Overview
Sponsor-declared trial summary
Prostate cancer
To assess the extent to which the antiandrogens (enzalutamide and apalutamide) influence the pharmacokinetics of the administered corticosteroid dexamethasone.
Key facts
- Sponsor
- Region Vaesterbotten
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Male Urogenital Diseases [C12]
- Decision date (initial)
- 2026-02-05
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic
To assess the extent to which the antiandrogens (enzalutamide and apalutamide) influence the pharmacokinetics of the administered corticosteroid dexamethasone.
Secondary objectives 2
- Evaluate the effect of an increased administrated dose of dexamethasone by a factor of two on the serum concentration of dexamethasone after steady-state of antiandrogen therapy.
- To evaluate the safety of giving a single dose of intravenous dexamethasone.
Conditions and MedDRA coding
Prostate cancer
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- 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
Exclusion criteria 6
- 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)
- Diabetes (defined as diagnosed diabetes type I or type II)
- Previous seizure in medical history
- Other serious illness or medical condition according to the investigator, e.g., other cancer, history of peptic ulcer, or bipolar disorder.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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 endpoints 3
- 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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Dexacur 4 mg/ml injektions-/infusionsvätska, lösning
PRD8971924 · Product
- Active substance
- Dexamethasone Phosphate
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 8 mg milligram(s)
- Max total dose
- 16 mg milligram(s)
- Max treatment duration
- 15 Week(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- 60138
- MA holder
- ABBOXIA AB
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 2
Xtandi - 40 mg film-coated tablets
PRD5512210 · Product
- Active substance
- Enzalutamide
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 160 mg milligram(s)
- Max total dose
- 48 g gram(s)
- Max treatment duration
- 10 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02BB04 — -
- Marketing authorisation
- EU/1/13/846/002
- MA holder
- ASTELLAS PHARMA EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Erleada 60 mg film-coated tablets
PRD6957689 · Product
- Active substance
- Apalutamide
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 240 mg milligram(s)
- Max total dose
- 72 g gram(s)
- Max treatment duration
- 10 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02BB05 — -
- Marketing authorisation
- EU/1/18/1342/001
- MA holder
- JANSSEN-CILAG INTERNATIONAL NV
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Vaesterbotten
- Sponsor organisation
- Region Vaesterbotten
- Address
- Koksvagen 11, Alidhem Alidhem
- City
- Umea
- Postcode
- 907 37
- Country
- Sweden
Scientific contact point
- Organisation
- Region Vaesterbotten
- Contact name
- Sarah Jonsson
Public contact point
- Organisation
- Region Vaesterbotten
- Contact name
- Sarah Jonsson
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Authorised, recruitment pending | 30 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ Appendix Flow chart 2025-520571-66-00 | 1 |
| Protocol (for publication) | D1_Appendix_List_of_CYP3A4 strong and moderate modulators | 1 |
| Protocol (for publication) | D1_Protocol 2025-520571-66-00 | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF | 1.1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Dexacur | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis sv 2025-520571-66-00 | 1.1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-11-19 | Sweden | Acceptable 2026-01-26
|
2026-02-05 |