Vaccine Therapy in Curative Resected Prostate Cancer Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Oslo University Hospital
Sponsor:
Information provided by (Responsible Party):
Svein Dueland, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01197625
First received: September 7, 2010
Last updated: April 7, 2014
Last verified: April 2014

September 7, 2010
April 7, 2014
September 2010
September 2018   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Time to treatment failure defined by two different measurement of PSA levels >0.5 µg/L with minimum of 4 weeks interval
Complete list of historical versions of study NCT01197625 on ClinicalTrials.gov Archive Site
Safety and toxicity of vaccination. Evaluation of immunological response. [ Time Frame: Up to 8 years after vaccination ] [ Designated as safety issue: Yes ]
Safety and toxicity of vaccination. Evaluation of immunological response.
  • 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 ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: From date of vaccination until the date of first documented treatment failure, assessed up to 8 years ] [ Designated as safety issue: No ]
    Pathological stage pT2 - pT3b and Gleason score 7B-8, pN0, pN+ or pNx. Negative bone marrow examination
Not Provided
 
Vaccine Therapy in Curative Resected Prostate Cancer Patients
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

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).

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Biological: Dendritic cell vaccine
Autologous Dendritic Cells Loaded With mRNA From Primary Prostate Cancer Tissue, hTERT and Survivin
Experimental: DC-vaccine
Intervention: Biological: Dendritic cell vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
September 2023
September 2018   (final data collection date for primary outcome measure)

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.
Male
18 Years to 75 Years
No
Contact: Svein Dueland, MD PhD 004722934000 svein.dueland@radiumhospitalet.no
Norway
 
NCT01197625
DC-005
No
Svein Dueland, Oslo University Hospital
Oslo University Hospital
Not Provided
Principal Investigator: Svein Dueland, M.D PhD Oslo University Hospital - Norwegian Radium Hospital
Oslo University Hospital
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP