The purpose of this study is to determine whether DCVAC/PCa added after radical primary prostatectomy can improve PSA doubling times for patients with localized Prostate Cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
DCVAC/PCa Experimental therapy
Unnamed facility
Brno, Czechia
Unnamed facility
Hradec Králové, Czechia
Unnamed facility
Jablonec nad Nisou, Czechia
Unnamed facility
Jihlava, Czechia
Change in Prostate Specific Antigen (PSA) Doubling Time from randomization to week 40
Time frame: 40 Weeks
Change in PSA Doubling Time during Follow-up from week 40 to 2 years after randomization
Time frame: 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
Proportion of Patients with Objective disease progression within 2 years
Time frame: 104 Weeks
Number of Patients requiring further therapy at 2 years
Time frame: 104 Weeks
Comparison of PSA Doubling Time in Treatment Phase with Immunotherapy with the Value Prior to Randomization
Time frame: 104 Weeks
Proportion of patients after RPE with biochemical relapse within 2 years of randomization
Time frame: 104 Weeks
Proportion of patients with progressive increase in PSA within 2 years of randomization
Time frame: 104 Weeks
Overall survival
Time frame: 104 Weeks
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Unnamed facility
Mníšek pod Brdy, Czechia
Unnamed facility
Nový Jičín, Czechia
Unnamed facility
Olomouc, Czechia
Unnamed facility
Pilsen, Czechia
Unnamed facility
Prague, Czechia
Unnamed facility
Uherské Hradiště, Czechia
...and 1 more locations