Clinical trial · Interventional

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

NCT02452307CI-TRIAL-00029123unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Recurrent Prostate Cancer	Malignant Prostate Neoplasm	CURATED_BROADER	0.78

Interventions

Interventions (7)

Intervention	Type	Mapped drug	Match
Granulocyte macrophage colony stimulating factor (GM-CSF)	Drug	—	UNRESOLVED
Imiquimod	Drug	Imiquimod	ALIAS
local hyperthermia	Procedure	—	UNRESOLVED
Montanide ISA-51	Drug	—	UNRESOLVED
mRNA	Drug	—	UNRESOLVED
Peptide vaccine	Biological	—	UNRESOLVED
Protamin	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (5)

type
EXPERIMENTAL
label
Peptide vaccine
description
Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51
interventionNames
1. Biological: Peptide vaccine
2. Drug: Montanide ISA-51
type
EXPERIMENTAL
label
Peptide vaccine + GM-CSF
description
Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with Granulocyte macrophage colony stimulating factor (GM-CSF)
interventionNames
1. Biological: Peptide vaccine
2. Drug: Montanide ISA-51
3. Drug: Granulocyte macrophage colony stimulating factor (GM-CSF)
type
EXPERIMENTAL

Eligibility

Eligibility (as posted)

Sex: Male
Minimum age: 45 Years
Maximum age: 80 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.