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Comparison of standard abiraterone dosing and dosing based on abiraterone blood levels
EU CTIS ID: 2025-524440-35-00
What this study is testing
To compare radiographic PFS in the TDMguided dosing arm for the subgroup who had a Cmin < 8.4 ng/mL at a certain time point during treatment, to the patients in the fixed dosing arm who had a Cmin < 8.4 ng/mL at a certain time point during treatment.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients with metastatic castration-resistant prostate cancer (mCRPC)
- Male ≥18 years old
- Histologically or cytology confirmed prostate cancer
- Patients can either be chemotherapy-naïve or have received one line of docetaxelbased chemotherapy in the HSPC or CRPC stage
- Measurable disease (by RECIST criteria version 1.1) prior to the first dose of study treatment
- Signed written Ethical Committee (EC) approved informed consent form, prior to performing any study-related procedures
You likely can't join if
- Patients with metastatic hormone sensitive prostate cancer (mHSPC)
- Patients who were previously treated with an androgen receptor signalling inhibitor (e.g. abiraterone, enzalutamide, darolutamide)
- Any significant concomitant disease determined by the investigator to be potentially aggravated by the investigational drug
- Consumption of agents which induce CYP3A4 (with the exception of dexamethasone) or agents with severe QT prolonging effects within 14 days prior to admission and during the study (see concomitant medication restrictions)
- Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study, or absorption of oral medications, or that would, in the opinion of the Principal Investigator, pose an unacceptable risk to the participant in this study.
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; those conditions should be discussed with the patient before trial entry.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.