Dexamethasone phosphate for Prostate cancer

Inclusion criteria

• {"criterion_text":"- Diagnosed prostate cancer"}
• {"criterion_text":"- Intended to begin treatment with antiandrogen therapy, -enzalutamide or apalutamide-"}
• {"criterion_text":"- Can understand all the requirements of the trial, provide informed consent, and provide authorization of use and disclosure of personal health information"}
• {"criterion_text":"- WHO performance status 0-1"}

Exclusion criteria

• {"criterion_text":"- Treatment with systemic corticosteroids (ongoing or last 4 weeks), inhalations steroids, topical steroids or nasal steroids are not regarded as systemic therapies"}
• {"criterion_text":"- Treatment with health product modulating CYP3A4"}
• {"criterion_text":"- Treatment with warfarin or NOAC (Non-vitamin K-antagonist anticoagulants)"}
• {"criterion_text":"- Diabetes (defined as diagnosed diabetes type I or type II)"}
• {"criterion_text":"- Previous seizure in medical history"}
• {"criterion_text":"- Other serious illness or medical condition according to the investigator, e.g., other cancer, history of peptic ulcer, or bipolar disorder."}

Primary endpoints

• {"endpoint_text":"- The difference in the AUC (area under curve) of dexamethasone serum concentration before, and after steady-state, of two different antiandrogens (enzalutamide or apalutamide).","definition_or_measurement_approach":"Difference in area under the curve (AUC) of dexamethasone serum concentration measured before and after attainment of steady-state of enzalutamide or apalutamide therapy."}

Secondary endpoints

• {"endpoint_text":"- To evaluate the AUC following administration of a doubled dose of dexamethasone during ongoing treatment with antiandrogens (enzalutamide or apalutamide).","definition_or_measurement_approach":"Measurement of dexamethasone serum concentration AUC after administration of a doubled dexamethasone dose during steady-state antiandrogen treatment."}
• {"endpoint_text":"- To assess whether doubling the corticosteroid dose can compensate for any reduction of the AUC by antiandrogen therapy (enzalutamide or apalutamide).","definition_or_measurement_approach":"Comparison of AUC values with standard vs. doubled dexamethasone dose to determine if doubling restores AUC reduced by antiandrogen therapy."}
• {"endpoint_text":"- To evaluate possible adverse events of giving a single dose dexamethasone at three separate occasions.","definition_or_measurement_approach":"Collection and assessment of adverse events/safety following single-dose intravenous dexamethasone given on three separate occasions."}

Sweden

Earliest CTIS Part Ii Submission Date

21-01-2026

Latest Decision Or Authorization Date

05-02-2026

Processing Time Days

15

Number Of Sites

1

Number Of Participants

30

Primary sponsor

Full Name

Region Vaesterbotten

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden