EMBARK:MDV3100-13 Phase3, Enzalutamide, nonmetastatic Prostate Cancer
Research type
Research Study
Full title
A Phase 3, Randomized, Efficacy and Safety Study of Enzalutamide Plus Leuprolide, Enzalutamide Monotherapy, and Placebo Plus Leuprolide in Men With High-Risk Nonmetastatic Prostate Cancer Progressing After Definitive Therapy
IRAS ID
177905
Contact name
Alison Tree
Contact email
Sponsor organisation
Medivation, Inc.
Eudract number
2014-001634-28
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 1 months, 19 days
Research summary
This is a Phase 3 Study to investigate the efficacy and safety of the investigational drug, Enzalutamide. To be included in this study patient must have castration naive prostate cancer with high risk for developing metastases and castration-resistant disease. “Castration resistant” means cancer of the prostate that is getting worse despite receiving therapies that lower the male sex hormone testosterone. “No evidence of metastasis” means the cancer has not spread, or metastasized, to other parts of the body. Approximately 200 study sites will take part globally with the aim of recruiting 1860 patients.
Patients enrolled in the study will be randomised (ratio 1:1:1) to one of the following study drug treatments:
- Group 1 - Enzalutamide plus leuprolide
- Group 2 - Enzalutamide monotherapy
- Group 3 - Placebo plus leuprolide
Treatment with enzalutamide monotherapy will be open label. Treatment with enzalutamide and placebo ("dummy drug" - with no active ingredient, identical in appearance to the enzalutamide capsules) will be double-blind in combination with open-label leuprolide. Open label means that both the study doctor and patient know which treatment is being administered. Double-blind means that neither the patient nor the study doctor/research team know whether patient is receiving enzalutamide or placebo. The main objective of the study is to determine how effective, in treating patients diagnosed with Castration naïve prostate cancer, is enzalutamide plus leuprolide and enzalutamide monotherapy compared with placebo plus leuprolide. The effectiveness of enzalutamide will be assessed by how long it takes for the cancer to spread to another part of the patient's body other than the prostate. This is called the metastasis free survival (MFS) time.
Patients will continue study drug administration until confirmation that their cancer is progressing (spreading to other body parts). To assess disease progression, radiographic techniques will be used throughout the study, including radionuclide bone scan, CT scan, MRI scan and X-ray.REC name
London - Central Research Ethics Committee
REC reference
15/LO/0710
Date of REC Opinion
28 May 2015
REC opinion
Further Information Favourable Opinion