Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Oslo University Hospital
Age
18–75
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Vaccine Therapy in Curative Resected Prostate Cancer Patients
