Castration resistant prostate cancer
Conditions
Interventions
Sponsors
Department of Urology, Osaka University Graduate School of Medicine
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. The patient who has provided a written informed consent prior to any study-related procedure. 2. The patient who is at least over 20 years and not exceeding 90 years. 3. The patient who has a histological or cytological diagnosis of adenocarcinoma of the prostate. 4. The patient who is castration resistant prostate cancer. 5. The patient who is not a candidate of standard docetaxel chemotherapy/ refractory to standard docetaxel chemotherapy according to criteria of The Prostate Cancer Clinical Trials Working Group (PCWG2), or deny to receive standard docetaxel chemotherapy. The patient who is refractory to standard docetaxel chemotherapy cannot include to this trial until 6 weeks has passed from last administration of docetaxel. 6. The patient who has PSA value less than 100ng/ml 7. The patient who has a life expectancy for at least 12 weeks or more. 8. The patient who has a ECOG Performance Status Scale of 0 or 1. 9. The patient who has injectable lesion in the prostate which can be evaluated by MRI or CT. 10. The patient who has the organs function adequately evaluated by the following lab values; WBC: equal or more than 2,000/microL PLT: equal or more than 75,000/microL Hemoglobin: equal or more than 8.0g/dL GOT: equal or less than 100IU/L GPT: equal or less than 100IU/L T-bil: equal or less than 2.5mg/dL Serum creatinine: equal or less than 2.3mg/dL
Exclusion criteria
Exclusion criteria: 1. The patient who has brain metastases. 2. The patient who shows positive immune response by HVJ-E prick test at screening. 3. The patient who has a uncontrolled serious complication such as active infection. 4. The patient who received chemotherapy/ radiotherapy, or immunotherapy within 6 weeks. 5. The patient who participated in another clinical trial of another investigational medical product within 4 weeks. 6. The patient who has history of second independent malignancy within 2 years. 7. The patient who has any active autoimmune diseases. 8. The patient who is undergoing on systemic corticosteroids except for the use of maximum 10mg/day oral prednisone over 6 months. 9. The patient who is undergoing on immunosuppressive agents. 10. The patient who has clinically relevant psychiatric disorders/ legal incapacity or limited legal capacity. 11. The patient who has a history of a transplantation of the allogeneic organ. 12. The patent who has inadequate blood property with PT and APTT more than 1.5 times of the upper limit of local reference range. 13. The patient who in inappropriate to be enrolled in this trial judged by the doctors in charge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess safety and tolerability of HVJ-E | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate induction of tumor immunitiy 2. To evaluate anti-tumor effect | — |
Countries
Japan
Contacts
Public ContactRIe Sumida
Osaka University Hospital Medical Center for Translational Research
Outcome results
None listed