Randomized, open-label, parallel-group, multi-centre phase II clinical trial with active cellular immunotherapy DCVAC/PCa in patients with localized high-risk prostate cancer after primary radiotherapy
- Conditions
- localized high-risk prostate cancerTherapeutic area: Diseases [C] - Cancer [C04]MedDRA version: 20.0Level: PTClassification code 10071119Term: Hormone-dependent prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2011-004967-65-CZ
- Lead Sponsor
- SOTIO a.s.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 62
I-1) Men aged = 18 years
I-2) Histologically confirmed localized high-risk or very high-risk prostate cancer meeting at least one of the following criteria: stage T3-T4 or Gleason Score 8 – 10 or PSA level higher than 20 ng/mL
I-3) Indication for radical radiotherapy for prostate cancer
I-4) The following laboratory values: WBC > 4 x 10(9)/L, platelet count > 100 x 10(9)/L, Hct > 30%, creatinine under 1.5 times the upper limit of normal, bilirubin, AST and ALT under two times the upper limit of normal
I-5) Neoadjuvant androgen deprivation therapy for prostate cancer with LHRH analogs lasting at least 2 months and not initiated more than 12 months before randomization
I-6) Indication for adjuvant androgen deprivation therapy
I-7) ECOG 0-2 Performance Status
I-8) Signed informed consent to participate in the study
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 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15
E-1) Sexually active fertile men not using effective birth control, if their partners are of fertile age and of child-bearing potential
E-2) Comorbidities of the patient:
E-2a) HIV-positive
E-2b) Active hepatitis B or C
E-2c) Active bacterial, viral or mycotic infection requiring systemic treatment
E-2d) Clinically significant cardiovascular disease, including myocardial infarction or ventricular tachyarrhythmia in previous 6 months, percutaneous coronary intervention or surgical revascularization in the past 6 months, heart failure NYHA II-IV, known left ventricular dysfunction with ejection fraction < 40% or haemodynamically significant arrhythmias or conduction problems, unless treated with permanent cardiac pacing
E-2e) Pleural or pericardial effusion of any CTC grade
E-2f) Peripheral neuropathy CTC Grade = 2
E-2g) Other uncontrolled coexisting condition, uncompensated psychiatric illness or social situation that would limit the patient’s compliance
E-2h) Patients with a history of malignancy other than non-melanoma skin cancer
E-2i) Unresolved ongoing urinary tract obstruction
E-2j) Active autoimmune disease requiring therapy
E-2k) History of primary immunodeficiency
E-3) Allergy and adverse drug reactions:
E-3a) History of allergic reaction to a compound of the same or similar structure as the medication used in this study
E-3b) History of anaphylaxis or other severe reaction following vaccination
E-4) Any other reason the Investigator considers serious so that the patient should not participate in the study
E-5) Primary surgical treatment for prostate cancer
E-6) History of or ongoing chemotherapy for prostate cancer
E-7) Participation in another clinical trial or administration of another investigational medicinal product within 30 days preceding the screening
E-8) Immunotherapy other than specified in this protocol
E-9) Presence of generalized metastatic disease
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The clinical trial’s objective is to estimate the survival rate of patients without PSA failure 5 years after randomization;Secondary Objective: The clinical trial’s objective is to estimate the survival rate of patients without PSA failure, the survival rate of patients without initiation of salvage therapy 5 years after randomization, time to objective disease progression (time to Distant Failure - DF), overall survival and the incidence of adverse events.<br><br>An exploratory objective is to search for potential biomarkers that could play a role as prognostic factors, indicate the biological effect of ACI on immuneresponse or identify a subgroup of patients profiting from cancer immunotherapy based on gene expression profiling.;Primary end point(s): The primary endpoint of the clinical trial is the survival rate of patients without PSA failure five years after randomization.;Timepoint(s) of evaluation of this end point: N/A
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The survival rate of patients without initiation of salvage therapy2 five years after randomization<br>Incidence of adverse events<br>The survival rate of patients without objective disease progression3 five years after randomization<br>Overall survival<br><br>Exploratory endpoints<br>Immune response<br>Gene expression profiling, and/or expression levels of pre-defined set of immune or cancer-related genes;Timepoint(s) of evaluation of this end point: N/A