{"entity":{"id":"vision","kind":"trial","name":"VISION","aka":[],"tldr":"VISION was the trial that established radioligand therapy in prostate cancer.","summary":"VISION, trial NCT03511664 sponsored by Novartis and published in the New England Journal of Medicine in 2021, was the trial that established radioligand therapy in prostate cancer. It randomised 831 men with PSMA-positive metastatic castration-resistant prostate cancer after an androgen receptor pathway inhibitor and a taxane to 177Lu-PSMA-617 plus standard care or standard care alone, selected by PSMA PET, and met both primary endpoints of overall and radiographic progression-free survival. Whether radioligand therapy should now be given before chemotherapy or even at diagnosis, as PSMAfore and PSMAddition test, is the open question.","status":"positive","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT03511664","url":"https://clinicaltrials.gov/study/NCT03511664"}],"tags":[],"related":["lu-177"],"indications":["prostate","prostate-mcrpc"],"sections":[],"technologies":["radioligand-therapy","psma-pet"],"targets":["psma"],"drugs":["pluvicto"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["oliver-sartor","ken-herrmann","michael-morris"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03511664","phase":"3","setting":"PSMA+ metastatic castration-resistant prostate cancer after ARPI and taxane: 177Lu-PSMA-617 + SOC vs SOC","sponsor":"Novartis","result":"OS HR 0.62.","yearReported":2021,"enrolled":861,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"177Lu-PSMA-617 + standard care","n":551,"value":15.3},{"name":"Standard care","n":280,"value":11.3}],"hr":0.62,"ci":[0.52,0.74],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2107322"},{"endpoint":"Radiographic progression-free survival","primary":true,"unit":"months","arms":[{"name":"177Lu-PSMA-617 + standard care","value":8.7},{"name":"Standard care","value":3.4}],"hr":0.4,"ci":[0.29,0.57],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2107322"}],"replication":"Consistent with TheraP (phase 2, 177Lu-PSMA-617 vs cabazitaxel: higher PSA response, similar OS) and with PSMAfore in an earlier line."},"route":"/trials/vision/","neighbours":{"isotope":[{"id":"lu-177","kind":"isotope","name":"Lutetium-177","route":"/isotopes/lu-177/"}],"indication":[{"id":"prostate-mcrpc","kind":"indication","name":"Metastatic castration-resistant prostate cancer","route":"/indications/prostate-mcrpc/"},{"id":"prostate","kind":"indication","name":"Prostate cancer","route":"/indications/prostate/"}],"technology":[{"id":"psma-pet","kind":"technology","name":"PSMA PET","route":"/technologies/psma-pet/"},{"id":"radioligand-therapy","kind":"technology","name":"Radioligand therapy (beta emitters)","route":"/technologies/radioligand-therapy/"}],"target":[{"id":"psma","kind":"target","name":"PSMA","route":"/targets/psma/"}],"drug":[{"id":"locametz","kind":"drug","name":"Locametz (kit for Ga-68 gozetotide)","route":"/drugs/locametz/"},{"id":"pluvicto","kind":"drug","name":"Lutetium-177 vipivotide tetraxetan","route":"/drugs/pluvicto/"}],"person":[{"id":"oliver-sartor","kind":"person","name":"A. Oliver Sartor","route":"/people/oliver-sartor/"},{"id":"ken-herrmann","kind":"person","name":"Ken Herrmann","route":"/people/ken-herrmann/"},{"id":"michael-morris","kind":"person","name":"Michael J. Morris","route":"/people/michael-morris/"},{"id":"phillip-kuo","kind":"person","name":"Phillip