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

Study summary

No information provided.

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

Study timelines

Date when funding contract was signed

Planned:03/07/2020

Actual:03/07/2020

Study start date

Planned:25/06/2020

Actual:25/06/2020

Date of final study report

Planned:30/11/2020

Actual:08/10/2021

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