Phase II clinical trial of personalized peptide vaccination for hormone refractory prostate cancer patients

Phase II clinical trial of personalized peptide vaccination for hormone refractory prostate cancer patients - Peptide vaccination for hormone refractory prostate cancer patients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001850

Enrollment

100

Registered

2009-04-10

Start date

2009-04-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Prostate cancer

Interventions

(1st treatment: total 6 times, every weeks) Day 1: Select peptide candidates (up to 4), to which peptide-specific IgGs are detected before vaccination, and administer peptides that showed the highe

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: The subjects must satisfy the following conditions. 1) Patients must be diagnosed as prostate cancer pathologically. The patients must be suffering from hormone-refractory prostate cancer after the treatment of castration, LH-RH analogue therapy, anti-androgen therapy, or female hormone therapy. 2) Patients must be at a score level of 0-1 of performance status (PS)(EOCG) 3) Patients must have IgG reactive to at least two of candidate peptides. 4) Patients must be expected to survive more than 3 months. 5) Patients must satisfy the followings: WBC > 2,500/mm3 Lymphocyte > 1,000/mm3 Hb > 8.0g/dl Platelet > 80,000/mm3 Serum Creatinine < 2.5 x upper limit of normal Total Bilirubin < 2 x upper limit of normal 6) Patients must be more 20 year-old. 7) Written informed consent must be obtained from patients. 8) Patients must be positive for HLA-A2, HLA-A24, HLA-A26. or HLA-A3 super type.

Exclusion criteria

Exclusion criteria: The following patients must be excluded: 1) Patients with severe symptoms (active and severe infectious disease, circulatory disease, respiratory disease, kidney disease, immunodeficiency, disturbance of coagulation). 2) Patients with the past history of severe allergic reactions. 3) Patients do not accept contraception during the 1st vaccination to 70 days after the last vaccination. 4) Patients who are judged inappropriate for the clinical trial by doctors.

Design outcomes

Primary

Measure	Time frame
Evaluation of immunological responses (anti-peptide IgG) before and after peptide vaccination.	—

Secondary

Measure	Time frame
1. Evaluation of long-term prognosis (progression free survival and total survival). 2. Adverse effects of peptide vaccination with estramustine / safety of the protocol is evaluated based on the NCI-CTC.	—

Countries

Japan

Contacts

Public ContactAkira Yamada

Kurume University Research Center for Innovative Cancer Therapy, Cancer Vaccine Development Division

akiymd@med.kurume-u.ac.jp0942-31-7744

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026