Back to resultsVaccine Therapy in Curative Resected Prostate Cancer Patients
Primary Purpose
Prostate Cancer
Status
Active
Phase
Phase 1
Locations
Norway
Study Type
Interventional
Intervention
Dendritic cell vaccine
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Vaccination treatment, dendritic cells
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.
Sites / Locations
- The Norwegian Radium Hospital, Department of Clinical Cancer Research
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DC-vaccine
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Safety and toxicity of vaccination. Evaluation of immunological response.
Full Information
NCT ID
NCT01197625
First Posted
September 7, 2010
Last Updated
September 25, 2022
Sponsor
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01197625
Brief Title
Vaccine Therapy in Curative Resected Prostate Cancer Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Vaccination treatment, dendritic cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DC-vaccine
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Dendritic cell vaccine
Intervention Description
Autologous Dendritic Cells Loaded With mRNA From Primary Prostate Cancer Tissue, hTERT and Survivin
Primary Outcome Measure Information:
Title
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
Time Frame
From date of vaccination until the date of first documented treatment failure, assessed up to 8 years
Secondary Outcome Measure Information:
Title
Safety and toxicity of vaccination. Evaluation of immunological response.
Time Frame
Up to 8 years after vaccination
Other Pre-specified Outcome Measures:
Title
Efficacy Outcome Measure Efficacy Outcome Measure Percentage of patients with a second positive bone marrow examination at the End of Treatment
Time Frame
Up to 36 month
Title
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
Description
Pathological stage pT2 - pT3b and Gleason score 7B-8, pN0, pN+ or pNx. Negative bone marrow examination
Time Frame
From date of vaccination until the date of first documented treatment failure, assessed up to 8 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Knut HB Smeland, M.D PhD
Organizational Affiliation
Oslo University Hospital - Norwegian Radium Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Norwegian Radium Hospital, Department of Clinical Cancer Research
City
Oslo
Country
Norway
12. IPD Sharing Statement
Links:
URL
https://oslo-universitetssykehus.no
Description
Hospital's website
Learn more about this trial
Vaccine Therapy in Curative Resected Prostate Cancer Patients
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