Informed Consent
Item
1. patients providing a written informed consent by voluntary agreement.
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. age 20 =< and =<85 years old at the time of informed consent
boolean
C0001779 (UMLS CUI [1])
Malignant Neoplasm
Item
3. have a diagnosis of malignant tumor as confirmed by histology or cytology.
boolean
C0006826 (UMLS CUI [1])
Castration-Resistant Prostatic Cancer Recurrence
Item
4. have a diagnosis of recurrence of castration resistant prostate cancer and meet the following condition
boolean
C3658266 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
Standard therapy Inappropriate | Standard therapy ineffective | Standard therapy Refused
Item
inapplicable to the standard treatment, ineffective through the criteria of the prostate cancer clinical trials working group (pcwg2) or refuse the standard treatment
boolean
C2936643 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C2936643 (UMLS CUI [2,1])
C3242229 (UMLS CUI [2,2])
C2936643 (UMLS CUI [3,1])
C1705116 (UMLS CUI [3,2])
Standard therapy ineffective | Time Interval Standard therapy Study Registration Date
Item
more than 6 week between the end date of the standard treatment and the registration date when the standard treatment has been ineffective
boolean
C2936643 (UMLS CUI [1,1])
C3242229 (UMLS CUI [1,2])
C0872291 (UMLS CUI [2,1])
C2936643 (UMLS CUI [2,2])
C2985881 (UMLS CUI [2,3])
Prostate specific antigen measurement
Item
5. serum psa <100 ng/ml at the screening visit
boolean
C0201544 (UMLS CUI [1])
Life Expectancy
Item
6. expected survival period is more than 8 weeks after planned start date of investigational product
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
7. ecog performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
Intraprostatic injection Possible Lesion
Item
8. have an injectable intraprostatic lesion confirmed by histologic examination
boolean
C1555364 (UMLS CUI [1,1])
C0332149 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,3])
Bone Marrow function | Liver function | Renal function | White Blood Cell Count procedure | Neutrophil count | Platelet Count measurement | Hemoglobin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement | Creatinine measurement, serum
Item
9. the marrow function, liver function and the kidney function must be kept as follows at the screening visit (1) leukocyte >= 3,000/mcl (2) neutrophil >=1,500/mcl (3) platelet >=75,000/mcl (4) hemoglobin >=8.0 g/dl. (5) ast =<100 iu/l (6) alt =<100 iu/l (7) total bilirubin =<2.5 mg/dl (8) serum creatinine =<2.5 mg/dl
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
C0023508 (UMLS CUI [4])
C0200633 (UMLS CUI [5])
C0032181 (UMLS CUI [6])
C0518015 (UMLS CUI [7])
C0201899 (UMLS CUI [8])
C0201836 (UMLS CUI [9])
C1278039 (UMLS CUI [10])
C0201976 (UMLS CUI [11])
Metastatic malignant neoplasm to brain Multiple
Item
1. have multiple brain metastases
boolean
C0220650 (UMLS CUI [1,1])
C0439064 (UMLS CUI [1,2])
Other Coding | Skin prick test
Item
2. positive result of the prick test of gen0101
boolean
C3846158 (UMLS CUI [1])
C0430561 (UMLS CUI [2])
Complications Serious | Communicable Disease Uncontrolled
Item
3. have serious complications such as uncontrolled active infection
boolean
C0009566 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Systemic Chemotherapy | Systemic Radiation Therapy | Immunotherapy Systemic | Exception Hormone Therapy | Exception Estramustine | Exception Enzalutamide | Exception Abiraterone | Exception Diphosphonates | Other Coding
Item
4. received systemic chemotherapy, radiotherapy or immunotherapy within 6 weeks before the planned registration date however the hormone therapy except for the estramustine, enzalutamide and abiraterone, bisphosphonate and anti-rankl antigen antibody is are not included in the systemic chemotherapy.
boolean
C1883256 (UMLS CUI [1])
C2985381 (UMLS CUI [2])
C0021083 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0279025 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0014921 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C3496793 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C0754011 (UMLS CUI [7,2])
C1705847 (UMLS CUI [8,1])
C0012544 (UMLS CUI [8,2])
C3846158 (UMLS CUI [9])
Investigational New Drugs
Item
5. received another investigational medical product within 4 weeks before the informed concent
boolean
C0013230 (UMLS CUI [1])
Cancer Other | Exception Relapse Free Duration | Exception Neoplasm Metastasis Free Duration
Item
6. had a history of malignancy other than prostate cancer, except for the relapse-free and metastasis-free for more than 5 years after the last treatment at the registration
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0035020 (UMLS CUI [2,2])
C0332296 (UMLS CUI [2,3])
C0449238 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0027627 (UMLS CUI [3,2])
C0332296 (UMLS CUI [3,3])
C0449238 (UMLS CUI [3,4])
Autoimmune Disease
Item
7. have an active autoimmune disease
boolean
C0004364 (UMLS CUI [1])
Glucocorticoids, Systemic | Exception Administration Low dose Long-term
Item
8. receiving systemic administration of glucocorticosteroid which restrains immunity response, except for the administration for a long period (over 6 months) of the low dose (equivalent to under 10 mg/day oral prednisolone).
boolean
C3540777 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1533734 (UMLS CUI [2,2])
C0445550 (UMLS CUI [2,3])
C0443252 (UMLS CUI [2,4])
Organ Transplantation Autologous | Organ Transplantation Homogeneous | Tissue Transplantation Autologous | Tissue Transplantation Homogeneous | Receiving Immunosuppressive Agents
Item
9. had a history of the autologous or homogeneous organ or tissue transplantation (receiving immunosuppressive medication)
boolean
C0029216 (UMLS CUI [1,1])
C0439859 (UMLS CUI [1,2])
C0029216 (UMLS CUI [2,1])
C1881065 (UMLS CUI [2,2])
C0080232 (UMLS CUI [3,1])
C0439859 (UMLS CUI [3,2])
C0080232 (UMLS CUI [4,1])
C1881065 (UMLS CUI [4,2])
C1514756 (UMLS CUI [5,1])
C0021081 (UMLS CUI [5,2])
Prothrombin time assay | Partial thromboplastin time increased
Item
10. pt(%) less than 10% of the lower limit of normal or aptt more than 1.5 times of the upper limit of normal of local reference range at the screening visit
boolean
C0033707 (UMLS CUI [1])
C0240671 (UMLS CUI [2])
Hepatitis B surface antigen positive | Hepatitis C antibody positive | HIV Seropositivity
Item
11. positive result of the hepatitis b surface antigen, hcv antibody or hiv test at the screening visit
boolean
C0149709 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
Study Subject Participation Status Inappropriate
Item
12. inappropriate to be enrolled in this study judged by the investigators
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])