The randomized, double blind, multicenter, parallel-group Phase III trial is designed to evaluate the safety and efficacy of DCVAC/PCa as an add-on therapy to 1st line standard of care chemotherapy in men with metastatic Castration Resistant Prostate Cancer (mCRPC).
The trial is based on overall survival (OS) in mCRPC patients treated with DCVAC/PCa versus placebo with standard of care chemotherapy.
First patient in the trial was enrolled in Hungarian Army Medical Center (Magyar Honvédség Egészségügyi Központ), Department of Oncology.
The trial will enroll patients through cooperation with medical centers in 20 countries including Belgium, Bulgaria, Croatia, the Czech Republic, France, Germany, Hungary, Italy, the Netherlands, Poland, Portugal, Romania, Russia, Serbia, Slovakia, Spain, Sweden, Turkey, the UK and the US.
The company said that initiations of individual countries have already been started and the first patients will be enrolled in the coming weeks.
About 1,170 prostate cancer patients are expected to be enrolled in the trial from Europe, Russia and the US.
Image: The Phase III VIABLE trial will evaluate the safety and efficacy of DCVAC/PCa in men with metastatic Castration Resistant Prostate Cancer (mCRPC). Photo: courtesy of jscreationzs/ freedigitalphotos.net