Prostate cancer
Conditions
Interventions
9mg budesonide once daily 9mg during 12 days
Sponsors
Medical Oncology BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Metastatic castrate resistant prostate cancer (mCRPC) patients with documented disease progression o If measureable: (RECIST v 1.1) progression o If non-measurable: documented rising PSA levels (at least 2 consecutive rises in PSA over a reference value taken at least 1 week apart) or appearance of new lesions • Previous treatment with a docetaxel-containing regimen • Age > 18 years; • WHO performance * 1 (see appendix B); • Adequate renal and hepatic functions (serum creatinin 1.5 x 109/L, platelets > 100 x 1012/L); • Written informed consent; • No chemotherapy within the last 4 weeks before start • No radiotherapy within the last 4 weeks before start • Castration, either surgically or by continued LHRH agonist therapy
Exclusion criteria
Exclusion criteria: • • Impossibility or unwillingness to take oral drugs; • Serious illness or medical unstable condition requiring treatment, symptomatic CNS-metastases or history of psychiatric disorder that would prohibit the understanding and giving of informed consent; • Use of medications or dietary supplements known to induce or inhibit CYP3A (see section 5.4) • Use of other hormonal agents than Gn-RH agonists • Hypersensitiveness to corticosteroids • Systemic or local bacterial, viral, fungal - or yeast infection. • Liver cirrhosis • Portal hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in exposure of cabazitaxel with co-administration of budesonide compared to exposure of cabazitaxel without co-administration of budesonide | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess side-effects of co-administration of budesonide and cabazitaxel | — |
Countries
Netherlands
Outcome results
None listed