MDV3100-10 TBP, Phase 4, Enzalutamide, metastatic CRPC patients
Research type
Research Study
Full title
A Phase 4, Randomized, Double-Blind, Placebo-Controlled Study of Continued Enzalutamide Treatment Beyond Progression in Patients With Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer
IRAS ID
137877
Contact name
Gerhardt Attard
Contact email
Sponsor organisation
Medivation, Inc.
Eudract number
2013-000722-54
ISRCTN Number
n/a
Research summary
This is a Phase 4 study to investigate whether taking enzalutamide with abiraterone and prednisone is better than taking abiraterone and prednisone alone. This study is also investigating the safety and tolerability of enzalutamide by itself and together with abiraterone and prednisone. Patients must have "metastatic castration-resistant prostate cancer (CRPC)" and must not have received chemotherapy treatment for their cancer. “Castration-resistant” means the cancer of the prostate is getting worse despite therapies that lower the male sex hormone testosterone. “Metastasic” means the cancer has spread, or metastasised, to other parts of the body. Chemotherapy is a specific type of treatment for cancer. Approximately 70 study sites will take part worldwide with the aim of recruiting 500 patients. The study has 2 periods. In period 1 patients will take 4 capsules of enzalutamide once daily by mouth. Patient's prostate-specific antigen (PSA) levels will be monitored. PSA is produced by the prostate and other tissues. An increasing blood level of PSA may be a sign that the prostate cancer is getting worse. Lowered PSA levels are considered to be a sign of clinical benefit. Patients with decreasing PSA levels will continue the study. Patients with increasing PSA levels will discontinue the study. Continuing patients' PSA levels will be monitored until it begins to increase; at which point patients are considered for period 2. In period 2 patients will receive abiraterone acetate (abiraterone) plus prednisone with either enzalutamide or placebo. A placebo is a dummy drug that is identical in appearance to the study medication but contains no active drug. There a 50% chance of receiving either enzalutamide or placebo. Abiraterone and prednisone are approved in the US and European Union to treat men with metastatic castration resistant prostate cancer. The study will use several different tests to determine whether taking enzalutamide with abiraterone and prednisone is better than taking abiraterone and prednisone alone.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
13/LO/1482
Date of REC Opinion
16 Oct 2013
REC opinion
Favourable Opinion