DAROTAXEL
Key facts
- Where
- 's-Gravenhage, 'S-Hertogenbosch, Almelo, Amsterdam, Apeldoorn, Deventer, Dordrecht, Drachten, Geleen, Goes, Leeuwarden, Nijmegen, Roosendaal, Rotterdam, Schiedam, Utrecht és Zwolle, HollandiaSee the 18 sites
- Phase
- 2. fázis
Where in Hollandia
- Haga Hospital's-Gravenhage, HollandiaTaking people
- Jeroen Bosch Ziekenhuis Stichting'S-Hertogenbosch, HollandiaTaking people
- Ziekenhuisgroep Twente StichtingAlmelo, HollandiaTaking people
- Amsterdam UMC StichtingAmsterdam, HollandiaTaking people
- Gelre HospitalsApeldoorn, HollandiaTaking people
- Deventer ZiekenhuisDeventer, HollandiaTaking people
- Albert Schweitzer ZiekenhuisDordrecht, HollandiaTaking people
- Ziekenhuis Nij SmellingheDrachten, HollandiaTaking people
- Zuyderland Medisch Centrum StichtingGeleen, HollandiaTaking people
- Admiraal De Ruyter Ziekenhuis B.V.Goes, HollandiaTaking people
- Frisius MCLeeuwarden, HollandiaTaking people
- Canisius Wilhelmina ZiekenhuisNijmegen, HollandiaTaking people
- Bravis ZiekenhuisRoosendaal, HollandiaTaking people
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)Rotterdam, HollandiaTaking people
- Maasstad Ziekenhuis StichtingRotterdam, HollandiaTaking people
- Franciscus Gasthuis en VlietlandSchiedam, HollandiaTaking people
- St Antonius ZiekenhuisUtrecht, HollandiaTaking people
- Isala Klinieken StichtingZwolle, HollandiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Trial code
- EU 2024-516939-28-00
- Record updated
- 2026. március 10.
- Original description
To compare progression free survival (PFS) between treatment with docetaxel or cabazitaxel and darolutamide versus treatment with docetaxel or cabazitaxel in mCRPC patients.Read full original descriptionShow less
A randomized phase II trial of docetaxel or cabazitaxel with or without darolutamide in men with metastatic castration-resistant prostate cancer.
To compare progression free survival (PFS) between treatment with docetaxel or cabazitaxel and darolutamide versus treatment with docetaxel or cabazitaxel in mCRPC patients.
Inclusion: 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.
Exclusion: Impossibility or unwillingness to take oral drugs; 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); Symptomatic peripheral neuropathy CTCAE grade ≥2; Docetaxel-rechallenge.