Peptide-specific Vaccination in HLA-A*02 Positive Patients With Biochemical Recurrence After Radical Prostatectomy

University Hospital Tuebingen36 enrolled

Overview

The study evaluates the prostate-specific antigen (PSA) response in HLA-A\*02 positive patients with biochemical recurrence after radical prostatectomy treated with a prostate-specific peptide vaccine in combination with different immune-adjuvants.

Patients with a biochemical recurrence after initial therapy can be included.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Recurrent Prostate Cancer

Interventions

Peptide vaccineBIOLOGICAL

subcutaneous

Montanide ISA-51DRUG

subcutaneous

Granulocyte macrophage colony stimulating factor (GM-CSF)DRUG

intradermal

Eligibility

Sex: MALEMin age: 45 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * biochemical recurrence after Radical Prostatectomy * no clinical metastases in CT or bone scan * HLA-Type: HLA-A\*02 positive * Karnofsky-Performance-Index \>70 * Age \>45 / \<80 years * no prior or ongoing hormonal therapy * no ongoing radiation therapy * Serum-Creatinine \<2mg/dl; Bilirubin: \<2gm/dl * no history of allergy or chronic obstructive lung disease (COLD) Exclusion Criteria: * Patients unable to consent * Karnofsky-Performance-Index \<70 * known allergy or COLD * presence of secondary malignancy * prior or ongoing hormonal treatment * ongoing radiotherapy * immunosuppressive medication * seizure

Outcomes

Primary Outcomes

Change from Baseline in Immune Response at day 70

Immune Response, as measured by the change of in vitro and in vivo T cell response from baseline at day 0 to day 70

Time frame: Days 0-70

Secondary Outcomes

Tolerability

Tolerability, as measured by number of Participants with Adverse Events

Time frame: Days 0-420

Treatment response

Treatment response, from date of randomization until the date of first documented progression as measured by PSA-value

Time frame: Months 0-60

Data from ClinicalTrials.gov

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