Patients with advanced oligometastatic prostate cancer (PCa) without lung and/or liver metastases who are eligible to Complete Androgen Blockade therapy (GnRH-agonist combined with anti-androgen). MedDRA version: 14.1 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: LLT Classification code 10071119 Term: Hormone-dependent prostate cancer System O
Conditions
Interventions
Sponsors
Oslo University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • Patients with advanced oligometastatic prostate cancer (PCa) without lung and/or liver metastases who are eligible to Complete Androgen Blockade (GnRH-agonist combined with anti-androgen) • Patients already on GnRH-agonist must have a history sPSA = 1.5 x 109/L - Platelets >= 100 x 109/L - Hemoglobin >= 9g/dL (>=5.6 mmol/L) - Creatinine = 2.5 g/L - Normal NSE - sPSA =65 years) yes F.1.3.1 Number of subjects for this age range 16
Exclusion criteria
Exclusion criteria: • History of other prior malignancy, with the exception of curatively treated basal cell or squamous cell carcinoma of the skin, cervical cancer stage IB or effectively treated malignancy that has been in remission for over 5 years and is highly likely to have been cured. • Treatment with any other investigational medicinal product (IMP) within 4 weeks prior to first administration of study drug. • Adverse reactions to vaccines such as anaphylaxis or other serious reactions. • History of immunodeficiency or autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, sclerodermia, polymyositis-dermatomyositis, juvenile onset insulin-dependent diabetes, or a vasculitic syndrome. • Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia. • Active infection requiring antibiotic therapy. • Known sensitivity to any of the components of the vaccine • Known hypersensitivity to Leukine®, yeast derived products or any component of the product • Patients who test positive for hepatitis B, C or HIV. • Any other anti-tumor treatment (including chemotherapy, immunotherapy, cytokines, interferons, protease inhibitors and gene therapy) administered with the exception of GnRH-agonist with or without bicalutamide started up to 6 months prior inclusion. • Use of not permitted concomitant medication: - chronic corticosteroids except for asthma inhalers / topical use - any alternative and complementary drugs. • Any reason why, in the opinion of the investigator, the patient should not participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Immunological response to UV1 vaccine and assessment of safety and tolerability of UV1. ;Secondary Objective: Selection of biological dose of peptides for further clinical trials and assessment. ;Primary end point(s): - Frequency and severity of adverse events and serious adverse events. The NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE) will be used. Changes in laboratory values, vital signs and ECOG performance status will also be assessed. - Number of T-cell responses including time to T-cell responses (up to 6 months), level of response and duration of response. ;Timepoint(s) of evaluation of this end point: - Safety profile will be evaluated at each visit. Patient will come during week 1, 2, 3, 4, 6, 8, 10, every 4 weeks until week 26. FU will be done at 3 months post vaccination. -T cell response will be measured at baseline, during vaccination (every 4 weeks starting at week 2), end of treatment and at the end of the 3 months follow up period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Safety profile and immunological responses of each dose level. ;Timepoint(s) of evaluation of this end point: -Safety profile and immunological responses of each dose level will be evaluated when patients have completed 6 months of vaccinations and have been followed up for at least a further 3 months. | — |
Countries
Norway
Contacts
Public ContactWolfgang Lilleby
Oslo University Hospital
Outcome results
None listed