{"entity":{"id":"peace-1","kind":"trial","name":"PEACE-1","aka":[],"tldr":"PEACE-1 is the European triplet trial: abiraterone added to hormone therapy and docetaxel improves survival, especially in high-volume disease.","summary":"PEACE-1, trial NCT01957436 sponsored by UNICANCER and Gustave Roussy and reported in 2021, is the European triplet trial in de novo metastatic hormone-sensitive prostate cancer, using a two-by-two factorial design to test adding abiraterone and adding prostate radiotherapy to androgen deprivation plus docetaxel. It randomised 1,173 men and showed that abiraterone improved overall survival, with the largest benefit in high-volume disease, while prostate radiotherapy reduced serious urinary events. OnCo links it to prostate cancer, abiraterone acetate, docetaxel, Karim Fizazi and Gustave Roussy, and its result is consistent with ARASENS for triplet therapy in high-volume de novo disease. Whether local radiotherapy to the prostate should be routine in men with metastatic disease is the second question the factorial design raised. Abiraterone acetate has its own page.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT01957436","url":"https://clinicaltrials.gov/study/NCT01957436"}],"tags":[],"related":[],"cancers":["prostate","prostate-mhspc"],"sections":[],"technologies":["androgen-deprivation"],"targets":[],"drugs":["abiraterone","docetaxel"],"companies":["unicancer"],"institutions":["gustave-roussy"],"pathways":[],"terms":[],"trials":[],"people":["karim-fizazi"],"bottlenecks":[],"keyPapers":["paper-peace-1-lancet-2022"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01957436","phase":"3","setting":"De novo metastatic hormone-sensitive prostate cancer: ADT + docetaxel ± abiraterone ± prostate radiotherapy (2×2 factorial)","sponsor":"UNICANCER / Gustave Roussy","result":"OS HR 0.82 in the overall population and HR 0.75 in the ADT plus docetaxel population; HR 0.72 in high-volume disease.","started":"2013-11-13","startedType":"actual","yearReported":2021,"enrolled":1173,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival, abiraterone vs no abiraterone (with ADT + docetaxel)","primary":true,"unit":"months","arms":[{"name":"Abiraterone + ADT + docetaxel","value":66},{"name":"ADT + docetaxel","value":52}],"hr":0.75,"ci":[0.59,0.95],"p":"0.017","source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)00367-1/fulltext"}],"replication":"Consistent with ARASENS for triplet therapy in high-volume de novo disease."},"route":"/trials/peace-1/","neighbours":{"cancer":[{"id":"prostate-mhspc","kind":"cancer","name":"Metastatic hormone-sensitive prostate cancer","route":"/cancers/prostate-mhspc/"},{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"}],"technology":[{"id":"androgen-deprivation","kind":"technology","name":"Androgen deprivation & AR pathway inhibitors","route":"/technologies/androgen-deprivation/"}],"drug":[{"id":"abiraterone","kind":"drug","name":"Abiraterone acetate","route":"/drugs/abiraterone/"},{"id":"docetaxel","kind":"drug","name":"Docetaxel","route":"/drugs/docetaxel/"}],"company":[{"id":"unicancer","kind":"company","name":"UNICANCER","route":"/companies/unicancer/"}],"institution":[{"id":"gustave-roussy","kind":"institution","name":"Gustave Roussy","route":"/institutions/gustave-roussy/"}],"person":[{"id":"karim-fizazi","kind":"person","name":"Karim Fizazi","route":"/people/karim-fizazi/"}],"paper":[{"id":"paper-peace-1-lancet-2022","kind":"paper","name":"Abiraterone plus prednisone added to androgen deprivation therapy and docetaxel in de novo metastatic castration-sensitive prostate cancer (PEACE-1): a multicentre, open-label, randomised, phase 3 study with a 2 × 2 factorial design","route":"/key-papers/paper-peace-1-lancet-2022/"}],"trial":[{"id":"arasens","kind":"trial","name":"ARASENS","route":"/trials/arasens/"}],"roadmap":[{"id":"hormonal-therapy-roadmap","kind":"roadmap","name":"Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test","route":"/roadmaps/hormonal-therapy-roadmap/"}]}}