2024-516939-28-00RecruitingPhase 2
DAROTAXEL
A randomized phase II trial of docetaxel or cabazitaxel with or without darolutamide in men with metastatic castration-resistant prostate cancer.
Source: EU CTIS (euclinicaltrials.eu) · Last updated 10 Mar 2026
Brief summary (registry, in English)
To compare progression free survival (PFS) between treatment with docetaxel or cabazitaxel and darolutamide versus treatment with docetaxel or cabazitaxel in mCRPC patients.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 245 (estimated)
- First submitted
- 2 Oct 2024
- Start date
- 28 Oct 2024
- Lead sponsor
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Diseases
- Prostate cancer
- EU CT number
- 2024-516939-28-00
- EudraCT number
- 2022-003792-41
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 245
- 18 sites 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 keeps growing despite hormone-lowering treatment. They need chemotherapy with docetaxel or cabazitaxel.
- Age
- 18 years or older
- Sex
- Men only
- Disease stage
- Metastatic castration-resistant prostate cancer that is getting worse (progressive), with an indication for docetaxel or cabazitaxel. Progression means growth on scans or rising PSA. PSA of 2 ng/mL or more is needed at study entry.
- Earlier treatment
- The cancer must have grown during at least one earlier hormone-blocking drug (abiraterone, apalutamide, darolutamide or enzalutamide). Docetaxel given earlier together with that drug is allowed.
- Biomarker or test result
- Blood testosterone of 1.7 nmol/L or lower. PSA of 2 ng/mL or more.
Main reasons for not taking part
- Cannot or will not take pills
- Allergy to taxane drugs
- Serious or unstable illness, for example HIV, hepatitis, organ transplant, kidney failure, severe liver disease, heart or lung disease
- Nerve damage in hands or feet with symptoms, grade 2 or higher
- Repeat treatment with docetaxel (docetaxel-rechallenge)
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
- Impossibility or unwillingness to take oral drugs
Other illness
- Hypersensitivity to taxanes
- Known serious illness or medical unstable conditions that could interfere with this study requiring treatment (e.g. HIV, hepatitis, Varicella zoster or herpes zoster, organ transplants, kidney failure, serious liver disease (e.g. severe cirrhosis), cardiac and respiratory diseases)
Other
- Symptomatic peripheral neuropathy CTCAE grade ≥2
- Docetaxel-rechallenge.
Who the study is looking for
- Age ≥ 18 years;
- A confirmed diagnosis of progressive mCRPC (progression according to Prostate cancer Working Group (PCWG) 3 criteria), with an indication for docetaxel or cabazitaxel. Progression defined as ≥ 1 of the following 3 criteria: a. Radiographic disease progression in soft tissue per RECIST v1.1 b. Radiographic disease progression in bone defined by the appearance of ≥ 2 new bone lesions on bone scan. c. PSA progression defined as ≥ 2 sequential rises in PSA obtained ≥ 1 week apart with a minimal starting value of ≥ 1 ng/mL. A PSA value ≥ 2 ng/mL is required at study entry.
- Patients should have had disease progression previously on at least one ARSi (abiraterone, apalutamide, darolutamide or enzalutamide). ARSi administration is allowed both in the mCNPC and in the mCRPC setting. Coadministration of docetaxel in mCNPC (triplet-therapy) is allowed.
- WHO performance ≤ 2 (see appendix A)
- Able and willing to sign the Informed Consent Form prior to screening evaluations
- Adequate haematological, renal and liver function and chemistry, defined as: a. Hemoglobin ≥ 6.0 mmol/L b. Platelets ≥ 100 x 109/L c. ALT/AST ≤ 3x ULN and ≤ 5x ULN in case of liver metastases d. Creatinine clearance ≥ 50 ml/min e. Serum testosterone ≤ 1.7 nmol/L
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (18)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ziekenhuisgroep Twente Stichting | Almelo | Netherlands | Recruiting |
| Amsterdam UMC Stichting | Amsterdam | Netherlands | Recruiting |
| Gelre Hospitals | Apeldoorn | Netherlands | Recruiting |
| Deventer Ziekenhuis | Deventer | Netherlands | Recruiting |
| Albert Schweitzer Ziekenhuis | Dordrecht | Netherlands | Recruiting |
| Ziekenhuis Nij Smellinghe | Drachten | Netherlands | Recruiting |
| Zuyderland Medisch Centrum Stichting | Geleen | Netherlands | Recruiting |
| Admiraal De Ruyter Ziekenhuis B.V. | Goes | Netherlands | Recruiting |
| Frisius MC | Leeuwarden | Netherlands | Recruiting |
| Canisius Wilhelmina Ziekenhuis | Nijmegen | Netherlands | Recruiting |
| Bravis Ziekenhuis | Roosendaal | Netherlands | Recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) | Rotterdam | Netherlands | Recruiting |
| Maasstad Ziekenhuis Stichting | Rotterdam | Netherlands | Recruiting |
| Franciscus Gasthuis en Vlietland | Schiedam | Netherlands | Recruiting |
| Haga Hospital | 's-Gravenhage | Netherlands | Recruiting |
| Jeroen Bosch Ziekenhuis Stichting | 'S-Hertogenbosch | Netherlands | Recruiting |
| St Antonius Ziekenhuis | Utrecht | Netherlands | Recruiting |
| Isala Klinieken Stichting | Zwolle | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.