Metastatic Castration Resistant Prostate Cancer Eligible for 1st Line Chemotherapy
Conditions
Interventions
2 treatment arms (2:1 randomisation):
- DCVAC/PCa + standard of care chemotherapy
- placebo + standard of care chemotherapy
Sponsors
SOTIO a.s.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: •Male 18 years and older. ;•Histologically or cytologically confirmed prostate adenocarcinoma.;•Presence of skeletal and/or soft-tissue/visceral/nodal metastases according to one of the following criteria: ;Confirmed pathological fracture related to the disease.;Confirmation of distant bone and/or soft-tissue and/or visceral metastases through at least one imaging modality including CT or MRI or scintigraphy scan. (confirmation by independent review facility (IRF) required);Positive pathology report of metastatic lesion.;•Disease progression despite androgen deprivation therapy (ADT) as indicated by: ;PSA increase that is >= 2 ng/mL and >= 25% above the minimum PSA as reached during ADT or above the pre-treatment level, if no response was observed and which is confirmed by a second value 1 or more weeks later. ;OR;Progression of measurable lymph nodes (short axis >= 15mm) or visceral lesion measurable per RECIST v1.1 criteria (confirmation by IRF required);;OR;Two or more new lesions appearing on bone scan/imaging compared with a previous scan (confirmation by IRF required);•Maintenance of castrate conditions: patients, who have not had a surgical orchiectomy, must continue with hormone therapy (GnRH/LHRH agonists or antagonists) to reach levels of serum testosterone of
Exclusion criteria
Exclusion criteria: •Confirmed brain and/or leptomeningeal metastases ;(other visceral metastases are acceptable).;•Current symptomatic spinal cord compression requiring surgery or radiation therapy.;•Prior chemotherapy for prostate cancer ;•Patient co-morbidities:;Subjects who are not indicated for chemotherapy treatment with first line Standard of Care chemotherapy (docetaxel and prednisone).;HIV positive, HTLV positive.;Active hepatitis B (active HBV), defined in protocol section 7.6.8, active hepatitis C (HCV), active syphilis. ;Evidence of active bacterial, viral or fungal infection requiring systemic treatment.;Clinically significant cardiovascular disease including: ;symptomatic congestive heart failure. ;unstable angina pectoris. ;serious cardiac arrhythmia requiring medication.;uncontrolled hypertension.;myocardial infarct or ventricular arrhythmia or stroke within a 6 months before screening, known left ventricular ejection fraction LVEF <40% or serious cardiac conduction system disorders, if a pacemaker is not present. ;Pleural and pericardial effusion of any CTCAE grade.;Peripheral neuropathy having a CTCAE >=grade 2.;History of active malignant disease (with the exception of non-melanoma skin tumors) in the preceding five years.;Active autoimmune disease requiring treatment.;History of severe forms of primary immune deficiencies.;History or anaphylaxis or other serious reaction following vaccination.;Known hypersensitivity to any constituent in of the DCVAC/PCa or placebo product;Uncontrolled co-morbidities including, psychiatric or social conditions which, in the Investigator*s opinion, would prevent participation in the trial.;•Systemic corticosteroids at doses greater than 40mg hydrocortisone daily or equivalent for any reason other than treatment of prostate cancer (PCa) within 6 months before randomization.;•Ongoing systemic immunosuppressive therapy for any reason. ;•Treatment with anti-androgens, inhibitors of adrenal-produced androgens or other hormonal tumor-focused treatment performed on the day of screening or within previous four weeks (except for GnRH/LHRH agonists or antagonists) to exclude possible anti-androgen withdrawal response. (This criterion is not applicable to subjects, who have never responded to anti-androgen treatment).;•Treatment with immunotherapy against PCa within 6 months before randomization.;•Treatment with radiopharmaceutical within previous 8 weeks before randomization.;•Participation in a clinical trial using experimental therapy within 4 weeks before randomization.;•Participation in a clinical trial using immunological experimental therapy (e.g. monoclonal antibodies, cytokines or active cellular immunotherapies) within 6 months prior to randomization.;•Refusal to sign the informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to show superiority of treatment with DCVAC/PCa in addition to Standard of Care chemotherapy (docetaxel plus prednisone) over placebo in addition to Standard of Care chemotherapy (docetaxel plus prednisone) in men with mCRPC as measured by OS. | — |
Secondary
| Measure | Time frame |
|---|---|
| Key Secondary objectives: The key secondary objectives include assessments of safety, treatment group comparison with regards to Radiographic progression free survival (rPFS), time to prostate-specific antigen progression, time to first occurrence of skeletal related events (SRE), Other Secondary objectives: To show clinical benefit of treatment with DCVAC/PCa plus Standard of Care over Placebo in addition to Standard of Care with regard to time to radiographic progression or SRE, proportion of patients with skeletal related events (SRE), | — |
Countries
Netherlands
Outcome results
None listed