RecruitingNCT07344363

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

Sponsor

Centro di Riferimento Oncologico - Aviano

Enrollment

100 participants

Start Date

Nov 19, 2025

Study Type

OBSERVATIONAL

Conditions

Prostate Cancer

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing different blood sampling methods (including a finger-prick dried blood spot test) alongside standard blood draws to measure how much prostate cancer medication is in a patient's blood. The goal is to find a more convenient, less invasive way for doctors to check if patients are getting the right dose. **You may be eligible if...** - You are 18 or older - You are currently being treated with one of the following prostate cancer medications: abiraterone, apalutamide, darolutamide, or enzalutamide - You have been on the medication long enough that levels in your blood are stable (steady state) - You have signed informed consent **You may NOT be eligible if...** - You have conditions that prevent you from properly following the study procedures - You refuse to give consent - Your doctor believes you are not suitable for this study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Centro di Riferimento Oncologico di Aviano (CRO), IRCCS

Aviano, Pordenone, Italy

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NCT07344363

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