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

Prospective Randomized Trial of Peptide-specific Vaccination in HLA-A*02 Positive Prostate Carcinoma Patients With Biochemical Recurrence After Radical Prostatectomy

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.

Study Overview

• Status: Unknown
• Conditions: Recurrent Prostate Cancer
• Intervention / Treatment: Biological: Peptide vaccine; Drug: Montanide ISA-51; Drug: Granulocyte macrophage colony stimulating factor (GM-CSF); Procedure: local hyperthermia; Drug: Imiquimod; Drug: mRNA; Drug: Protamin

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Peptide vaccine; Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51	Biological: Peptide vaccine; subcutaneous; Drug: Montanide ISA-51; subcutaneous
EXPERIMENTAL: Peptide vaccine + GM-CSF; Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with Granulocyte macrophage colony stimulating factor (GM-CSF)	Biological: Peptide vaccine; subcutaneous; Drug: Montanide ISA-51; subcutaneous; Drug: Granulocyte macrophage colony stimulating factor (GM-CSF); intradermal
EXPERIMENTAL: Peptide vaccine + local hyperthermia; Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with local hyperthermia	Biological: Peptide vaccine; subcutaneous; Drug: Montanide ISA-51; subcutaneous; Procedure: local hyperthermia
EXPERIMENTAL: Peptide vaccine + Imiquimod; Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with Imiquimod	Biological: Peptide vaccine; subcutaneous; Drug: Montanide ISA-51; subcutaneous; Drug: Imiquimod; epicutaneous
EXPERIMENTAL: Peptide vaccine + mRNA/Protamin; Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with mRNA/Protamin	Biological: Peptide vaccine; subcutaneous; Drug: Montanide ISA-51; subcutaneous; Drug: mRNA; subcutaneous; Drug: Protamin; subcutaneous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Days 0-70

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerability	Tolerability, as measured by number of Participants with Adverse Events	Days 0-420
Treatment response	Treatment response, from date of randomization until the date of first documented progression as measured by PSA-value	Months 0-60

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Investigators: Principal Investigator: Arnulf Stenzl, Prof., Department of Urology, University of Tuebingen

Study record dates

Study Major Dates

• Study Start: April 1, 2004
• Primary Completion (ANTICIPATED): October 1, 2017
• Study Completion (ANTICIPATED): October 1, 2017

Study Registration Dates

• First Submitted: April 14, 2015
• First Submitted That Met QC Criteria: May 19, 2015
• First Posted (ESTIMATE): May 22, 2015

Study Record Updates

• Last Update Posted (ACTUAL): August 17, 2017
• Last Update Submitted That Met QC Criteria: August 14, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Immunologic Factors; Adjuvants, Immunologic; Coagulants; Interferon Inducers; Heparin Antagonists; Imiquimod; Sargramostim; Monatide (IMS 3015); Molgramostim; Protamines
• Other Study ID Numbers: 167/2003