Randomized, open-label, parallel-group, multi-centre phase II clinical trial with active cellular immunotherapy DCVAC/PCa in combination with hormone therapy in patients with metastatic prostate cancer

Phase 1

• Conditions: metastatic prostate cancer; MedDRA 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: EUCTR2011-004986-34-CZ
• Lead Sponsor: SOTIO a.s.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-10
• Last Update Posted: 10 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified