{"entity":{"id":"latitude","kind":"trial","name":"LATITUDE","aka":[],"tldr":"LATITUDE established abiraterone at first metastatic diagnosis for high-risk disease.","summary":"LATITUDE, trial NCT01715285 sponsored by Janssen and reported in 2017, established abiraterone at first metastatic diagnosis for men with high-risk de novo metastatic hormone-sensitive prostate cancer. It randomised 1,199 men to androgen deprivation with abiraterone or placebo and met its primary overall survival endpoint, confirmed at the final analysis. OnCo links it to prostate cancer, abiraterone acetate, Karim Fizazi and the terms for androgen receptor pathway inhibitors and for hormone-sensitive versus castration-resistant disease, and the result was replicated by arm G of the STAMPEDE platform in a broader population. Whether abiraterone should be combined with docetaxel as a triplet, as PEACE-1 later tested, or used alone, is the question that followed from it. Abiraterone acetate has its own page.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT01715285","url":"https://clinicaltrials.gov/study/NCT01715285"},{"label":"NICE TA1110: abiraterone (originator and generics) for treating newly diagnosed high-risk hormone-sensitive metastatic prostate cancer","url":"https://www.nice.org.uk/guidance/ta1110"},{"label":"NICE TA721: abiraterone for treating newly diagnosed high-risk hormone-sensitive metastatic prostate cancer, replaced by TA1110","url":"https://www.nice.org.uk/guidance/ta721"}],"tags":[],"related":[],"cancers":["prostate","prostate-mhspc"],"sections":[],"technologies":["androgen-deprivation"],"targets":[],"drugs":["abiraterone"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":["prostate-uk-drug-approvals"],"trials":["stampede","nct02489318"],"people":["karim-fizazi"],"bottlenecks":[],"keyPapers":["paper-latitude-nejm-2017","paper-latitude-lancet-oncol-2019-update"],"journals":[],"dependsOn":[],"notes":["LATITUDE and the STAMPEDE abiraterone comparison were published within days of each other in 2017 and together moved abiraterone to first diagnosis of metastatic disease. In England the appraisal that covered this indication, NICE TA721 of 18 August 2021, said abiraterone with prednisone or prednisolone plus androgen deprivation was not recommended. It has been replaced by NICE TA1110 of 19 November 2025, which recommends abiraterone (originator and generics) plus androgen deprivation with prednisolone or prednisone within its marketing authorisation for newly diagnosed high-risk hormone-sensitive metastatic prostate cancer, so England went from a refusal to routine funding within 30 days of that publication. The evaluation notes that usual treatment in the NHS for this population is enzalutamide plus androgen deprivation or apalutamide plus androgen deprivation, and that abiraterone works in a similar way and would be offered to the same men."],"nct":"NCT01715285","phase":"3","setting":"High-risk de novo metastatic hormone-sensitive prostate cancer: ADT + abiraterone vs ADT","sponsor":"Janssen","result":"OS HR 0.66.","started":"2013-02-12","startedType":"actual","yearReported":2017,"enrolled":1209,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"ADT + abiraterone","n":597,"value":53.3},{"name":"ADT + placebo","n":602,"value":36.5}],"hr":0.66,"ci":[0.56,0.78],"p":"<0.0001","source":"https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(19)30082-8/fulltext"}],"replication":"Replicated by STAMPEDE arm G."},"route":"/trials/latitude/","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/"}],"company":[{"id":"johnson-johnson","kind":"company","name":"Johnson & Johnson","route":"/companies/johnson-johnson/"}],"term":[{"id":"arpi","kind":"term","name":"Androgen receptor pathway inhibitor (ARPI)","route":"/terms/arpi/"},{"id":"mcrpc-mhspc","kind":"term","name":"mCRPC and mHSPC (castration-resistant vs hormone-sensitive prostate cancer)","route":"/terms/mcrpc-mhspc/"},{"id":"prostate-uk-drug-approvals","kind":"term","name":"Prostate cancer drugs in England: what NICE recommends, and what it refuses","route":"/terms/prostate-uk-drug-approvals/"},{"id":"prostate-stampede-arms","kind":"term","name":"STAMPEDE's arms, and what each one answered","route":"/terms/prostate-stampede-arms/"}],"trial":[{"id":"nct02489318","kind":"trial","name":"A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC","route":"/trials/nct02489318/"},{"id":"stampede","kind":"trial","name":"STAMPEDE","route":"/trials/stampede/"}],"person":[{"id":"karim-fizazi","kind":"person","name":"Karim Fizazi","route":"/people/karim-fizazi/"}],"paper":[{"id":"paper-latitude-lancet-oncol-2019-update","kind":"paper","name":"Abiraterone acetate plus prednisone in patients with newly diagnosed high-risk metastatic castration-sensitive prostate cancer (LATITUDE): final overall survival analysis of a randomised, double-blind, phase 3 trial","route":"/key-papers/paper-latitude-lancet-oncol-2019-update/"},{"id":"paper-latitude-nejm-2017","kind":"paper","name":"LATITUDE: abiraterone plus prednisone in newly diagnosed high-risk metastatic castration-sensitive prostate cancer","route":"/key-papers/paper-latitude-nejm-2017/"}],"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/"}]}}