{"entity":{"id":"synergy-custirsen","kind":"trial","name":"SYNERGY","aka":["SYNERGY","custirsen with first-line docetaxel"],"tldr":"Blocking the survival protein clusterin did not make chemotherapy work better for advanced prostate cancer.","summary":"SYNERGY randomised 1,022 men with chemotherapy-naive metastatic castration-resistant prostate cancer to docetaxel and prednisone with or without custirsen, an antisense oligonucleotide against the chaperone protein clusterin. Randomisation was stratified by opioid use for cancer-related pain and by radiographic evidence of progression.\n\nMedian overall survival was 23.4 months (95 percent confidence interval 20.9 to 24.8) with custirsen and 22.0 months (19.5 to 24.0) without, hazard ratio 0.93 (0.79 to 1.10, p=0.415).\n\nThe commonest grade 3 or worse events with custirsen against control were neutropenia (grade 3 in 13 against 6 percent, grade 4 in 20 against 15 percent), febrile neutropenia (grade 3 in 10 against 6 percent) and fatigue (grade 3 in 11 against 8 percent). Serious adverse events were reported for 214 of 501 men (43 percent) on custirsen and 181 of 499 (36 percent) on control, and adverse events were attributed to 23 and 24 deaths respectively.","status":"negative","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT01188187","url":"https://clinicaltrials.gov/study/NCT01188187"},{"label":"SYNERGY (Lancet Oncology 2017)","url":"https://doi.org/10.1016/S1470-2045(17)30168-7"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["antisense-sirna","cytotoxic-chemotherapy"],"targets":[],"drugs":["custirsen","docetaxel","prednisone"],"companies":["achieve-life-sciences"],"institutions":[],"pathways":[],"terms":["castration-resistance"],"trials":["affinity-custirsen","tax-327"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01188187","phase":"3","setting":"Metastatic castration-resistant prostate cancer with no previous chemotherapy, PSA above 5 and Karnofsky score 70 percent or higher: docetaxel 75 mg/m2 with prednisone 5 mg twice daily, with or without weekly custirsen 640 mg after three loading doses, with overall survival as the primary endpoint","sponsor":"OncoGenex Technologies","result":"Median overall survival 23.4 against 22.0 months (hazard ratio 0.93, 95 percent confidence interval 0.79 to 1.10, p=0.415): no benefit.","yearReported":2017,"enrolled":1022,"enrolledBasis":"randomised","enrolledNote":"1,022 men were enrolled at 134 study centres in 12 countries between 10 December 2010 and 7 November 2012.","outcomes":[{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"Docetaxel, prednisone and custirsen","n":510,"value":23.4},{"name":"Docetaxel and prednisone","n":512,"value":22}],"hr":0.93,"ci":[0.79,1.1],"p":"0.415","source":"https://doi.org/10.1016/S1470-2045(17)30168-7"}],"replication":"AFFINITY tested the same drug with cabazitaxel after docetaxel in 635 men and also found no benefit."},"route":"/trials/synergy-custirsen/","neighbours":{"cancer":[{"id":"prostate-mcrpc","kind":"cancer","name":"Metastatic castration-resistant prostate cancer","route":"/cancers/prostate-mcrpc/"},{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"id":"antisense-sirna","kind":"technology","name":"Oligonucleotide therapeutics","route":"/technologies/antisense-sirna/"}],"drug":[{"id":"custirsen","kind":"drug","name":"Custirsen","route":"/drugs/custirsen/"},{"id":"docetaxel","kind":"drug","name":"Docetaxel","route":"/drugs/docetaxel/"},{"id":"prednisone","kind":"drug","name":"Prednisone","route":"/drugs/prednisone/"}],"company":[{"id":"achieve-life-sciences","kind":"company","name":"Achieve Life Sciences (formerly OncoGenex)","route":"/companies/achieve-life-sciences/"}],"term":[{"id":"castration-resistance","kind":"term","name":"Castration-resistant prostate cancer (CRPC)","route":"/terms/castration-resistance/"},{"id":"prostate-failed-programmes","kind":"term","name":"Prostate cancer programmes that failed, and what each failure taught","route":"/terms/prostate-failed-programmes/"}],"trial":[{"id":"affinity-custirsen","kind":"trial","name":"AFFINITY","route":"/trials/affinity-custirsen/"},{"id":"tax-327","kind":"trial","name":"TAX 327","route":"/trials/tax-327/"}]}}