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

NCT02254785 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2017-12-06

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Ozmosis Research Inc.

    collaborator INDUSTRY

  • British Columbia Cancer Agency

    lead OTHER

Principal Investigators

  • Kim N Chi, MD · British Columbia Cancer Agency

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2020-05-31
Completion
2020-05-31

Countries

  • Australia
  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02254785 on ClinicalTrials.gov