A randomized clinical trial of personalized peptide vaccination with oral low-dose metronomic cyclophosphamide for metastatic castration-resistant prostate cancer (CRPC)

A randomized clinical trial of personalized peptide vaccination with oral low-dose metronomic cyclophosphamide for metastatic castration-resistant prostate cancer (CRPC) - Personalized peptide vaccination with metronomic cyclophosphamide for metastatic CRPC

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005329

Enrollment

Registered

2011-04-01

Start date

2011-04-01

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

Castration-resistant prostate cancer

Interventions

A: Personalized peptide vaccination with oral metronomic cyclophosphamide treatment Select peptide candidates (up to 4), to which peptide-specific IgGs are detected before vaccination, and administer

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: The subjects must satisfy the following conditions. 1) Patients must be diagnosed as prostate cancer pathologically at the initial treatment. The patients must be suffering from metastatic castration-resistant prostate cancer after standard treatment. 2) Patients must be positive for HLA-A2, HLA-A24 or HLA-A3 super type. 3) Patients must have IgG reactive to at least two of 31 peptide candidates. 4) Patients must be at a score level of 0-1 of performance status (PS) (ECOG). 5) Patients must be expected to survive more than 3 months. 6) Patients must satisfy the followings: WBC > 2,500/mm3 Lymphocyte > 1,000/mm3 Hb > 8.0g/dl Platelet > 100,000/mm3 Serum Creatinine < 2.5 x upper limit of normal Total Bilirubin < 2 x upper limit of normal 7) Patients must be more 20 year-old. 8) Written informed consent must be obtained from patients.

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 who are judged inappropriate for the clinical trial by doctors.

Design outcomes

Primary

Measure	Time frame
Evaluation of ability of oral metronomic cyclophosphamide with personalized peptide vaccination to deplete immuno-suppression cells.	—

Secondary

Measure	Time frame
1. Evaluation of long-term prognosis (progression free survival and overall survival). 2. Adverse effects of peptide vaccination / The safety of the protocol is evaluated based on the NCI-CTC. 3. Evaluation of immunological responses (cytotoxic T lymphocytes [CTL]and anti-peptide IgG) before and after peptide vaccination.	—

Countries

Japan

Contacts

Public ContactAkira Yamada

Kurume University School of Medicine Research Center for Innovative Cancer Therapy, Cancer Vaccine Department Division

akiymd@med.kurume-u.ac.jp0942-31-7572

Outcome results

None listed

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