ENZAMET Trial
Research type
Research Study
Full title
Randomised phase 3 trial of enzalutamide in first line androgen deprivation therapy for metastatic prostate cancer.
IRAS ID
161762
Contact name
Dr. Simon Chowdhury
Contact email
Eudract number
2014-003190-42
Clinicaltrials.gov Identifier
Australian New Zealand Clinical Trial Registry, ACTRN12614000110684
Duration of Study in the UK
5 years, 6 months, 0 days
Research summary
Participants are invited to take part in this research study to test a new treatment combination for metastatic prostate cancer. This is because they have cancer that started in the prostate and has spread to other parts of their body. Current treatment for newly diagnosed metastatic prostate cancer involves androgen deprivation therapy (ADT).
ADT has two components:
1. The main component is by stopping the release of androgen from the testicles. This is mainly done by using drugs that prevent the testicles from making androgens, and therefore reducing the levels of androgens in the body to low levels. These drugs are called luteinising hormone releasing hormone analogues (LHRHA). This is usually part of the standard initial treatment. The other way of reducing androgen production by the testicles is with a surgical operation to remove both testicles. This is not part of the trial. If participants have already had this surgical procedure or it is planned to be done, they will not need to be on LHRHA, but can still take part in this study.
2. The second component of ADT is to block the effects of androgens produced in other parts of the body with anti-androgen drugs. These drugs block testosterone and related androgens from attaching to molecules in the cancer cell called 'androgen receptors'. Blocking this attachment prevents androgens from having their effect. This might provide additional benefit in treating the cancer although this has not yet been proven. Several different types
of anti-androgen drugs are available for use already. Enzalutamide is a new anti-androgen. This study will compare the effectiveness of enzalutamide versus the currently available anti-androgen drugs when used on a background of treatment with a LHRHA (or surgical removal of the testicles). The main aim of the study is to see which of these combinations is best at improving the survival of men in this situation.REC name
London - Harrow Research Ethics Committee
REC reference
14/LO/2218
Date of REC Opinion
4 Feb 2015
REC opinion
Further Information Favourable Opinion