Comparing dried blood spot testing with plasma testing for drug levels in prostate cancer

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with prostate cancer who are taking abiraterone, apalutamide, darolutamide or enzalutamide. It compares dried blood spot samples with plasma samples for drug monitoring.

Age

18 years or older

Sex

All sexes

Earlier treatment

Must be treated with abiraterone, apalutamide, darolutamide or enzalutamide at the doses in the Summary of Product Characteristics, and must be at steady state. The treatment cycle does not matter.

Main reasons for not taking part

• Conditions that limit the ability to follow the study procedures
• Refusal to give informed consent
• Any condition that the investigator thinks could compromise taking part

The registry criteria, word for word

What the trial wants to find out

Applying Dried Blood Spots (DBS) techniques to pharmacokinetic analysis could significantly streamline the use of Therapeutic Drug Monitoring (TDM) in clinical practice. To establish DBS as a viable alternative sampling method, it is essential to demonstrate that results obtained from DBS analysis are reliable. This validation can be achieved through a cross-validation study. In this protocol, an original validated method, the plasma-based assay, serves as the "reference", while the alternative DBS-based analytical technique is the "comparator." The reliability will be defined analysing patients' samples with the new methods and comparing these results with those obtained with the reference LC-MS/MS (Liquid Chromatography-Mass Spectrometry) methods (in plasma). The possibility to apply DBS technique to pharmacokinetic analysis should largely facilitate the application of TDM to clinical practice.