prostate cancer
Conditions
Interventions
None listed
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Histological or cytological metastatic prostate cancer with an indication for systemic treatment with intravenous docetaxel at the discretion of the physician Planned to receive first time docetaxel for prostate cancer. • Group 1: Metastatic castration-resistant prostate cancer with progressive disease defined as biochemical and/or radiological progression according to the Prostate Cancer Working group 3 recommendations. (4) These patients have progressive disease despite long term treatment with hormonal therapy, so they have longterm castrate levels of testosterone. Docetaxel is started after progression on hormonal therapy. • Group 2: Non-castration-resistant metastatic prostate cancer with an indication for first line docetaxel according to standard clinical care. These patients have metastatic disease at diagnosis and they receive their first systemic treatment as a combined treatment with hormonal therapy and docetaxel. The hormonal therapy is started between 12 and 4 weeks prior to the start of docetaxel. Therefore these patients have castrate levels of testosterone at the start of docetaxel. 2. Considered fit for docetaxel treatment as assessed by the treating physician. 3. Castrate levels of testosterone, defined as = 18 years. 5. Able and willing to give written informed consent. 6. Able and willing to undergo blood sampling for PK and pharmacogenetics analysis. 7. Able and willing to comply with study restrictions and to remain at the study center for the required duration. 8. Adequate organ system function.
Exclusion criteria
Exclusion criteria: not applicable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the clinical pharmacokinetics, specifically exposure and total plasma clearance, of docetaxel between castration-resistant prostate cancer patients and non-castration-resistant prostate cancer patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| • To measure plasma concentrations of docetaxel metabolites M1, M2, M3 and M4 • To determine metabolite pharmacokinetics • To determine androgen levels in the predose sample and to explore the correlation between androgen levels and docetaxel pharmacokinetics • To determine a1-acid glycoprotein levels and the free fraction of docetaxel at timepoints t=1h and t=48h and to explore the correlation between these levels and docetaxel pharmacokinetics • To establish the effect of functional genetic polymorphisms on the pharmacokinetics of docetaxel (21) • To compare the pharmacokinetics of docetaxel in patients with prostate cancer (both castration-resistant and non-castration-resistant) with literature docetaxel pharmacokinetics in patients with a different solid tumor type | — |
Countries
Netherlands
Outcome results
None listed