Frontlight ResearchEarly access
Taking people in SwedenPhase 3
How enzalutamide and apalutamide change dexamethasone levels in men with prostate cancer
Studies how two prostate cancer drugs affect dexamethasone levels in the body.
Key facts
- Who runs it
- Region Vaesterbotten
- Where
- Umea, SwedenSee the site
- Trial code
- Registry title
- CYPENZA - A prospective cohort trial on antiandrogens influences on the pharmacokinetics of corticosteroids.
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 30 people, planned
- Started
- 30 Jun 2026
- Expected to end
- 30 Jun 2029
- Type of study
- Interventional
- Record updated
- 11 June 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with prostate cancer who are about to start enzalutamide or apalutamide. It studies how these drugs change the way the body handles dexamethasone.
- Age
- 18 years or older
- Sex
- Men only
- Disease stage
- Diagnosed prostate cancer. WHO performance status 0-1.
- Earlier treatment
- Must plan to start treatment with enzalutamide or apalutamide. Must not have had systemic corticosteroids now or in the last 4 weeks.
Main reasons for not taking part
- Treatment with systemic corticosteroids now or in the last 4 weeks
- Treatment with a health product that changes CYP3A4
- Treatment with warfarin or NOAC blood thinners
- Diabetes type I or type II
- Previous seizure
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- Diagnosed prostate cancer
- Intended to begin treatment with antiandrogen therapy, -enzalutamide or apalutamide-
- Can understand all the requirements of the trial, provide informed consent, and provide authorization of use and disclosure of personal health information
- WHO performance status 0-1
Who cannot take part
- Treatment with systemic corticosteroids (ongoing or last 4 weeks), inhalations steroids, topical steroids or nasal steroids are not regarded as systemic therapies
- Treatment with health product modulating CYP3A4
- Treatment with warfarin or NOAC (Non-vitamin K-antagonist anticoagulants)
- Previous seizure in medical history
- Diabetes (defined as diagnosed diabetes type I or type II)
- Other serious illness or medical condition according to the investigator, e.g., other cancer, history of peptic ulcer, or bipolar disorder
Where in Sweden
- Region VaesterbottenUmea, SwedenTaking people
About the trial
What the trial wants to find out
To assess the extent to which the antiandrogens (enzalutamide and apalutamide) influence the pharmacokinetics of the administered corticosteroid dexamethasone.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- CYPENZA - A prospective cohort trial on antiandrogens influences on the pharmacokinetics of corticosteroids.
- Plain-language title
- How enzalutamide and apalutamide change dexamethasone levels in men with prostate cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 11 June 2026