A phase II randomized clinical trial of personalized peptide vaccination in combination with Japanese herbal medicines for castration-resistant prostate cancer (CRPC)
- Conditions
- Castration-resistant prostate cancer
- Registration Number
- JPRN-UMIN000010290
- Lead Sponsor
- Kurume University School of medicine, Department of Immunology and Immunotherapy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 70
Not provided
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)Active double cancer (synchronous double cancer and metachronous double cancer within 5 disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) judged to have been cured with local treatment. 2) Patients with the past history of severe allergic reactions. 3) Patients who are judged inappropriate for the clinical trial by doctors. 4) Patients who do not accept contraception from the 1st vaccination until 70 days after the last vaccination. 5) Patients who are judged inappropriate for entry to this clinical trial by doctors.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of immune-enhancing effects between two groups.
- Secondary Outcome Measures
Name Time Method 1. Comparison of peptide-specific CTL responses in PBMCs between two groups. 2. Comparison of safety between two groups. 3. Comparison of overall survival between two groups .