{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["8(4)"],"submitter":["Vogelzang NJ"],"pubmed_abstract":["<h4>Importance</h4>DCVAC/PCa is an active cellular immunotherapy designed to initiate an immune response against prostate cancer.<h4>Objective</h4>To evaluate the efficacy and safety of DCVAC/PCa plus chemotherapy followed by DCVAC/PCa maintenance treatment in patients with metastatic castration-resistant prostate cancer (mCRPC).<h4>Design, setting, and participants</h4>The VIABLE double-blind, parallel-group, placebo-controlled, phase 3 randomized clinical trial enrolled patients with mCRPC among 177 hospital clinics in the US and Europe between June 2014 and November 2017. Data analyses were performed from December 2019 to July 2020.<h4>Interventions</h4>Eligible patients were randomized (2:1) to receive DCVAC/PCa (add-on and maintenance) or placebo, both in combination with chemotherapy"],"journal":["JAMA oncology"],"pagination":["546-552"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC8832307"],"repository":["biostudies-literature"],"pubmed_title":["Efficacy and Safety of Autologous Dendritic Cell-Based Immunotherapy, Docetaxel, and Prednisone vs Placebo in Patients With Metastatic Castration-Resistant Prostate Cancer: The VIABLE Phase 3 Randomized Clinical Trial."],"pmcid":["PMC8832307"],"pubmed_authors":["Aapro M","Tomova A","Purkalne G","Rodrigues T","Polee M","Dzamic Z","Vilarino-Varela M","Hajek J","Jhangiani H","Gandhi J","Mikulas J","Montesa A","Tulyte S","Stadler W","von Schmeling IK","Beeker A","Bodoky G","Kucuk O","Cortesi E","Ritter M","Bahl A","Kindlova E","Kukielka-Budny B","Williamson S","Corman J","Reyes E","Sartor A","Kurth KH","Beer TM","Boszormenyi-Nagy G","Singal R","Arranz JA","Juretic A","Melichar B","Bryce A","Jansa J","Shtivelband M","Gaur R","Hruby S","Mincik I","Gartrell B","Sousa N","Ackaert K","Miller K","Herden J","Feyerabend S","Asadauskiene J","Pedley I","Csoszi T","Jarolim L","Nieboer P","Chapado MS","Karlsson ET","Wiechno P","Dimitrov B","Gil T","Stenzl A","Kadlecova P","Koleva M","Agarwala S","Flaig T","Lumen N","Prausova J","Berg AS","Rubio G","Drabek M","Spisek R","Shore N","SotoParra H","Higano CS","Culine S","Sousa G","Ferrau F","Hauke R","Nordquist L","Cheung E","Maio M","Schraml J","Agrawal A","Brezovsky M","Ahlgren J","van de Eertwegh F","Wuelfing C","Karaszewska B","Agrawal M","Grimm MO","Chodacka M","Polyakov S","Law A","Karim N","Krainer M","Janciauskiene R","Gajdos M","Haberkorn B","Fijuth J","Wirth M","Schnadig I","Belkoff L","Minchev V","McCroskey R","Oudard S","Elliott T","Le Moulec S","Sikora-Kupis B","Olmos D","Castellano D","Hussain S","Deplanque G","Vogelzang NJ","Cesas A","Sokol R","Burke J","Fornara P","Korolkiewicz RP","Cvetkovic B","Bloom S","Dawson N","Sharma S","Daugaard G","Rodemer G","Roumeguere T","Clarkson D","McClay E","Fernandes I","Breza J","Calvo V","Boegemann M","Papai Z","Passalacqua R","Staroslawska E","Prokhorov A","Samal V","Delonchamps N","Filipovic Z","Keck B","Gerritsen W","Choi B","Vojnovic Z","Buchler T","Merseburger A","Slater D","Bilusic M","Fleming M","Mellado B","Redfern C","Jaeger E","Boreu PG","Zemanova M","Appleman L","Hammerer P","Vaishampayan U","Zarkar A","Goncalves F","Oh W","Harshman L","Machiels JP","Bartunkova J","Meran J","Karlin G","Puente J","Hussain A","Frobe A","Babovic N","Fricke H","Walsh W","Poiesz B","Pandha H","Damjanoski I","van den Berg P","Fratino L","Gunuganti V","Scheiner T","Vanella P","Hwang C","Burmester M","VIABLE Investigators","Mayer T","Khoo V","Mazhar D","Zdrojowy R","Winter A","Duclos B"],"additional_accession":[]},"is_claimable":false,"name":"Efficacy and Safety of Autologous Dendritic Cell-Based Immunotherapy, Docetaxel, and Prednisone vs Placebo in Patients With Metastatic Castration-Resistant Prostate Cancer: The VIABLE Phase 3 Randomized Clinical Trial.","description":"<h4>Importance</h4>DCVAC/PCa is an active cellular immunotherapy designed to initiate an immune response against prostate cancer.<h4>Objective</h4>To evaluate the efficacy and safety of DCVAC/PCa plus chemotherapy followed by DCVAC/PCa maintenance treatment in patients with metastatic castration-resistant prostate cancer (mCRPC).<h4>Design, setting, and participants</h4>The VIABLE double-blind, parallel-group, placebo-controlled, phase 3 randomized clinical trial enrolled patients with mCRPC among 177 hospital clinics in the US and Europe between June 2014 and November 2017. Data analyses were performed from December 2019 to July 2020.<h4>Interventions</h4>Eligible patients were randomized (2:1) to receive DCVAC/PCa (add-on and maintenance) or placebo, both in combination with chemotherapy","dates":{"release":"2022-01-01T00:00:00Z","publication":"2022 Apr","modification":"2026-05-09T22:21:59.908Z","creation":"2024-11-12T22:05:38.747Z"},"accession":"S-EPMC8832307","cross_references":{"pubmed":["35142815"],"doi":["10.1001/jamaoncol.2021.7298"]}}