Phase I/II clinical trial: Immunotherapy of prostate cancer patients in biochemical relapse with dendritic cell-based vaccine - Imunoterapie karcinomu prostaty dendritickými bunkami
- Conditions
- Patients with prostate cancer in the stage of biochemical relapse
- Registration Number
- EUCTR2009-017259-91-CZ
- Lead Sponsor
- niversity Hospital Motol
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- Not specified
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method