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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Cabazitaxel 25mg/m2 intravenous every 3 weeks until disease progression
Abiraterone 1000mg daily (oral) until disease progression
Enzalutamide 160mg daily (oral) until disease progression
Box Hill Hospital
Box Hill, Victoria, Australia
Monash Health-Monash Medical Centre
Clayton, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Tom Baker Cancer Cantre
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
BCCA - Kelowna
Kelowna, British Columbia, Canada
BCCA- Vancouver Center
Vancouver, British Columbia, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada
Juravinski Cancer Centre
Hamilton, Ontario, Canada
...and 5 more locations
Clinical benefit rate
To assess and compare the clinical benefit rate in patients with mCRPC 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 greater than or equal to 12 weeks, in the absence of other indicators of progression.
Time frame: 12 weeks or more
Duration of treatment time to progression
To measure the treatment time before any type of progression (symptomatic, PSA, or radiological) between Arm A and Arm B
Time frame: 12 weeks until disease progression
Progression Free Survival
To measure the progression-free survival of metastatic castration-resistant prostate cancer patients following treatment with cabazitaxel or abiraterone/enzalutamide as initial therapy.
Time frame: 12 weeks until disease progression
Overall Survival
To measure the overall survival of metastatic castration-resistant prostate cancer patients following treatment with cabazitaxel or abiraterone/enzalutamide as initial therapy.
Time frame: 12 weeks until 2 years after last study visit
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