{"entity":{"id":"nct00450619","kind":"trial","name":"153Sm-EDTMP With or Without a PSA/TRICOM Vaccine To Treat Men With Androgen-Insensitive Prostate Cancer","aka":[],"tldr":"A phase 2 trial of Samarium-153 lexidronam and Sargramostim in Prostate cancer, run by National Cancer Institute (NCI), completed.","summary":"153Sm-EDTMP With or Without a PSA/TRICOM Vaccine To Treat Men With Androgen-Insensitive Prostate Cancer is a phase 2 interventional study registered as NCT00450619 by National Cancer Institute (NCI), with 44 participants recorded, started 2007-02 and reaching its primary completion in 2012-11. Interventions recorded: Samarium Sm 153 lexidronam pentasodium, Sargramostim, Recombinant vaccinia-TRICOM vaccine, Recombinant fowlpox-TRICOM vaccine. Conditions recorded: Prostate Cancer.\n\nLinked to the drug Samarium-153 lexidronam because the registry names it among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00450619","url":"https://clinicaltrials.gov/study/NCT00450619"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":[],"targets":[],"drugs":["samarium-153-lexidronam","sargramostim"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00450619","phase":"2","setting":"A Randomized Phase 2.5 Study of (153)Sm-EDTMP (Quadramet) With or Without a PSA/TRICOM Vaccine in Men With Androgen-Insensitive Metastatic Prostate Cancer","sponsor":"National Cancer Institute (NCI)","started":"2007-02","yearReported":2013,"enrolled":44,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression Free Survival (PFS)","primary":true,"unit":"months","arms":[{"name":"Arm A - EDTMP Alone","n":18,"value":1.7,"note":"95% CI 1.3 to 2.3; Figures from the ClinicalTrials.gov results section (first posted 2013-07-01), not from a publication"},{"name":"Arm B - 153Sm-EDTMP With Vaccine","n":21,"value":3.7,"note":"95% CI 2.4 to 4.7"}],"hr":0.5019,"p":"0.041","source":"https://clinicaltrials.gov/study/NCT00450619?tab=results"},{"endpoint":"Overall Survival","unit":"months","arms":[{"name":"Arm A - EDTMP Alone","n":18,"value":8.1,"note":"95% CI 3.5 to 13.3; Figures from the ClinicalTrials.gov results section (first posted 2013-07-01), not from a publication"},{"name":"Arm B - 153Sm-EDTMP With Vaccine","n":21,"value":9.2,"note":"95% CI 5.0 to 12.6"}],"hr":0.71,"ci":[0.37,1.35],"p":"0.30","source":"https://clinicaltrials.gov/study/NCT00450619?tab=results"}]},"route":"/trials/nct00450619/","neighbours":{"cancer":[{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"}],"drug":[{"id":"samarium-153-lexidronam","kind":"drug","name":"Samarium-153 lexidronam","route":"/drugs/samarium-153-lexidronam/"},{"id":"sargramostim","kind":"drug","name":"Sargramostim","route":"/drugs/sargramostim/"}]}}