Randomized, open-label, parallel-group, multi-centre phase II clinical trial with active cellular immunotherapy DCVAC/PCa in patients with castrate-resistant prostate cancer
- Conditions
- metastatic castrate-resistant prostate cancerMedDRA version: 19.0Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-004735-32-CZ
- Lead Sponsor
- SOTIO a.s.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- Not specified
I-1) Men aged = 18 years
I-2) Histologically confirmed prostate cancer
I-3) Presence of metastatic bone disease according to at least one of the following modalities: bone scan (scintigraphy, PET-CT), confirmed pathological fracture, evidence of bone metastases confirmed by MRI or CT
I-4) Presence of progression defined as at least one of the following:
I-4a) PSA level increasing by at least 2 ng/mL at an interval of at least 14 days with an absolute value = 5 ng/mL and = 50% above the PSA minimum reached during the ADT (androgen deprivation therapy) or above the level prior to treatment, if there was no response.
I-4b) Two or more new lesions discovered on the bone scan or CT or MRI as compared with the preceding scan
I-5) Continuing castrate condition: Patients who did not undergo surgical orchiectomy have to continue hormone drug therapy (GnRH/LHRH analogs) to maintain the castrate level of serum testosterone = 1.7 nmol/l (50 ng/dl). The castrate condition has to be at least 3 months before enrolment to the study and continue for the study duration.
I-6) The following laboratory values: WBC > 4 x 10(9)/L, ANC = 1.5x 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.
I-7) ECOG 0-2 Performance Status
I-8) Signed informed consent to participate in the study
I-9) Recovery from primary local surgery, radiotherapy or orchiectomy.
I-10) At least 8 weeks from radioisotope therapy (Samarium-153, Strontium -89 or similar)
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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
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 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 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) Patients already treated with chemotherapy for prostate cancer (except estramustine)
E-6) Patients with brain and leptomeningeal metastases
E-7) Participation in another clinical trial or administration of another investigational medicinal product within 30 days preceding the screening
E-8) Treatment with antiandrogens, inhibitors of adrenal androgen production, or any other anti-tumor hormone therapy ongoing on the day of screening or in preceding 4 weeks except GnRH/LHRH analogs
E-9) Immunotherapy other than specified in this protocol
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 34 months after randomization, estimate the proportion of patients without progression 34 months after randomization, evaluate quality of life and the influence on the pain scale scoring using the standardized EORTC QLQ-C30 (version 3.0) questionnaire 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 the immune-reponse or identify a subgroup of patients profiting from cancer immunotherapy based on gene expression profiling.<br>;Secondary Objective: not applicable;Primary end point(s): • The survival rate of patients 34 months 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 disease progression and without PSA progression 34 months after randomization<br>•The survival rate of patients without disease progression 34 months after randomization <br>•Incidence of adverse events<br>•Quality of life as per standardized EORTC QLQ-C30 questionnaire, version 3, European Organization for Research and Treatment of Cancer<br>•Pain scale influence scoring as per standardized EORTC QLQ-C30 questionnaire version 3, European Organization for Research and Treatment of Cancer<br><br>Exploratory endpoints<br>•Immune response <br>•Gene expression profiling, and/or expression levels of a defined set of immune or cancer-related genes, respectively;Timepoint(s) of evaluation of this end point: N/A