ENZARAD Trial
Research type
Research Study
Full title
Randomised phase 3 trial of enzalutamide in androgen deprivation therapy with radiation therapy for high risk, clinically localised, prostate cancer.
IRAS ID
163775
Contact name
Dr. Simon Hughes
Contact email
Eudract number
2014-003191-23
Clinicaltrials.gov Identifier
ACTRN12614000126617, Australian New Zealand Clinical Trial Registry
Duration of Study in the UK
7 years, 6 months, 0 days
Research summary
Participants are invited to take part in this research study that is testing a new treatment combination for localised prostate cancer that is going to be treated with radiotherapy. This is because they have prostate cancer that has features suggesting that its risk of recurrence after radiotherapy is higher than average. Current treatment for high risk localised prostate cancer involves radiation therapy with or without androgen deprivation therapy (ADT).
Androgen deprivation therapy can have 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 releasing hormone analogues (LHRHA). This is usually part of the standard initial treatment of men in this situation.
2.The second component blocks the effects of androgens produced in other parts of the body with anti-androgen drugs. Anti-androgen 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 an anti-androgen drug approved for use in Europe for the treatment of adult men with metastatic prostate cancer that has continued to grow after hormone treatments and chemotherapy. The use of enzalutamide is currently experimental for localised prostate cancer.
The treatment plan for these participants is androgen deprivation therapy combined with external beam radiotherapy to prevent further growth and spread of the prostate cancer. All participants will receive LHRHA treatment for 24 months and radiotherapy. Radiotherapy is standard practice and is not under investigation in this trial. Participants will be randomly allocated to either receive enzalutamide for 24 months or currently available anti-androgen therapy for 6 months. The study will compare the effectiveness of standard deprivation therapy and radiation therapy combined either with enzalutamide or with currently available anti-androgen drugs. The main aim of the study is to see which of these combinations of treatment is better for improving the survival of men in this situation.
Recent studies show promising results from the use of enzalutamide in patients who had been treated with androgen deprivation therapy and were no longer responding to the standard anti-androgens. These men had prostate cancer that is at a more advanced stage than the stage of prostate cancer studied here. We want to see whether this positive effect can also be shown in men with high risk prostate cancer localised to the prostate area and planned for radiotherapy. This is the first study evaluating the potential benefit of enzalutamide in this patient group. To do this, a total of 800 participants will participate where half the participants on the study will receive enzalutamide with a LHRHA and radiation therapy and the other half (400 participants) will receive an already available anti-androgen with a LHRHA and radiation therapy. All participants on this study will receive active therapy and no placebo treatment will be used. The study is open label, meaning that both the participants and the investigators will know the treatment the participant will receive.REC name
London - Fulham Research Ethics Committee
REC reference
14/LO/2219
Date of REC Opinion
4 Feb 2015
REC opinion
Further Information Favourable Opinion