Phase I/II trial of vaccine therapy in curative resected prostate cancer patients using autologous dendritic cells loaded with mRNA from primary prostate cancer tissue, hTERT and surviving.

• Conditions: Prostatic cancer patients who have received curative surgery.

• Registration Number: EUCTR2010-018770-20-NO
• Lead Sponsor: Oslo University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-30
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

•Radical prostatectomy with negative resection margins. Preferably accessible tumor tissue with enough volume and quality for vaccine production (extraction of tumor mRNA).
•Pathological stage pT2 - pT3b and Gleason score 7B-10, pN0, pN+ or pNx.
•Must be ambulatory with an ECOG performance status 0 or 1.
•Tumor cells detected in bone-marrow samples (micrometastatic disease). Patients with Gleason score 9-10 may also be included with negative bone-marrow aspiration. Bone-marrow aspirates and plasma for microRNA will be obtained before start of surgery.
•Must be at least 18 years of age and less than 75 years.
•PSA < 0.2µg/L within 6 weeks after surgery.
•Must have lab values as the following:
ANC = 1.5 x 109/L
Platelets = 100 x 109/L
Hb = 9 g/dL (= 5.6 mmol/L)
Creatinine = 140 µmol/L (1.6 mg/dL); if borderline, the creatinine clearance = 40 mL/min
Bilirubin within the upper limit of normal
ASAT and ALAT = 2.5 the upper limit of normal
Albumin levels above lower normal value
•No metastasis on bone scans or MRI, last 3 months before inclusion.
•Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH/GCP, and national/local regulations

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Previous treatment with LHRH agonist.
•Previous anti-androgen treatment (Casodex).
•History of prior malignancy within the last 5 years, with the exception of curatively treated basal cell carcinoma.
•Active infection requiring antibiotic therapy.
•Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia.
•Adverse reactions to vaccines such as asthma, anaphylaxis or other serious reactions.
•History of immunodeficiency or autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis-dermatomyositis, juvenile onset insulin dependent diabetes, or a vasculitic syndrome.
•Use of systemic glucocorticoids.
•Negative testing for HIV, Hepatitis B and C
•Any reason why, in the opinion of the investigator, the patient should not participate.

Study & Design

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