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Brief Title: Cabazitaxel vs Abiraterone or Enzalutamide in Patients With Poor Prognosis Metastatic Castration-resistant Prostate Cancer
Official Title: A Phase II, Randomized, Multi-center Study of Cabazitaxel Versus Abiraterone or Enzalutamide in Poor Prognosis-metastatic Castration-resistant Prostate Cancer
Study ID: NCT02254785
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
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
Durham Regional Cancer Centre (Lakeridge Health), Oshawa, Ontario, Canada
The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Jewish General Hospital, Montreal, Quebec, Canada
Saskatoon Cancer Center, Saskatoon, Saskatchewan, Canada
Name: Kim N Chi, MD
Affiliation: British Columbia Cancer Agency
Role: PRINCIPAL_INVESTIGATOR