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

NCT07344363 | Recruiting

• 1 other identifier: CRO-2025-012
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• To assess the reliability of innovative analytical methods based on DBS sampling for the quantification of abiraterone, apalutamide, darolutamide, and enzalutamide

  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: 1. Calculation of Lin's concordance correlation coefficient (ρc) that quantifies the agreement between two measures of the same variable (e.g. chemical concentration); 2. Quantification of the mean difference and of the limits of agreement between the two methods with Bland-Altman method; 3. Evaluation of the slope and the intercept obtained using Passing-Bablok regression analysis; 4. 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 Outcomes (3)

• To collect preliminary data regarding intra-patient (consecutive samples collected from the same patient) variability of Cmin values;

  24 months

• To collect preliminary data regarding inter-patient (samples from different patients treated at the same drug dose) variability of Cmin values;

  24 months

• To conduct a preliminary evaluation of the correlation between drug exposure and toxicity

  24 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro di Riferimento Oncologico - Aviano: lead

Study Sites (1)

Centro di Riferimento Oncologico di Aviano (CRO), IRCCS

Aviano, Pordenone, 33081, Italy

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Erika Cecchin

CONTACT

+ 39 0434 659667; ececchin@cro.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 15, 2026
• Study Start: November 19, 2025
• Primary Completion (Estimated): November 19, 2027
• Study Completion (Estimated): November 19, 2027
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

IT (1)