Vaccine Therapy in Curative Resected Prostate Cancer Patients

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01197625
• Other study ID #: DC-005
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: September 2010
• Est. completion date: September 2025

Study information

• Verified date: September 2022
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: September 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Biological:
• Dendritic cell vaccine
Autologous Dendritic Cells Loaded With mRNA From Primary Prostate Cancer Tissue, hTERT and Survivin

Locations

Country	Name	City	State
Norway	The Norwegian Radium Hospital, Department of Clinical Cancer Research	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Efficacy Outcome Measure Efficacy Outcome Measure Percentage of patients with a second positive bone marrow examination at the End of Treatment		Up to 36 month
Other	Time to PSA levels > 0.5 µg/L defined by two different measurement of PSA levels > 0.5 µg/L with minimum of 4 weeks interval in patients included by signing the informed concent form, but not receiving treatment	Pathological stage pT2 - pT3b and Gleason score 7B-8, pN0, pN+ or pNx. Negative bone marrow examination	From date of vaccination until the date of first documented treatment failure, assessed up to 8 years
Primary	Time to treatment failure defined by two different measurement of PSA levels >0.5 µg/L with minimum of 4 weeks interval in patients receiving treatment		From date of vaccination until the date of first documented treatment failure, assessed up to 8 years
Secondary	Safety and toxicity of vaccination. Evaluation of immunological response.		Up to 8 years after vaccination

External Links

•   Hospital's website