NCT02254785

Cabazitaxel vs Abiraterone or Enzalutamide in Patients With Poor Prognosis Metastatic Castration-resistant Prostate Cancer

A Phase II, Randomized, Multi-center Study of Cabazitaxel Versus Abiraterone or Enzalutamide in Poor Prognosis-metastatic Castration-resistant Prostate Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: British Columbia Cancer Agency · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess and compare the clinical benefit rate in patients with metastatic castrate-resistant prostate cancer and poor prognostic factors treated with cabazitaxel or novel hormonal agents (abiraterone or enzalutamide) as initial therapy, to determine which treatment is most active in this population. Clinical benefit rate is defined as PSA or measurable radiological response of any duration or stable disease for \> or equal to 12 weeks, in the absence of other indicators of progression. There is option to cross-over onto the other arm if the patient progresses.

Conditions

• Metastatic Castration-Resistant Prostatic Cancer

Interventions

Type	Name	Description
DRUG	cabazitaxel	Cabazitaxel 25mg/m2 intravenous every 3 weeks until disease progression
DRUG	Abiraterone	Abiraterone 1000mg daily (oral) until disease progression
DRUG	Enzalutamide 160mg daily (oral)	Enzalutamide 160mg daily (oral) until disease progression

Timeline

• Start date: 2014-10-01
• Primary completion: 2020-05-01
• Completion: 2020-05-01
• First posted: 2014-10-02
• Last updated: 2017-12-06

Locations

15 sites across 2 countries: Australia, Canada