Docetaxel or Cabazitaxel With or Without Darolutamide in mCRPC - Trial NCT05762536

Timeline & Enrollment

Primary Outcome

Progression free survival

Summary

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 inducing effect in the case of enzalutamide,
 resulting in a significant and clinically relevant reduction of cabazitaxel plasma
 concentrations. The investigators have previously reported preclinical data showing that
 addition of an androgen receptor signaling inhibitor (ARSi) improves cabazitaxel efficacy,
 even in metastatic castration-resistant prostate cancer (mCRPC). As treatment options for
 mCRPC) patients are scarce and patients often develop drug resistance relatively early, a new
 treatment regimen for this population to delay drug resistance is highly desired. The
 investigators propose a randomized phase II trial to investigate the efficacy of docetaxel or
 cabazitaxel plus darolutamide compared to docetaxel or cabazitaxel monotherapy in men with
 metastatic CRPC, who have progressed on an ARSI.

ICD-10 Classifications