Prostate CancerPRECISIONNCT07344363
Prostate Cancer REsearch Using Cross-validation of Innovative Sampling, Integrating LC-MS/MS for Optimized Therapeutic Drug moNitoring
An observational study of Prostate Cancer, run by Centro di Riferimento Oncologico - Aviano at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 19 Nov 2025to 19 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated with abiraterone, apalutamide, darolutamide, and enzalutamide according to the dosing regimens described in the Summary of Product Characteristics.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Centro di Riferimento Oncologico di Aviano (CRO), IRCCS
Aviano, Pordenone, 33081
Erika Cecchin, PhD, PharmD, + 39 0434 659667, ececchin@cro.it
Erika Cecchin, PhD, PharmD
About this study
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.
Read the 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.
- Conditions
- Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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
Measured: 24 months
Secondary outcomes (3)
To collect preliminary data regarding intra-patient (consecutive samples collected from the same patient) variability of Cmin values;
Intra-patient variation will be evaluated with intrapatient variation coefficient
Measured: 24 months
To collect preliminary data regarding inter-patient (samples from different patients treated at the same drug dose) variability of Cmin values;
Inter-patient variation will be evaluated with variation coefficient
Measured: 24 months
To conduct a preliminary evaluation of the correlation between drug exposure and toxicity
Mean difference in Cmin between patients with of without drug-related toxicity
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start19 Nov 2025
- Primary completion19 Nov 2027 (estimated)
- Study completion19 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro di Riferimento Oncologico - Aviano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07344363
- Sponsor's protocol ID
- CRO-2025-012
- Acronym
- PRECISION
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Cancer REsearch Using Cross-validation of Innovative Sampling, Integrating LC-MS/MS for Optimized Therapeutic Drug moNitoring
- ClinicalTrials.gov ID
- NCT07344363
- Acronym / sponsor ID
- PRECISION / CRO-2025-012
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centro di Riferimento Oncologico - AvianoUniversity, hospital or other
- Study start
- 19 Nov 2025 (actual)
- Primary completion
- 19 Nov 2027 (estimated)
- Study completion
- 19 Nov 2027 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with abiraterone, apalutamide, darolutamide, and enzalutamide according to the dosing regimens described in the Summary of Product Characteristics.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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: 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
3 secondary outcomes
To collect preliminary data regarding intra-patient (consecutive samples collected from the same patient) variability of Cmin values;
Time frame: 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
To conduct a preliminary evaluation of the correlation between drug exposure and toxicity
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Centro di Riferimento Oncologico - Aviano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erika Cecchin (+ 39 0434 659667, ececchin@cro.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.