Comparison of standard abiraterone dosing and dosing based on abiraterone blood levels

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Neoplasms [C04], Diseases [C] - Male Urogenital Diseases [C12]

Decision date (initial)

2026-04-07

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic

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.

Secondary objectives 13

1. To assess physician adherence to TDM advice
2. To assess patient adherence
3. To assess Quality of life (QoL)
4. To assess the feasibility and safety of TDM and to compare clinical progression
5. To assess the overall response rates (ORR)
6. To assess Prostate Specific Antigen response rate (PSArr)
7. To assess PSA response at 12 weeks
8. To assess the maximal PSA response
9. To assess the time to PSA progression
10. To assess the Time on treatment (ToT)
11. To assess Overall survival (OS)
12. To assess cost-effectiveness
13. To assess toxicity

Conditions and MedDRA coding

metastatic castration resistant prostate cancer (mCRPC)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

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

Exclusion criteria 6

1. Patients with metastatic hormone sensitive prostate cancer (mHSPC)
2. Patients who were previously treated with an androgen receptor signalling inhibitor (e.g. abiraterone, enzalutamide, darolutamide)
3. Any significant concomitant disease determined by the investigator to be potentially aggravated by the investigational drug
4. 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)
5. 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.
6. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Radiographic progression-free survival (PFS)

Secondary endpoints 14

1. Feasibility and safety of TDM
2. Physician adherence to TDM advice
3. Clinical progression
4. Overall response rates (ORR)
5. Prostate Specific Antigen response rate (PSArr)
6. PSA response at 12 weeks
7. Maximal PSA response
8. Time to PSA progression
9. Time on treatment (ToT)
10. Overall survival (OS)
11. Quality of life (QoL)
12. Cost-effectiveness
13. Patient adherence
14. Toxicity (also in relationship to abiraterone concentrations and dose interventions)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Sponsor organisation

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Address

Plesmanlaan 121

City

Amsterdam

Postcode

1066 CX

Country

Netherlands

Scientific contact point

Organisation

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Contact name

Neeltje Steeghs

Public contact point

Organisation

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Contact name

Neeltje Steeghs

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 13 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications