A pharmacokinetic study of Docetaxel and Prednisone in men with metastatic castration-resistant or hormone-sensitive prostate cancer.
- Conditions
- metastatic prostate cancer10038597
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
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;3. Age *18 years;4. Metastatic disease progression;5. ECOG performance status 0-1;6. Written informed consent according to ICH-GCP
1. Impossibility or unwillingness to take oral drugs;2. Serious concurrent illness or medical unstable condition requiring treatment;3. Symptomatic CNS metastases or history of psychiatric disorder that would prohibit the understanding and giving of informed consent;4. Known hypersensitivity to studiemedication;5. Use of medication or dietary supplements known to induce CYP3A;6. Any active systemic or local bacterial, viral, fungal - or yeast infection.;7. Abnormal renal function defined as (within 21 days before randomization);8. Abnormal liver functions consisting of any of the following (within 21 days before randomization):;9. Abnormal hematological blood counts consisting of any of the following (within 21 days before randomization):;10. Geographical, psychological or other non-medical conditions interfering with follow-up
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To determine the influence of prednisone use on docetaxel pharmacokinetics<br /><br>compared to docetaxel alone in patients with metastatic castration-resistant<br /><br>prostate cancer (mCRPC) and metastatic hormone-sensitive prostate cancer<br /><br>(mHSPC).</p><br>
- Secondary Outcome Measures
Name Time Method <p>* To evaluate the incidence and severity of side-effects of treatment with<br /><br>docetaxel in absence and presence of prednisone.<br /><br>* Other pharmacokinetic outcomes (i.e. clearance, maximum concentration (Cmax))</p><br>