Studying the influence of prednisone on docetaxel exposure.
Completed
- Conditions
- patients with metastatic castration-resistant and hormone-sensitive prostate cancer
- Registration Number
- NL-OMON22101
- Lead Sponsor
- Erasmus Medical Center
- Brief Summary
http://dx.doi.org/10.1111/bcp.13889
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
Inclusion Criteria
1.Histologicallly or cytologically confirmed adenocarcinoma of the prostate without neuro-endocrine differentitation or small cell features.
2. Continued androgen deprivation therapy either by gonadotropin releasing hormone (GnRH) analogues or orchiedectomy
Exclusion Criteria
1. Impossibility or unwillingness to take oral drugs
2. Serious concurrent illness or medical unstable condition requiring treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the influence of prednisone use on the pharmacokinetics (primary parameter AUC) of docetaxel, compared to docetaxel alone, in mCRPC and mHSPC patients.
- Secondary Outcome Measures
Name Time Method To evaluate the incidence and severity of side-effects of treatment with docetaxel in absence and presence of prednisone.<br> Other pharmacokinetic outcomes (i.e. clearance, maximum concentration (Cmax))