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

Primary Purpose

Recurrent Prostate Cancer

Status

Unknown status

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Peptide vaccine

Montanide ISA-51

Granulocyte macrophage colony stimulating factor (GM-CSF)

Imiquimod

mRNA

Protamin

local hyperthermia

About this trial

This is an interventional treatment trial for Recurrent Prostate Cancer

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

Peptide vaccine

Peptide vaccine + GM-CSF

Peptide vaccine + local hyperthermia

Peptide vaccine + Imiquimod

Peptide vaccine + mRNA/Protamin

Arm Description

Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in 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)

Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with local hyperthermia

Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with Imiquimod

Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with mRNA/Protamin

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Tolerability

Tolerability, as measured by number of Participants with Adverse Events

Treatment response

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

Full Information

NCT ID

NCT02452307

First Posted

April 14, 2015

Last Updated

August 14, 2017

Sponsor

University Hospital Tuebingen

1. Study Identification

Unique Protocol Identification Number

NCT02452307

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Unknown status

Study Start Date

April 2004 (undefined)

Primary Completion Date

October 2017 (Anticipated)

Study Completion Date

October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital Tuebingen

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent Prostate Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Peptide vaccine

Arm Type

Experimental

Arm Description

Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51

Arm Title

Peptide vaccine + GM-CSF

Arm Type

Experimental

Arm Description

Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with Granulocyte macrophage colony stimulating factor (GM-CSF)

Arm Title

Peptide vaccine + local hyperthermia

Arm Type

Experimental

Arm Description

Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with local hyperthermia

Arm Title

Peptide vaccine + Imiquimod

Arm Type

Experimental

Arm Description

Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with Imiquimod

Arm Title

Peptide vaccine + mRNA/Protamin

Arm Type

Experimental

Arm Description

Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with mRNA/Protamin

Intervention Type

Biological

Intervention Name(s)

Peptide vaccine

Intervention Description

subcutaneous

Intervention Type

Drug

Intervention Name(s)

Montanide ISA-51

Intervention Description

subcutaneous

Intervention Type

Drug

Intervention Name(s)

Granulocyte macrophage colony stimulating factor (GM-CSF)

Intervention Description

intradermal

Intervention Type

Drug

Intervention Name(s)

Imiquimod

Intervention Description

epicutaneous

Intervention Type

Drug

Intervention Name(s)

mRNA

Intervention Description

subcutaneous

Intervention Type

Drug

Intervention Name(s)

Protamin

Intervention Description

subcutaneous

Intervention Type

Procedure

Intervention Name(s)

local hyperthermia

Primary Outcome Measure Information:

Title

Change from Baseline in Immune Response at day 70

Description

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 Outcome Measure Information:

Title

Tolerability

Description

Tolerability, as measured by number of Participants with Adverse Events

Time Frame

Days 0-420

Title

Treatment response

Description

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

Time Frame

Months 0-60

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Arnulf Stenzl, Prof.

Organizational Affiliation

Department of Urology, University of Tuebingen

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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