metastatic prostate cancer MedDRA version: 19.0 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: DCVAC/PCa
Product Code: DCVAC/PCa
Pharmaceutical Form: Solution for injection
INN or Proposed INN: DCVAC/PCa
CAS Number: DCVAC/PCa
Current Sponsor code: DCVAC/PCa
Other descriptive name:
Sponsors
SOTIO a.s.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Inc-1) Men aged = 18 years Inc-2) Histologically confirmed prostate carcinoma Inc-3) Bone or soft-tissue (other than brain or leptomeningeal) metastases confirmed by CT of the abdomen and small pelvis and/or bone scintigraphy Inc-4) The androgen deprivation therapy with LHRH analogs started not less than 1 month and not more than 3 months prior to the screening, or orchiectomy performed not less than 1 month and not more than 3 months prior to the screening Inc-5) ECOG 0-2 Performance Status Inc-6) The following laboratory values: WBC > 4 x 10(9)/L, ANC = 1.5 x 10(9)/L, platelet count > 100 x 10(9)/L, Hb = 90 g/L, Hct > 30%, Creatinine under 1.5 times the upper limit of normal, bilirubin, AST and ALT under 1.5 times the upper limit of normal. Inc-7) Castrate level of serum testosterone at screening (= 1.7 nmol/L, or = 50 ng/dL) Inc-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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 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 patient’s compliance. E-2h) Patients with a history of second malignancy other than non-melanoma skin cancer. E-2i) Unresolved ongoing clinically significant 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 medication used in this study. E-3b) History of anaphylaxis or other severe reaction following vaccination E-4) Any other serious reason the Investigator considers the patient should not participate in the study E-5) History of or ongoing chemotherapy for prostate cancer E-6) Patients with brain metastases or leptomeningeal metastases E-7) Ongoing unresolved post-operative complication of orchiectomy, which either requires treatment or restricts patient’s everyday activities E-8) Participation in another clinical trial or administration of another investigational medicinal product within 30 days preceding the screening E-9) Immunotherapy other than specified in this protocol E-10) Prohibited concomitant medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The clinical trial’s objective is to estimate the proportion of patients with PSA progression within two years after randomization.;Secondary Objective: The clinical trial’s objective is to estimate the proportion of patients with a disease progression within two years of randomization, quality of life and the influence on the pain scale scoring using the standardized EORTC QLQ-C30 (v3.0) questionnaire, the incidence of adverse events and overall survival. An exploratory objective is to search for potential biomarkers that could play role as prognostic factors, indicate the biological effect of ACI on immune-response or identify a subgroup of patients profiting from cancer immunotherapy based on gene expression profiling.;Primary end point(s): The proportion of patients with a PSA progression within two years after randomization;Timepoint(s) of evaluation of this end point: 2 years after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The proportion of patients with disease progression within two years of randomization; Incidence of adverse events; Overall survival; Quality of life; Pain scale influence scoring; Exploratory endpoints - Immune response; Gene expression profiling, and/or expression levels of defined set of immune or cancer related genes, respectively;Timepoint(s) of evaluation of this end point: N/A | — |
Countries
Czech Republic
Contacts
Public ContactClinical Trials Sotio
SOTIO a.s.
Outcome results
None listed