Vaccine Therapy in Curative Resected Prostate Cancer Patients

September 25, 2022 updated by: Knut Halvor Bjøro Smeland, Oslo University Hospital

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway
        • The Norwegian Radium Hospital, Department of Clinical Cancer Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DC-vaccine
Biological: Dendritic cell vaccine
Autologous Dendritic Cells Loaded With mRNA From Primary Prostate Cancer Tissue, hTERT and Survivin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
From date of vaccination until the date of first documented treatment failure, assessed up to 8 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and toxicity of vaccination. Evaluation of immunological response.
Time Frame: Up to 8 years after vaccination
Up to 8 years after vaccination

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 36 month
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Investigators

  • Principal Investigator: Knut HB Smeland, M.D PhD, Oslo University Hospital - Norwegian Radium Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Anticipated)

September 1, 2024

Study Completion (Anticipated)

September 1, 2025

Study Registration Dates

First Submitted

September 7, 2010

First Submitted That Met QC Criteria

September 8, 2010

First Posted (Estimate)

September 9, 2010

Study Record Updates

Last Update Posted (Actual)

September 27, 2022

Last Update Submitted That Met QC Criteria

September 25, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DC-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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