NCT02452307

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2004

Longer than P75 for phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
11 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 22, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

August 17, 2017

Status Verified

August 1, 2017

Enrollment Period

13.5 years

First QC Date

April 14, 2015

Last Update Submit

August 14, 2017

Conditions

Recurrent Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Tolerability

    Days 0-420

  • Treatment response

    Months 0-60

Study Arms (5)

Peptide vaccine

EXPERIMENTAL

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

Biological: Peptide vaccineDrug: Montanide ISA-51

Peptide vaccine + GM-CSF

EXPERIMENTAL

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 vaccineDrug: Montanide ISA-51Drug: Granulocyte macrophage colony stimulating factor (GM-CSF)

Peptide vaccine + local hyperthermia

EXPERIMENTAL

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

Biological: Peptide vaccineDrug: Montanide ISA-51Procedure: local hyperthermia

Peptide vaccine + Imiquimod

EXPERIMENTAL

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

Biological: Peptide vaccineDrug: Montanide ISA-51Drug: Imiquimod

Peptide vaccine + mRNA/Protamin

EXPERIMENTAL

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

Biological: Peptide vaccineDrug: Montanide ISA-51Drug: mRNADrug: Protamin

Interventions

Peptide vaccineBIOLOGICAL

subcutaneous

Peptide vaccinePeptide vaccine + GM-CSFPeptide vaccine + ImiquimodPeptide vaccine + local hyperthermiaPeptide vaccine + mRNA/Protamin
Montanide ISA-51DRUG

subcutaneous

Peptide vaccinePeptide vaccine + GM-CSFPeptide vaccine + ImiquimodPeptide vaccine + local hyperthermiaPeptide vaccine + mRNA/Protamin
Granulocyte macrophage colony stimulating factor (GM-CSF)DRUG

intradermal

Peptide vaccine + GM-CSF
ImiquimodDRUG

epicutaneous

Peptide vaccine + Imiquimod
mRNADRUG

subcutaneous

Peptide vaccine + mRNA/Protamin
ProtaminDRUG

subcutaneous

Peptide vaccine + mRNA/Protamin
local hyperthermiaPROCEDURE
Peptide vaccine + local hyperthermia

Eligibility Criteria

Age45 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Protein Subunit Vaccinesmontanide ISA 51Granulocyte-Macrophage Colony-Stimulating FactorImiquimodRNA, Messengersomatostatin, protamine zinc-Hyperthermia, Induced

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Vaccines, AcellularVaccines, SubunitVaccinesBiological ProductsComplex MixturesColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsAminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsRNANucleic AcidsNucleic Acids, Nucleotides, and NucleosidesTherapeutics

Study Officials

  • Arnulf Stenzl, Prof.

    Department of Urology, University of Tuebingen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2015

First Posted

May 22, 2015

Study Start

April 1, 2004

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

August 17, 2017

Record last verified: 2017-08