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

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 18 人开始时间: 待定最近更新: 2024年2月28日

适应症

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•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

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