The purpose of this study is to determine whether DCVAC/PCa added onto hormone therapy can improve PSA progression times for patients with Metastatic Prostate Cancer.
Use of vaccine to improve Prostate Specific Antigen (PSA) levels.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
63
Combination therapy with DCVAC/PCA add on to and Standard of Care Hormone Therapy
Standard of Care Hormone Therapy as an Active Comparator
Standard of Care Hormone Therapy as an Active Comparator
Unnamed facility
Jablonec nad Nisou, Czechia
Unnamed facility
Jihlava, Czechia
Unnamed facility
Liberec, Czechia
Unnamed facility
Mníšek pod Brdy, Czechia
Proportion of patients with PSA Progression
Time frame: 104 weeks
Proportion of patients with Progression of Disease
Time frame: 0, 6, 16, 28, 40, 52, 65, 78, 91, 104 weeks
Frequency of Adverse Events
Time frame: 0, 2, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 52, 65, 78, 91, 104 weeks
Frequency of Skeletal Related Events
Time frame: 0, 2, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 52, 65, 78, 91, 104 weeks
Changes in Quality of Life (QOL) assessed by EORTC QLQ-C30
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) form C30
Time frame: 0, 16, 28, 40, 52, 52, 65, 78, 91, 104 weeks
Changes in Pain assessed by EORTC QLQ-C30
Pain Scale from European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) form C30
Time frame: 0, 16, 28, 40, 52, 52, 65, 78, 91, 104 weeks
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Unnamed facility
Olomouc, Czechia
Unnamed facility
Pilsen, Czechia
Unnamed facility
Prague, Czechia
Unnamed facility
Ústí nad Labem, Czechia
Unnamed facility
Zlín, Czechia