Study identification

EU PAS number

EUPAS36621

Study ID

43583

Official title and acronym

Association between androgen deprivation therapy and excess mortality after covid-19 in patients with prostate cancer

DARWIN EU® study

No

Study countries

Sweden

Study description

Men appear to have an approximately 50% higher risk for infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) than women, also when adjusted for other risk factors. Male sex also predicts a 50-60% increased risk for critical care admission and/or death in covid-19. One proposed mechanism is that androgen signaling facilitates entry of SARS-CoV-2 into host cells. Internalization of the SARS-Cov-2 virus relies on proteases such as the Transmembrane Protease Serine 2 (TMPRSS2). The regulation of TMPRSS2 expression is androgen-dependent, suggesting that androgen deprivation therapy (ADT) could potentially have a protective effect against covid-19. More than a dozen clinical trials are being planned or are already ongoing to evaluate the effects of ADT in men with Covid-19. This rapid progression from hypothesis to clinical trials also raises concern. ADT is associated with an increased risk of cardiovascular disease (CVD) in men with prostate cancer. Even short-term ADT may increase the risk. The benefit-risk ratio for exposing men with covid-19 could therefore be supported by further observational data, indicating that ADT in men with prostate cancer confers protection against severe covid-19. 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.

Study status

Finalised

Contact details

Rolf Gedeborg

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Other

More details on funding

Swedish Research Council
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable