A randomized controlled trial comparing personalized peptide vaccine plus low-dose estramustine with full dose estramustine for patients with hormone refractory prostate cancer
Phase 2
- Conditions
- Prostate cancer
- Registration Number
- JPRN-UMIN000001096
- Lead Sponsor
- Kurume University School of medicine, Department of Immunology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 80
Inclusion Criteria
Not provided
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 multiple cancers 3) Patients with the past history of severe allergic reactions. Patients who are judged inappropriate for the clinical trial by doctors.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival
- Secondary Outcome Measures
Name Time Method 1.adverse events 2.overall survival 3.Subjective effects (pain due to metastatic lesion, symptoms based on urinary disturbance due to primary lesion, PS, progression of cancer / change of body weight according to improvement) and evaluation of quality of life based on FACT examination sheet. 4.Evaluation of immunological responses (cytotoxic T lymphocytes (CTL), CTL precursors, anti-peptide IgG) before and after peptide vaccination.