A pharmacokinetic study of Docetaxel and Prednisone in men with metastatic castration-resistant or hormone-sensitive prostate cancer.

INTERVENTION: Trade Name: Taxotere Pharmaceutical Form: Concentrate and solvent for solution for infusion CONDITION: Metastatic prostate cancer Therapeutic area: Diseases [C] ‐ Cancer [C04] PRIMARY OUTCOME: Main Objective: To determine the influence of prednisone use on the pharmacokinetics (primary parameter AUC) of docetaxel, compared to docetaxel alone, in mCRPC and mHSPC patients. Primary end point(s): 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 Objective: • To evaluate the incidence and severity of side‐effects of treatment with docetaxel in absence and presence of prednisone. ; • Other pharmacokinetic outcomes (i.e. clearance, maximum concentration (Cmax)) Timepoint(s) of evaluation of this end point: End of study SECONDARY OUTCOME: Secondary end point(s): • To evaluate the incidence and severity of side‐effects of treatment with docetaxel in absence and presence of prednisone. ; • Other pharmacokinetic outcomes (i.e. clearance, maximum concentration (Cmax)) Timepoint(s) of evaluation of this end point: End of Study 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 3. Age =18 years 4. Metastatic disease progression 5. ECOG performance status 0‐1 6. Written informed consent according to ICH‐GCP Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 6 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12