localized high-risk prostate cancer MedDRA version: 20.0 Level: PT Classification code 10071119 Term: Hormone-dependent prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
SOTIO a.s.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): The survival rate of patients without initiation of salvage therapy2 five years after randomization Incidence of adverse events The survival rate of patients without objective disease progression3 five years after randomization Overall survival Exploratory endpoints Immune response 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 | — |
Countries
Czech Republic
Contacts
Public ContactClinical Trials Sotio
SOTIO a.s.
Outcome results
None listed