Study type

Study topic

Human medicinal product
Disease /health condition

Study type

Non-interventional study

Scope of the study

Effectiveness study (incl. comparative)

Data collection methods

Secondary data collection
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

100000096794
bicalutamide
100000096780
Gonadotropin releasing hormone analogues
100000096025
Anti-gonadotropin-releasing hormones
100000163806
enzalutamide
100000135905
abiraterone

Medical condition to be studied

COVID-19 treatment
Prostate cancer metastatic
Population studied

Short description of the study population

Men with prostate cancer were identified in The National Prostate Cancer Register (NPCR) of Sweden, which since 1998 captures 98% of all cases of prostate cancer in Sweden as compared to the Swedish Cancer Register to which registration is mandatory.
In PCBaSe an open cohort was defined with men with prevalent prostate cancer alive on 1 March 2020 and similar subsets for corresponding months in 2015–2019. Men from three regions in which GnRH agonists were provided directly from the hospital without prescription were excluded.

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Special population of interest

Other

Special population of interest, other

Prostate cancer patients

Estimated number of subjects

720000
Study design details

Main study objective

The aim of this study was to estimate the impact of ADT on excess mortality in men with prostate cancer during the initial peak of covid-19 in the spring of 2020 compared to previous years.

Data analysis plan

In order to avoid misclassification of cause of death, we will also compare excess mortality among men on ADT vs. men not on ADT regardless of cause of death. By use of Poisson regression we will compare the number of deaths during the pandemic with number of deaths in corresponding time periods in the previous five years. We will take Pca risk category, age, and comorbidity into account.
Documents
Study results
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