Docetaxel or Cabazitaxel With or Without Darolutamide in mCRPC (DAROTAXEL)
Metastatic Castration-resistant Prostate Cancer
About this trial
This is an interventional treatment trial for Metastatic Castration-resistant Prostate Cancer
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years; A confirmed diagnosis of progressive mCRPC (progression according to Prostate cancer Working Group (PCWG) 3 criteria, castration defined as castrate levels of testosterone of <0.5 ng/mL) with an indication for docetaxel or cabazitaxel. 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. Previous co-administration of docetaxel in mCNPC (triplet-therapy) is allowed, if patients will receive cabazitaxel in this study. WHO performance ≤ 2 Able and willing to sign the Informed Consent Form prior to screening evaluations Adequate haematological, renal and liver function and chemistry. Exclusion Criteria: 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.
Sites / Locations
- Erasmus MC Cancer InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Docetaxel or cabazitaxel (SOC)
Docetaxel or cabazitaxel with darolutamide