2025-524440-35-00Not yet recruitingPhase 4
Comparison of standard abiraterone dosing and dosing based on abiraterone blood levels
Standard dosed abiraterone versus Therapeutic Drug Monitoring guided abiraterone dosing – The Adapt Abi trial
Source: EU CTIS (euclinicaltrials.eu) · Last updated 28 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 230 (estimated)
- First submitted
- 15 Dec 2025
- Start date
- 1 May 2026
- Lead sponsor
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Diseases
- Prostate cancer
- EU CT number
- 2025-524440-35-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 230
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with prostate cancer that has spread and no longer responds to hormone therapy. It compares standard abiraterone dosing with dosing guided by blood levels of the drug.
- Age
- 18 years or older
- Sex
- Men only
- Disease stage
- Metastatic castration-resistant prostate cancer (mCRPC), confirmed by tissue or cell tests, with disease that can be measured by RECIST 1.1 before the first dose.
- Earlier treatment
- Can join if never had chemotherapy, or had one line of docetaxel-based chemotherapy in the HSPC or CRPC stage. Cannot join if previously treated with an androgen receptor signalling inhibitor such as abiraterone, enzalutamide or darolutamide.
Main reasons for not taking part
- Metastatic hormone sensitive prostate cancer (mHSPC)
- Previous treatment with abiraterone, enzalutamide, darolutamide or a similar drug
- Taking drugs that induce CYP3A4 (except dexamethasone) or drugs with severe QT prolonging effects within 14 days before admission
- Another serious illness that the study drug could make worse
- Any condition that could interfere with the study or make taking part an unacceptable risk, as judged by the investigator
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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.
Other illness
- Patients with metastatic hormone sensitive prostate cancer (mHSPC)
- 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.
Lab values
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting | Amsterdam | Netherlands | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.