Dried blood spot sampling with LC‑MS/MS to monitor prostate cancer medicines
Prostate Cancer REsearch Using Cross-validation of Innovative Sampling, Integrating LC-MS/MS for Optimized Therapeutic Drug moNitoring
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centro di Riferimento Oncologico - Aviano Academic / other |
| Locations | 1 site (Aviano, Pordenone) |
| Trial ID | NCT07344363 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: DBS techniques have shown promise for therapeutic drug monitoring in other medications, but cross‑validation specifically for these prostate cancer agents is limited.
Eligibility criteria
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 this trial is running
Aviano, Pordenone
- Centro di Riferimento Oncologico di Aviano (CRO), IRCCS — Aviano, Pordenone, Italy (Recruiting)
Study contacts
- Study coordinator: Erika Cecchin
- Email: ececchin@cro.it
- Phone: + 39 0434 659667
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.