Docetaxel or Cabazitaxel With or Without Darolutamide in mCRPC

Taxane efficacy in metastatic prostate cancer is modest due to resistance development. Several clinical phase III studies in metastatic castration-naïve prostate cancer (mCNPC) patients have shown that adding an androgen receptor signalling inhibitor (ARSi) to patients receiving a taxane and androgen deprivation therapy (ADT) improves survival endpoints. Adding ARSi darolutamide to docetaxel+ADT in mCNPC patients resulted in a robust OS benefit (HR 0.68). Importantly, the combination of a taxane and darolutamide is not prone to a drug-drug interaction, while there is a detrimental CYP3A4 induc

Trial Details

NCT ID
NCT05762536
Phase
PHASE2
Sponsor
Erasmus Medical Center
Status
RECRUITING
Cancer Type
Castration-Resistant (CRPC) Prostate Cancer
Interventions
  • Darolutamide
  • Docetaxel or cabazitaxel
Locations (sample)
  • Rotterdam, Netherlands|51.9225,4.47917

Key Eligibility Criteria

  • Age ≥ 18 years;
  • A confirmed diagnosis of progressive mCRPC (progression according to Prostate cancer Working Group (PCWG) 3 criteria, castration defined as castrat…
  • Patients should have had disease progression previously on at least one ARSi (abiraterone, apalutamide, darolutamide or enzalutamide). ARSi adminis…
  • WHO performance ≤ 2

For full eligibility, visit ClinicalTrials.gov.

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