vaccine therapy in curative resected prostate cancer patients

Conditions: Prostate Cancer

Summary: in this study the investigators will include patients with high risk of psa relapse scheduled to receive curative surgical treatment. this include patients with high gleason score (9-10) or micrometastatic disease (tumor cells detected in specimens obtained from bone marrow). they are scheduled for regular follow-ups with psa measurements. we have previously published that some patients with metastatic prostate cancer may respond to dc-vaccination with tumor mrna, with a decrease in psa. psa response is related to immunological response. patients receiving dc-vaccination may have a reduced risk of psa relapse or increased time to psa relapse. previous experience with different dc-vaccine protocols in our hospital has resulted in only minor side-effects (grade 1-2 fever, rubor, fatigue, local swelling or pain).


Eligibility criteria:
inclusion criteria: * 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 national/local regulations. exclusion criteria: * 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 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. * 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 participate.

Keywords: vaccination treatment, dendritic cells