least 1-year of continuous registration in CPRD before the first recorded medications listed. All patients will be followed up from the index date until censure (death, practice transfer out date or study end). All patients will be followed up from the index date until censure (death, practice transfer out date or study end) and during follow up we will examine adherence, as well as missed or delayed injection treatment and overall survival by treatment adherence. We will determine adherence using proportion of prescription days covered and patients medication delay will be defined as an injection delayed of >= 3 days and >=7 days compared to pre-specified time window. Patients demographic and clinical traits will be described using descriptive statistics. Missed/delayed LHRH agonist injections per patients per year will be presented as mean (± standard deviation). Proportion of days (PDC) covered will be computed for each of the LHRH agonist injection and the association between patient variables and PDC will be analysed using non-parametric tests (Wilcoxon rank sum and Kruskal Wallis test). Lastly, joinpoint regression analysis will be used to model temporal changes in PSA-levels and testosterone levels during follow up and Kaplan-Meier curves will be produced to visualize the survival function.
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Number and percentage of missed prescription days (≥3 day, ≥7 days, ≥14 days and ≥28 days delay) in a year. Proportion of days covered by drug formulation (in mean, median, min, max, s.d and IQR). Mean and median follow up time, PSA-levels and serum testosterone levels (in mean, median, min, max, sd and IQR). Survival time by drug formulation. Demographics (mean and median age on inclusion, age distribution, percent of males, deprivation, region, ethnicity) and clinical variables (Charlson comorbid index score, smoking status, BMI as categories).
Jennifer Davidson - Chief Investigator - Health iQ Ltd ( UK ) t/a CorEvitas
Jennifer Davidson - Corresponding Applicant - Health iQ Ltd ( UK ) t/a CorEvitas
Archie Farrer - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Boglarka Kovacs - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Caoimhe Rice - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Gulsah Akin Unal - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Judith Ruzangi - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Gulsah Akin Unal - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data;Patient Level Index of Multiple Deprivation