Trial of Vaccine Therapy in Curative Resected Prostate Cancer Patients Using Autologous Dendritic Cells Loaded With mRNA From Primary Prostate Cancer Tissue, hTERT and Survivin
- Radical prostatectomy. 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 or pT3b Gleason score 8 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 < 0.2 µg/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
- Previous treatment with LHRH (Luteinizing Hormone-Releasing Hormone) 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
- 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.
- Positive testing for syphilis (treponema pallidum), HIV, Hepatitis B and C
- Use of systemic glucocorticoids.
- Any reason why, in the opinion of the investigator, the patient should not