{"entity":{"id":"proselica","kind":"trial","name":"PROSELICA","aka":["PROSELICA","cabazitaxel 20 against 25 mg/m2"],"tldr":"A lower dose of cabazitaxel works nearly as well and causes far fewer serious side effects, which is why most men now start on the lower dose.","summary":"PROSELICA randomised 1,200 men with metastatic castration-resistant prostate cancer after docetaxel to cabazitaxel 20 mg/m2 (598) or 25 mg/m2 (602), stratified by ECOG performance status, measurability of disease and region. Non-inferiority required the upper bound of the hazard ratio confidence interval for the lower dose to stay below 1.214, which corresponds to keeping at least half the survival advantage cabazitaxel had over mitoxantrone in TROPIC.\n\nMedian overall survival was 13.4 months at 20 mg/m2 and 14.5 months at 25 mg/m2, hazard ratio 1.024 with an upper bound of 1.184: non-inferiority was met.\n\nThe efficacy secondary endpoints favoured the higher dose. PSA response occurred in 29.5 percent at 20 mg/m2 against 42.9 percent at 25 mg/m2 (nominal p<0.001), and median time to PSA progression was 5.7 against 6.8 months, hazard ratio 1.195 (95 percent confidence interval 1.025 to 1.393). Health-related quality of life did not differ.\n\nThe safety endpoint is why the trial changed practice: grade 3 or 4 treatment-emergent adverse events occurred in 39.7 percent at 20 mg/m2 against 54.5 percent at 25 mg/m2. For an older or frailer man the lower dose is the reasonable default, and the trade-off, a poorer PSA response for a substantially lower chance of a serious event, is one worth stating to him.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT01308580","url":"https://clinicaltrials.gov/study/NCT01308580"},{"label":"PROSELICA (Journal of Clinical Oncology 2017)","url":"https://doi.org/10.1200/JCO.2016.72.1076"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["cabazitaxel","prednisone"],"companies":["sanofi"],"institutions":[],"pathways":[],"terms":["castration-resistance","psa50","qol-pro"],"trials":["tropic","firstana","card"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01308580","phase":"3","setting":"Metastatic castration-resistant prostate cancer after docetaxel: cabazitaxel 20 mg/m2 against 25 mg/m2, with a non-inferiority design requiring the lower dose to keep at least half the survival benefit cabazitaxel showed against mitoxantrone in TROPIC","sponsor":"Sanofi","result":"Median overall survival 13.4 months at cabazitaxel 20 mg/m2 against 14.5 months at 25 mg/m2 (hazard ratio 1.024, upper bound 1.184, non-inferior); grade 3 or 4 adverse events 39.7 against 54.5 percent, PSA response 29.5 against 42.9 percent.","yearReported":2017,"enrolled":1200,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"Cabazitaxel 20 mg/m2","n":598,"value":13.4,"note":"Upper bound of the confidence interval 1.184, below the non-inferiority margin of 1.214."},{"name":"Cabazitaxel 25 mg/m2","n":602,"value":14.5}],"hr":1.024,"source":"https://doi.org/10.1200/JCO.2016.72.1076"},{"endpoint":"Grade 3 or 4 treatment-emergent adverse events","unit":"%","arms":[{"name":"Cabazitaxel 20 mg/m2","n":598,"value":39.7},{"name":"Cabazitaxel 25 mg/m2","n":602,"value":54.5}],"source":"https://doi.org/10.1200/JCO.2016.72.1076"},{"endpoint":"PSA response","unit":"%","arms":[{"name":"Cabazitaxel 20 mg/m2","n":598,"value":29.5},{"name":"Cabazitaxel 25 mg/m2","n":602,"value":42.9}],"p":"<0.001 nominal","source":"https://doi.org/10.1200/JCO.2016.72.1076"}],"replication":"Confirms the efficacy of cabazitaxel established in TROPIC at a lower dose; FIRSTANA, run in parallel, showed cabazitaxel is not superior to docetaxel in the first line."},"route":"/trials/proselica/","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/"}],"drug":[{"id":"cabazitaxel","kind":"drug","name":"Cabazitaxel","route":"/drugs/cabazitaxel/"},{"id":"prednisone","kind":"drug","name":"Prednisone","route":"/drugs/prednisone/"}],"company":[{"id":"sanofi","kind":"company","name":"Sanofi","route":"/companies/sanofi/"}],"term":[{"id":"castration-resistance","kind":"term","name":"Castration-resistant prostate cancer (CRPC)","route":"/terms/castration-resistance/"},{"id":"psa50","kind":"term","name":"PSA50 / PSA90 response","route":"/terms/psa50/"},{"id":"qol-pro","kind":"term","name":"Quality of life and patient-reported outcomes (QoL, PRO)","route":"/terms/qol-pro/"},{"id":"prostate-crpc-sequencing","kind":"term","name":"What follows what in castration-resistant prostate cancer","route":"/terms/prostate-crpc-sequencing/"}],"trial":[{"id":"card","kind":"trial","name":"CARD","route":"/trials/card/"},{"id":"firstana","kind":"trial","name":"FIRSTANA","route":"/trials/firstana/"},{"id":"tropic","kind":"trial","name":"TROPIC","route":"/trials/tropic/"}]}}