PROSPER:MDV3100-14 Phase 3,Enzalutamide,non-metastatic CRPC patients
Research type
Research Study
Full title
PROSPER: A Multinational, Phase 3, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer
IRAS ID
132715
Contact name
Gerhardt Attard
Contact email
Sponsor organisation
Medivation, Inc
Eudract number
2012-005665-12
Duration of Study in the UK
5 years, 0 months, 23 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 patients must have "castration-resistant prostate cancer with no evidence of metastasis". “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 250 study centres will take part globally with the aim of recruiting 1560 patients. Patients enrolled in the study will be randomised to either enzalutamide or placebo ("dummy drug") treatment in a 2:1 ratio. Neither the patient nor the study doctor/research team will know whether an individual patient is receiving enzalutamide or placebo treatment. The main objective of the study is to determine how effective enzalutamide is in treating patients diagnosed with castration-resistant prostate cancer (CRPC), compared with placebo. 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 metastatis-free survival (MFS) time. During the study patients will have to take four capsules of either enzalutamide or placebo by mouth once daily with or without food. Eligible patients will have to visit the study centre for a screening visit, further visits at week 1, 5 and 17 and then every 16 weeks following this. Patients will continue study drug administration until confirmation that their cancer is progressing (spreading to other body parts). To assess disease progression, radiographical methods will be used throughout the study, including radionuclide bone scans, CT scans, MRI scans and X-rays.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
13/LO/1081
Date of REC Opinion
4 Oct 2013
REC opinion
Further Information Favourable Opinion