Vaccine Therapy in Curative Resected Prostate Cancer Patients

NCT01197625 | Unknown Phase 1

• 1 other identifier: DC-005
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Prostate Cancer

Keywords

Vaccination treatment, dendritic cells

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety and toxicity of vaccination. Evaluation of immunological response.

  Up to 8 years after vaccination

Other Outcomes (2)

• 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

• 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

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

Study Arms (1)

DC-vaccine

EXPERIMENTAL

Biological: Dendritic cell vaccine

Interventions

Dendritic cell vaccine BIOLOGICAL

Autologous Dendritic Cells Loaded With mRNA From Primary Prostate Cancer Tissue, hTERT and Survivin

DC-vaccine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

The Norwegian Radium Hospital, Department of Clinical Cancer Research

Oslo, Norway

Location

Related Links

• Hospital's website

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Knut HB Smeland, M.D PhD

  Oslo University Hospital - Norwegian Radium Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: September 7, 2010
• First Posted: September 9, 2010
• Study Start: September 1, 2010
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2025
• Last Updated: September 27, 2022

Record last verified: 2022-09

Locations

NO (1)