Prostate Cancer REsearch Using Cross-validation of Innovative Sampling, Integrating LC-MS/MS for Optimized Therapeutic Drug moNitoring
Sponsor: Centro di Riferimento Oncologico - Aviano
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Primary Endpoints (CT.gov)
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
Secondary Endpoints
To collect preliminary data regarding intra-patient (consecutive samples collected from the same patient) variability of Cmin values;
To collect preliminary data regarding inter-patient (samples from different patients treated at the same drug dose) variability of Cmin values;
To conduct a preliminary evaluation of the correlation between drug exposure and toxicity
Eligibility 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.
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