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

Phase 1

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

• Registration Number: NCT02452307
• Lead Sponsor: University Hospital Tuebingen

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2015-04-14
• Study First Submitted QC: 2015-05-19
• Study First Posted: 2015-05-22
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-14
• Last Update Posted: 2017-08-17
• Primary Completion: 2017-10
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peptide vaccine + GM-CSF	Peptide vaccine	Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with Granulocyte macrophage colony stimulating factor (GM-CSF)
Peptide vaccine + Imiquimod	Montanide ISA-51	Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with Imiquimod
Peptide vaccine + local hyperthermia	Montanide ISA-51	Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with local hyperthermia
Peptide vaccine + local hyperthermia	local hyperthermia	Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with local hyperthermia
Peptide vaccine + mRNA/Protamin	Montanide ISA-51	Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with mRNA/Protamin
Peptide vaccine	Montanide ISA-51	Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51
Peptide vaccine + GM-CSF	Granulocyte macrophage colony stimulating factor (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)
Peptide vaccine + mRNA/Protamin	Peptide vaccine	Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with mRNA/Protamin
Peptide vaccine + mRNA/Protamin	mRNA	Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with mRNA/Protamin
Peptide vaccine + mRNA/Protamin	Protamin	Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with mRNA/Protamin
Peptide vaccine	Peptide vaccine	Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51
Peptide vaccine + GM-CSF	Montanide ISA-51	Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with Granulocyte macrophage colony stimulating factor (GM-CSF)
Peptide vaccine + local hyperthermia	Peptide vaccine	Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with local hyperthermia
Peptide vaccine + Imiquimod	Peptide vaccine	Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with Imiquimod
Peptide vaccine + Imiquimod	Imiquimod	Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with Imiquimod

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Immune Response at day 70	Days 0-70	Immune Response, as measured by the change of in vitro and in vivo T cell response from baseline at day 0 to day 70

Secondary Outcome Measures

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