Actively Recruiting
Prostate Cancer REsearch Using Cross-validation of Innovative Sampling, Integrating LC-MS/MS for Optimized Therapeutic Drug moNitoring
Led by Centro di Riferimento Oncologico - Aviano · Updated on 2026-02-02
100
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prostate Cancer REsearch Using Cross-validation of Innovative Sampling, Integrating LC-MS/MS for Optimized Therapeutic Drug moNitoring
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients treated with abiraterone, apalutamide, darolutamide, or enzalutamide according to approved dosing regimens and at steady state
- Age 18 years or older
- Signed informed consent required
You will not qualify if you...
- Conditions limiting the ability to comply with study procedures
- Refusal to provide informed consent
- Any condition judged by the investigator to compromise participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Centro di Riferimento Oncologico di Aviano (CRO), IRCCS
Aviano, Pordenone, Italy, 33081
Actively Recruiting
Research Team
E
Erika Cecchin
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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