Status:
UNKNOWN
Vaccine Therapy in Curative Resected Prostate Cancer Patients
Lead Sponsor:
Oslo University Hospital
Conditions:
Prostate Cancer
Eligibility:
MALE
18-75 years
Phase:
PHASE1
PHASE2
Brief 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 micrometas...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01197625
Start Date
September 1 2010
End Date
September 1 2025
Last Update
September 27 2022
Active Locations (1)
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1
The Norwegian Radium Hospital, Department of Clinical Cancer Research
Oslo, Norway