PEACE III (EORTC 1333)
Research type
Research Study
Full title
A Randomized multicenter phase III trial comparing enzalutamide vs. a combination of Ra223 and enzalutamide in asymptomatic or mildly symptomatic castration resistant prostate cancer patients metastatic to bone.
IRAS ID
190300
Contact name
Santhanam Sundar
Contact email
Sponsor organisation
European Organisation for Research and Treatment of Cancer (EORTC)
Eudract number
2014-001787-36
Clinicaltrials.gov Identifier
Duration of Study in the UK
8 years, 0 months, 0 days
Research summary
This trial involves patients with advanced prostate cancer. This trial will compare a group on hormone tablets alone with a group on combination of hormone tablets and a radioactive substance. This trial is supported by the European Organisation for Research and Treatment of Cancer (EORTC).
Doctors often treat advanced prostate cancer with a hormone therapy injection or on rare occasions by removal of both testicles. Both these treatments usually stop working after 13 to 22 months. This trial will recruit these men whose prostate cancer is no longer responding to hormone injections or removal of testicles. Prostate cancer often spreads to bones and more than 90% of men with advanced prostate cancer have secondary cancer in their bones at this stage. Cancer that has spread to the bones can cause significant pain. The secondary cancer in bone significantly affects the men's ability to enjoy life.
Radium 223 is a new type of radioactive injection. Radium 223 specifically targets cancer cells in the bones. Radium 223 spares lot of normal body tissues and lose its radioactivity very quickly. Radium 223 is safe to use and is already approved for use in advanced prostate cancer in UK and Europe.
Enzalutamide is also a newly licensed hormone therapy tablet that is proven to work in patients after the first hormone injection has failed to work.This trials aims to find out
>> if men having Enzalutamide tablets in combination with Radium 223 injection have longer duration of cancer control in bones compared to men having Enzalutamide tablets alone;
>> if men having the combination treatment live longer, have less bone complications, better pain control and have a better quality of life.
The trial also aims to collect the safety information in men having Radium 223 injections in combination with Enzalutamide tablets and in men having Enzalutamide tablets alone.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
16/EM/0017
Date of REC Opinion
7 Mar 2016
REC opinion
Further Information Favourable Opinion