Vaccine Therapy in Curative Resected Prostate Cancer Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 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: October 17, 2014
Last verified: October 2014
  Purpose

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).


Condition Intervention Phase
Prostate Cancer
Biological: Dendritic cell vaccine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

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 [ Time Frame: From date of vaccination until the date of first documented treatment failure, assessed up to 8 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and toxicity of vaccination. Evaluation of immunological response. [ Time Frame: Up to 8 years after vaccination ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • 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


Estimated Enrollment: 30
Study Start Date: September 2010
Estimated Study Completion Date: September 2023
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DC-vaccine Biological: Dendritic cell vaccine
Autologous Dendritic Cells Loaded With mRNA From Primary Prostate Cancer Tissue, hTERT and Survivin

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01197625

Contacts
Contact: Svein Dueland, MD PhD 004722934000 svein.dueland@radiumhospitalet.no

Locations
Norway
The Norwegian Radium Hospital, Department of Clinical Cancer Research Recruiting
Oslo, Norway
Contact: Svein Dueland, MD PhD    004722934000    svein.dueland@radiumhospitalet.no   
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Svein Dueland, M.D PhD Oslo University Hospital - Norwegian Radium Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Svein Dueland, MD PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01197625     History of Changes
Other Study ID Numbers: DC-005
Study First Received: September 7, 2010
Last Updated: October 17, 2014
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by Oslo University Hospital:
Vaccination treatment, dendritic cells

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 21, 2014