Today, metastatic prostate cancer is both deadly and incurable, and the median survival of patients diagnosed with this disease is just four to five years. In Europe, about 15% of all patients diagnosed with prostate cancer have metastatic disease; in the United States this number is 4%, and in China 68%. Patients with metastatic prostate cancer currently receive androgen deprivation therapy (ADT), and this treatment initially almost always provides them with response. Even so, the disease eventually becomes fatal, as nearly all patients develop castration-resistant disease.
The Peace-1 trial (GETUG-AFU-21, EORTC trial 1201) is now open and aims to improve treatment for patients with metastatic prostate cancer. Prof. Karim Fizazi (photo) of Gustave Roussy in Villejuif, France, and International Coordinating Investigator for this study says, “We designed Peace-1 to see if abiraterone and local radiotherapy, combined with androgen deprivation therapy could improve outcome in patients with hormone-naïve metastatic prostate cancer. We randomize patients into four arms: arm A receives ADT, arm B ADT plus abiraterone, arm C ADT plus local radiotherapy to the prostate, and arm D ADT plus abiraterone plus radiotherapy. The idea is to assess the efficacy of androgen deprivation therapy with and without local radiotherapy as well as with and without abiraterone acetate and prednisone in terms of overall and progression-free survival.”
Treatment for patients in this intergroup multicenter phase III trial is administered until progression to the castrate-resistant stage. It is planned to accrue a total of 916 patients: 458 patients in arms B and D and 458 in arms A and C.
Peace-1 (GETUG-AFU-21,EORTC trial 1201) is sponsored by UNICANCER in collaboration with the French Genito-Urinary Oncology Group (GETUG), the Irish Clinical Oncology Research Group (ICORG), members from the Spanish Oncology Genito Urinary Group (SOGUG), and the EORTC Genito-Urinary Cancers and Radiation Oncology Groups and will be conducted at more than 90 sites located in eleven countries: Belgium, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Poland, Romania, Spain, Switzerland and the Netherlands. Sites are already open in France, Spain, Ireland and Belgium, and have already recruited more than 120 patients. This intergroup trial is supported by an Educational grant from Janssen-Cilag Ltd and Ipsen.
John Bean, PhD
EORTC, Medical Science Writer