Prostate Cancer REsearch Using Cross-validation of Innovative Sampling, Integrating LC-MS/MS for Optimized Therapeutic Drug moNitoring

Condition(s) studied

Study summary

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.

Eligibility

Primary outcome measure(s)

• To assess the reliability of innovative analytical methods based on DBS sampling for the quantification of abiraterone, apalutamide, darolutamide, and enzalutamide — 24 months
  The reliability will be assessed comparing results obtained with the new methods and with the reference LC-MS/MS methods (in plasma) evaluating the comprehensive results of the following analysis: 1. Calculation of Lin's concordance correlation coefficient (ρc) that quantifies the agreement between two measures of the same variable (e.g. chemical concentration); 2. Quantification of the mean difference and of the limits of agreement between the two methods with Bland-Altman method; 3. Evaluation of the slope and the intercept obtained using Passing-Bablok regression analysis; 4. Check for agreement with FDA/EMA guidelines requirements: the difference between the results obtained with the new method and the results obtained with the gold standard assay (% difference) should be within 20% in least two-thirds (67%) of the samples analyzed

Trial sites (1)

More Centro di Riferimento Oncologico - Aviano trials in Italy

Other trials for the same condition