Skip to content

CYPENZA - A prospective cohort trial on antiandrogens influences on the pharmacokinetics of corticosteroids.

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-520571-66-00
Enrollment
30
Registered
2026-02-05
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer

Brief summary

The difference in the AUC (area under curve) of dexamethasone serum concentration before, and after steady-state, of two different antiandrogens (enzalutamide or apalutamide).

Detailed description

To evaluate the AUC following administration of a doubled dose of dexamethasone during ongoing treatment with antiandrogens (enzalutamide or apalutamide)., To assess whether doubling the corticosteroid dose can compensate for any reduction of the AUC by antiandrogen therapy (enzalutamide or apalutamide)., To evaluate possible adverse events of giving a single dose dexamethasone at three separate occasions.

Interventions

DRUGDexacur 4 mg/ml injektions-/infusionsvätska
DRUGlösning

Sponsors

Region Vaesterbotten
Lead SponsorOTHER

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The difference in the AUC (area under curve) of dexamethasone serum concentration before, and after steady-state, of two different antiandrogens (enzalutamide or apalutamide).

Secondary

MeasureTime frame
To evaluate the AUC following administration of a doubled dose of dexamethasone during ongoing treatment with antiandrogens (enzalutamide or apalutamide)., To assess whether doubling the corticosteroid dose can compensate for any reduction of the AUC by antiandrogen therapy (enzalutamide or apalutamide)., To evaluate possible adverse events of giving a single dose dexamethasone at three separate occasions.

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 6, 2026