Abiraterone acetate for Metastatic castration-resistant prostate cancer (mCRPC)

Inclusion criteria

• {"criterion_text":"-Patients with metastatic castration-resistant prostate cancer (mCRPC)"}
• {"criterion_text":"-Male ≥18 years old"}
• {"criterion_text":"-Histologically or cytology confirmed prostate cancer"}
• {"criterion_text":"-Patients can either be chemotherapy-naïve or have received one line of docetaxelbased chemotherapy in the HSPC or CRPC stage"}
• {"criterion_text":"-Measurable disease (by RECIST criteria version 1.1) prior to the first dose of study treatment"}
• {"criterion_text":"-Signed written Ethical Committee (EC) approved informed consent form, prior to performing any study-related procedures"}

Exclusion criteria

• {"criterion_text":"-Patients with metastatic hormone sensitive prostate cancer (mHSPC)"}
• {"criterion_text":"-Patients who were previously treated with an androgen receptor signalling inhibitor (e.g. abiraterone, enzalutamide, darolutamide)"}
• {"criterion_text":"-Any significant concomitant disease determined by the investigator to be potentially aggravated by the investigational drug"}
• {"criterion_text":"-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)"}
• {"criterion_text":"-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."}
• {"criterion_text":"-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."}

Primary endpoints

• {"endpoint_text":"-Radiographic progression-free survival (PFS)","definition_or_measurement_approach":"Primary objective: comparison of radiographic PFS between the TDM-guided dosing arm and the fixed dosing arm in the subgroup of patients who had a Cmin < 8.4 ng/mL at a certain time point during treatment."}

Secondary endpoints

• {"endpoint_text":"-Feasibility and safety of TDM","definition_or_measurement_approach":""}
• {"endpoint_text":"-Physician adherence to TDM advice","definition_or_measurement_approach":""}
• {"endpoint_text":"-Clinical progression","definition_or_measurement_approach":""}
• {"endpoint_text":"-Overall response rates (ORR)","definition_or_measurement_approach":""}
• {"endpoint_text":"-Prostate Specific Antigen response rate (PSArr)","definition_or_measurement_approach":""}
• {"endpoint_text":"-PSA response at 12 weeks","definition_or_measurement_approach":""}
• {"endpoint_text":"-Maximal PSA response","definition_or_measurement_approach":""}
• {"endpoint_text":"-Time to PSA progression","definition_or_measurement_approach":""}
• {"endpoint_text":"-Time on treatment (ToT)","definition_or_measurement_approach":""}
• {"endpoint_text":"-Overall survival (OS)","definition_or_measurement_approach":""}
• {"endpoint_text":"-Quality of life (QoL)","definition_or_measurement_approach":""}
• {"endpoint_text":"-Cost-effectiveness","definition_or_measurement_approach":""}
• {"endpoint_text":"-Patient adherence","definition_or_measurement_approach":""}
• {"endpoint_text":"-Toxicity (also in relationship to abiraterone concentrations and dose interventions)","definition_or_measurement_approach":"Assessment of toxicity including analysis in relation to abiraterone plasma concentrations and any dose interventions."}

Netherlands

Earliest CTIS Part Ii Submission Date

09-03-2026

Latest Decision Or Authorization Date

07-04-2026

Processing Time Days

29

Number Of Sites

1

Number Of Participants

230

Primary sponsor

Full Name

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands