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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

Status
UNKNOWN
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02452307
Enrollment
36
Registered
2015-05-22
Start date
2004-04-30
Completion date
2017-10-31
Last updated
2017-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Prostate Cancer

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.

Interventions

BIOLOGICALPeptide vaccine

subcutaneous

DRUGMontanide ISA-51

subcutaneous

DRUGGranulocyte macrophage colony stimulating factor (GM-CSF)

intradermal

DRUGImiquimod

epicutaneous

DRUGmRNA

subcutaneous

DRUGProtamin

subcutaneous

PROCEDURElocal hyperthermia

Sponsors

University Hospital Tuebingen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
45 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
TolerabilityDays 0-420Tolerability, as measured by number of Participants with Adverse Events
Treatment responseMonths 0-60Treatment response, from date of randomization until the date of first documented progression as measured by PSA-value

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026