Castration-resistant prostate cancer
Conditions
Interventions
Arm A: Patients receive mixed 20 peptides vaccine (KRM-20
20mg/0.5ml) subcutaneously (SC) on days 1, 8, 15, 22 and 29, and oral dexamethasone (1mg) once daily on days 1 - 36. Begining on day 36, patients receive docetaxel IV (70mg/m2) over 1 hour and KRM-20
Sponsors
Research Center for Innovative Cancer Therapy, Kurume University School of Medicine
Kyushu University Kitasato University Dokkyo Koshigaya Hospital Kumamoto University Kagoshima University Okayama University Kinki University Jikei University Hirosaki University
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. 2.Patients who had progressive disease after androgen deprivation therapy (ADT) either by surgical castration, gonadotropin-releasing hormone or antagonist treatment. Progression disease while receiving ADT, defined by any 1 of the following: 1) At least 2 consecutive rises in serum PSA obtained at a minimum of 1-week intervals. 2) Measurable disease with >=50% increase in the sum of the cross products of all measurable lesions, or the development of new measurable lesions by RESIST. 3) Non-measurable (bone) disease consisting of new areas of uptake by bone scan consistent with metastatic disease compared to previous imaging. 3. Patients have serum PSA level 2>= ng/mL. 4. Anti-androgen therapy is discontinued for at least 4 weeks before the first vaccination for patients receiving flutamide and 6 weeks for those receiving bicalutamide. 5. Patients continue to stay on medical treatment such as LHRH agonists of LHRH antagonists to maintain testosterone level of 0.5ng/mL. 6. Patients must be positive for HLA-A2, HLA-A24, HLA-A26 or HLA-A3 super type (A3,A11,A31,A33). 7. Written informed consent must be obtained from patients. 8. Patients must be more 20 year-old. 9. Patients must be at a score level of 0-1 of performance status (ECOG). 10. Patients must be expected to survive more than 6 months. 11. Patients must satisfy the followings: WBC >= 3,000/mm3 Neutrophil >= 2,000/mm3 Lymphocyte >= 1,000/mm3 Hb >= 8.0g/dl Platelet >= 100,000/mm3 Serum Creatinine <= 2 times upper limit of normal Total Bilirubin <= 1.5 times upper limit of normal AST, ALT <= 2 times upper limit of normal
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rates of serum Prostate-specific antigen (PSA) level declines of &#61619;&#61472;&#61493;&#61488;&#61477;&#61472;in treatment patients | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactAkira Yamada
Kurume University School of Medicine Cancer Vaccine Division of Research Center for Innovative Cancer Therapy
Outcome results
None listed