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

January 29, 2026 updated by: Centro di Riferimento Oncologico - Aviano

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.

Study Overview

Status

Recruiting

Conditions

Prostate Cancer

Detailed Description

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 methods (in plasma). The possibility to apply DBS technique to pharmacokinetic analysis should largely facilitate the application of TDM to clinical practice.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Erika Cecchin
Phone Number: + 39 0434 659667
Email: ececchin@cro.it

Study Locations

Italy
- Pordenone
  - Aviano, Pordenone, Italy, 33081
    - Recruiting
    - Centro di Riferimento Oncologico di Aviano (CRO), IRCCS
    - Principal Investigator:
      
      Lucia Fratino, MD
    - Contact:
      
      Erika Cecchin, PhD, PharmD
      
      Phone Number: + 39 0434 659667
      
      Email: ececchin@cro.it
    - Principal Investigator:
      
      Erika Cecchin, PhD, PharmD
    - Sub-Investigator:
      
      Bianca Posocco, PhD
    - Sub-Investigator:
      
      Sara Gagno, PhD
    - Sub-Investigator:
      
      Eleonora Cecchin, Dr
    - Sub-Investigator:
      
      Arianna Dri, Dr
    - Sub-Investigator:
      
      Giorgia Bortolus, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Patients treated with abiraterone, apalutamide, darolutamide, and enzalutamide according to the dosing regimens described in the Summary of Product Characteristics.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the reliability of innovative analytical methods based on DBS sampling for the quantification of abiraterone, apalutamide, darolutamide, and enzalutamide Time Frame: 24 months	The reliability will be assessed comparing results obtained with the new methods and with the reference LC-MS/MS methods (in plasma) evaluating the comprehensive results of the following analysis: Calculation of Lin's concordance correlation coefficient (ρc) that quantifies the agreement between two measures of the same variable (e.g. chemical concentration); Quantification of the mean difference and of the limits of agreement between the two methods with Bland-Altman method; Evaluation of the slope and the intercept obtained using Passing-Bablok regression analysis; Check for agreement with FDA/EMA guidelines requirements: the difference between the results obtained with the new method and the results obtained with the gold standard assay (% difference) should be within 20% in least two-thirds (67%) of the samples analyzed	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To collect preliminary data regarding intra-patient (consecutive samples collected from the same patient) variability of Cmin values; Time Frame: 24 months	Intra-patient variation will be evaluated with intrapatient variation coefficient	24 months
To collect preliminary data regarding inter-patient (samples from different patients treated at the same drug dose) variability of Cmin values; Time Frame: 24 months	Inter-patient variation will be evaluated with variation coefficient	24 months
To conduct a preliminary evaluation of the correlation between drug exposure and toxicity Time Frame: 24 months	Mean difference in Cmin between patients with of without drug-related toxicity	24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro di Riferimento Oncologico - Aviano

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2025

Primary Completion (Estimated)

November 19, 2027

Study Completion (Estimated)

November 19, 2027

Study Registration Dates

First Submitted

January 7, 2026

First Submitted That Met QC Criteria