H. Kuo","route":"/people/phillip-kuo/"},{"id":"scott-tagawa","kind":"person","name":"Scott T. Tagawa","route":"/people/scott-tagawa/"}],"institution":[{"id":"essen-wtz","kind":"institution","name":"West German Cancer Center (WTZ), University Hospital Essen","route":"/institutions/essen-wtz/"}],"term":[{"id":"crossover","kind":"term","name":"Crossover in trials","route":"/terms/crossover/"},{"id":"estimand","kind":"term","name":"Estimands and intercurrent events (ICH E9(R1))","route":"/terms/estimand/"},{"id":"mcrpc-mhspc","kind":"term","name":"mCRPC and mHSPC (castration-resistant vs hormone-sensitive prostate cancer)","route":"/terms/mcrpc-mhspc/"},{"id":"myelosuppression-after-rlt","kind":"term","name":"Myelosuppression after radioligand therapy","route":"/terms/myelosuppression-after-rlt/"},{"id":"psma-rads","kind":"term","name":"PSMA-RADS (PSMA reporting and data system)","route":"/terms/psma-rads/"},{"id":"salivary-gland-toxicity","kind":"term","name":"Salivary gland toxicity (xerostomia) from PSMA radioligand therapy","route":"/terms/salivary-gland-toxicity/"}],"roadmap":[{"id":"dosimetry-roadmap","kind":"roadmap","name":"Dosimetry roadmap: MIRD schema → fixed dosing → personalised, image-based dose","route":"/roadmaps/dosimetry-roadmap/"},{"id":"psma-theranostics-roadmap","kind":"roadmap","name":"PSMA theranostics roadmap: antigen discovery → PSMA PET → 177Lu-PSMA-617 → earlier lines and alpha","route":"/roadmaps/psma-theranostics-roadmap/"},{"id":"radiopharma-roadmap","kind":"roadmap","name":"Radiopharmaceutical roadmap: iodine → lutetium → actinium","route":"/roadmaps/radiopharma-roadmap/"}],"bottleneck":[{"id":"b-manufacturing-cell-therapy","kind":"bottleneck","name":"Manufacturing cost and time for living and radioactive medicines","route":"/bottlenecks/b-manufacturing-cell-therapy/"}],"paper":[{"id":"paper-hofman-lupsma-lancet-oncol-2018","kind":"paper","name":"LuPSMA trial: single-arm phase 2 study of 177Lu-PSMA-617 in metastatic castration-resistant prostate cancer","route":"/key-papers/paper-hofman-lupsma-lancet-oncol-2018/"},{"id":"paper-psmafore-lancet-2024","kind":"paper","name":"PSMAfore: 177Lu-PSMA-617 versus a change of androgen receptor pathway inhibitor in taxane-naive mCRPC","route":"/key-papers/paper-psmafore-lancet-2024/"},{"id":"paper-therap-lancet-2021","kind":"paper","name":"TheraP: [177Lu]Lu-PSMA-617 versus cabazitaxel in metastatic castration-resistant prostate cancer","route":"/key-papers/paper-therap-lancet-2021/"},{"id":"paper-vision-nejm-2021","kind":"paper","name":"VISION: lutetium-177 PSMA-617 radioligand therapy extends survival in advanced prostate cancer","route":"/key-papers/paper-vision-nejm-2021/"}],"section":[{"id":"f-radioligand-therapy","kind":"section","name":"Radioligand therapy","route":"/fronts/f-radioligand-therapy/"}],"idea":[{"id":"idea-rlt-plus-checkpoint-inhibitor","kind":"idea","name":"Adding a checkpoint inhibitor to PSMA radioligand therapy","route":"/ideas/idea-rlt-plus-checkpoint-inhibitor/"},{"id":"idea-dosimetry-guided-dosing-standard","kind":"idea","name":"Kidney-dosimetry-guided dosing as the default for PSMA radioligand therapy","route":"/ideas/idea-dosimetry-guided-dosing-standard/"}],"pairing":[{"id":"docetaxel-then-lu177-psma","kind":"pairing","name":"Docetaxel (taxane chemotherapy) then 177Lu-PSMA-617","route":"/pairings/docetaxel-then-lu177-psma/"}],"trial":[{"id":"prince-trial","kind":"trial","name":"PRINCE","route":"/trials/prince-trial/"}]}}