A Phase 2 Trial of the Effect of Antiandrogen Therapy on COVID-19 Outcome: No Evidence of Benefit, Supported by Epidemiology and In Vitro Data

Welén et al., European Urology, doi:10.1016/j.eururo.2021.12.013, NCT04475601

Dec 2021

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Retrospective 7,894 COVID+ prostate cancer patients, analyzing patients on antiandrogen treatment, ADT, and ADT + abiraterone acetate or enzalutamide, showing mixed results and higher mortality for ADT + abiraterone acetate or enzalutamide.
This paper also includes a small RCT which is listed separately, and an In Vitro HBEC study showing no significant differences (p = 0.084). The supplementary data is not currently available. NCT04475601 (history).

For discussion of issues with this study see sciencedirect.com, sciencedirect.com (B), sciencedirect.com (C), sciencedirect.com (D).

1. sciencedirect.com, www.sciencedirect.com/science/article/pii/S030228382201661X.www.sciencedirect.com/science/article/pii/S030228382201661X.

2. sciencedirect.com (B), www.sciencedirect.com/science/article/pii/S0302283822016591.www.sciencedirect.com/science/article/pii/S0302283822016591.

3. sciencedirect.com (C), www.sciencedirect.com/science/article/pii/S0302283822016062.www.sciencedirect.com/science/article/pii/S0302283822016062.

4. sciencedirect.com (D), www.sciencedirect.com/science/article/pii/S0302283822016050.www.sciencedirect.com/science/article/pii/S0302283822016050.

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risk of death, 2.0% lower, HR 0.98, p = 0.94, treatment 21 of 358 (5.9%), control 167 of 4,980 (3.4%), adjusted per study, antiandrogen treatment.

risk of death, 11.0% lower, HR 0.89, p = 0.66, treatment 20 of 334 (6.0%), control 167 of 4,980 (3.4%), adjusted per study, ADT.

risk of death, 151.0% higher, HR 2.51, p < 0.001, treatment 24 of 152 (15.8%), control 167 of 4,980 (3.4%), adjusted per study, ADT and abiraterone acetate or enzalutamide.

risk of ICU admission, 28.0% higher, HR 1.28, p = 0.28, treatment 24 of 358 (6.7%), control 216 of 4,980 (4.3%), adjusted per study, antiandrogen treatment.

risk of ICU admission, 13.0% lower, HR 0.87, p = 0.62, treatment 16 of 334 (4.8%), control 216 of 4,980 (4.3%), adjusted per study, ADT.

risk of ICU admission, 21.0% lower, HR 0.79, p = 0.60, treatment 6 of 152 (3.9%), control 216 of 4,980 (4.3%), adjusted per study, ADT and abiraterone acetate or enzalutamide.

risk of hospitalization, 23.0% higher, HR 1.23, p = 0.09, treatment 126 of 358 (35.2%), control 1,108 of 4,980 (22.2%), adjusted per study, antiandrogen treatment.

risk of hospitalization, 24.0% higher, HR 1.24, p = 0.09, treatment 126 of 334 (37.7%), control 1,108 of 4,980 (22.2%), adjusted per study, ADT.

risk of hospitalization, 40.0% higher, HR 1.40, p = 0.06, treatment 66 of 152 (43.4%), control 1,108 of 4,980 (22.2%), adjusted per study, ADT and abiraterone acetate or enzalutamide.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

Welén et al., 14 Dec 2021, retrospective, Sweden, peer-reviewed, 27 authors, trial NCT04475601 (history).

Contact: andreas.josefsson@umu.se.

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