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

Recurrent Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02452307
• Other study ID #: 167/2003
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: April 14, 2015
• Last updated: August 14, 2017
• Start date: April 2004
• Est. completion date: October 2017

Study information

• Verified date: August 2017
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Recurrence
• Recurrent Prostate Cancer

Intervention

Biological:
• Peptide vaccine
subcutaneous

Drug:
• Montanide ISA-51
subcutaneous
• Granulocyte macrophage colony stimulating factor (GM-CSF)
intradermal
• Imiquimod
epicutaneous
• mRNA
subcutaneous
• Protamin
subcutaneous

Procedure:
• local hyperthermia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Tolerability	Tolerability, as measured by number of Participants with Adverse Events	Days 0-420
Secondary	Treatment response	Treatment response, from date of randomization until the date of first documented progression as measured by PSA-value	Months 0-60