Bcl-XL_42-CAF09b Vaccination for Patients With Prostate Cancer With Lymph Node Metastases

Inclusion Criteria:

1. Age ≥ 18 years
2. Histologically Verified Adenocarcinoma Prostatae
3. Diagnostic and / or histologically verified lymph node metastases
4. ECOG Performance Status ≤2
5. Primary anti-androgen treatment started
6. Adequate haematological, renal and hepatic function:

   1. Neutrophil granulocytes ≥ 1.5 x 109 / l
   2. Platelet counts ≥ 100 x 109 / l
   3. hemoglobin ≥ 5.6 mmol / l
   4. Serum creatinine ≤ 1.5 times upper normal limit
   5. AST or ALAT ≤ 2.5 times upper normal limit
   6. serum bilirubin ≤ 1.5 times upper normal limit
   7. Alkaline phosphatase ≤ 2.5 times upper normal limit
   8. INR \<1.5 / PP \<40

Exclusion Criteria:

1. Verified bone or visceral metastases
2. Serious allergy or previous anaphylactic reactions
3. Known hypersensitivity to any of the active substances or to any of the excipients.
4. Other malignant disease within the last three years, rendering planocellular and basocellular skin carcinoma
5. Known infection with HIV, hepatitis B and C virus, regardless of whether the infection is kept calm with medical treatment
6. Severe medical disorder, severe asthma, severe COPD, poorly regulated cardiovascular disease or diabetes
7. Active autoimmune disease, e.g. autoimmune neutropenia / thrombocytopenia or hemolytic anemia, systemic lupus erythematosus, scleroderma, myasthenia gravis, goodpasture syndrome, Addison's disease, Hashimoto's thyroiditis, active grave disease, morbus chrohn or ulcerative colitis
8. Major gastrointestinal surgical procedures within the last 3 months
9. Previous treatment with other cancer vaccine
10. Concomitant immunosuppressive treatment including prednisolone and methotrexate
11. Ongoing anticoagulant treatment (treatment with acetylsalicylic acid and clopidogrel is allowed)
12. Psychiatric disease which, according to the investigator's discretion, may affect compliance
13. Co-administration with other experimental drugs.