NCT07344363Recruiting
Prostate Cancer REsearch Using Cross-validation of Innovative Sampling, Integrating LC-MS/MS for Optimized Therapeutic Drug moNitoring
Source: ClinicalTrials.gov · Last updated 2 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 7 Jan 2026
- Start date
- 19 Nov 2025
- Primary completion date
- 19 Nov 2027
- Lead sponsor
- Centro di Riferimento Oncologico - Aviano
- Diseases
- Prostate cancer
- NCT number
- NCT07344363
What you commit to
- Study type: Observational
- Planned participants: 100
- From 19 Nov 2025 to the primary completion date, 19 Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Conditions that may limit the ability to adequately comply with the study procedures outlined in the protocol;
- Any condition that, in the investigator's judgment, could compromise appropriate participation in the study.
Other
- Refusal of informed consent;
Who the study is looking for
- Patients treated with abiraterone, apalutamide, darolutamide, and enzalutamide according to the dosing regimens described in the Summary of Product Characteristics. The treatment cycle does not matter but patients should be at the steady state (see section 4.2);• Age ≥18;
- Signed informed consent is required
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro di Riferimento Oncologico di Aviano (CRO)-IRCCS Coordinator of this site? Confirm its status | Aviano | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.