Phase II, randomized, placebo-controlled study of docetaxel in combination with a mixed 20 peptides vaccine in patients with castration-resistant prostate cancer (CRPC)
- Conditions
- Castration-resistant prostate cancer
- Registration Number
- JPRN-UMIN000011028
- Lead Sponsor
- Research Center for Innovative Cancer Therapy, Kurume University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 46
Not provided
The following patients must be excluded: 1. Patients who had received chemotherapy using docetaxel any time before the treatment. 2. Patients who had received pre-therapies including chemotherapy or immunotherapy within 28 days before the treatment. 3. Patients who had received radiotherapy or strontium-89 within the last 8 weeks before the treatment. 4. Patients with severe symptoms (active and severe infectious disease, circulatory disease, respiratory disease, kidney disease, immunodeficiency, disturbance of coagulation). 5. Patients with active multiple cancers 6. Patients with the past history of severe allergic reactions. 7. Patients who do not agree with contraception during treatment and until 70 days after treatment. 8. Patients who had enrolled in another trial within 3 months or who are treating in another trial. 9. Patients who had received any peptides consist of a mixed 20 peptides (KRM-20). 10. Patients who are difficult to participate in this trial because of psychiatric symptoms. 11. 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 Rates of serum Prostate-specific antigen (PSA) level declines of in treatment patients
- Secondary Outcome Measures
Name Time Method 1. Progression-free survival (RECIST and PSA response) 2. Immune response 3. 1 year Progression-free survival (RESIST and PSA response) 4. Overall survival 5. Adverse effects