Single Arm Study of Enzalutamide in Patients with Prostate Cancer
Research type
Research Study
Full title
A multicenter, Single Arm Study of Enzalutamide in Patients with Progressive Metastatic Castration-Resistant Prostate Cancer Previously Treated With Abiraterone Acetate.
IRAS ID
148388
Contact name
J De-Bono
Contact email
Sponsor organisation
Astellas Pharma Europe B.V.
Eudract number
2013-002271-17
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
castration-resistant prostate cancer is cancer that has become resistant to medical or surgical treatments that lower testosterone.
Enzalutamide has already been tested in approximately 2981 patients with advanced prostate cancer. In patients previously treated with docetaxel, but not with abiraterone, Enzalutamide has shown that it can reduce the growth of prostate cancer. Based on this, Enzalutamide has been approved in the European Union for the treatment of adult men with metastatic castration-resistant prostate cancer whose disease has progressed on or after therapy. The information collected will be used to find out whether use of Enzalutamide after treatment with abiraterone is effective.
A total of approximately 200 patients in Europe will take part in this study. Doctors in the Oncology Departments of NHS hospitals will be treating participants in the United Kingdom.
Patients, who are eligible, will be expected to go to the clinic 4 weeks after the day they start taking the study medication and then every 12 weeks after that. After the final patient has been in the study for ~12 months, study-specific visits to the clinic will no longer have to take place every 12 weeks. From this moment, patients will only have to go to the clinic every 6 months for study-specific visits until the doctor believes continued treatment is no longer needed. How long the period of 12-weekly visits will be, depends on when patients start to participate in the study. In every case, it will be at least ~12 months. The study will last approximately 2 years.
Patients will receive a dose of 160 mg/day (four 40 mg capsules) of the active medication (Enzalutamide) each day. Tests will be conducted by the doctor during this time to monitor health, including physical examinations, blood/urine samples, CT or MRI and bone scans.
A pharmaceutical company is funding this research.REC name
London - Chelsea Research Ethics Committee
REC reference
14/LO/0298
Date of REC Opinion
9 May 2014
REC opinion
Further Information Favourable Opinion