LPS14201 (XRP6258) Cabazitaxel vs abiraterone or enzalutamide in mCRPC
Research type
Research Study
Full title
A randomized, open label, multicenter study of Cabazitaxel versus an Androgen Receptor (AR)-targeted agent (abiraterone or enzalutamide) in mCRPC patients previously treated with Docetaxel and who rapidly failed a prior AR-targeted agent (CARD)
IRAS ID
180894
Contact name
Johann de Bono
Contact email
Sponsor organisation
Sanofi-aventis Groupe
Eudract number
2014-004676-29
Duration of Study in the UK
2 years, 6 months, 17 days
Research summary
This is a multinational clinical study taking place at several centres located in Europe. It is expected that 274 patients who have metastatic Castration Resistant Prostate Cancer (mCRPC) will participate.
The study's aim is to determine if cabazitaxel (Jevtana®) is better than an AR (androgen receptor) targeted agent, either abiraterone acetate (Zytiga®) or enzalutamide (Xtandi®), in patients previously treated with docetaxel and likely to have resistance to AR targeted agents.
Participants to this study will be randomly assigned to receive study treatment, either cabazitaxel (at the dose of 25 mg/m² by intravenous route every three weeks) or abiraterone acetate (at 1000 mg/4 tablets once daily) or enzalutamide (at 160 mg/4 capsules once daily). A steroid therapy (prednisone or prednisolone) by oral route will be given in addition to Cabazitaxel and abiraterone acetate.
Participants who will receive cabazitaxel will also receive G-CSF (Granulocyte-Colony Stimulating Factor) as a preventative treatment to prevent a decrease of white blood cells which are important in fighting infection.
Each participant will be treated until they experience unacceptable side effects, it is determined that their cancer has progressed, they meet withdrawal criteria, or they wish to be discontinued from further study treatment.
REC name
London - Central Research Ethics Committee
REC reference
15/LO/1179
Date of REC Opinion
15 Sep 2015
REC opinion
Further Information Favourable Opinion