A Randomized, Double Blind, Multicenter, Parallel-group, Phase III study to evaluate efficacy and safety of DCVAC/PCa versus Placebo in Men with metastatic Castration Resistant Prostate Cancer eligible for 1st line chemotherapy
- Conditions
- Metastatic Castration Resistant Prostate Cancer Eligible for 1st Line Chemotherapy1003859710036958
- Registration Number
- NL-OMON46876
- Lead Sponsor
- SOTIO a.s.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 73
•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 <=1.7nmol/l (50ng/dl). The duration of the castration period must be at least 4 months before screening as evidenced by combination of clinical/laboratory data (see section 6.8.1). ;•Laboratory criteria:;White blood cells greater than 4,000/mm(3) (4.0 x10(9)/L).;Neutrophil count greater than 1,500/mm(3) (1.5 x10(9)/L).;Hemoglobin of at least 10 g/dL (100g/L).;Platelet count of at least 100,000/mm(3) (100 x10(9)/L).;Total bilirubin within normal limits (benign hereditary hyperbilirubinaemias, e.g. Gilbert*s syndrome are permitted). ;Serum alanine aminotransferase, aspartate aminotransferase, and creatinine <1.5x times the ULN. ;•Life expectancy of at least 6 months based on Investigator*s judgment.;•Eastern Cooperative Oncology group (ECOG) Performance status 0-2. ;•At least 4 weeks after surgery or radiotherapy before randomization ;•A minimum of 28 days beyond initiation of bisphosphonate or denosumab therapy before randomization;•Recovery from primary local surgical treatment, radiotherapy or orchiectomy before randomization;•Signed informed consent including patient*s ability to comprehend its contents
•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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective is to show superiority of treatment with DCVAC/PCa in<br /><br>addition to Standard of Care chemotherapy (docetaxel plus prednisone) over<br /><br>placebo in addition to Standard of Care chemotherapy (docetaxel plus<br /><br>prednisone) in men with mCRPC as measured by OS.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Key Secondary objectives:<br /><br>The key secondary objectives include assessments of safety, treatment group<br /><br>comparison with regards to Radiographic progression free survival (rPFS), time<br /><br>to prostate-specific antigen progression, time to first occurrence of skeletal<br /><br>related events (SRE),<br /><br><br /><br>Other Secondary objectives:<br /><br>To show clinical benefit of treatment with DCVAC/PCa plus Standard of Care over<br /><br>Placebo in addition to Standard of Care with regard to time to radiographic<br /><br>progression or SRE, proportion of patients with skeletal related events (SRE), </p><br>