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Clinical trial Recruiting at 1 site Observational Ages 18 and up

Dried blood spot sampling with LC‑MS/MS to monitor prostate cancer medicines

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

Run by Centro di Riferimento Oncologico - Aviano · NCT07344363 · Data updated 2026-11-12

This project will test whether a small finger‑prick blood sample can reliably measure levels of abiraterone, apalutamide, darolutamide, or enzalutamide in adults with prostate cancer.

More Prostate Cancer trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorCentro di Riferimento Oncologico - Aviano
Academic / other
Locations1 site (Aviano, Pordenone)
StatusRecruiting
StartedNovember 19, 2025
Main results expectedNovember 19, 2027
Study endsNovember 19, 2027
Registry record updatedFebruary 2, 2026
Trial IDNCT07344363 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (≥18) with prostate cancer who are taking abiraterone, apalutamide, darolutamide, or enzalutamide at steady‑state and can provide informed consent are ideal candidates.

Probably not a fit

Patients not taking the listed medications, those unable to comply with sampling procedures, or those who cannot give informed consent are unlikely to benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The protocol cross‑validates a dried blood spot (DBS) analytical method against an established plasma LC‑MS/MS assay by comparing patient samples analyzed with both approaches. Participants are adults on steady‑state dosing of one of the specified prostate cancer medications. Paired DBS and plasma samples will be collected and analyzed to determine accuracy, precision, and agreement between methods. Successful validation would support using DBS as a less invasive sampling option for therapeutic drug monitoring.

Why it matters

Potential benefit: If successful, DBS sampling could make therapeutic drug monitoring easier, less invasive, and more convenient for patients.

How similar studies have gone: DBS techniques have shown promise for therapeutic drug monitoring in other medications, but cross‑validation specifically for these prostate cancer agents is limited.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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

Exclusion Criteria:

* Conditions that may limit the ability to adequately comply with the study procedures outlined in the protocol;
* Refusal of informed consent;
* Any condition that, in the investigator's judgment, could compromise appropriate participation in the study.

Where it's running

  • Centro di Riferimento Oncologico di Aviano (CRO), IRCCS
    Aviano, Pordenone, Italy     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.