Patients with prostate cancer in the stage of biochemical relapse
Conditions
Sponsors
University Hospital Motol
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Histological confirmed prostatic adenocarcinoma Biochemical relapse after prostatectomy or radiotherapy Absence of hormonal therapy Karnofsky performance status more than 80% Signed informed consent Inclusion criteria for extension (for cycle 2 and following cycles): Administration of at least 5 vaccines in the previous cycle PSA=0.5 ng/ml Signed informed consent for extension Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Stage T3a, T3b, T4 or any other T with N1 M1 HIV positivity, active B or C hepatitis Severe cardiac or other internal disease limiting patient survival History of primary immunodeficiency, active autoimmunity requiring treatment or anaphylactic reaction after previous vaccination Negative informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Safety and toxicity;Secondary Objective: Immunological and biochemical responses;Primary end point(s): Evaluation of adverse reaction to the vaccination with DC, immunological and biochemical response to vaccine | — |
Countries
Czech Republic
Outcome results
None listed