Metastatic Hormone-Sensitive Prostate Cancer Clinical Trial
Official title:
A Prospective Open-label, Randomized, Two-arm Pilot Study to Investigate the Toxicity and Pharmacokinetics of 2-Weekly and 3-Weekly Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer.
This study is designed to investigate the toxicity and pharmacokinetics (PK) of 2-weekly and 3-weekly docetaxel in metastatic hormone-sensitive prostate cancer (mHSPC). Also, a mechanism-based population pharmacokinetics/pharmacodynamics (PK/PD) model will be developed to provide a better understanding of the complex relationships between the drug exposure and toxicity profiles of docetaxel in mHSPC.
This pilot study is designed to investigate the toxicity and PK of 2-weekly and 3-weekly docetaxel in mHSPC. Furthermore, a mechanism-based population PK/ pharmacodynamics (PD) model will be developed to provide a better understanding of the complex relationships between the drug exposure and toxicity profiles of docetaxel in mHSPC. In addition, selected pro-inflammatory and macrophage-associated cytokines will be collected to assess the potential role of these cytokines as the early markers of docetaxel resistance in patients with mHSPC. (Cytokines: macrophage inhibitory cytokine 1 (MIC1), interleukin (IL)-1ra, IL-1β, IL-4, IL-6, IL-12, and IFNγ). Serological response, defined as a prostate-specific antigen (PSA) level of <0.2 ng/mL at 12 months, and progression-free survival at 12 months are selected as the secondary clinical endpoints of the study. ;
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